Dexketoprofen Kern Pharma 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Dexketoprofeno Kern Pharma 25 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 you should not give it to others, even if they have the same symptoms as you, because it could 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 Dexketoprofeno Kern Pharma is and what it is used for

2. What you need to know before taking Dexketoprofeno Kern Pharma

3. How to take Dexketoprofeno Kern Pharma

4. Possible side effects

5. How to store Dexketoprofeno Kern Pharma

6. Contents of the container and other information

1. What Dexketoprofen Kern Pharma is and what it is used for

Dexketoprofen Kern Pharma 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 or joint pain, menstrual pain (dysmenorrhea), and dental pain.

2. What you need to know before taking Dexketoprofeno Kern Pharma

Allergic reactions to dexketoprofen have been reported, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Immediately stop treatment with Dexketoprofeno Kern Pharma and contact your doctor or nearest emergency service if you experience any of these symptoms.

Do not take Dexketoprofeno Kern Pharma

• If you are allergic to dexketoprofen trometamol or to any of the other components of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid (aspirin) or to any other non-steroidal anti-inflammatory drug (NSAID);
• If you have asthma or have previously 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 (aspirin) or other NSAIDs;
• If you currently have or have previously had peptic ulcer, gastrointestinal bleeding, or suffer from chronic digestive problems (e.g., indigestion, heartburn);
• If you have previously experienced gastrointestinal bleeding or perforation due to prior use of NSAIDs taken 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 renal impairment, or severe hepatic impairment;
• If you have bleeding disorders or blood coagulation disorders;
• If you are pregnant or breastfeeding;
• If you are under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting Dexketoprofeno Kern Pharma.

• If you are allergic or have previously had allergic reactions;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have previously suffered from any of these conditions;
• If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of stroke, or think you may be at risk of such conditions (e.g., high blood pressure, diabetes, high cholesterol, or if you smoke), you should discuss this treatment with your doctor or pharmacist. Medicines like Dexketoprofeno Kern Pharma may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke (“cerebrovascular accident”). This risk is 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 susceptible to adverse effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems, this medicine may reduce fertility; therefore, do 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 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 clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In such cases, consult your doctor before taking this medicine: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other drugs that block gastric acid production).

Children and adolescents

Do not take this medicine if you are under 18 years of age.

Taking Dexketoprofeno Kern Pharma with other medicines

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines. 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 this medicine, you are taking any of the following:

Combinations not recommended:

• Acetylsalicylic acid (aspirin), corticosteroids, and other NSAIDs;
• Warfarin, heparin, and other medicines used to prevent clot formation;
• Lithium, used to treat certain mood disorders;
• Methotrexate, used for rheumatoid arthritis and cancer;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections.

Combinations requiring caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used for controlling high blood pressure and heart disorders;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycoside antibiotics, used to treat bacterial infections;
• Chlorpropamide and glyburide, used for diabetes.

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.

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

Taking Dexketoprofeno Kern Pharma 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 adverse effects. However, in the case of acute pain, take the tablets on an empty stomach; that is, at least 30 minutes before meals, as this allows the medicine to act slightly faster.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine during pregnancy or while breastfeeding.

Consult your doctor or pharmacist before using any medicine.

• Inform your doctor if you are pregnant or planning to become pregnant, as this medicine may not be suitable for you.
• Do not take this medicine if you are breastfeeding. Seek medical advice.
• Do not take dexketoprofen during the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labor more than expected. You should not take dexketoprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, dexketoprofen may cause kidney problems in your fetus 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.

Driving and use of machines

This medicine may slightly affect your ability to drive or operate machinery, as it may cause drowsiness or dizziness as adverse effects. If you experience these effects, do not operate machinery or drive until these symptoms resolve. Seek advice from your doctor.

3. How to take Dexketoprofeno Kern Pharma

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

The dose of this medicine you need may vary, depending on the type, intensity, and duration of the pain. Your doctor will tell you how many tablets you should take each day and for how long.

Generally, the recommended dose is 1 tablet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 tablets per day (75 mg).

If you are elderly or suffer from any kidney or liver disease, it is recommended to start treatment with a maximum of 2 tablets per day (50 mg).

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

If your pain is severe and you need rapid relief, take the tablets on an empty stomach (at least 30 minutes before food), as they will be absorbed more easily (see section 2 “Taking Dexketoprofeno Kern Pharma with food and drink”).

If you take more Dexketoprofeno Kern Pharma than you should

If you have taken too much medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Please remember to always bring the medicine carton or this leaflet with you.

If you forget to take Dexketoprofeno Kern Pharma

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 Dexketoprofeno Kern Pharma”).

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 will experience them.

The possible adverse effects are detailed below according to their frequency. The following table indicates how many patients may experience these adverse effects:

Frequent adverse effects

Nausea and/or vomiting, stomach pain, diarrhoea, digestive disorders (dyspepsia).

Uncommon adverse effects

Spinning sensation (vertigo), dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling feverish and chills, general malaise.

Rare adverse effects

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

Very rare

Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), skin, mouth, eye or genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of lips and throat (angioedema), breathing difficulty due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decrease in white blood cell count (neutropenia), decrease in platelet count (thrombocytopenia).

Frequency not known

Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome. Fixed drug eruption: an allergic skin reaction known as fixed drug 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 can persist after healing. Fixed drug eruption usually reappears in the same location or locations if the medicine is taken again.

Inform your doctor immediately if you notice any gastrointestinal adverse effects when starting treatment (e.g. stomach pain or burning, or bleeding), especially if you have previously experienced such adverse effects during long-term treatment with anti-inflammatory medicines, and particularly if you are elderly.

Stop taking this medicine immediately if you develop a skin rash or any lesions in the mouth or genital area, 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 Dexketoprofen Kern Pharma 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.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if these adverse reactions are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: website: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

If you experience adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

5. Storage of Dexketoprofen Kern Pharma

PVC/PVDC/Al packaging: Do not store above 25°C. Keep in the original packaging to protect from light.

PA/Al/PVC/Al packaging: Do not store above 30°C.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister, following “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexketoprofen Kern Pharma

• The active substance is dexketoprofen trometamol. Each tablet contains 36.90 mg of dexketoprofen trometamol, equivalent to 25 mg of dexketoprofen.
• The other components are: corn starch, pregelatinized corn starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate and Opadry White (hypromellose, titanium dioxide, and polyethylene glycol 400).

Appearance of the product and contents of the pack

Dexketoprofen Kern Pharma is available in packs containing 20, 50 tablets and in hospital pack containing 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas – Madrid

Spain

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas - Madrid

Spain

Date of the most recent revision of this leaflet: August 2025

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