Ketesse

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ketesse 25 mg film-coated tablets

Dexketoprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What Ketesse is and what it is used for
2. What you need to know before taking Ketesse
3. How to take Ketesse
4. Possible side effects
5. How to store Ketesse
6. Contents of the pack and other information

1. What Ketesse is and what it is used for

Ketesse is a pain-relieving medicine belonging to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used to treat mild to moderate pain, such as muscle pain, painful menstruation (dysmenorrhoea), and toothache.

2. What you need to know before taking Ketesse

Do not take Ketesse:
If you are allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in
section 6);
If you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs);
If you have asthma or have previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation
of the nasal mucosa), nasal polyps (polypoid masses in the nose due to allergy), urticaria (skin rash),
angioedema (swelling of the face, eyes, lips, or tongue, or breathing difficulties) after taking
acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
If you have previously experienced photoallergic or phototoxic reactions (a particular type of skin redness and/or blistering following exposure to sunlight) during treatment with ketoprofen (a non-steroidal anti-inflammatory drug) or with fibrates (medicines used to reduce blood fat levels);
If you suffer from a peptic ulcer/bleeding of the stomach or intestine, or if you have previously experienced stomach or intestinal bleeding, ulceration, or perforation;
If you suffer from chronic digestive problems (e.g. indigestion, heartburn);
If you have previously experienced stomach or intestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) taken for pain;
If you suffer from inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
If you have severe heart failure, or moderate to severe kidney impairment, or serious liver problems;
If you have bleeding disorders or coagulation problems;
If you are severely dehydrated (have lost a large amount of body fluids) due to vomiting, diarrhoea, or insufficient fluid intake;
If you are in the third trimester of pregnancy or are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketesse:
If you suffer from allergies, or have previously experienced allergic reactions;
If you have kidney, liver, or heart problems (hypertension and/or heart failure), or fluid retention, or have previously suffered from any of these conditions;
If you are taking diuretics or have very poor hydration or reduced blood volume due to excessive fluid loss (e.g. from excessive urination, diarrhoea, vomiting);
If you have heart conditions, have had a stroke, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or are a smoker); you should discuss treatment with your doctor or pharmacist; medicines such as Ketesse may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. These risks are more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
If you are elderly: you may be more likely to experience side effects (see section 4). If side effects occur, consult your doctor immediately;
If you are a woman with fertility problems (Ketesse may reduce fertility; therefore, you should not take this medicine if you are planning a pregnancy or undergoing fertility investigations);
If you suffer from blood and blood cell formation disorders;
If you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
If you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
If you currently have or have previously had other stomach or intestinal disorders;
If you have chickenpox, as NSAIDs may exceptionally worsen the infection;
If you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral corticosteroids, certain antidepressants (SSRIs, i.e. Selective Serotonin Reuptake Inhibitors), medicines that prevent blood clotting such as acetylsalicylic acid or anticoagulants like warfarin. In such cases, consult your doctor before taking Ketesse: your doctor may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other medicines that block gastric acid production);
If you suffer from asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyposis, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in individuals allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents
Ketesse has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and the product must not be used in children and adolescents.

Other medicines and Ketesse
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Some medicines cannot be used in combination, while others require dosage adjustments when taken together.
Always inform your doctor, dentist, or pharmacist if you are using or are being given any of the following medicines in addition to Ketesse:

Combinations not recommended:
Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs
Warfarin, heparin, or other medicines used to prevent blood clotting
Lithium, used to treat certain mood disorders
Methotrexate (anti-cancer or immunosuppressive medicine), used at doses higher than 15 mg/week
Phenytoin and phenytoin, used for epilepsy
Sulfamethoxazole, used for bacterial infections

Combinations requiring caution:
ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure and heart conditions
Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers
Zidovudine, used in the treatment of viral infections
Aminoglycoside antibiotics, used to treat bacterial infections
Sulfonylureas (e.g. chlorpropamide and glibenclamide), used for diabetes
Methotrexate, used at low doses, less than 15 mg/week

Combinations requiring careful evaluation:
Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin), used for bacterial infections
Cyclosporine or tacrolimus, used to treat immune system disorders and in organ transplants
Streptokinase and other thrombolytics or fibrinolytic medicines, i.e. medicines used to dissolve blood clots
Probenecid, used for gout
Digoxin, used in the treatment of chronic heart failure
Mifepristone, used as an abortifacient (to terminate a pregnancy)
Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants
Antiplatelet agents used to reduce platelet aggregation and blood clot formation
Beta-blockers, used for high blood pressure and heart problems
Tenofovir, deferasirox, pemetrexed.

If you have any doubts about taking other medicines in combination with Ketesse, consult your doctor or pharmacist.

Ketesse with food and drink
Take the tablets with an adequate amount of water and with food, as this helps reduce the risk of gastrointestinal side effects. However, in case of severe pain, take the tablets on an empty stomach, i.e. at least 30 minutes before meals, to allow the medicine to act more quickly.

Pregnancy, breastfeeding, and fertility
Do not use Ketesse during the last three months of pregnancy or if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine, as Ketesse may not be the right medicine for you.
The use of Ketesse should be avoided by women who are planning a pregnancy or who are pregnant.
Treatment at any stage of pregnancy should only be carried out under direct medical supervision.
The use of Ketesse is not recommended while planning a pregnancy or during fertility investigations.
Regarding potential effects on female fertility, also refer to section 2, "Warnings and precautions".

Driving and using machines
Ketesse may slightly affect the ability to drive vehicles and use machinery due to possible adverse effects such as dizziness and fatigue associated with treatment. If you experience these effects, do not drive or operate machinery until symptoms resolve. Consult your doctor.

3. How to take Ketesse

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The dose of Ketesse you need depends on the type, intensity, and duration of pain. Your doctor will tell you how many tablets you should take each day and for how long.

The recommended dose is generally 1 tablet (25 mg) every 8 hours, not exceeding 3 tablets per day (75 mg).

If you are elderly or suffer from renal or hepatic impairment, you should start treatment with a total daily dose of no more than 2 tablets (50 mg).

In elderly patients, this initial dose may subsequently be increased to the generally recommended dose (75 mg) if Ketesse has been well tolerated.

If the pain is severe and you wish to achieve faster relief, take the tablets on an empty stomach (at least 30 minutes before meals), as this will facilitate absorption (see section 2 "Ketesse with food and drink").

Use in children and adolescents
This medicine must not be taken by children and adolescents (under 18 years of age).

If you take more Ketesse than you should
If you take an excessive dose of this medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine package or this leaflet with you.

If you forget to take Ketesse
Do not take a double dose to make up for a forgotten dose. Take your next regular dose at the scheduled time (refer to section 3 "How to take Ketesse").

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects are listed below, grouped by how likely they are to occur.

Common side effects: may affect up to 1 in 10 people
Nausea and/or vomiting, abdominal pain mainly in the upper quadrants, diarrhoea, digestive problems (dyspepsia).

Uncommon side effects: may affect up to 1 in 100 people
Dizziness, vertigo, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, inflammation of the gastric wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling of fever and chills, feeling of general malaise.

Rare side effects: may affect up to 1 in 1,000 people
Peptic ulcer, haemorrhagic or perforated peptic ulcer (which may present with blood traces in vomit or faeces), fainting, high blood pressure, slow breathing, fluid retention and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), disturbances in sensation (paraesthesias), itchy rash, acne, increased sweating, low back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), hepatocellular damage (hepatitis), acute renal failure.

Very rare side effects: may affect up to 1 in 10,000 people
Anaphylactic reaction (hypersensitivity reaction which may lead to collapse), skin, mouth, eye and genital ulceration (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of the lips and throat (angioedema), breathing difficulty due to contraction of muscles surrounding the airways (bronchospasm), laboured breathing, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin reactions, photosensitivity, itching, kidney problems.
Reduction in white blood cells in the blood (neutropenia), reduction in platelets in the blood (thrombocytopenia).

Immediately inform your doctor if you notice any stomach or intestinal side effects at the beginning of treatment (e.g. stomach pains, acidity or bleeding), if you have previously experienced any of these side effects due to prolonged use of anti-inflammatory medicines, and especially if you are elderly.

Stop using Ketesse immediately if you notice the appearance of a skin rash, or any lesion inside the mouth or on the genitals, or any sign of allergy.

During treatment with non-steroidal anti-inflammatory drugs (NSAIDs), fluid retention and swelling (particularly in the ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines such as Ketesse may be associated with a small increased risk of heart attack ("myocardial infarction") or cerebrovascular events (stroke).

In patients affected by immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported following administration. Gastric wall inflammation (gastritis) has been observed less frequently.

As with other NSAIDs, haematological reactions (purpura, aplastic and haemolytic anaemia, and rarely agranulocytosis and bone marrow hypoplasia) may occur.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketesse

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 30°C. Keep blisters in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ketesse contains

• The active substance is dexketoprofen (as dexketoprofen trometamol). Each film-coated tablet contains 25 mg of dexketoprofen.
• The other components are: maize starch, microcrystalline cellulose, sodium starch glycolate, glycerol distearate, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.

Description of the appearance of Ketesse and pack sizes
Round, white, film-coated tablet, divisible.
Ketesse is available in packs containing 4, 10, 20, 30, 50 and 500 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A. - 1, Avenue de la Gare – L-1611 Luxembourg (Luxembourg)
Marketing Authorisation Holder for distribution:
Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori - Strada 6 - Edificio L - Rozzano (MI)
Manufacturer

• LABORATORIOS MENARINI S.A. Alfons XII 587, 08918-Badalona (Barcelona) - Spain.
• A. MENARINI MANUFACTURING LOGISTICS and SERVICES srl, Via Campo di Pile s/n Loc. Campo di Pile - L'Aquila - Italy

This medicinal product is authorised in the European Economic Area countries under the following
names:
Spain (RMS), Austria, Belgium, Denmark, Finland, France, Iceland, Italy, Luxembourg, Norway,
Portugal, Sweden: Ketesse
Cyprus, Greece: Nosatel
Czech Republic: Dexoket
Germany: Sympal
Estonia, Latvia, Lithuania: Dolmen
Hungary: Ketodex
Ireland, Malta, United Kingdom: Keral
Netherlands: Stadium
Poland: Dexak
Slovakia: Dexadol
Slovenia: Menadex
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Ketesse 25 mg film-coated tablets

Dexketoprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after 3–4 days.
Contents of this leaflet:

1. What Ketesse is and what it is used for
2. What you need to know before taking Ketesse
3. How to take Ketesse
4. Possible side effects
5. How to store Ketesse
6. Contents of the packaging and other information

2. What Ketesse is and what it is used for

Ketesse is a pain-relieving medicine belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for the treatment of mild to moderate pain, such as muscle pain, painful periods (dysmenorrhoea), toothache.
If you do not feel better or feel worse after 3 - 4 days, consult your doctor.

4. What you should know before taking Ketesse

Do not take Ketesse:
If you are allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in
section 6);
If you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs);
If you have asthma or have previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation
of the nasal mucosa), nasal polyps (polypoid masses in the nose due to allergy), urticaria (skin rash),
angioedema (swelling of the face, eyes, lips, or tongue, or breathing difficulties) or wheezing in the chest
after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
If you have previously experienced photoallergic or phototoxic reactions (a particular type of skin redness and/or blistering following exposure to sunlight) during treatment with ketoprofen (a non-steroidal anti-inflammatory drug) or with fibrates (medicines used to reduce blood fat levels);
If you have a peptic ulcer, gastrointestinal bleeding, or if you have previously experienced stomach or intestinal bleeding, ulceration, or perforation;
If you suffer from chronic digestive problems (e.g. indigestion, heartburn);
If you have previously experienced stomach or intestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) taken for pain;
If you have inflammatory bowel diseases (Crohn’s disease or ulcerative colitis);
If you have severe heart failure, or moderate to severe kidney or serious liver problems;
If you have bleeding disorders or coagulation problems;
If you are severely dehydrated (have lost a large amount of body fluids) due to vomiting, diarrhoea, or insufficient fluid intake;
If you are in the third trimester of pregnancy or are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using Ketesse:
If you suffer from allergies, or have previously had allergy-related problems;
If you have kidney, liver, or heart problems (hypertension and/or heart failure), or fluid retention, or have previously experienced any of these conditions;
If you are being treated with diuretics or have very poor hydration or reduced blood volume due to excessive fluid loss (e.g. due to excessive urination, diarrhoea, or vomiting);
If you have heart conditions, have had a stroke, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss treatment with your doctor or pharmacist; medicines like Ketesse may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. These risks are more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
If you are elderly: you may be more likely to experience side effects (see section 4).
If this occurs, consult your doctor immediately;
If you are a woman with fertility problems (Ketesse may reduce fertility, therefore you should not take the
medicine if you are planning a pregnancy or undergoing fertility investigations);
If you suffer from a blood and blood cell formation disorder;
If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
If you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
If you have or have previously had other stomach or intestinal disorders;
If you have chickenpox, as NSAIDs may exceptionally worsen the infection;
If you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as
oral steroids, certain antidepressants (SSRIs, i.e. Selective Serotonin Reuptake Inhibitors), or medicines that prevent blood clotting such as aspirin or anticoagulants like warfarin. In these cases, consult your doctor before taking Ketesse: they may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other medicines that inhibit gastric acid production);
If you suffer from asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyps, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in individuals allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents
Ketesse has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and the product must not be used in children and adolescents.

Other medicines and Ketesse
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Some medicines should not be used together, while others may require dose adjustments when taken concurrently.
Always inform your doctor, dentist, or pharmacist if you are using or are being given any of the following medicines in addition to Ketesse:

Combinations not recommended:
Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs
Warfarin, heparin, or other medicines used to prevent blood clotting
Lithium, used to treat certain mood disorders
Methotrexate (anti-cancer or immunosuppressive medicine), used at doses higher than 15 mg/week
Hydantoin and phenytoin, used for epilepsy
Sulfamethoxazole, used for bacterial infections

Combinations requiring caution:
ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure and heart conditions
Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers
Zidovudine, used in the treatment of viral infections
Aminoglycoside antibiotics, used to treat bacterial infections
Sulfonylureas (e.g. chlorpropamide and glibenclamide), used for diabetes
Methotrexate, used at low doses, less than 15 mg/week

Combinations requiring careful evaluation:
Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin), used for bacterial infections
Cyclosporine or tacrolimus, used to treat immune system disorders and in organ transplants
Streptokinase and other thrombolytics or fibrinolytic medicines, i.e. medicines used to dissolve blood clots
Probenecid, used for gout
Digoxin, used in the treatment of chronic heart failure
Mifepristone, used as an abortifacient (to terminate a pregnancy)
Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants
Antiplatelet agents used to reduce platelet aggregation and blood clot formation
Beta-blockers, used for high blood pressure and heart problems
Tenofovir, deferasirox, pemetrexed

If you have any doubts about taking other medicines in combination with Ketesse, consult your doctor or pharmacist.

Ketesse with food and drink
Take the tablets with an adequate amount of water and with food, as this helps reduce the risk of gastrointestinal side effects. However, in case of severe pain, take the tablets on an empty stomach, i.e. at least 30 minutes before meals, to allow the medicine to act more quickly.

Pregnancy, breastfeeding, and fertility
Do not use Ketesse during the last three months of pregnancy or if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine, as Ketesse may not be the right medicine for you.
The use of Ketesse should be avoided in women who are planning a pregnancy or who are pregnant.
Treatment at any stage of pregnancy should only be carried out under direct medical supervision.
The use of Ketesse is not recommended while planning a pregnancy or during fertility investigations.
Regarding potential effects on female fertility, also refer to section 2, "Warnings and precautions".

Driving and using machines
Ketesse may slightly affect the ability to drive vehicles and use machinery due to possible adverse effects such as dizziness and fatigue associated with treatment. If you experience these effects, do not drive or operate machinery until symptoms resolve. Consult your doctor.

5. How to take Ketesse

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is generally 1 tablet (25 mg) every 8 hours, and no more than 3 tablets per day (75 mg).
If you do not feel better after 3–4 days, or if you feel worse, consult your doctor.
Your doctor will tell you how many tablets to take each day and for how long. The dose of Ketesse you need depends on the type, intensity, and duration of your pain.
If you are elderly or suffer from kidney or liver disorders, you should start treatment with a total daily dose of no more than 2 tablets (50 mg).
In elderly patients, this initial dose may later be increased to the generally recommended dose (75 mg) if Ketesse has been well tolerated.
If the pain is severe and you wish to achieve faster relief, take the tablets on an empty stomach (at least 30 minutes before meals), as this will facilitate absorption (see section 2 “Ketesse with food and drink”).

Use in children and adolescents
This medicine must not be taken by children and adolescents (under 18 years of age).

If you take more Ketesse than you should
If you take an excessive dose of this medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine pack or this leaflet with you.

If you forget to take Ketesse
Do not take a double dose to make up for the forgotten dose. Take the next scheduled dose at the usual time (refer to section 3 “How to take Ketesse”).

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The possible side effects are listed below, grouped according to their frequency of occurrence.

Common side effects: may affect up to 1 in 10 people
Nausea and/or vomiting, abdominal pain mainly in the upper quadrants, diarrhoea, digestive problems (dyspepsia).

Uncommon side effects: may affect up to 1 in 100 people
Dizziness, vertigo, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, inflammation of the stomach lining (gastritis), constipation, dry mouth, flatulence, rash, fatigue, pain, feeling of fever and chills, feeling of general malaise.

Rare side effects: may affect up to 1 in 1,000 people
Peptic ulcer, haemorrhagic or perforated peptic ulcer (which may present with blood traces in vomit or stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), altered sensation (paraesthesiae), itchy rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), hepatocellular damage (hepatitis), acute renal failure.

Very rare side effects: may affect up to 1 in 10,000 people
Anaphylactic reaction (hypersensitivity reaction that may even lead to collapse), skin ulceration, of the mouth, eyes and genital area (Stevens-Johnson syndrome and Lyell’s syndrome), facial swelling or swelling of the lips and throat (angioedema), breathing difficulty due to contraction of muscles surrounding the airways (bronchospasm), laboured breathing, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin reactions, photosensitivity, itching, kidney problems.
Reduction in white blood cells in the blood (neutropenia), reduction in platelets in the blood (thrombocytopenia).

Immediately inform your doctor if you notice any gastrointestinal side effects at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if you have previously experienced any of these side effects due to prolonged use of anti-inflammatory medicines, and particularly if you are elderly.

Stop using Ketesse immediately if you notice the appearance of a skin rash, or any lesion inside the mouth or in the genital area, or any sign of allergy.

During treatment with non-steroidal anti-inflammatory drugs (NSAIDs), fluid retention and swelling (particularly in the ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines such as Ketesse may be associated with a small increased risk of heart attack ("myocardial infarction") or cerebrovascular events (stroke).

In patients affected by immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.

The most frequently observed adverse events are of a gastrointestinal nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported following administration. Less frequently, inflammation of the stomach lining (gastritis) has been observed.

As with other NSAIDs, haematological reactions (purpura, aplastic and haemolytic anaemia, and rarely agranulocytosis and bone marrow hypoplasia) may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketesse

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 30°C. Keep the blisters in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ketesse contains

• The active substance is dexketoprofen (as dexketoprofen trometamol). Each film-coated tablet contains 25 mg of dexketoprofen.
• Other excipients are: maize starch, microcrystalline cellulose, sodium starch glycolate, glycerol distearate, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.

Description of the appearance of Ketesse and the contents of the pack
Film-coated, round, white tablet, divisible.
Ketesse is available in packs containing 4, 10, 20, 30, 50 and 500 film-coated tablets. It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Menarini International Operations Luxembourg S.A. - 1, Avenue de la Gare – L-1611 Luxembourg (Luxembourg)
Marketing authorization holder in Italy:
Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori - Strada 6 - Edificio L - Rozzano (MI)

Manufacturer

• LABORATORIOS MENARINI S.A. Alfons XII 587, 08918-Badalona (Barcelona) - Spain.
• A. MENARINI MANUFACTURING LOGISTICS and SERVICES srl, Via Campo di Pile s/n Loc. Campo di Pile - L'Aquila - Italy

This medicinal product is authorized in the European Economic Area countries under the following
names:
Spain (RMS), Austria, Belgium, Denmark, Finland, France, Iceland, Italy, Luxembourg, Norway, Portugal, Sweden: Ketesse
Cyprus, Greece: Nosatel
Czech Republic: Dexoket
Germany: Sympal
Estonia, Latvia, Lithuania: Dolmen
Hungary: Ketodex
Ireland, Malta, United Kingdom: Keral
Netherlands: Stadium
Poland: Dexak
Slovakia: Dexadol
Slovenia: Menadex

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ketesse 12.5 mg film-coated tablets

Dexketoprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What Ketesse is and what it is used for
2. What you need to know before taking Ketesse
3. How to take Ketesse
4. Possible side effects
5. How to store Ketesse
6. Contents of the pack and other information

3. What Ketesse is and what it is used for

Ketesse is a pain-relieving medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used to treat mild to moderate pain, such as muscle pain, painful periods (dysmenorrhoea), and toothache.

6. What you need to know before taking Ketesse

Do not take Ketesse:
If you are allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in
section 6);
If you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs);
If you have asthma or have previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (polypoid masses in the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or breathing difficulties) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
If you have previously experienced photoallergic or phototoxic reactions (a particular type of skin redness and/or blistering after exposure to sunlight) during treatment with ketoprofen (a non-steroidal anti-inflammatory drug) or with fibrates (medicines used to reduce blood fat levels);
If you currently have a peptic ulcer or gastrointestinal bleeding, or if you have previously experienced stomach or intestinal bleeding, ulceration, or perforation;
If you suffer from chronic digestive problems (e.g. indigestion, heartburn);
If you have previously experienced stomach or intestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) taken for pain;
If you have chronic inflammatory bowel diseases (Crohn’s disease or ulcerative colitis);
If you have severe heart failure, or moderate to severe kidney or serious liver problems;
If you have bleeding disorders or coagulation problems;
If you are severely dehydrated (have lost a large amount of body fluids) due to vomiting, diarrhoea, or insufficient fluid intake;
If you are in the third trimester of pregnancy or are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketesse if:
You have allergies or have previously experienced allergic reactions;
You have kidney, liver, or heart problems (hypertension and/or heart failure), or fluid retention, or have previously suffered from any of these conditions;
You are taking diuretics or have very poor hydration or reduced blood volume due to excessive fluid loss (e.g. from excessive urination, diarrhoea, vomiting);
You have heart conditions, have had a stroke, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or are a smoker); you should discuss treatment with your doctor or pharmacist; medicines such as Ketesse may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. These risks are more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
You are elderly: there is a higher likelihood of experiencing side effects (see section 4). If any of these occur, consult your doctor immediately;
You are a woman with fertility problems (Ketesse may reduce your fertility, therefore you should not take this medicine if you are planning a pregnancy or undergoing fertility investigations);
You have a blood or blood cell formation disorder;
You have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
You have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
You currently have or have previously had other stomach or intestinal disorders;
You have chickenpox, as NSAIDs may exceptionally worsen the infection;
You are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral steroids, certain antidepressants (SSRIs, i.e. selective serotonin reuptake inhibitors), or medicines that prevent blood clotting such as aspirin or anticoagulants like warfarin. In such cases, consult your doctor before taking Ketesse: they may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other medicines that block gastric acid production);
You have asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyposis, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, especially in individuals allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents
Ketesse has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and the product must not be used in children and adolescents.

Other medicines and Ketesse
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Some medicines should not be used together, while others require dose adjustments when taken concurrently.
Always inform your doctor, dentist, or pharmacist if you are using or are prescribed any of the following medicines in addition to Ketesse:

Combinations not recommended:
Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs
Warfarin, heparin, or other medicines used to prevent blood clotting
Lithium, used to treat certain mood disorders
Methotrexate (anti-cancer or immunosuppressive medicine), used at doses higher than 15 mg/week
Phenytoin and phenytoin, used for epilepsy
Sulfamethoxazole, used for bacterial infections

Combinations requiring caution:
ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used for high blood pressure and heart conditions
Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers
Zidovudine, used in the treatment of viral infections
Aminoglycoside antibiotics, used to treat bacterial infections
Sulfonylureas (e.g. chlorpropamide and glibenclamide), used for diabetes
Methotrexate, used at low doses, less than 15 mg/week

Combinations requiring careful evaluation:
Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin), used for bacterial infections
Cyclosporine or tacrolimus, used to treat immune system disorders and in organ transplantation
Streptokinase and other thrombolytics or fibrinolytic medicines, i.e. medicines used to dissolve blood clots
Probenecid, used for gout
Digoxin, used in the treatment of chronic heart failure
Mifepristone, used as an abortifacient (to terminate pregnancy)
Selective Serotonin Reuptake Inhibitors (SSRIs), a type of antidepressant
Antiplatelet agents used to reduce platelet aggregation and blood clot formation
Beta-blockers, used for high blood pressure and heart problems
Tenofovir, deferasirox, pemetrexed

If you have any doubts about taking other medicines in combination with Ketesse, consult your doctor or pharmacist.

Ketesse with food and drinks
Take the tablets with an adequate amount of water and with food, as this helps reduce the risk of gastrointestinal side effects. However, in case of severe pain, take the tablets on an empty stomach, i.e. at least 30 minutes before meals, to allow the medicine to act more quickly.

Pregnancy, breastfeeding and fertility
Do not use Ketesse during the last three months of pregnancy or if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine, as Ketesse may not be suitable for you.
The use of Ketesse should be avoided in women who are planning a pregnancy or who are pregnant.
Treatment at any stage of pregnancy should only be undertaken under direct medical supervision.
The use of Ketesse is not recommended when planning a pregnancy or during fertility investigations.
Regarding potential effects on female fertility, also refer to section 2, "Warnings and precautions".

Driving and using machines
Ketesse may slightly affect the ability to drive vehicles and use machinery due to possible adverse effects such as dizziness and fatigue associated with the treatment. If you experience these effects, do not drive or operate machinery until symptoms resolve. Consult your doctor.

7. How to take Ketesse

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The dose of Ketesse you need depends on the type, intensity, and duration of your pain. Your doctor will tell you how many tablets you should take each day and for how long.

The recommended dose is generally 1 tablet (12.5 mg) every 4–6 hours, and no more than 6 tablets per day (75 mg).

If you are elderly or suffer from kidney or liver disease, you should start treatment with a maximum total daily dose of no more than 4 tablets (50 mg).
In elderly patients, this initial dose may subsequently be increased to the generally recommended dose (75 mg) if Ketesse has been well tolerated.

If the pain is severe and you wish to achieve faster relief, take the tablets on an empty stomach (at least 30 minutes before meals), as this will facilitate absorption (see section 2 “Ketesse with food and drink”).

Use in children and adolescents
This medicine must not be taken by children and adolescents (under 18 years of age).

If you take more Ketesse than you should
If you take too much of this medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine pack or this leaflet with you.

If you forget to take Ketesse
Do not take a double dose to make up for the forgotten dose. Take your next regular dose at the scheduled time (refer to section 3 “How to take Ketesse”).

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The possible side effects are listed below, grouped according to their frequency of occurrence.

Common side effects: may affect up to 1 in 10 patients
Nausea and/or vomiting, abdominal pain mainly in the upper quadrants, diarrhoea, digestive problems (dyspepsia).

Uncommon side effects: may affect up to 1 in 100 patients
Dizziness, vertigo, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, inflammation of the gastric wall (gastritis), constipation, dry mouth, flatulence, rash, fatigue, pain, feeling of fever and chills, feeling of general malaise.

Rare side effects: may affect up to 1 in 1,000 patients
Peptic ulcer, haemorrhagic or perforated peptic ulcer (which may present with blood traces in vomit or faeces), fainting, high blood pressure, slow breathing, fluid retention and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), changes in sensation (paraesthesia), itchy rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), hepatocellular damage (hepatitis), acute renal failure.

Very rare side effects: may affect up to 1 in 10,000 patients
Anaphylactic reaction (hypersensitivity reaction which may lead to collapse), skin ulceration, mouth, eyes and genital area (Stevens-Johnson syndrome and Lyell's syndrome), facial oedema or swelling of lips and throat (angioedema), breathing difficulty due to contraction of muscles surrounding the airways (bronchospasm), laboured breathing, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin reactions, photosensitivity, itching, kidney problems.
Decrease in white blood cells in the blood (neutropenia), decrease in platelets in the blood (thrombocytopenia).

Inform your doctor immediately if you notice any gastrointestinal side effects at the beginning of treatment (e.g. stomach pain, acidity or bleeding), if you have previously experienced any of these side effects due to prolonged use of anti-inflammatory medicines, and especially if you are elderly.

Stop taking Ketesse immediately if you notice the appearance of a skin rash, or any lesions inside the mouth or on the genital area, or any signs of allergy.

During treatment with non-steroidal anti-inflammatory drugs (NSAIDs), fluid retention and swelling (particularly in the ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines such as Ketesse may be associated with a small increased risk of heart attack ("myocardial infarction") or cerebrovascular events (stroke).

In patients affected by immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache, and neck stiffness.

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported following administration. Gastric wall inflammation (gastritis) has been observed less frequently.

As with other NSAIDs, haematological reactions (purpura, aplastic and haemolytic anaemia, and rarely agranulocytosis and marrow hypoplasia) may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketesse

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 30°C. Keep blisters in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ketesse contains

• The active substance is dexketoprofen (as dexketoprofen trometamol). Each film-coated tablet contains 12.5 mg of dexketoprofen.
• The other components (excipients) are: maize starch, microcrystalline cellulose, sodium starch glycolate, glycerol distearate, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.

Description of the appearance of Ketesse and contents of the pack
Round, white, film-coated tablet.
Ketesse is available in packs containing 10, 20, 30, 40, 50 and 500 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder
Menarini International Operations Luxembourg S.A. - 1, Avenue de la Gare – L-1611 Luxembourg (Luxembourg)
Sales Licensee:
Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori - Strada 6 - Edificio L - Rozzano (MI)
Manufacturer

• LABORATORIOS MENARINI S.A. Alfons XII 587, 08918-Badalona (Barcelona) - Spain.
• A. MENARINI MANUFACTURING LOGISTICS and SERVICES srl, Via Campo di Pile s/n Loc. Campo di Pile - L'Aquila - Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Spain (RMS), Austria, Belgium, France, Iceland, Italy, Luxembourg, Norway, Portugal, Sweden: Ketesse
Cyprus, Greece: Nosatel
Germany: Sympal
Ireland, Malta: Keral
Netherlands: Stadium
Poland: Dexak
Slovakia: Dexadol
Slovenia: Menadex

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ketesse 12.5 mg film-coated tablets

Dexketoprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after 3–4 days.
Contents of this leaflet:

1. What Ketesse is and what it is used for
2. What you need to know before taking Ketesse
3. How to take Ketesse
4. Possible side effects
5. How to store Ketesse
6. Contents of the pack and other information

4. What Ketesse is and what it is used for

Ketesse is an analgesic belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
It is used to treat mild to moderate pain, such as muscle pain, painful menstruation (dysmenorrhoea), and toothache.
Consult your doctor if you do not feel better or if you feel worse after 3 - 4 days.

8. What you need to know before taking Ketesse

Do not take Ketesse:
If you are allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in
section 6);
If you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs);
If you have asthma or have previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation
of the nasal mucosa), nasal polyps (polypoid masses in the nose due to allergy), urticaria (skin rash),
angioedema (swelling of the face, eyes, lips, or tongue, or breathing difficulties) or wheezing in the chest
after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
If you have previously experienced photoallergic or phototoxic reactions (a particular form of skin redness and/or blistering
following exposure to sunlight) during treatment with ketoprofen (a non-steroidal anti-inflammatory drug) or with fibrates (medicines used to reduce blood lipid levels);
If you currently have a peptic ulcer or gastrointestinal bleeding, or if you have previously experienced stomach or intestinal bleeding, ulceration, or perforation;
If you suffer from chronic digestive problems (e.g. indigestion, heartburn);
If you have previously experienced stomach or intestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) taken for pain;
If you have inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
If you have severe heart failure, or moderate to severe kidney problems, or serious liver problems;
If you have bleeding disorders or coagulation disorders;
If you are severely dehydrated (have lost a large amount of body fluids) due to vomiting, diarrhoea, or insufficient fluid intake;
If you are in the third trimester of pregnancy or are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using Ketesse:
If you suffer from allergies, or have previously experienced allergy-related problems;
If you have kidney, liver, or heart problems (hypertension and/or heart failure), or fluid retention, or have previously suffered from any of these conditions;
If you are taking diuretics or have very poor hydration or reduced blood volume due to excessive fluid loss (e.g. due to excessive urination, diarrhoea, or vomiting);
If you have heart conditions, have had a stroke, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or are a smoker); you should discuss treatment with your doctor or pharmacist; medicines such as Ketesse may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. These risks are more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
If you are elderly: there is a higher likelihood of experiencing side effects (see section 4).
If side effects occur, consult your doctor immediately;
If you are a woman with fertility problems (Ketesse may reduce your fertility; therefore, you should not take the
medicine if you are planning a pregnancy or undergoing fertility investigations);
If you suffer from a blood and blood cell formation disorder;
If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
If you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
If you currently have or have previously had other stomach or intestinal disorders;
If you have chickenpox, as NSAIDs may exceptionally worsen the infection;
If you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral steroids, certain antidepressants (SSRIs, i.e. Selective Serotonin Reuptake Inhibitors), or medicines that prevent blood clotting such as aspirin or anticoagulants like warfarin. In such cases, consult your doctor before taking Ketesse: your doctor may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other medicines that block gastric acid production);
If you have asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyposis, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in individuals allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents
Ketesse has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and the product must not be used in children and adolescents.

Other medicines and Ketesse
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those obtained without a prescription. Some medicines should not be used together, while others may require dose adjustments when taken concurrently.
Always inform your doctor, dentist, or pharmacist if you are using or are being given any of the following medicines in addition to Ketesse:

Combinations not recommended:
Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs
Warfarin, heparin, or other medicines used to prevent blood clotting
Lithium, used to treat certain mood disorders
Methotrexate (anti-cancer or immunosuppressive medicine), used at doses higher than 15 mg/week
Phenytoin and phenobarbital, used for epilepsy
Sulfamethoxazole, used for bacterial infections

Combinations requiring caution:
ACE inhibitors, diuretics, and angiotensin II receptor antagonists, used for high blood pressure and heart conditions
Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers
Zidovudine, used in the treatment of viral infections
Aminoglycoside antibiotics, used to treat bacterial infections
Sulfonylureas (e.g. chlorpropamide and glibenclamide) used for diabetes
Methotrexate, used at low doses, less than 15 mg/week

Combinations requiring careful evaluation:
Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used for bacterial infections
Cyclosporine or tacrolimus, used to treat immune system disorders and in organ transplantation
Streptokinase and other thrombolytics or fibrinolytic medicines, i.e. medicines used to dissolve blood clots
Probenecid, used for gout
Digoxin, used in the treatment of chronic heart failure
Mifepristone, used as an abortifacient (to terminate a pregnancy)
Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants
Antiplatelet agents used to reduce platelet aggregation and blood clot formation
Beta-blockers, used for high blood pressure and heart problems
Tenofovir, deferasirox, pemetrexed

If you have any doubts about taking other medicines in combination with Ketesse, consult your doctor or pharmacist.

Ketesse with food and drinks
Take the tablets with an adequate amount of water and with food, as this helps reduce the risk of gastrointestinal side effects. However, in case of severe pain, take the tablets on an empty stomach, i.e. at least 30 minutes before meals, to allow the medicine to act more quickly.

Pregnancy, breastfeeding and fertility
Do not use Ketesse during the last three months of pregnancy or if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine, as Ketesse may not be the appropriate medicine for you.
The use of Ketesse should be avoided in women who are planning a pregnancy or who are pregnant.
Treatment at any stage of pregnancy should only be initiated under direct medical supervision.
The use of Ketesse is not recommended when planning a pregnancy or during fertility investigations.
Regarding potential effects on female fertility, also refer to section 2, "Warnings and precautions".

Driving and using machines
Ketesse may slightly affect the ability to drive vehicles and use machinery due to possible adverse effects such as dizziness and fatigue associated with treatment. If you experience these effects, do not drive or operate machinery until symptoms resolve. Consult your doctor.

9. How to take Ketesse

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is generally 1 tablet (12.5 mg) every 4–6 hours, and no more than 6 tablets per day (75 mg). If you do not feel better or feel worse after 3–4 days, consult your doctor.

Your doctor will tell you how many tablets you should take each day and for how long. The dose of Ketesse you need depends on the type, intensity, and duration of pain.

If you are elderly or suffer from kidney or liver disorders, treatment should be started with a maximum total daily dose of no more than 4 tablets (50 mg).
In elderly patients, this initial dose may subsequently be increased to the generally recommended dose (75 mg), provided Ketesse has been well tolerated.

If pain is severe and you wish to achieve faster relief, take the tablets on an empty stomach (at least 30 minutes before meals), as this will facilitate absorption (see section 2 "Ketesse with food and drink").

Use in children and adolescents
This medicine must not be taken by children and adolescents (under 18 years of age).

If you take more Ketesse than you should
If you take an excessive dose of this medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine pack or this leaflet with you.

If you forget to take Ketesse
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time (refer to section 3 "How to take Ketesse").

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The possible side effects are listed below, grouped according to their frequency of occurrence.

Common side effects: may affect up to 1 in 10 people
Nausea and/or vomiting, abdominal pain mainly in the upper quadrants, diarrhoea, digestive problems (dyspepsia).

Uncommon side effects: may affect up to 1 in 100 people
Dizziness, vertigo, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, inflammation of the stomach lining (gastritis), constipation, dry mouth, flatulence, rash, fatigue, pain, feeling of fever and chills, feeling of general malaise.

Rare side effects: may affect up to 1 in 1,000 people
Peptic ulcer, haemorrhagic or perforated peptic ulcer (which may present with blood traces in vomit or stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), changes in sensation (paraesthesiae), itchy rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), hepatocellular damage (hepatitis), acute renal failure.

Very rare side effects: may affect up to 1 in 10,000 people
Anaphylactic reaction (hypersensitivity reaction which may even lead to collapse), skin ulceration, mouth, eyes and genital area (Stevens-Johnson syndrome and Lyell's syndrome), facial oedema or swelling of lips and throat (angioedema), breathing difficulty due to contraction of muscles surrounding the airways (bronchospasm), laboured breathing, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin reactions, photosensitivity, itching, kidney problems.
Reduction in white blood cells in the blood (neutropenia), reduction in platelets in the blood (thrombocytopenia).

Immediately inform your doctor if you notice any gastrointestinal side effects at the beginning of treatment (e.g. stomach pain, acidity or bleeding), if you have previously experienced any of these side effects due to prolonged use of anti-inflammatory medicines, and especially if you are elderly.

Stop using Ketesse immediately if you notice the onset of a skin rash, or any lesions inside the mouth or on the genitals, or any signs of allergy.

During treatment with non-steroidal anti-inflammatory medicines, fluid retention and swelling (particularly in the ankles and legs), increased blood pressure and heart failure have been reported.

Medicines such as Ketesse may be associated with a small increased risk of heart attack ("myocardial infarction") or cerebrovascular events (stroke).

In patients affected by immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported following administration. Gastric inflammation (gastritis) has been observed less frequently.

As with other NSAIDs, haematological reactions (purpura, aplastic and haemolytic anaemia, and rarely agranulocytosis and marrow hypoplasia) may occur.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketesse

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 30°C. Keep the blisters in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ketesse contains

• The active substance is dexketoprofen (as dexketoprofen trometamol). Each tablet contains 12.5 mg of dexketoprofen.
• The other components are: maize starch, microcrystalline cellulose, sodium starch glycolate, glycerol distearate, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.

Description of the appearance of Ketesse and package contents
White, round, film-coated tablet.
Ketesse is available in packages containing 10, 20, 30, 40, 50 and 500 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder
Menarini International Operations Luxembourg S.A. - 1, Avenue de la Gare – L-1611 Luxembourg (Luxembourg)
Sales License Holder:
Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori - Strada 6 - Edificio L - Rozzano (MI)
Manufacturer

• LABORATORIOS MENARINI S.A. Alfons XII 587, 08918-Badalona (Barcelona) - Spain.
• A. MENARINI MANUFACTURING LOGISTICS and SERVICES srl, Via Campo di Pile s/n Loc. Campo di Pile - L'Aquila - Italy

This medicinal product is authorized in the European Economic Area countries under the following
names:
Spain (RMS), Austria, Belgium, France, Iceland, Italy, Luxembourg, Norway, Portugal, Sweden: Ketesse
Cyprus, Greece: Nosatel
Germany: Sympal
Ireland, Malta: Keral
Netherlands: Stadium
Poland: Dexak
Slovakia: Dexadol
Slovenia: Menadex
PACKAGE LEAFLET: INFORMATION FOR THE USER

Ketesse 25 mg granules for oral solution

Dexketoprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after 3–4 days.
Contents of this leaflet:

1. What Ketesse is and what it is used for
2. What you need to know before taking Ketesse
3. How to take Ketesse
4. Possible side effects
5. How to store Ketesse
6. Contents of the pack and other information

5. What Ketesse is and what it is used for

Ketesse is an analgesic belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for the short-term symptomatic treatment of mild to moderate pain, such as acute muscle pain, joint pain, painful menstruation (dysmenorrhoea), and toothache.

10. What you need to know before taking Ketesse

Do not take Ketesse:
if you are allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in
section 6);
if you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs);
if you suffer from asthma or have previously experienced asthma attacks, acute allergic rhinitis (short episodes of nasal mucosa inflammation), nasal polyps (polypoid masses in the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue, or breathing difficulties) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
if you have previously experienced photoallergic or phototoxic reactions (a specific type of redness and/or irritation of skin exposed to sunlight) while taking ketoprofen (an NSAID) or fibrates (medicines used to lower blood lipid levels);
if you have peptic ulcer disease, gastrointestinal bleeding, or have previously experienced gastrointestinal bleeding, ulceration or perforation;
if you suffer from chronic digestive problems (e.g. indigestion, heartburn);
if you have previously experienced gastrointestinal bleeding or perforation due to the use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain;
if you suffer from chronic inflammatory bowel diseases (Crohn’s disease or ulcerative colitis);
if you have severe heart failure, moderate or severe renal failure, or severe hepatic failure;
if you have bleeding disorders or coagulation disorders;
if you are severely dehydrated (have lost a lot of fluids) due to vomiting, diarrhoea or insufficient fluid intake;
if you are in the third trimester of pregnancy or if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketesse:
if you suffer from allergies or have previously experienced allergic reactions;
if you have kidney, liver or heart disease (hypertension and/or heart failure), fluid retention, or if you have previously experienced any of these conditions;
if you are taking diuretics or are poorly hydrated, or if you have reduced blood volume due to excessive fluid loss (e.g. due to excessive urination, diarrhoea, vomiting);
if you have heart conditions, have had a stroke, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol or are a smoker); discuss treatment with your doctor or pharmacist; medicines like Ketesse may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke. These risks are more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
if you are elderly: the risk of side effects is higher (see section 4). If any occur, consult your doctor immediately;
if you are a woman with fertility problems (Ketesse may reduce female fertility; therefore, you should not take this medicine if you are planning a pregnancy or undergoing fertility investigations);
if you suffer from a blood or blood cell formation disorder;
if you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
if you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
if you have previously suffered from other stomach or intestinal disorders;
if you have chickenpox, because, in rare cases, NSAIDs may worsen the infection;
if you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral steroids, certain antidepressants (e.g. SSRIs, selective serotonin reuptake inhibitors), antiplatelet agents like aspirin, or anticoagulants like warfarin. In such cases, consult your doctor before taking Ketesse: they may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other drugs that reduce gastric acid production);
if you suffer from asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, especially in individuals allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents
The use of Ketesse has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and the medicine must not be used in children and adolescents.

Other medicines and Ketesse
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Some medicines cannot be used together, while others require dosage adjustments when taken concurrently.

Always inform your doctor, dentist or pharmacist if you are using or are being given any of the following medicines in addition to Ketesse:

Combinations not recommended:
Acetylsalicylic acid, corticosteroids or other anti-inflammatory drugs
Warfarin, heparin or other medicines used to prevent blood clot formation
Lithium, used to treat mood disorders
Methotrexate (anti-cancer or immunosuppressive medicine), used at doses higher than 15 mg/week
Hydantoin and phenytoin, used for epilepsy
Sulfamethoxazole, used for bacterial infections

Combinations requiring caution:
ACE inhibitors, diuretics and angiotensin II antagonists, used for hypertension and heart conditions
Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers
Zidovudine, used in the treatment of viral infections
Aminoglycoside antibiotics, used to treat bacterial infections
Sulfonylureas (e.g. chlorpropamide and glibenclamide) used for diabetes
Methotrexate, used at low doses, less than 15 mg/week

Combinations requiring careful evaluation:
Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used for bacterial infections
Cyclosporine or tacrolimus, used to treat immune system disorders and as therapy in organ transplantation
Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. medicines used to dissolve blood clots
Probenecid, used for gout
Digoxin, used in the treatment of chronic heart failure
Mifepristone, used to induce abortion (to terminate pregnancy)
Selective serotonin reuptake inhibitor (SSRI) antidepressants
Antiplatelet agents used to reduce platelet aggregation and blood clot formation
Beta-blockers, used for high blood pressure and heart problems
Tenofovir, deferasirox, pemetrexed

If you have any doubts about taking other medicines in combination with Ketesse, consult your doctor or pharmacist.

Ketesse with food and drinks
In case of severe pain, take the sachet on an empty stomach, i.e. at least 15 minutes before meals, to allow the medicine to act more quickly.

Pregnancy, breastfeeding and fertility
Do not use Ketesse during the last three months of pregnancy or if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine, as Ketesse may not be the right medicine for you.
The use of Ketesse should be avoided by women who are planning a pregnancy or who are pregnant.
Treatment at any stage of pregnancy should only be carried out under direct medical supervision.
The use of Ketesse is not recommended while planning a pregnancy or during fertility investigations.
Regarding potential effects on female fertility, also refer to section 2 “Warnings and precautions”.

Driving and using machines
Ketesse may cause undesirable effects such as dizziness, drowsiness and visual disturbances, which may impair your ability to drive or operate machinery. If you experience these effects, do not drive or operate machinery until symptoms have resolved. Consult your doctor for advice.

Ketesse contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains 2.418 g of sucrose per dose. This should be taken into account in patients with diabetes mellitus.

11. How to use Ketesse

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults over 18 years of age
The recommended dose is 1 sachet (25 mg) every 8 hours, not more than 3 sachets per day (75 mg).
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3–4 days. Your doctor will advise you on how many sachets you should take daily and for how long. The dose of Ketesse you need depends on the type, intensity, and duration of pain.
If you are elderly or suffer from renal or hepatic disorders, you should start treatment with a total daily dose of no more than 2 sachets (50 mg).
In elderly patients, this initial dose may subsequently be increased to the generally recommended dose (75 mg of dexketoprofen) if Ketesse has been well tolerated.
If pain is severe and you wish to achieve faster relief, take the sachets on an empty stomach (at least 15 minutes before meals), as this will facilitate absorption (see section 2 "Ketesse with food and drink").
Use in children and adolescents
This medicine must not be used in children and adolescents (under 18 years of age).
Instructions for correct use
Dissolve the entire contents of each sachet in a glass of water; shake or stir well to ensure complete dissolution. The resulting solution should be taken immediately after reconstitution.
If you take more Ketesse than you should
If you have taken an excessive dose of this medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine pack or this leaflet with you.
If you forget to take Ketesse
Do not take a double dose to make up for the forgotten dose. Take the next dose at the scheduled time (as stated in section 3 "How to use Ketesse").
If you have further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The possible side effects are listed below, grouped according to how likely they are to occur.
Since this list is partly based on the side effects of the Ketesse tablet formulation, and Ketesse granules are absorbed more rapidly than tablets, the actual frequency of side effects (particularly gastrointestinal) may be higher with Ketesse granules.

Common side effects (may affect up to 1 in 10 patients)
Nausea and/or vomiting, abdominal pain mainly in the upper quadrants, diarrhoea, digestive problems (dyspepsia).

Uncommon side effects (may affect up to 1 in 100 patients)
Dizziness, vertigo, drowsiness, insomnia, nervousness, headache, palpitations, hot flushes, inflammation of the stomach lining (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling of fever and chills, feeling of general malaise (malaise).

Rare side effects (may affect up to 1 in 1,000 patients)
Peptic ulcer, haemorrhagic or perforated peptic ulcer (presenting with haematemesis, i.e. vomiting blood, or black stools), fainting, hypertension, slowed breathing, fluid retention and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), altered sensation (particularly tactile), itchy rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), hepatocellular damage (hepatitis), acute renal failure.

Very rare side effects (may affect up to 1 in 10,000 patients)
Anaphylactic reactions (hypersensitivity reactions which may even lead to collapse), open sores on the skin, mouth, eyes, and genital area (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of the lips and throat (angioneurotic oedema), breathlessness due to contraction of muscles surrounding the airways (bronchospasm), shortness of breath, rapid heartbeat, hypotension, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Reduced number of white blood cells (neutropenia), decreased platelets in the blood (thrombocytopenia).

Inform your doctor immediately if you notice any stomach or intestinal side effects at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if you have previously experienced such side effects due to prolonged use of anti-inflammatory medicines, and particularly if you are elderly.

Stop using Ketesse as soon as you notice a skin rash or any lesions inside the mouth or in the genital area, or any signs of allergy.

During treatment with non-steroidal anti-inflammatory drugs (NSAIDs), fluid retention and swelling (particularly in the ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines such as Ketesse may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke (cerebrovascular accident).

In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may, in rare cases, cause fever, headache, and neck stiffness.

The most frequently observed adverse events are of a gastrointestinal nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported following administration. Gastric inflammation (gastritis) has been observed less frequently.

As with other NSAIDs, haematological reactions (purpura, aplastic and haemolytic anaemia, and rarely agranulocytosis and bone marrow hypoplasia) may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketesse

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachets. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ketesse contains

• The active substance is dexketoprofen (as dexketoprofen trometamol). Each sachet contains 25 mg of dexketoprofen.
• The other components are: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, quinoline yellow (E104), lemon flavour, sucrose (see section 2, “Ketesse contains sucrose”).

Description of the appearance of Ketesse and pack contents
Sachets containing a lemon-yellow granulate.
Ketesse 25 mg is available in packs containing 2, 4, 10, 20, 30, 40, 50, 100 and 500 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Menarini International Operations Luxembourg S.A. - Avenue de la Gare, 1 - Luxembourg

Legal representative and marketing authorisation holder:
Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori - Strada 6 - Edificio L - Rozzano (MI), Italy

Manufacturer
LABORATORIOS MENARINI, S.A.,
Alfons XII 587, 08918-Badalona (Barcelona), SPAIN

This medicinal product has been authorised in the Member States of the European Economic Area
under the following brand names:
Austria, Belgium, Denmark, Finland, France, Iceland, Italy, Luxembourg, Norway, Portugal, Spain,
Sweden: Ketesse
Cyprus, Greece: Nosatel
Czech Republic: Dexoket
Estonia, Latvia, Lithuania: Dolmen
Germany: Sympal
Hungary: Ketodex
Ireland, Malta, United Kingdom: Keral
Netherlands: Stadium
Poland: Dexak
Slovakia: Dexadol
Slovenia: Menadex

This leaflet was last updated on

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ketesse 12.5 mg granules for oral solution

Dexketoprofen
Please read this entire leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3–4 days.
Contents of this leaflet

7. What Ketesse is and what it is used for
8. What you need to know before taking Ketesse
9. How to take Ketesse
10. Possible side effects
11. How to store Ketesse
12. Contents of the pack and other information

6. What Ketesse is and what it is used for

Ketesse is a painkiller belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for the short-term symptomatic treatment of mild to moderate pain, such as acute muscle pain, joint pain, painful periods (dysmenorrhoea), and toothache.

12. What you need to know before taking Ketesse

Do not take Ketesse:
if you are allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in
section 6);
if you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs);
if you suffer from asthma or have previously experienced asthma attacks, acute allergic rhinitis (short episodes of inflammation
of the nasal mucosa), nasal polyps (polypoid masses in the nose due to allergy), urticaria (skin rash),
angioedema (swelling of the face, eyes, lips, or tongue, or breathing difficulties) or wheezing in the chest
after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
if you have previously experienced photoallergic or phototoxic reactions (a particular type of redness and/or
irritation of sun-exposed skin) while taking ketoprofen (an NSAID) or fibrates (medicines used to lower blood lipid levels);
if you have peptic ulcer or gastrointestinal bleeding, or if you have previously experienced bleeding, ulceration, or perforation of the stomach or intestine;
if you suffer from chronic digestive problems (e.g. indigestion, heartburn);
if you have previously experienced gastrointestinal bleeding or perforation due to the use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief;
if you suffer from chronic inflammatory bowel diseases (Crohn’s disease or ulcerative colitis);
if you have severe heart failure, moderate or severe renal failure, or severe hepatic impairment;
if you have bleeding disorders or coagulation problems;
if you are severely dehydrated (have lost a lot of fluids) due to vomiting, diarrhoea, or insufficient fluid intake;
if you are in the third trimester of pregnancy or if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketesse:
if you suffer from allergies or have previously experienced allergic reactions;
if you have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or if you have previously suffered from any of these conditions;
if you are being treated with diuretics or are poorly hydrated, or if you have reduced blood volume due to excessive fluid loss (e.g. due to excessive urination, diarrhoea, vomiting);
if you suffer from heart disease, have had a stroke, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or if you smoke); discuss treatment with your doctor or pharmacist; medicines such as Ketesse may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or cerebrovascular accident (stroke). These risks are more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
if you are elderly: the risk of side effects is higher (see section 4). If any occur, consult your doctor immediately;
if you are a woman with fertility problems (Ketesse may reduce female fertility; therefore, you should not take the medicine if you are planning a pregnancy or undergoing fertility investigations);
if you suffer from a blood or blood cell formation disorder;
if you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
if you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
if you have previously suffered from other stomach or intestinal disorders;
if you have chickenpox, because, in rare cases, NSAIDs may worsen the infection;
if you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral steroids, certain antidepressants (e.g. SSRIs, selective serotonin reuptake inhibitors), antiplatelet agents like aspirin, or anticoagulants like warfarin. In such cases, consult your doctor before taking Ketesse: they may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other drugs that reduce gastric acid production);
if you suffer from asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyps, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, especially in individuals allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents
The use of Ketesse has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and the medicine must not be used in children and adolescents.

Other medicines and Ketesse
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those without a prescription. Some medicines should not be used together, while others may require dose adjustments when taken concurrently.

Always inform your doctor, dentist, or pharmacist if you are using or are being given any of the following medicines in addition to Ketesse:

Combinations not recommended:
Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs
Warfarin, heparin, or other medicines used to prevent blood clot formation
Lithium, used to treat mood disorders
Methotrexate (anti-cancer or immunosuppressive medicine), used at doses higher than 15 mg/week
Phenytoin and phenytoin, used for epilepsy
Sulfamethoxazole, used for bacterial infections

Combinations requiring caution:
ACE inhibitors, diuretics, and angiotensin II antagonists, used for hypertension and heart conditions
Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers
Zidovudine, used in the treatment of viral infections
Aminoglycoside antibiotics, used to treat bacterial infections
Sulfonylureas (e.g. chlorpropamide and glibenclamide), used for diabetes
Methotrexate, used at low doses (less than 15 mg/week)

Combinations requiring careful evaluation:
Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin), used for bacterial infections
Cyclosporine or tacrolimus, used to treat immune system disorders and as transplant therapy
Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. medicines used to dissolve blood clots
Probenecid, used for gout
Digoxin, used in the treatment of chronic heart failure
Mifepristone, used to induce abortion (terminate pregnancy)
Selective serotonin reuptake inhibitor (SSRI) antidepressants
Antiplatelet agents used to reduce platelet aggregation and blood clot formation
Beta-blockers, used for high blood pressure and heart problems
Tenofovir, deferasirox, pemetrexed

If you have any doubts about taking other medicines in combination with Ketesse, consult your doctor or pharmacist.

Ketesse with food and drinks
In case of severe pain, take the sachet on an empty stomach, i.e. at least 15 minutes before meals, to allow the medicine to act more quickly.

Pregnancy, breastfeeding and fertility
Do not use Ketesse during the last three months of pregnancy or if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine, as Ketesse may not be the right medicine for you.
The use of Ketesse should be avoided in women who are planning a pregnancy or who are pregnant.
Treatment at any stage of pregnancy should only be carried out under direct medical supervision.
The use of Ketesse is not recommended when planning a pregnancy or during fertility investigations.
Regarding potential effects on female fertility, also refer to section 2 “Warnings and precautions”.

Driving and using machines
Ketesse may cause undesirable effects such as dizziness, drowsiness, and visual disturbances, which may impair the ability to drive or operate machinery. If you experience these effects, do not drive or operate machinery until symptoms have resolved. Consult your doctor for advice.

Ketesse contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. This medicine contains 1.20 – 1.22 g of sucrose per dose. This should be taken into account in patients with diabetes mellitus.

13. How to use Ketesse

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults over 18 years of age
The recommended dose is 1 sachet (12.5 mg) every 4–6 hours, not exceeding 6 sachets per day (75 mg).
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3–4 days. Your doctor will advise you on how many sachets to take daily and for how long. The dose of Ketesse you need depends on the type, intensity, and duration of pain.
If you are elderly or suffer from kidney or liver disease, you should start treatment with a maximum total daily dose of no more than 4 sachets (50 mg).
In elderly patients, this initial dose may subsequently be increased to the generally recommended dose (75 mg of dexketoprofen) if Ketesse has been well tolerated.
If pain is severe and you wish to achieve faster relief, take the sachets on an empty stomach (at least 15 minutes before meals), as this will facilitate absorption (see section 2 "Ketesse with food and drink").
Use in children and adolescents
This medicine must not be used in children and adolescents (under 18 years of age).
Instructions for correct use
Dissolve the entire contents of each sachet in a glass of water; shake/mix thoroughly to ensure complete dissolution. The resulting solution should be taken immediately after reconstitution.
If you take more Ketesse than you should
If you have taken an excessive dose of this medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine pack or this leaflet with you.
If you forget to take Ketesse
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time (as described in section 3 "How to use Ketesse ” ).
If you have further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The possible side effects are listed below, grouped according to how likely they are to occur.
Since this list is partly based on the side effects of the Ketesse tablet formulation, and Ketesse granules are absorbed more rapidly than tablets, the actual frequency of side effects (particularly gastrointestinal) may be higher with Ketesse granules.

Common side effects (may affect up to 1 in 10 people)
Nausea and/or vomiting, abdominal pain mainly in the upper quadrants, diarrhoea, digestive problems (dyspepsia).

Uncommon side effects (may affect up to 1 in 100 people)
Dizziness, vertigo, somnolence, insomnia, nervousness, headache, palpitations, hot flushes, inflammation of the gastric wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling of fever and chills, general malaise.

Rare side effects (may affect up to 1 in 1,000 people)
Peptic ulcer, haemorrhagic or perforated peptic ulcer (presenting with haematemesis, i.e. vomiting blood, or black stools), fainting, hypertension, slow breathing, fluid retention and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), altered sensation (particularly tactile), itchy rash, acne, increased sweating, low back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), hepatocellular damage (hepatitis), acute kidney failure.

Very rare side effects (may affect up to 1 in 10,000 people)
Anaphylactic reactions (hypersensitivity reactions that may even lead to collapse), open skin lesions, in the mouth, eyes, and genital area (Stevens-Johnson syndrome and Lyell syndrome), facial oedema or swelling of the lips and throat (angioedema), breathlessness due to contraction of muscles surrounding the airways (bronchospasm), shortness of breath, rapid heartbeat, hypotension, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Reduced number of white blood cells (neutropenia), decreased platelets in the blood (thrombocytopenia).

Inform your doctor immediately if you notice any stomach or intestinal side effects at the beginning of treatment (e.g. stomach pain, heartburn, or bleeding), especially if you have previously experienced such side effects due to prolonged use of anti-inflammatory medicines and particularly if you are elderly.

Stop using Ketesse immediately if you develop a skin rash or any lesions inside the mouth or in the genital area, or any signs of allergy.

During treatment with non-steroidal anti-inflammatory drugs (NSAIDs), fluid retention and swelling (particularly in the ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines such as Ketesse may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke (cerebrovascular accident).

In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may, in rare cases, cause fever, headache, and neck stiffness.

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation, or bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported following administration. Gastric wall inflammation (gastritis) has been observed less frequently.

As with other NSAIDs, haematological reactions (purpura, aplastic anaemia, haemolytic anaemia, and rarely agranulocytosis and bone marrow hypoplasia) may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketesse

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachets. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ketesse contains

• The active substance is dexketoprofen (as dexketoprofen trometamol). Each sachet contains 12.5 mg of dexketoprofen (as dexketoprofen trometamol).
• The other components are ammonium glycyrrhizinate, neohesperidin dihydrochalcone, quinoline yellow (E104), lemon flavour, sucrose and hydrated colloidal silica (see section 2, “Enantyum contains sucrose”).

Description of the appearance of KETESSE and contents of the pack
Sachets containing a lemon-yellow granulate.
Ketesse 12.5 mg is available in packs containing 2, 10, 20, 30, 40, 50, 100 and 500 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Menarini International Operations Luxembourg SA - Avenue de la Gare, 1 - Luxembourg
Legal representative and distributor:
Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori - Strada 6 - Edificio L - Rozzano (MI), Italy

Manufacturer
LABORATORIOS MENARINI, S.A.,
Alfons XII 587, 08918-Badalona (Barcelona), SPAIN

This medicinal product has been authorised in the European Economic Area Member States
under the following trade names:
Austria, Belgium, Denmark, Iceland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden: Ketesse
Cyprus, Greece: Nosatel
Estonia: Dolmen
Hungary: Ketodex
Ireland, Malta, United Kingdom: Keral
Netherlands: Stadium
Poland: Dexak
Slovakia: Dexadol
Slovenia: Menadex

This leaflet was last updated on
PACKAGE LEAFLET

Ketesse 50 mg/2 ml injectable solution or infusion solution

Dexketoprofen
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What Ketesse is and what it is used for
2. What you need to know before using Ketesse
3. How to use Ketesse
4. Possible side effects
5. How to store Ketesse
6. Contents of the pack and other information

1. What Ketesse is and what it is used for

Ketesse is a pain-relieving medicine belonging to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used to treat moderate to severe acute pain when oral tablet administration is not appropriate, such as in postoperative pain, renal colic, and lumbago.

14. What you need to know before using Ketesse

Do not use Ketesse:
if you are allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in
section 6);
if you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs);
if you have asthma or have previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation
of the nasal mucosa), nasal polyps (growths in the nose due to allergy), urticaria (skin rash),
angioedema (swelling of the face, eyes, lips, or tongue, or breathing difficulties) or wheezing in the
chest, after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
if you have previously experienced photoallergic or phototoxic reactions (a particular type of skin redness and/or blistering
following exposure to sunlight) during treatment with ketoprofen (a non-steroidal anti-inflammatory drug) or with fibrates (medicines used to reduce blood fat levels);
if you have a peptic ulcer/bleeding in the stomach or intestine, or if you have previously experienced bleeding from the
stomach or intestine, ulceration, or perforation;
if you currently suffer or have previously suffered from bleeding in the stomach or intestine or perforation, due to previous use of non-steroidal anti-inflammatory drugs (NSAIDs);
if you have chronic digestive problems (e.g. indigestion, heartburn);
if you have inflammatory bowel diseases (Crohn’s disease or ulcerative colitis);
if you have severe heart failure, moderate or severe kidney problems, or serious liver problems;
if you have bleeding disorders or coagulation disorders;
if you are severely dehydrated (have lost a large amount of body fluids) due to vomiting, diarrhoea, or insufficient fluid intake;
if you are in the third trimester of pregnancy or are breastfeeding;

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketesse:
if you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
if you currently suffer or have previously suffered from other stomach or intestinal disorders;
if you are taking other medicines that increase the risk of peptic ulcer or bleeding, for example
oral steroids, certain antidepressants (SSRIs, i.e. selective serotonin reuptake inhibitors), or medicines that prevent blood clotting such as aspirin or anticoagulants like warfarin. In such cases, consult your doctor before taking Ketesse: they may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other medicines that block gastric acid production);
if you have heart problems, have had a stroke, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or are a smoker); discuss treatment with your doctor or pharmacist; medicines such as Ketesse may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. These risks are more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
if you are elderly: there is a higher likelihood of experiencing side effects (see section 4).
If any occur, consult your doctor immediately;
if you have allergies or have previously experienced allergic reactions;
if you have kidney, liver, or heart problems (hypertension and/or heart failure), fluid retention, or have previously suffered from any of these conditions;
if you are taking diuretics or are severely dehydrated or have reduced blood volume due to excessive fluid loss (e.g. due to excessive urine production, diarrhoea, vomiting);
if you are a woman with fertility problems (Ketesse may reduce female fertility; therefore, do not use this medicine if you are planning a pregnancy or undergoing fertility investigations);
if you are in the first or second trimester of pregnancy;
if you have a blood or blood cell formation disorder;
if you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
if you have chickenpox, as NSAIDs may exceptionally worsen the infection;
if you suffer from asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyps, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in individuals allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents
Ketesse has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and the product must not be used in children and adolescents.

Other medicines and Ketesse
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Some medicines should not be used in combination with Ketesse, while others require specific adjustments, for example in dosage.
Always inform your doctor if you are using or are being administered any of the following medicines in addition to Ketesse:

Combinations not recommended:
Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs
Warfarin, heparin, or other medicines used to prevent blood clotting
Lithium, used to treat certain mood disorders
Methotrexate (anti-cancer or immunosuppressive medicine), used at doses higher than 15 mg/week
Hydantoin and phenytoin, used for epilepsy
Sulfamethoxazole, used for bacterial infections

Combinations requiring caution:
ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure and heart conditions
Pentoxifylline and oxpentifilline, used to treat chronic venous ulcers
Zidovudine, used in the treatment of viral infections
Aminoglycoside antibiotics, used to treat bacterial infections
Sulfonylureas (e.g. chlorpropamide and glibenclamide), used for diabetes
Methotrexate, used at low doses, below 15 mg/week

Combinations requiring careful evaluation:
Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin), used for bacterial infections
Cyclosporine or tacrolimus, used to treat immune system disorders and as transplant therapy
Streptokinase and other thrombolytics or fibrinolytic medicines, i.e. medicines used to dissolve blood clots
Probenecid, used for gout
Digoxin, used in the treatment of chronic heart failure
Mifepristone, used to induce abortion (to terminate a pregnancy)
Selective serotonin reuptake inhibitor (SSRI) antidepressants
Antiplatelet agents used to reduce platelet aggregation and blood clot formation
Beta-blockers, used for high blood pressure and heart problems
Tenofovir, deferasirox, pemetrexed

If you have any doubts about taking other medicines in combination with Ketesse, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility
Do not use Ketesse during the last three months of pregnancy or while breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine, as Ketesse may not be suitable for you.
The use of Ketesse should be avoided in women who are planning a pregnancy or who are pregnant.
Treatment at any stage of pregnancy should only be carried out under direct medical supervision.
Ketesse is not recommended when planning a pregnancy or during fertility investigations.
Regarding potential effects on female fertility, also refer to section 2, "Warnings and precautions".

Driving and using machines
Ketesse may have moderate effects on the ability to drive and use machines due to possible adverse effects such as dizziness and drowsiness associated with treatment. If you experience these effects, do not drive or operate machinery until symptoms resolve. Consult your doctor.

Ketesse contains ethanol and sodium
Each vial of Ketesse contains 12.5 vol% ethanol (alcohol), i.e. more than 200 mg ethanol per dose, equivalent to 5 ml of beer or 2.08 ml of wine per dose.
It is therefore harmful for individuals suffering from alcoholism.
This should be taken into account when administering the medicine to pregnant or breastfeeding women, children, and high-risk groups, for example patients with liver disorders or epilepsy.
This medicine contains less than 1 mmol of sodium (23 mg) per dose and is therefore essentially "sodium-free".

15. How to take Ketesse

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Your doctor will determine the dose of Ketesse you need, depending on the type, severity, and duration of your symptoms. The recommended dose is generally 1 vial (50 mg) of Ketesse every 8–12 hours. If necessary, the injection may be repeated after only 6 hours. In any case, do not exceed the total daily dose of 150 mg of Ketesse (3 vials).

Use the injectable therapy only during the acute phase (i.e., for no more than two days). Switch to an oral painkiller as soon as possible.

Elderly patients with renal disease and patients with kidney or liver disorders must not exceed the total daily dose of 50 mg of Ketesse (1 vial).

Method of administration
Ketesse can be administered either intramuscularly or intravenously (technical details for intravenous injection are provided in section 7):
When Ketesse is administered intramuscularly, the solution must be injected slowly and deeply into the muscle immediately after withdrawal from the colored vial.
Use only if the solution is clear and colourless.

Use in children and adolescents
This medicine must not be used in children and adolescents (under 18 years of age).

If you take more Ketesse than you should
If you take an excessive dose of this medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the package of this medicine or this patient information leaflet with you.

If you forget to take Ketesse
Do not use a double dose to make up for a missed dose. Take the next scheduled dose at the usual time (refer to section 3 “How to use Ketesse”).

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The possible side effects are listed below, grouped according to their frequency of occurrence.

Common side effects: may affect up to 1 in 10 people
Nausea and/or vomiting, pain at the injection site, reactions at the injection site such as inflammation, bruising or bleeding.

Uncommon side effects: may affect up to 1 in 100 people
Vomiting blood, low blood pressure, fever, blurred vision, dizziness, drowsiness, sleep disturbances, headache, anaemia, abdominal pain, constipation, indigestion problems, diarrhoea, dry mouth, hot flushes, skin rash, dermatitis, itching, increased sweating, fatigue, pain, feeling cold.

Rare side effects: may affect up to 1 in 1,000 people
Peptic ulcer, haemorrhagic or perforated peptic ulcer, high blood pressure, fainting, slow breathing, inflammation of a superficial vein due to a blood clot (superficial thrombophlebitis), sensation of missed heartbeat (extrasystoles), rapid heartbeat, peripheral oedema, laryngeal oedema, altered sensations, feeling feverish and shivering, ringing in the ears (tinnitus), itchy rash, jaundice, acne, back pain, kidney pain, increased frequency of urination, menstrual disorders, prostate problems, muscle stiffness, joint stiffness, muscle cramps, altered liver function tests (blood tests), increased blood glucose (hyperglycaemia), decreased blood glucose (hypoglycaemia), increased blood triglyceride concentration (hypertriglyceridaemia), ketones in urine (ketonuria), protein in urine (proteinuria), liver cell damage (hepatitis), acute kidney failure.

Very rare side effects: may affect up to 1 in 10,000 people
Anaphylactic reaction (hypersensitivity reaction that may lead to collapse), skin ulceration, mouth, eyes and genital area (Stevens-Johnson syndrome and Lyell syndrome), swelling of the face, lips or throat (angioedema), breathing difficulty due to contraction of muscles surrounding the airways (bronchospasm), shortness of breath, pancreatitis, skin hypersensitivity reactions and photosensitivity, kidney damage, reduced number of white blood cells (neutropenia), reduced number of platelets (thrombocytopenia).

Immediately inform your doctor if you notice gastrointestinal side effects at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if you have previously experienced such side effects from long-term use of anti-inflammatory medicines and particularly if you are elderly.

Stop using Ketesse immediately if you notice a skin rash, or any lesion of the mucous membranes (e.g. inside the mouth), or any sign of allergy.

During treatment with non-steroidal anti-inflammatory drugs (NSAIDs), fluid retention and swelling (particularly in the ankles and legs), increased blood pressure and heart failure have been reported.

Medicines such as Ketesse may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke (cerebrovascular accident).

In patients with systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue), anti-inflammatory medicines may, in rare cases, cause fever, headache and stiffness of the back and neck.

Immediately inform your doctor if signs of infection appear or worsen during use of Ketesse.

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, especially in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported following administration. Less frequently, inflammation of the stomach lining (gastritis) has been observed.

As with other NSAIDs, haematological reactions (purpura, aplastic and haemolytic anaemia, and rarely agranulocytosis and bone marrow hypoplasia) may occur.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketesse

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial. The expiry date refers to the last day of that month.
Keep the vial in the outer cardboard packaging to protect the medicine from light.
Do not use this medicine if you notice that the solution is not clear and colourless, or if there are any signs of deterioration (e.g. presence of particulate matter). Ketesse injectable solution for infusion is for single use only and must be used immediately after opening. Discard any unused amounts of the product (see the subsection “Disposal” below).
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use and how to correctly discard used needles and syringes. This will help protect the environment.

6. Package contents and other information

What Ketesse contains

• The active substance is dexketoprofen (as dexketoprofen trometamol). Each vial contains 50 mg of dexketoprofen.
• The other components (excipients) are: alcohol (ethanol, see section 2 “Ketesse contains ethanol”), sodium chloride, sodium hydroxide, and water for injections.

Appearance of Ketesse and contents of the pack
Ketesse is a solution for injection or infusion.
It is available in packs containing 1, 5, 6, 10, 20, 50 or 100 coloured Type I glass vials, each containing 2 ml of clear, colourless solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Menarini International Operations Luxembourg SA – Avenue de la Gare 1, L-1611 Luxembourg
Legal representative and marketing authorisation holder:
Istituto Luso Farmaco d’Italia S.p.A. - Milanofiori - Strada 6 - Edificio L - Rozzano (MI), Italy

Manufacturer
A. Menarini Manufacturing Logistics and Services S.r.l.
Via Sette Santi, 3 - 50131 Florence, Italy
or
Alfasigma S.p.A.
Via Enrico Fermi, 1 - 65020 Alanno (Pescara), Italy

This medicinal product has been authorised in the Member States of the European Economic Area
under the following trade names:
This leaflet was last updated on

Spain (RMS), Austria, Belgium, Denmark, Finland, France, Iceland, Italy, Luxembourg, Norway, Portugal, Sweden: Ketesse
Cyprus, Greece: Nosatel
Czech Republic: Dexoket
Estonia, Latvia, Lithuania: Dolmen
Germany: Sympal
Hungary: Ketodex forte
Ireland, Malta: Keral
Netherlands: Stadium
Poland: Dexak
Slovakia: Dexadol
Slovenia: Menadex

7. Information for physicians and healthcare professionals

The following information is intended exclusively for physicians or healthcare professionals:
Intravenous use:
Intravenous infusion: the contents of one vial (2 ml) of Ketesse must be diluted in a volume
of 30 to 100 ml of normal saline solution, 5% glucose solution, or Ringer's lactate solution. The diluted solution should be administered by slow intravenous infusion over a period of 10 to 30 minutes. The solution must always be protected from light.
Intravenous bolus: if necessary, the contents of one vial (2 ml) of Ketesse may be
administered as a slow intravenous bolus over a period of not less than 15 seconds.
Ketesse is contraindicated for neuroaxial administration (intrathecal or epidural) due to its high ethanol content.
Instructions for handling the product:
When Ketesse is administered as an intravenous bolus, the solution must be injected immediately after withdrawal from the amber vial.
For administration as intravenous infusion, the solution must be aseptically diluted and protected from light.
Use only a clear and colourless solution.
Compatibility:
Ketesse has been shown to be compatible when mixed in small volumes (e.g., in a syringe) with injectable solutions of heparin, lidocaine, morphine, and theophylline.
The injectable solution diluted as indicated results in a clear solution. Ketesse diluted in
a volume of 100 ml of normal saline solution or glucose solution has been shown to be compatible with the following injectable solutions: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine, and theophylline.
No adsorption of the active substance was found when diluted solutions of Ketesse were stored in plastic bags or in EVA (ethylene-vinyl acetate), CP (cellulose propionate), LDPE (low-density polyethylene), and PVC (polyvinyl chloride) administration devices.
Package leaflet: information for the user

Ketesse 25 mg oral solution in sachet

Dexketoprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if you experience worsening of symptoms after 3-4 days.
Contents of this leaflet

13. What Ketesse is and what it is used for
14. What you need to know before taking Ketesse
15. How to take Ketesse
16. Possible side effects
17. How to store Ketesse
18. Package contents and other information

7. What Ketesse is and what it is used for

Ketesse is an analgesic belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for the short-term symptomatic treatment of mild to moderate acute pain, such as acute muscle pain, joint pain, painful menstruation (dysmenorrhoea), and toothache. Ketesse is indicated for adults.

16. What you need to know before taking Ketesse

Do not take Ketesse
if you are allergic to dexketoprofen trometamol or to any of the other ingredients of this medicine
(listed in section 6);
if you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs);
if you suffer from asthma or have previously experienced asthma attacks, acute allergic rhinitis (short episodes of nasal mucosa inflammation), nasal polyps (polypoid masses in the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue, or breathing difficulties), or wheezing after taking aspirin or other non-steroidal anti-inflammatory drugs;
if you have previously experienced photoallergic or phototoxic reactions (a particular form of redness and/or irritation of sun-exposed skin) while taking ketoprofen (an NSAID) or fibrates (medicines used to lower blood lipid levels);
if you have peptic ulcer/gastrointestinal bleeding, or if you have previously experienced gastrointestinal bleeding, ulceration or perforation;
if you have chronic digestive problems (e.g. indigestion, heartburn);
if you have previously experienced gastrointestinal bleeding or perforation due to the use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief;
if you suffer from chronic inflammatory bowel diseases (Crohn’s disease or ulcerative colitis);
if you have severe heart failure, moderate or severe renal failure, or severe hepatic failure;
if you have bleeding disorders or coagulation disorders;
if you are severely dehydrated (have lost a lot of fluids) due to vomiting, diarrhoea or insufficient fluid intake;
if you are in the third trimester of pregnancy or if you are breastfeeding;

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketesse:
if you suffer from allergies or have previously experienced allergic reactions;
if you have kidney, liver or heart disease (hypertension and/or heart failure) and fluid retention, or if you have previously experienced any of these conditions;
if you are being treated with diuretics or if you are poorly hydrated and have reduced blood volume due to excessive fluid loss (e.g. from excessive urination, diarrhoea, vomiting);
if you have heart disease, have had a stroke, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes or high cholesterol, or if you smoke); discuss treatment with your doctor or pharmacist; medicines like Ketesse may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or cerebrovascular accident (stroke). These risks are more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
if you are elderly, the risk of side effects is higher (see section 4); if any occur, consult your doctor immediately;
if you are a woman with fertility problems (Ketesse may reduce female fertility; therefore you should not take the medicine if you are planning a pregnancy or undergoing fertility investigations);
if you suffer from a blood or blood cell disorder;
if you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
if you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
if you currently suffer or have previously suffered from other stomach or intestinal disorders;
if you have chickenpox, because in rare cases NSAIDs may worsen the infection;
if you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral steroids, certain antidepressants (e.g. SSRIs, selective serotonin reuptake inhibitors), antiplatelet agents like aspirin, or anticoagulants like warfarin. In such cases, consult your doctor before taking Ketesse: they may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other drugs that reduce gastric acid production);
if you suffer from asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, especially in individuals allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents
The use of Ketesse has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and the medicine must not be used in children and adolescents.

Other medicines and Ketesse
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Some medicines cannot be used together, while others require dosage adjustments when taken concurrently.
Always inform your doctor, dentist or pharmacist if you are using or are being given any of the following medicines in addition to Ketesse.

Combinations not recommended:
Acetylsalicylic acid (aspirin), corticosteroids or other anti-inflammatory drugs;
Warfarin, heparin or other medicines used to prevent blood clot formation;
Lithium, used to treat mood disorders;
Methotrexate (anti-cancer or immunosuppressive medicine), used at doses exceeding 15 mg/week;
Hydantoin and phenytoin, used for epilepsy;
Sulfamethoxazole, used for bacterial infections.

Combinations requiring caution:
ACE inhibitors, diuretics, beta-blockers and angiotensin II antagonists, used for hypertension and heart conditions;
Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
Zidovudine, used in the treatment of viral infections;
Aminoglycoside antibiotics, used to treat bacterial infections;
Chlorpropamide and glibenclamide, used for diabetes;
Methotrexate, used at low doses (less than 15 mg/week).

Combinations requiring careful evaluation:
Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin), used for bacterial infections;
Cyclosporine or tacrolimus, used to treat immune system disorders and as transplant therapy;
Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. medicines used to dissolve blood clots;
Probenecid, used for gout;
Digoxin, used in the treatment of chronic heart failure;
Mifepristone, used to induce abortion (to terminate pregnancy);
Selective serotonin reuptake inhibitor (SSRI) antidepressants;
Antiplatelet agents used to reduce platelet aggregation and blood clot formation;
Beta-blockers, used for high blood pressure and heart problems.

If you have any doubts about taking other medicines in combination with Ketesse, consult your doctor or pharmacist.

Ketesse with food and drink
Take the sachets with food, as this helps reduce the risk of gastrointestinal side effects. However, if you have acute pain, take the sachet on an empty stomach, i.e. at least 30 minutes before meals, to allow the medicine to act more quickly.

Pregnancy, breastfeeding and fertility
Do not use Ketesse during the third trimester of pregnancy or while breastfeeding. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Regarding potential effects on female fertility, also refer to section 2 “Warnings and precautions”.

Driving and using machines
Ketesse may slightly impair the ability to drive or operate machinery due to possible side effects such as dizziness, drowsiness or visual disturbances. If you experience these effects, do not drive or use machinery until symptoms resolve. Consult your doctor for advice.

Ketesse contains methyl parahydroxybenzoate
This medicine may cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate.

Ketesse contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. This medicine contains 2.0 g of sucrose per dose. This should be taken into consideration in patients with diabetes mellitus.

17. How to take Ketesse

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The dose of Ketesse you need depends on the type, intensity, and duration of pain. Your doctor will tell you how many sachets you should take each day and for how long.
Adults over 18 years of age
The recommended dose is generally 1 sachet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 sachets per day (75 mg).
Consult your doctor if you do not feel better or if you feel worse after 3-4 days. Your doctor will tell you how many sachets per day to take and for how long. The dose of Ketesse you need depends on the type, intensity, and duration of pain.
If you are elderly or suffer from renal or hepatic impairment, treatment should be initiated with a total daily dose of no more than 2 sachets (50 mg of dexketoprofen).
In elderly patients, this initial dose may subsequently be increased to the generally recommended dose (75 mg of dexketoprofen) if Ketesse has been well tolerated.
If the pain is severe and you wish to achieve faster relief, take the sachets on an empty stomach (at least 30 minutes before meals), as this will facilitate absorption (see section 2 "Taking Ketesse with food and drink").
Use in children and adolescents
This medicine must not be used in children and adolescents (under 18 years of age).
Instructions for correct use
The oral solution can be taken directly from the sachet or after mixing the entire contents into a glass of water. Once the sachet is opened, take all of its contents.
If you take more Ketesse than you should
If you have taken an excessive dose of this medicine, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine package or this leaflet with you.
If you forget to take Ketesse
Do not take a double dose to make up for a forgotten dose. Take the next dose at the scheduled time (as stated in section 3 "How to use Ketesse").
If you have further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ketesse can cause side effects, although not everyone experiences them.
The possible side effects are listed below, grouped according to their frequency of occurrence.
Since this list is partly based on the side effects reported with the tablet formulation of Ketesse, and Ketesse
oral solution is absorbed more rapidly than tablets, the actual frequency of gastrointestinal side effects may be
higher with Ketesse oral solution in sachets.

Common side effects (may affect up to 1 in 10 people):
Nausea and/or vomiting, abdominal pain mainly in the upper quadrants, diarrhoea, digestive problems (dyspepsia).

Uncommon side effects (may affect up to 1 in 100 people):
Dizziness, vertigo, somnolence, insomnia, nervousness, headache, palpitations, flushing, inflammation of the stomach lining (gastritis), constipation, dry mouth, flatulence, rash, fatigue, pain, feeling of fever and chills, feeling of general malaise (malaise).

Rare side effects (may affect up to 1 in 1,000 people):
Peptic ulcer, haemorrhagic or perforated peptic ulcer (presenting with haematemesis, i.e. vomiting blood, or black stools), fainting, hypertension, slowed breathing, fluid retention and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), altered sensation, pruritic rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), hepatocellular damage (hepatitis), acute renal failure.

Very rare side effects (may affect up to 1 in 10,000 people):
Anaphylactic reactions (hypersensitivity reactions that may even lead to collapse), open skin sores, in the mouth, eyes, and genital area (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of the lips and throat (angioedema), breathlessness due to contraction of the muscles surrounding the airways (bronchospasm), shortness of breath, rapid heartbeat, hypotension, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Reduced number of white blood cells (neutropenia), decreased platelet count in the blood (thrombocytopenia).

Immediately inform your doctor if you notice any stomach or intestinal side effects at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if you have previously experienced such side effects due to prolonged use of anti-inflammatory medicines, and particularly if you are elderly.

Discontinue use of Ketesse immediately if you develop a skin rash or any lesions inside the mouth or in the genital area, or any signs of allergy.

During treatment with non-steroidal anti-inflammatory drugs (NSAIDs), fluid retention and swelling (particularly in the ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines such as Ketesse may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke (cerebrovascular accident).

In patients affected by immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may, in rare cases, cause fever, headache, and neck stiffness.

The most frequently observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported following administration. Gastric inflammation (gastritis) has been observed less frequently.

As with other NSAIDs, aseptic meningitis may occur, particularly in patients with systemic lupus erythematosus or mixed connective tissue disease, as well as haematological reactions (purpura, aplastic anaemia and haemolytic anaemia, and more rarely agranulocytosis and bone marrow hypoplasia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store Ketesse

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and sachets. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ketesse contains

• The active substance is dexketoprofen (as dexketoprofen trometamol). Each oral solution sachet contains 25 mg of dexketoprofen as dexketoprofen trometamol.
• The other components are ammonium glycyrrhizinate, neohesperidin dihydrochalcone, methyl parahydroxybenzoate (E 218), sodium saccharin, sucrose, macrogol 400, lemon flavour, povidone K-90, anhydrous disodium phosphate, sodium dihydrogen phosphate dihydrate, purified water.

Description of the appearance of Ketesse and package contents
Slightly coloured solution with a lemon odour and sweet citrus-lemon taste.
Ketesse 25 mg oral solution in sachets is supplied in packs containing 20 sachets.
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 – Luxembourg
Manufacturer
LABORATORIOS MENARINI, S.A.
Alfonso XII 587, 08918-Badalona (Barcelona), SPAIN
This medicinal product has been authorised in the Member States of the European Economic Area
under the following trade names:
Austria, Belgium, Denmark, Finland, France, Iceland, Italy, Luxembourg, Norway, Portugal, Spain,
Sweden: Ketesse
Cyprus, Greece: Nosatel
Czech Republic: Dexoket
Estonia, Latvia, Lithuania: Dolmen
Germany: Sympal
Hungary: Ketodex
Ireland, Malta, United Kingdom: Keral
Netherlands: Stadium
Poland: Dexak
Slovakia: Dexadol
Slovenia: Menadex
This leaflet was last updated on
PACKAGE LEAFLET: INFORMATION FOR THE USER

Ketesse 25 mg granules in sachet

Dexketoprofen
[For medicines available only on prescription:]
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

[For medicines available without a prescription:]
Please read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed.
Keep this leaflet. You may need to read it again.
If you need further information or advice, consult your pharmacist.
If you experience any adverse reaction, including those not listed in this leaflet,
contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3–4 days.
Contents of this leaflet:

1. What Ketesse is and what it is used for
2. What you need to know before taking Ketesse
   How to take Ketesse
3. Possible side effects
4. How to store Ketesse
5. Contents of the pack and other information

1. What Ketesse is and what it is used for

6. Ketesse is a pain reliever belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
7. It is used in adults for the short-term symptomatic treatment of mild to moderate acute pain, such as muscle and joint pain (e.g. back pain, sprains and acute injuries), painful menstruation, and toothache.

2. What you need to know before taking Ketesse

Do not take Ketesse:
if you are allergic to dexketoprofen or to any of the other ingredients of this medicine
(listed in section 6);
if you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs);
if you suffer from asthma or have previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (polypoid masses in the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue, or breathing difficulties) or wheezing in the chest after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
if you have previously experienced photoallergic or phototoxic reactions (a specific type of skin redness and/or blistering after exposure to sunlight) during treatment with ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood fat levels);
if you suffer from peptic ulcer or gastrointestinal bleeding, or if you have previously experienced bleeding, ulceration or perforation of the stomach or intestine;
if you have chronic digestive problems (e.g. indigestion, heartburn);
if you have previously experienced stomach or intestinal bleeding or perforation due to the use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief;
if you suffer from chronic inflammatory bowel diseases (Crohn’s disease or ulcerative colitis);
if you have severe heart failure, moderate or severe renal failure, or serious liver problems;
if you have bleeding disorders or coagulation problems;
if you are severely dehydrated (have lost a lot of fluids) due to vomiting, diarrhoea or insufficient fluid intake;
if you are in the third trimester of pregnancy or if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketesse:
if you suffer from allergies or have previously experienced allergic reactions;
if you have kidney, liver or heart problems (hypertension and/or heart failure) and fluid retention, or if you have previously experienced any of these conditions;
if you are being treated with diuretics or are poorly hydrated, or if you have reduced blood volume due to excessive fluid loss (e.g. due to excessive urination, diarrhoea, vomiting);
if you suffer from heart disease, have had a stroke, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol or if you smoke); discuss treatment with your doctor or pharmacist; medicines such as Ketesse may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke. These risks are more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
if you are elderly: the risk of side effects is higher (see section 4). If any occur, consult your doctor immediately;
if you are a woman with fertility problems (see section 2, "Pregnancy, breastfeeding and fertility");
if you suffer from a blood or blood cell formation disorder;
if you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
if you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
if you suffer or have previously suffered from other stomach or intestinal disorders;
if you have an infection – see section “Infections” below;
if you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral steroids, certain antidepressants (e.g. SSRIs, selective serotonin reuptake inhibitors), or agents that prevent blood clotting such as aspirin or anticoagulants like warfarin. In such cases, consult your doctor before taking Ketesse: they may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other drugs that block gastric acid production);
if you suffer from asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, especially in individuals allergic to acetylsalicylic acid or NSAIDs.

Infections
Dexketoprofen may mask symptoms of infection such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
Do not use Ketesse if you have chickenpox.

Children and adolescents
The use of Ketesse has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and the medicine should not be used in children and adolescents.

Other medicines and Ketesse
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription. Some medicines should not be used together, while others may require dosage adjustments when taken simultaneously.

Always inform your doctor, dentist or pharmacist if you are using or are given any of the following medicines in addition to Ketesse:

Combinations not recommended:
Acetylsalicylic acid, corticosteroids or other anti-inflammatory drugs
Warfarin, heparin or other medicines used to prevent blood clotting
Lithium, used to treat mood disorders
Methotrexate (anti-cancer or immunosuppressive medicine), used at doses higher than 15 mg/week
Phenytoin and phenytoin, used for epilepsy
Sulfamethoxazole, used for bacterial infections

Combinations requiring caution:
ACE inhibitors, diuretics and angiotensin II antagonists, used for high blood pressure and heart conditions
Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers
Zidovudine, used in the treatment of viral infections
Aminoglycoside antibiotics, used to treat bacterial infections
Sulfonylureas (e.g. chlorpropamide and glibenclamide) used for diabetes
Methotrexate, used at low doses (less than 15 mg/week)

Combinations requiring careful evaluation:
Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used for bacterial infections
Cyclosporine or tacrolimus, used to treat immune system disorders and as transplant therapy
Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. medicines used to dissolve blood clots
Probenecid, used for gout
Digoxin, used in the treatment of chronic heart failure
Mifepristone, used to induce abortion (to terminate pregnancy)
Selective serotonin reuptake inhibitor (SSRI) antidepressants
Antiplatelet agents used to reduce platelet aggregation and blood clot formation
Beta-blockers, used for high blood pressure and heart problems
Tenofovir, deferasirox, pemetrexed

If you have any doubts about taking other medicines in combination with Ketesse, consult your doctor or pharmacist.

Ketesse with food and drink and alcohol
In general, it is recommended to take this medicine with food to reduce the possibility of gastrointestinal disturbances (see also section 3, "Method of administration").
The use of NSAIDs in combination with alcohol may intensify adverse reactions caused by the active ingredient.

Pregnancy, breastfeeding and fertility
Do not use Ketesse during the last three months of pregnancy or if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine, as Ketesse may not be the appropriate medicine for you.
The use of Ketesse should be avoided by women who are planning a pregnancy or who are pregnant. Treatment at any stage of pregnancy should only be carried out under the direct supervision of a doctor.
The use of Ketesse may impair your fertility; therefore, it is not recommended to take the medicine if you are planning a pregnancy or undergoing fertility investigations.

Driving and using machines
Ketesse may have a slight influence on the ability to drive and use machines, due to the possibility of side effects associated with therapy such as dizziness or drowsiness. If you experience these effects, do not drive or use machines until symptoms have disappeared. Consult your doctor for advice.

Ketesse contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dosage unit, i.e. it is essentially "sodium-free".

3. How to take Ketesse

[For medicines available only on prescription:]
Take this medicine exactly as your doctor has told you. If you are unsure,
consult your doctor or pharmacist.
Your doctor will tell you how many sachets you need to take each day and for how long.
[For medicines available without prescription:]
Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The dose of Ketesse you need depends on the type, intensity and duration of your pain.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Adults over 18 years of age
The recommended dose is generally 1 sachet (25 mg) every 8 hours, not more than 3 sachets per day (75 mg).
Elderly, hepatic and renal impairment
If you are elderly or have mild renal problems or mild to moderate liver problems, treatment should be started with a total daily dose not exceeding 2 sachets (50 mg).
In elderly patients, this initial dose may be subsequently increased to the generally recommended dose (75 mg) if Ketesse has been well tolerated.
Do not use Ketesse if you have moderate or severe renal problems or severe liver problems. If in doubt, consult your doctor or pharmacist.
Use in children and adolescents
This medicine must not be used in children and adolescents (under 18 years of age).
Method of administration
Place the entire contents of one sachet of granules directly on the tongue and swallow as soon as it dissolves in the mouth, or drink a glass of water.
It may be taken with or without food. Taking Ketesse with food may help reduce the risk of stomach upset; however, if pain is severe and you need faster relief, take the granules on an empty stomach (at least 30 minutes before any meal or food intake), as it will then be absorbed more quickly (see section 2 "Ketesse with food, drinks and alcohol").
[For medicines available without prescription:]
Duration of treatment
Consult your doctor if you do not notice any improvement after 3–4 days or if your symptoms worsen.
If you take more Ketesse than you should
If you have taken an excessive dose of this medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine pack or this leaflet with you.
If you forget to take Ketesse
Do not take a double dose to make up for the missed sachet. Take the next dose at the scheduled time (according to section 3 “How to take Ketesse”).
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The possible side effects are listed below, grouped according to their frequency of occurrence.

Common side effects: (may affect up to 1 in 10 people)
Nausea and/or vomiting, abdominal pain mainly in the upper quadrants, diarrhoea, digestive problems (dyspepsia).

Uncommon side effects: (may affect up to 1 in 100 people)
Dizziness, vertigo, drowsiness, sleep disturbances, nervousness, headache, palpitations, flushing, inflammation of the gastric wall (gastritis), constipation, dry mouth, flatulence, rash, fatigue, pain, sensation of fever and chills, feeling of general malaise (malaise).

Rare side effects: (may affect up to 1 in 1,000 people)
Peptic ulcer, ulcer perforation or bleeding (manifesting as vomiting blood or black stools), fainting, high blood pressure, slowed breathing, fluid retention and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), altered sensation, itchy rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute renal failure.

Very rare side effects: (may affect up to 1 in 10,000 people)
Anaphylactic reactions (hypersensitivity reactions that may lead to collapse), open skin lesions, in the mouth, eyes, and genital area (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of the lips and throat (angioedema), shortness of breath due to narrowing of the airways (bronchospasm), shortness of breath, rapid heartbeat, low blood pressure, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Reduced number of white blood cells (neutropenia), decreased platelets in the blood (thrombocytopenia).

Immediately inform your doctor if you notice any stomach or intestinal side effects at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if you have previously experienced such side effects due to prolonged use of anti-inflammatory medicines, and particularly if you are elderly.

Stop using Ketesse immediately if you develop a skin rash or any lesions inside the mouth or in the genital area, or any signs of allergy.

During treatment with non-steroidal anti-inflammatory drugs (NSAIDs), fluid retention and swelling (particularly in the ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines such as Ketesse may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke (cerebrovascular accident).

In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may, in rare cases, cause fever, headache, and neck stiffness.

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported following administration. Gastric wall inflammation (gastritis) has been observed less frequently.

As with other NSAIDs, haematological reactions (purpura, aplastic and haemolytic anaemia, and rarely agranulocytosis and bone marrow hypoplasia) may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketesse

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachets after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ketesse contains

• The active substance is dexketoprofen (as dexketoprofen trometamol). Each sachet contains 25 mg of dexketoprofen.
• The other components are: butylated methacrylate copolymer, anhydrous colloidal silica, mannitol (E-421), lime flavour (containing natural lime flavour, arabic gum, and medium-chain triglycerides), sucralose.

Description of the appearance of Ketesse and contents of the pack
White to pale yellow granules, packed in single-dose sachets.
Available in packs of 2, 4, 10, 20, 30, 50 or 100 sachets and in multipacks containing 5 cartons, each containing 100 sachets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Menarini International Operations Luxembourg S.A. - Avenue de la Gare, 1 - Luxembourg
Legal representative and marketing authorisation holder:
Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori - Strada 6 - Edificio L - Rozzano (MI), Italy

Manufacturer:
LOSAN PHARMA GmbH
Otto-Hahn-Strasse 13-15
79395 Neuchâtel, Baden-Württemberg, GERMANY

This medicinal product is authorised in the European Economic Area countries under the following names:
Spain, Italy: Ketesse
Czech Republic: Dexoket
Estonia, Lithuania, Latvia: Dolmen
Hungary: Ketodex
Ireland, United Kingdom (Northern Ireland): Keral
Austria, Belgium, Luxembourg, Portugal: Ketesse
Netherlands: Stadium
Greece: Nosatel
Poland: Dexak
Slovakia: Dexadol