Ketesse

Patient Information Leaflet

Ketesse SL, 25 mg, granules for oral solution
Dexketoprofen
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3 to 4 days, you should contact your doctor.

Contents of the leaflet:

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

1. What Ketesse SL is and what it is used for

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

2. Important information before using Ketesse SL

When not to use Ketesse SL:

• If the patient is allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in section 6);
• If the patient is allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• If the patient has asthma or previously experienced asthma attacks, acute allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (nasal swellings caused by allergy), urticaria (blister-like rash), angioedema (swelling of the face, eyes, lips, tongue or a combination of breathing difficulties), or wheezing after taking acetylsalicylic acid or another NSAID;
• If the patient has previously experienced photosensitivity reactions or phototoxic reactions (a type of redness and/or peeling of the skin after exposure to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood fat levels);
• If the patient has gastric or duodenal ulcer disease, gastrointestinal bleeding, or if there has been previous gastrointestinal bleeding, ulceration or perforation;
• If the patient has chronic digestive problems (e.g. indigestion, heartburn);
• If the patient has previously experienced gastrointestinal bleeding or perforation due to prior use of NSAIDs used for pain relief;
• If the patient has chronic inflammatory bowel diseases (Crohn’s disease or ulcerative colitis);
• If the patient has severe heart failure, moderate or severe renal impairment, or severe hepatic impairment;
• If the patient has a tendency to bleed excessively or has coagulation disorders;
• If the patient is severely dehydrated (significant fluid loss) due to vomiting, diarrhoea, or insufficient fluid intake;
• If the patient is in the third trimester of pregnancy or is breastfeeding.

Warnings and precautions:
Before starting treatment with Ketesse SL, consult your doctor or pharmacist if:

• The patient has allergies or a history of allergic reactions;
• The patient has kidney, liver or heart problems (hypertension and/or heart failure), fluid retention, or if any of these conditions occurred previously;
• In patients receiving diuretics or in patients with reduced hydration and decreased blood volume due to excessive fluid loss (e.g. frequent urination, diarrhoea or vomiting);
• If the patient has heart problems, has had a stroke, or is suspected of being at risk for these conditions (e.g. due to high blood pressure, diabetes, high cholesterol levels or smoking). In such cases, consult a doctor before using Ketesse SL. Medicines such as Ketesse SL may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment duration than recommended;
• If the patient is elderly: there is an increased risk of adverse effects (see section 4). In such cases, contact a doctor immediately;
• In women experiencing fertility problems or undergoing fertility investigations (Ketesse SL may impair female fertility and should not be used in women planning pregnancy or undergoing fertility treatment);
• If the patient has blood or blood cell formation disorders;
• If the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If the patient has had chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease);
• If the patient has or has had other stomach or intestinal disorders;
• If the patient has an infection – see the section below titled “Infections”;
• If the patient is taking other medicines that increase the risk of gastric or duodenal ulceration or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, e.g. selective serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid or anticoagulants such as warfarin. In such cases, consult a doctor before taking the medicine. The doctor may decide to prescribe an additional protective medicine (e.g. misoprostol or medicines that inhibit gastric acid secretion);
• In patients with asthma, chronic rhinitis, chronic sinusitis and/or nasal polyps, the risk of hypersensitivity to acetylsalicylic acid and/or NSAIDs is higher than in the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid and/or NSAIDs.

Infections
Ketesse SL may mask symptoms of infection such as fever and pain. Therefore, Ketesse SL may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an ongoing infection and symptoms persist or worsen, consult a doctor immediately. Avoid using this medicine during chickenpox.
Allergic reactions to dexketoprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported during treatment. If any of these symptoms occur, stop using Ketesse SL immediately and contact a doctor or emergency services without delay.

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

Ketesse SL and other medicines
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. Some medicines should not be used together with Ketesse SL, while others may require dose adjustments when used concomitantly with Ketesse SL.
Always inform your doctor, dentist or pharmacist if you are taking any of the following medicines together with Ketesse SL:

Not recommended to use simultaneously:

• Acetylsalicylic acid, corticosteroids or other anti-inflammatory medicines
• Warfarin, heparin or other anticoagulant medicines
• Lithium used to treat certain mood disorders
• Methotrexate (an anticancer or immunosuppressive medicine) used in high doses of 15 mg per week
• Hydantoin derivatives and phenytoin used to treat epilepsy
• Sulfamethoxazole used to treat bacterial infections

Concomitant use requiring caution:

• ACE inhibitors, diuretics and angiotensin II antagonists used to treat high blood pressure and heart conditions
• Pentoxifylline and oxpentifylline used to treat ulcers in chronic venous insufficiency
• Zidovudine used to treat viral infections
• Aminoglycoside antibiotics used to treat bacterial infections
• Sulfonylurea derivatives (e.g. chlorpropamide and glibenclamide) used to treat diabetes
• Methotrexate used in low doses, below 15 mg per week

Concomitant use requiring special consideration:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used to treat bacterial infections
• Cyclosporine and tacrolimus used to treat immune system disorders and in transplant patients
• Streptokinase and other thrombolytic or fibrinolytic medicines used to dissolve blood clots
• Probenecid used to treat gout
• Digoxin used to treat chronic heart failure
• Mifepristone used as an abortion-inducing agent (to terminate pregnancy)
• Selective serotonin reuptake inhibitors (SSRIs) used as antidepressants
• Antiplatelet medicines used to reduce platelet aggregation and blood clot formation
• Beta-blockers used to treat high blood pressure and heart conditions
• Tenofovir, deferasirox, pemetrexed

If you have any doubts about taking Ketesse SL, consult your doctor or pharmacist.

Ketesse SL with food and drink
In case of acute pain, it is recommended to take the medicine on an empty stomach, e.g. at least 15 minutes before a meal, to allow faster onset of action.

Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use Ketesse SL during the last three months of pregnancy or while breastfeeding.
It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. Ketesse SL should not be used during the first 6 months of pregnancy unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time.
From the 20th week of pregnancy, Ketesse SL, if taken for longer than a few days, may cause:
renal dysfunction in the unborn child – this may lead to reduced amniotic fluid volume surrounding the foetus (oligohydramnios) or narrowing of blood vessels (ductus arteriosus) in the foetal heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring. Ketesse SL is not recommended for women planning pregnancy or undergoing fertility investigations.
Information on the potential effect on fertility is provided in section 2, “Warnings and precautions”.

Driving and operating machinery
Ketesse SL may have a minor influence on the ability to drive and operate machinery, as it may cause dizziness and visual disturbances. If such symptoms occur, do not drive or operate machinery until symptoms subside. If in doubt, consult a doctor.

Ketesse SL contains sucrose.
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Each dose contains 2.418 g of sucrose. This should also be taken into account in patients with diabetes.

3. How to use Ketesse SL

This medicine should always be taken exactly as described in the patient leaflet or as prescribed by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If symptoms of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Adults over 18 years of age
The recommended daily dose is 1 sachet (25 mg) every 8 hours, but not more than 3 sachets per day (75 mg).
If there is no improvement after 3 to 4 days, or if the patient feels worse, medical advice should be sought.
The doctor will inform the patient how many sachets should be taken per day and for how long.
The dose of Ketesse SL will depend on the type, severity, and duration of the patient's pain.
In elderly patients or those with kidney or liver disease, treatment should be initiated with a lower total daily dose corresponding to no more than 2 sachets (50 mg).
In elderly patients who tolerate the initial dose well, it may subsequently be increased to the recommended dose for the general population (75 mg of dexketoprofen).
In cases of acute pain requiring rapid relief, it is recommended to take the medicine on an empty stomach (at least 15 minutes before a meal), which will result in faster absorption of the drug (see section 2 "Taking Ketesse SL with food and drink").
Children and adolescents
This medicine must not be used in children and adolescents (under 18 years of age).
How to use Ketesse SL
Dissolve the contents of one sachet in a glass of water and stir well to facilitate dissolution.
The resulting solution should be taken immediately after preparation.
Taking more Ketesse SL than recommended
In case of suspected overdose, inform a doctor or pharmacist immediately or go to the nearest hospital emergency department.
Remember to bring the medicine packaging or patient leaflet with you.
If you forget to take Ketesse SL
Do not take a double dose to make up for a missed dose. The next dose should be taken according to the prescribed dosing schedule (see section 3 "How to use Ketesse SL").
If you have any further questions about the use of Ketesse SL, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The possible adverse effects listed below are categorized according to their likelihood of occurrence. The information provided below is partly based on data regarding adverse effects of Ketesse tablets; since Ketesse SL granules are absorbed more rapidly than tablets, the frequency of gastrointestinal adverse effects may be higher.

Common adverse effects (may affect up to 1 in 10 people):
Nausea and/or vomiting, abdominal pain, mainly in the upper abdomen, diarrhoea, indigestion (dyspepsia).

Uncommon adverse effects (may affect up to 1 in 100 people):
Vestibular dizziness, dizziness, somnolence, sleep disturbances, nervousness, headache, palpitations, facial flushing, inflammation of the stomach lining (gastritis), constipation, dryness of the oral mucosa, bloating, rash, fatigue, pain, feeling of fever and chills, malaise.

Rare adverse effects (may affect up to 1 in 1,000 people):
Peptic ulcer disease, bleeding or perforation of the gastrointestinal ulcer, which may present as vomiting blood or black stools, fainting, hypertension, reduced respiratory rate, fluid retention in the limbs and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, back pain, increased urination, menstrual disorders, prostate gland disorders, abnormal liver function tests (blood tests), liver damage (hepatitis), acute renal failure.

Very rare adverse effects (may affect up to 1 in 10,000 people):
Anaphylactic reactions (acute hypersensitivity reactions which may lead to anaphylactic shock), skin ulceration, ulceration of the mouth, eyes and genital areas (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of lips and throat (angioedema), shortness of breath due to airway narrowing (bronchospasm), shortness of breath, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin hypersensitivity reactions, photosensitivity, itching, kidney function problems, reduced white blood cell count (neutropia), reduced platelet count (thrombocytopenia).

Frequency not known: cannot be estimated from available data
Chest pain, which may be a symptom of an allergic reaction with potentially severe course, known as Kounis syndrome.

Fixed drug eruption
An allergic skin reaction known as fixed drug eruption, which may include round or oval areas of redness and swelling of the skin, blister formation and itching. Skin pigmentation changes in affected areas may also occur, which may persist after healing. Fixed drug eruptions typically recur in the same location(s) upon re-administration of the drug.

Patients should inform their doctor if they experience any adverse effects affecting the stomach or intestines at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if they have previously experienced similar adverse effects due to long-term use of anti-inflammatory medicines, particularly in elderly patients.

If a skin rash or any mucosal damage inside the mouth or on the genital organs occurs, or if any symptoms of allergy appear, treatment with Ketesse SL should be stopped immediately.

During administration of non-steroidal anti-inflammatory drugs, fluid retention and oedema (particularly of the ankles and legs), increased blood pressure and heart failure may occur.

Use of medicines such as Ketesse SL may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

In patients with systemic lupus erythematosus or mixed connective tissue disease (immunological disorders affecting connective tissue), administration of anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.

The most frequently observed adverse effects involved gastrointestinal disorders. Particularly in elderly patients, gastric or duodenal ulcer disease, perforation or bleeding from the stomach and/or duodenum may occur, sometimes with fatal outcome.

After administration of the medicine, the following have been reported: nausea, vomiting, diarrhoea, bloating, constipation, indigestion, abdominal pain, tarry stools, vomiting blood, ulcerative inflammation of the oral mucosa, exacerbation of colitis, and Crohn's disease.

Gastritis (inflammation of the stomach lining) has been observed less frequently.

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, patients should inform their doctor, pharmacist, or nurse.

Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Ketesse SL

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and on the sachet.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Ketesse SL contains

• The active substance is dexketoprofen (in the form of dexketoprofen trometamol). Each sachet contains 25 mg of dexketoprofen.
• Other ingredients: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, quinoline yellow (E-104), lemon flavor, sucrose (see section 2, Ketesse SL contains sucrose).

What Ketesse SL looks like and contents of the pack
Sachets containing yellow-lemon colored granules.
Ketesse SL is available in packs containing 10, 20, and 30 sachets.
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

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

This medicinal product is authorised in the following European Economic Area countries under the following names:
Hungary, Italy, Spain: Enantyum
Estonia, Latvia, Lithuania: Ketesse
Greece: Viaxal
Poland: Ketesse SL

For further information, please contact the local representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel. (22) 566 21 00
Fax. (22) 566 21 01