Ketesse 25 mg granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ketesse 25 mg granules for oral solution

dexketoprofen

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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 adverse effects

5. Storage of Ketesse

6. Contents of the pack and other information

1. 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 or joint pain, menstrual pain (dysmenorrhoea), and dental pain.

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 another non-steroidal anti-inflammatory drug (NSAID);
• If you have asthma or have experienced asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths inside the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue, or difficulty breathing), 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 special type of redness or sunburn-like skin damage on sun-exposed skin) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
• If you have peptic ulcer, gastrointestinal bleeding, or have previously had gastrointestinal bleeding, ulceration, or perforation;
• If you have 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) used for pain relief;
• If you have chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• If you have severe heart failure, moderate to severe kidney failure, or severe liver failure;
• If you have bleeding disorders or blood coagulation disorders;
• If you are severely dehydrated (have lost a large amount of body fluid) due to vomiting, diarrhoea, or insufficient fluid intake;
• If you are in the third trimester of pregnancy or breastfeeding;

Warnings and precautions

Consult your doctor or pharmacist before taking Ketesse:

• If you are allergic or have had allergic problems in the past;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have had any of these conditions in the past;
• If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhoea, or vomiting);
• If you have heart problems, a history of stroke, or think you may be at risk of these conditions (e.g., you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist. Medicines like Ketesse may be associated with a small increased risk of heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). This risk is more likely when high doses are used or treatment is prolonged. Do not exceed the recommended dose or duration of treatment;
• If you are elderly, you may be more likely to experience adverse effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (Ketesse may reduce fertility, so you should not take it if you are planning to become pregnant or undergoing fertility investigations);
• If you have a disorder affecting blood or blood cell production;
• If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If you currently have or have previously had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you currently have or have previously had stomach or intestinal disorders;
• 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 corticosteroids, certain antidepressants (SSRIs, selective serotonin reuptake inhibitors), or agents that prevent blood clotting such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin or acenocumarol (Sintrom). 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 drugs that block gastric acid production).
• If you have asthma, combined with rhinitis or chronic sinusitis, and/or nasal polyps, as you are at higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Ketesse may mask signs of infection such as fever and pain. Therefore, Ketesse may delay appropriate treatment of the infection, 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 a doctor without delay.

During chickenpox, it is advisable to avoid using this medicine.

Kounis syndrome

Cases of allergic reaction to dexketoprofen, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported with dexketoprofen. Discontinue treatment with Ketesse immediately and contact your doctor or the nearest emergency service immediately if you experience any of these symptoms.

Children and adolescents

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

Taking Ketesse with other medicines

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

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

Combinations not recommended:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin or acenocumarol (Sintrom), heparin, or other medicines used to prevent blood clot formation;
• Lithium, used to treat certain mood disorders;
• Methotrexate (a cancer and immunosuppressive medicine), when used at high doses of 15 mg/week;
• Hydantoins 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 to treat viral infections;
• Aminoglycoside antibiotics, used to treat bacterial infections;
• Sulfonylureas (e.g., chlorpropamide and glibenclamide), used for diabetes;
• Methotrexate, when used at low doses, less than 15 mg/week.

Combinations to be aware of:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used for bacterial infections;
• Cyclosporine or tacrolimus, used to treat immune system disorders and in organ transplantation;
• Streptokinase and other thrombolytic and fibrinolytic medicines; i.e., medicines used to dissolve clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (for termination of pregnancy);
• Selective serotonin reuptake inhibitors (SSRIs);
• Antiplatelet agents used to reduce platelet aggregation and clot formation;
• Beta-blockers, used for high blood pressure and heart conditions;
• Tenofovir, deferasirox, pemetrexed.

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

Ketesse with food and drinks

For acute pain, take the sachets on an empty stomach; i.e., at least 15 minutes before meals, as this helps the medicine act slightly faster.

Pregnancy, breastfeeding and fertility

Do not take Ketesse during the last three months of pregnancy or while breastfeeding. It may cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and may delay or prolong labour more than expected.

Do not take Ketesse during the first six months of pregnancy unless clearly necessary and specifically advised by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time.

From week 20 of pregnancy, Ketesse may cause kidney problems in your unborn baby if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Use of Ketesse is not recommended when trying to conceive or while undergoing fertility investigations.

For potential effects on female fertility, see also section 2, "Warnings and precautions".

Driving and using machines

Ketesse may slightly affect your ability to drive and use machines, as it may cause somnolence, dizziness, and blurred vision as adverse effects of treatment. If you experience these effects, do not operate machinery or drive until these symptoms have resolved. Seek advice from your doctor.

Ketesse contains sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Contains 2.418 g of sucrose per dose, which should be taken into account in patients with diabetes mellitus.

3. How to take Ketesse

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults over 18 years

The dose of Ketesse you need may vary depending on the type, intensity, and duration of pain. Your doctor will tell you how many sachets to take per day and for how long.

The recommended dose is 1 sachet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 sachets per day (75 mg).

If you are elderly or suffer from kidney or liver disease, treatment should be initiated with a maximum of 2 sachets per day (50 mg).

In elderly patients, this initial dose may subsequently be increased according to the general recommended dose (75 mg of dexketoprofen), provided Ketesse has been well tolerated.

If your pain is severe and you need rapid relief, take the sachets on an empty stomach (at least 15 minutes before meals), as they will be absorbed more easily (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 proper use

Dissolve the entire contents of one sachet in a glass of water; stir to help dissolve. The resulting solution should be taken immediately after reconstitution.

If you take more Ketesse than you should

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91.562.04.20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Ketesse

Do not take a double dose to make up for missed doses. Take the next dose as scheduled (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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The possible adverse effects are listed below according to their frequency. Since this list is partly based on adverse effects observed with the use of Ketesse tablets, and since Ketesse granules are absorbed faster than tablets, the actual frequency of (gastrointestinal) adverse effects may be higher with Ketesse granules.

Frequent adverse effects: may affect up to 1 in 10 people

Nausea and/or vomiting, mainly pain in the upper abdominal quadrant, diarrhoea, digestive disorders (dyspepsia).

Uncommon adverse effects: may affect up to 1 in 100 people

Sensation of spinning (vertigo), dizziness, somnolence, sleep disorders, nervousness, headache, palpitations, hot flushes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling feverish and chills, general malaise.

Rare adverse effects: may affect up to 1 in 1,000 people

Peptic ulcer, peptic ulcer perforation or bleeding (which may present as vomiting blood or black stools), fainting, elevated blood pressure, slow breathing, fluid retention and peripheral swelling (e.g., swelling of ankles), laryngeal oedema, loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, low back pain, frequent urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests), acute renal failure.

Very rare: may affect up to 1 in 10,000 people

Anaphylactic reaction (hypersensitivity reaction that may also lead to collapse), skin ulcers in mouth, eyes and genital areas (Stevens-Johnson syndrome and Lyell syndrome), swelling of the face or swelling of lips and throat (angioedema), breathing difficulty due to narrowing of airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, inflammation of the pancreas, liver cell damage (hepatitis), blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decreased number of white blood cells (neutropenia), decreased number of platelets (thrombocytopenia).

Frequency not known: cannot be estimated from available data

Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Drug-induced fixed eruption

Allergic skin reaction known as drug-induced fixed eruption, which may include round or oval red patches and skin swelling, blisters and itching. Darkening of the skin in affected areas may also occur, which may persist after healing. Drug-induced fixed eruption usually reappears in the same location or locations if the medicine is taken again.

Immediately inform your doctor if you notice any gastrointestinal adverse effects at the beginning of treatment (e.g., stomach pain or burning sensation or bleeding), especially if you have previously experienced such adverse effects during long-term treatment with non-steroidal anti-inflammatory drugs, and particularly 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 genitals, or any other signs of allergy.

During treatment with non-steroidal anti-inflammatory drugs, cases of fluid retention and swelling (especially in 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 having a 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 rarely cause fever, headache, and neck stiffness.

The most commonly observed adverse effects are gastrointestinal. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, especially in elderly patients.

After administration, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported. Less frequently, inflammation of the stomach wall (gastritis) has been observed.

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 sachet. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Instead, return any unused medicines and their packaging to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ketesse

• 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 (E-104), lemon flavour, and sucrose (see section 2, Ketesse contains sucrose).

Appearance of the product and contents of the pack

Sachets containing a lemon-yellow granule.

Ketesse 25 mg is available in packs of 2, 4, 10, 20, 30, 40, 50, 100 and 500 sachets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

MENARINI INTERNATIONAL O.L., S.A.

1, Avenue de la Gare, L-1611, Luxembourg

Local representative

GUIDOTTI FARMA, S.L.

Alfons XII, 587

08918 Badalona (Barcelona)

Spain

Manufacturer

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 - Badalona (Barcelona) Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Belgium, France, Italy, Luxembourg, Portugal, Spain: Ketesse

Cyprus, Greece: Nosatel

Czech Republic: Dexoket

Estonia, Latvia, Lithuania: Dolmen

Germany: Sympal

Hungary: Ketodex

Ireland, Malta, United Kingdom (Northern Ireland): Keral

Netherlands: Stadium

Poland: Dexak

Slovak Republic: Dexadol

Slovenia: Menadex

Date of the most recent review of this leaflet: September 2025

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/.