Dexketoprofen Tevagen 25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dexketoprofen Tevagen 25 mg film-coated tablets

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• 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.
• You must consult a doctor if your condition worsens or does not improve after 4 days.

Contents of the leaflet

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

1. What Dexketoprofeno Tevagen is and what it is used for

This medicine is an analgesic belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

Dexketoprofeno Tevagen is used in adults for the short-term symptomatic treatment of mild to moderate acute pain, such as muscle or joint pain (for example, back pain, sprains and acute injuries), menstrual pain, and dental pain.

2. What you need to know before taking Dexketoprofeno Tevagen

Do not take Dexketoprofeno Tevagen:

• 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 (aspirin) 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 experienced gastrointestinal bleeding, ulceration, or perforation;
• If you suffer from chronic digestive problems (e.g., indigestion, heartburn);
• If you have previously experienced gastrointestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) taken for pain;
• 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 severely dehydrated (have lost a large amount of body fluid) due to vomiting, diarrhea, or insufficient fluid intake;
• If you are in the third trimester of pregnancy or breastfeeding;

Warnings and precautions:

Talk to your doctor or pharmacist before taking Dexketoprofeno Tevagen:

• 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), or 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, diarrhea, or vomiting);
• If you have heart problems, a history of stroke, or think you may be at risk of these conditions (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker). You should discuss this treatment with your doctor or pharmacist. Medicines like dexketoprofen may be associated with a small increased risk of heart attacks (“myocardial infarction”) or strokes (“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 likely to experience adverse effects (see section 4). If they occur, consult your doctor immediately;
• If you are a woman with fertility problems (see section 2, “Pregnancy, breastfeeding and fertility”);
• If you have a disorder affecting blood or blood cell production;
• If you have systemic lupus erythematosus or mixed connective tissue disease (immune system diseases 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 blood clotting 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);
• If you have asthma, especially when associated with chronic rhinitis or sinusitis, and/or nasal polyps, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the general population. Taking this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Dexketoprofen may mask signs of infection such as fever and pain. Therefore, this medicine may delay appropriate treatment of an infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately.

Avoid using this medicine if you have chickenpox.

Kounis syndrome

Allergic reactions to dexketoprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported. Stop treatment with Dexketoprofeno Tevagen immediately and contact your doctor or the nearest emergency service right away if you experience any of these symptoms.

Children and adolescents

This medicine has not been studied in children or adolescents. Therefore, safety and efficacy have not been established, and it should not be used in children or adolescents.

Other medicines and Dexketoprofeno Tevagen

Tell 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 dexketoprofen, you are taking any of the following medicines:

Combinations not recommended:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent blood clotting;
• Lithium, used to treat certain mood disorders;
• Methotrexate (a cancer and immunosuppressant 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 to control 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;
• Sulfonylureas (e.g., chlorpropamide and glyburide), 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 blood clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (for termination of pregnancy);
• Antidepressants of the Selective Serotonin Reuptake Inhibitor (SSRI) type;
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation;
• Beta-blockers, used for high blood pressure and heart disorders;
• Tenofovir, deferasirox, pemetrexed.

If you have any questions about taking other medicines with Dexketoprofeno Tevagen, consult your doctor or pharmacist.

Taking Dexketoprofeno Tevagen with food, drinks, and alcohol

In general, it is recommended to take the medicine with food to reduce the possibility of stomach-related problems (see also section 3, “How to take”).

Using NSAIDs together with alcohol may worsen adverse reactions caused by the active ingredient.

Pregnancy, breastfeeding, and fertility

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 the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. 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 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 effective dose for the shortest possible time.

From week 20 of pregnancy, dexketoprofen 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 this medicine is not recommended while trying to conceive or while being evaluated for infertility. For potential effects on female fertility, see also section 2, “Warnings and precautions”.

Driving and using machines

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

Dexketoprofeno Tevagen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Dexketoprofeno Tevagen

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The required dose of the medicine may vary depending on the type, intensity, and duration of pain.

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

The tablets can be divided into equal doses.

Adults over 18 years old

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

Elderly patients or patients with renal or hepatic impairment

If you are elderly or have mild kidney problems or mild to moderate liver problems, treatment should be initiated with a maximum of 2 tablets per day (50 mg of dexketoprofen).

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

Dexketoprofen must not be used if you have moderate or severe kidney problems or severe liver problems. Consult your doctor or pharmacist if you are unsure.

Use in children and adolescents

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

Method of administration

Take the tablets with an adequate amount of water.

The medicine can be taken with or without food. Taking the medicine with food helps reduce the risk of stomach disturbances. However, if your pain is more intense and you need faster relief, take the tablet on an empty stomach (at least 30 minutes before any meal or food intake), as it will be absorbed more easily (see section 2, "Taking Dexketoprofeno Tevagen with food, drinks, and alcohol").

Duration of treatment

Treatment should not exceed 4 days. If pain persists beyond this period, worsens, or new symptoms appear, you must stop treatment and consult your doctor or pharmacist.

If you take more Dexketoprofeno Tevagen than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If you forget to take Dexketoprofeno Tevagen

Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time (according to section 3, "How to take Dexketoprofeno Tevagen").

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 everybody will experience them.

The possible adverse effects are listed below according to their frequency:

Frequent adverse effects (may affect up to 1 in 10 people)

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

Uncommon adverse effects (may affect up to 1 in 100 people)

Spinning sensation (vertigo), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flushes, stomach problems, 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, 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, pruritic 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 adverse effects (may affect up to 1 in 10,000 people)

Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), skin ulcers, mouth, eyes and genital areas (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, photosensitivity, itching, kidney problems. Decrease in the number of white blood cells (neutropenia), decrease in the number of platelets (thrombocytopenia).

Adverse effects with unknown frequency (cannot be estimated from the 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. Skin darkening 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 any of these adverse effects during long-term treatment with anti-inflammatory medicines, and particularly if you are elderly.

Stop taking this medicine immediately if you notice the appearance of a skin rash or any lesions inside the mouth or in the 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 Tevagen 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 in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients.

Following 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 may occur (purpura, aplastic and haemolytic anaemia, and more rarely agranulocytosis and bone marrow hypoplasia).

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 through the national reporting system included in the Spanish System of Pharmacovigilance of Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexketoprofen Tevagen

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 on the blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Dexketoprofen Tevagen:

• The active substance is dexketoprofen trometamol. Each film-coated tablet contains 25 mg of dexketoprofen, equivalent to 36.90 mg of dexketoprofen trometamol.

• The other components are:

Tablet core: maize starch, microcrystalline cellulose, sodium carboxymethyl starch (type A) from potato, glycerol distearate; Coating: hypromellose (E464), titanium dioxide (E171), macrogol 400.

Appearance of Dexketoprofen Tevagen and contents of the pack:

Film-coated, white, biconvex cylindrical tablets, scored on one side and marked with "DT2" on one side. The tablet can be divided into equal doses.

It is presented in packs containing 10 film-coated tablets.

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas

Madrid, Spain

Manufacturer

Galenicum Health, S.L.

San Gabriel, 50, Esplugues de Llobregat

08950 Barcelona (Spain)

SAG Manufacturing, S.L.U.

Ctra N-I, km. 36

28750 San Agustín del Guadalix

Madrid - Spain

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

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