Leviadex

Package Leaflet: Information for the User

Dexketoprofene Pharmacare 25 mg oral solution
Dexketoprofene
Equivalent medicine
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 others, 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 Dexketoprofene Pharmacare is and what it is used for
2. What you need to know before taking Dexketoprofene Pharmacare
3. How to take Dexketoprofene Pharmacare
4. Possible side effects
5. How to store Dexketoprofene Pharmacare
6. Contents of the pack and other information

1. What Dexketoprofene Pharmacare is and what it is used for

Dexketoprofene Pharmacare is a pain-relieving medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for the short-term symptomatic treatment of mild to moderate acute pain, such as muscle or joint pain, painful menstruation (dysmenorrhoea), and toothache. Dexketoprofene Pharmacare is indicated for adults.

2. What you need to know before taking Dexketoprofene Pharmacare

Do not take Dexketoprofene Pharmacare

• 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 periods 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 aspirin 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 sun-exposed skin) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower lipid levels in the blood);
• if you have peptic ulceration/gastrointestinal bleeding or 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 related 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 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 Dexketoprofene Pharmacare:

• if you suffer from allergies or have previously had allergic problems;
• 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 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 Dexketoprofene Pharmacare 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 (Dexketoprofene Pharmacare 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 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 suffer or have previously suffered from other stomach or intestinal disorders;
• if you have chickenpox, because NSAIDs may exceptionally worsen the infection;
• if you have an infection – see the 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), antiplatelet agents such as aspirin, or anticoagulants such as warfarin. In these cases, consult your doctor before taking Dexketoprofene Pharmacare: 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 subjects allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents
The use of Dexketoprofene Pharmacare 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 Dexketoprofene Pharmacare
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines cannot be used in combination, while others may require dosage adjustments when taken together.
Always inform your doctor, dentist or pharmacist if you are using or are prescribed any of the following medicines in addition to Dexketoprofene Pharmacare.

Combinations not recommended:

• Acetylsalicylic acid (aspirin), corticosteroids or other anti-inflammatory medicines;
• 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, 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;
• Tenofovir, an anti-HIV medicine;
• Deferasirox, used to remove excess iron from the body;
• Pemetrexed, a medicine used in the treatment of lung carcinoma.

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

Dexketoprofene Pharmacare 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 15 minutes before meals, so that the medicine can act more quickly.

Pregnancy, breastfeeding and fertility
Do not use Dexketoprofene Pharmacare during the third trimester 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.
Regarding potential effects on female fertility, also refer to section 2 “Warnings and precautions”.

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

Infections
Dexketoprofene Pharmacare may mask symptoms of infections such as fever and pain. Therefore, Dexketoprofene Pharmacare could 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.

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

Dexketoprofene Pharmacare 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 account in patients with diabetes mellitus.

Dexketoprofene Pharmacare contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially sodium-free.

Dexketoprofene Pharmacare contains ethanol
This medicine contains 12.22 mg of alcohol (ethanol) in each dosage unit. The amount in 25 mg of this medicine is equivalent to less than 0.33 ml of beer or 0.125 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

3. How to take Dexketoprofene Pharmacare

Always follow exactly your doctor's instructions when taking this medicine. If you have any doubts, consult your doctor or pharmacist.
The dose of Dexketoprofene Pharmacare 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.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

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).

If you are elderly or suffer from renal or hepatic disease, treatment should be started with a total daily dose of no more than 2 sachets (50 mg of dexketoprofen).
In elderly patients, this initial dose may later be increased to the generally recommended dose (75 mg of dexketoprofen) if dexketoprofen 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 "Dexketoprofene Pharmacare 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, if preferred, the entire contents can be dissolved in a glass of water. Once the sachet is opened, take all of its contents.

If you take more Dexketoprofene Pharmacare than you should
If you take too high a 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 Dexketoprofene Pharmacare
Do not take a double dose to make up for the missed dose. Take the next scheduled dose at the usual time (as stated in section 3 "How to take Dexketoprofene Pharmacare").

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 gets them.
The possible side effects are listed below, grouped according to their frequency of occurrence. Since the maximum concentration of dexketoprofen in the oral solution formulation is higher than that reported for the tablet formulation, a potentially increased risk of adverse effects (gastrointestinal) cannot be excluded.

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, somnolence, insomnia, nervousness, headache, palpitations, flushing, inflammation of the gastric wall (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 (manifesting as 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, itchy skin rash, acne, increased sweating, 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 patients):
Anaphylactic reactions (hypersensitivity reactions which 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 muscles surrounding 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 gastrointestinal 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 Dexketoprofene Pharmacare immediately if you notice the appearance of 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 Dexketoprofene Pharmacare 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, melena, haematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported following administration. Less frequently, inflammation of the gastric wall (gastritis) has been observed.

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 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, 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 Dexketoprofene Pharmacare

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.
Store below 25 °C.
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 Dexketoprofene Pharmacare contains

• The active substance is dexketoprofen (25 mg) as dexketoprofen trometamol (36.90 mg).
• The other components are: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, methyl para-hydroxybenzoate (E-218), sodium saccharin E954, sucrose, macrogol 400, lemon flavouring,
  (ethanol, lemon essential oils), povidone K-90, anhydrous disodium phosphate, sodium dihydrogen phosphate dihydrate, purified water.

Description of the appearance of Dexketoprofene Pharmacare and package contents
Colourless solution with a sweet taste and a citrus-lemon aroma.
Dexketoprofene Pharmacare 25 mg oral solution in sachets is supplied in packs containing 10 and 20 sachets.
Each sachet contains 10 ml of oral solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharmacare Srl
Via Marghera, 29
20149 Milan
Italy

Manufacturer
SAG MANUFACTURING S.L.U.
Crta N-I, Km 36
28750 San Agustin de Guadalix
Madrid - Spain

Galenicum Health, S.L.
Avda. Cornellá 144, 7th floor, 1st building LEKLA,
Esplugues de Llobregat,
08950, Barcelona, Spain

Package leaflet: Information for the patient

Dexketoprofene Pharmacare 25 mg film-coated tablets
Dexketoprofene
Equivalent medicine
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 they have the same symptoms as yours, because it may 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 Dexketoprofene Pharmacare is and what it is used for
2. What you need to know before taking Dexketoprofene Pharmacare
3. How to take Dexketoprofene Pharmacare
4. Possible side effects
5. How to store Dexketoprofene Pharmacare
6. Contents of the pack and other information

1. What Dexketoprofene Pharmacare is and what it is used for

Dexketoprofene Pharmacare is a pain-relieving medicine 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.

2. What you should know before taking Dexketoprofene Pharmacare

Do not take Dexketoprofene Pharmacare

• 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 (aspirin) 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 aspirin or other NSAIDs;
• if you have previously experienced photoallergic or phototoxic reactions (a specific type of redness and/or irritation of sun-exposed skin) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
• if you currently have 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 gastrointestinal bleeding or perforation due to the use of 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 Dexketoprofene Pharmacare:

• if you suffer from allergies or have previously had allergic reactions;
• if you have kidney, liver, or heart disease (hypertension and/or heart failure), or fluid retention, or if you have previously suffered from any of these conditions;
• if you are being treated with diuretics, or if you are poorly hydrated or have reduced blood volume due to excessive fluid loss (e.g. from excessive urination, diarrhoea, or 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, high cholesterol, or if you smoke); discuss treatment with your doctor or pharmacist. Medicines such as Dexketoprofene Pharmacare may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke. These risks are higher 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 (Dexketoprofene Pharmacare may reduce female fertility; therefore, you should not take this medicine if you are planning a pregnancy or undergoing fertility investigations);
• if you have 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 have or have previously had other stomach or intestinal disorders;
• if you have chickenpox, because in rare cases NSAIDs may worsen the infection;
• if you have an infection – see the 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), antiplatelet agents such as aspirin, or anticoagulants such as warfarin. In these cases, consult your doctor before taking Dexketoprofene Pharmacare: 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 Dexketoprofene Pharmacare 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 Dexketoprofene Pharmacare
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. 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 Dexketoprofene Pharmacare.

Not recommended combinations:

• 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, used for rheumatoid arthritis or cancer;
• 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.

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 immunosuppressive 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;
• Tenofovir, an HIV medicine;
• Deferasirox, used to remove excess iron from the body;
• Pemetrexed, a medicine used in the treatment of lung carcinoma.

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

Dexketoprofene Pharmacare with food and drinks
Take the tablets with an adequate amount of water. Take the tablets with food, as this helps reduce the risk of gastrointestinal side effects. However, if you have acute pain, take the tablet on an empty stomach, i.e. at least 30 minutes before meals, so that the medicine can act more quickly.

Pregnancy, breastfeeding and fertility
Do not use Dexketoprofene Pharmacare during the third trimester of pregnancy or while breastfeeding. Consult your doctor.
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine, as Dexketoprofene Pharmacare may not be suitable for you.
Women who are planning a pregnancy or are pregnant should avoid using Dexketoprofene Pharmacare. At any stage of pregnancy, treatment should only be carried out under medical supervision.
The use of Dexketoprofene Pharmacare is not recommended when trying to conceive or during fertility investigations.

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

Infections
Dexketoprofene Pharmacare may mask symptoms of infections such as fever and pain. Therefore, Dexketoprofene Pharmacare could delay appropriate treatment of an 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.

Dexketoprofene Pharmacare contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially sodium-free.

3. How to take Dexketoprofene Pharmacare

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
The dose of Dexketoprofene Pharmacare 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 (25 mg) every 8 hours, not exceeding 3 tablets per day (75 mg).
If you are elderly or suffer from kidney or liver disease, treatment should begin 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 Dexketoprofene Pharmacare 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 "Dexketoprofene Pharmacare with food and drink").
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 (such as fever and pain) persist or worsen (see section 2).
Use in children and adolescents
This medicine must not be used in children and adolescents (under 18 years of age).
If you take more Dexketoprofene Pharmacare 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 patient information leaflet with you.
If you forget to take Dexketoprofene Pharmacare
Do not take a double dose to make up for a forgotten dose. Take the next regular dose at the scheduled time (as stated in section 3 "How to use Dexketoprofene Pharmacare").
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 will experience them.
The possible side effects are listed below, grouped according to how likely they are to occur.
Common side effects: may affect up to 1 in 10 people
Nausea and/or vomiting, stomach pain, diarrhoea, digestive problems (dyspepsia).
Uncommon side effects: may affect up to 1 in 100 people
Dizziness, vertigo, drowsiness, insomnia, nervousness, headache, palpitations, flushing, stomach problems, 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 (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 sense of sensation, itchy 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 which may even lead to collapse), open sores on the skin, mouth, eyes and genital area (Stevens-Johnson syndrome and Lyell’s syndrome), facial oedema or swelling of the lips and throat (angioedema), breathlessness due to contraction of the muscles surrounding 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).
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), if you have previously suffered from these side effects due to prolonged use of anti-inflammatory medicines, and especially if you are elderly.
Stop using Dexketoprofene Pharmacare 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 medicines, fluid retention and swelling (particularly in the ankles and legs), increased blood pressure and heart failure have been reported.
Medicines such as Dexketoprofene Pharmacare may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
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.
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 Dexketoprofene Pharmacare

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The
expiry date refers to the last day of that month.
Do not store above 25°C. Keep the blister packs in the outer 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 Dexketoprofene Pharmacare contains

• The active substance is dexketoprofen trometamol (36.90 mg), equivalent to dexketoprofen (INN) 25 mg.
• The other ingredients are: maize starch, microcrystalline cellulose, sodium starch glycolate, glycerol distearate, hypromellose, titanium dioxide and polyethylene glycol 400.

Description of the appearance of Dexketoprofene Pharmacare and the contents of the pack
Dexketoprofene Pharmacare is available as white, biconvex, cylindrical film-coated tablets with a score line and "DT2" engraved on one side. The tablet can be divided into two equal doses.
The tablets are available in packs containing 20 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare Srl
Via Marghera, 29
20149 Milan
Italy

Manufacturer
SAG Manufacturing S.L.U.
Crta N-I, Km 36
28750 San Agustin de Guadalix
Madrid - Spain

Galenicum Health, S.L.
Avda. Cornellá 144, 7º-1ª Edificio LEKLA,
Esplugues de Llobregat,
08950, Barcelona, Spain