Dexketoprofen Tevagen 25 mg oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dexketoprofen Tevagen 25 mg oral solution

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for taking this medicine 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 effects not listed in this leaflet. See section 4.
• You should 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 side effects
5. How to store Dexketoprofen Tevagen
6. Contents of the pack and other information

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

This medicine is an analgesic belonging to a 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 muscle or joint pain, menstrual pain (dysmenorrhoea), or dental pain.

Dexketoprofen is indicated for use in adult patients.

2. What you need to know before starting to take Dexketoprofen Tevagen

Do not take Dexketoprofeno Tevagen

• If you are allergic (hypersensitive) to dexketoprofen trometamol or to any of the other components of this medicine (listed in section 6);

• If you are allergic to acetylsalicylic acid or to any other 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 breathing difficulty), 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 a peptic ulcer, gastrointestinal bleeding, or 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 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, diarrhea, or insufficient fluid intake;

• If you are in the third trimester of pregnancy or breastfeeding;

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dexketoprofeno Tevagen:

• If you are allergic or have previously had allergic problems;
• 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 insufficient 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 (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 Dexketoprofeno Tevagen may be associated with a small increased risk of heart attacks (“myocardial infarction”) or strokes (“cerebrovascular accident”). Any risk is more likely when high doses or prolonged treatment are used. 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 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. 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 combined with chronic rhinitis or sinusitis, and/or nasal polyps, as you have a higher risk of being allergic 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.

Children and adolescents

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

Infections

This medicine may mask signs of infection, such as fever and pain. Consequently, it may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and 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

Cases of allergic reaction to dexketoprofen, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Immediately discontinue treatment with Dexketoprofeno Tevagen and contact your doctor or nearest emergency service if you experience any of these symptoms.

Other medicines and Dexketoprofeno Tevagen

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

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, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent blood clotting;
• Lithium, used to treat certain mood disorders;
• Methotrexate, used for rheumatoid arthritis and cancer, 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 control 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 glibenclamide, used for diabetes;
• Methotrexate, used at low doses, less than 15 mg/week.

Combinations to be considered:

• 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 pregnancy termination);
• Antidepressants of the type Selective Serotonin Reuptake Inhibitors (SSRIs);
• Antiplatelet agents used to reduce platelet aggregation and 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 upset (see also section 3, “How to take”).

The use of NSAIDs in combination with alcohol may worsen adverse reactions caused by the active substance.

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 dexketoprofen during the last three 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 tendency and your baby's tendency to bleed and may delay or prolong labor beyond expected. You should not take dexketoprofen during the first six 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, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Women who are planning a pregnancy or are pregnant should avoid using this medicine. Treatment at any time during pregnancy should only occur under a doctor's guidance.

The use of this medicine is not recommended while trying to conceive or while being evaluated for infertility.

Regarding 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 dizziness, drowsiness, or vertigo as adverse effects of treatment. If you experience these effects, do not operate machinery or drive until symptoms resolve. Seek advice from your doctor.

Dexketoprofeno Tevagen contains sucrose, methyl parahydroxybenzoate (E-218), ethanol, and sodium

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate.

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

This medicine contains 0.1% ethanol (alcohol); this small amount corresponds to 13.8 mg per sachet.

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

3. How to take Dexketoprofen Tevagen

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

The dose you need may vary depending on the type, intensity, and duration of the pain.

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

If pain persists for more than 4 days, you must stop treatment and consult your doctor.

Adults over 18 years of age

Generally, 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, it is recommended to start treatment 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) if the medicine has been well tolerated.

Use in children and adolescents

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

Instructions for proper use

The oral solution can be taken directly from the sachet or after mixing its contents into a glass of water. Once the sachet has been opened, consume all of its contents.

Take the medicine with food, as this helps reduce the risk of adverse effects on the stomach or intestines. However, if your pain is severe and you need rapid relief, take the sachets on an empty stomach (at least 15 minutes before food), as they will be absorbed more easily.

If you take more Dexketoprofen Tevagen than you should

If you have taken too much medicine, inform your doctor or pharmacist immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken. Please remember to always carry the medicine packaging or this leaflet with you.

If you forget to take Dexketoprofen Tevagen

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 Dexketoprofen Tevagen”).

If you have any doubts about using this medicine, 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 are listed below according to their frequency.

Since peak plasma concentrations of dexketoprofen achieved with the oral solution formulation are higher than those obtained with tablets, a potential increased risk of experiencing adverse reactions (particularly gastrointestinal) cannot be ruled out.

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 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 (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 renal failure.

Very rare adverse effects (may affect up to 1 in 10,000 people)

Anaphylactic reaction (hypersensitivity reaction that 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), difficulty breathing due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, liver cell damage (hepatitis), blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Adverse effects not known (frequency cannot be estimated from available data)

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

Fixed drug eruption: A drug-induced allergic skin reaction known as fixed drug eruption, which may include round or oval-shaped 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 recurs in the same location(s) 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 due to long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), and particularly if you are elderly.

Stop taking this medicine immediately if you develop a skin rash or 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 Dexketoprofen Tevagen may be associated with a small increased risk of 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 gastrointestinal bleeding, sometimes fatal, may occur, particularly in elderly patients.

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

As with other NSAIDs, aseptic meningitis may occur, predominantly in patients with systemic lupus erythematosus or mixed connective tissue disease, and haematological reactions (purpura, aplastic and haemolytic anaemia, and more rarely agranulocytosis and bone marrow hypoplasia).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, 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 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 which is stated on the packaging and on the sachet after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexketoprofen Tevagen

• The active substance is dexketoprofen trometamol (36.90 mg), equivalent to 25 mg of dexketoprofen.
• The other components (excipients) are: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, methyl parahydroxybenzoate (E-218), sodium saccharin, sucrose, macrogol, lemon flavour (contains ethanol), povidone, anhydrous sodium hydrogen phosphate, sodium dihydrogen phosphate dihydrate, and purified water.

Appearance of Dexketoprofen Tevagen and pack contents

Yellowish-orange transparent solution with a lemon-citrus odour, supplied in 10 ml single-dose sachets.

It is available in packs containing 10 or 15 single-dose sachets.

Marketing Authorization Holder:

Teva Pharma, S.L.U.

Anabel Segura, 11 Edificio Albatros B, 1st floor

Alcobendas, 28108 Madrid

Spain

Manufacturer

SAG MANUFACTURING S.L.U.

Crta N-I, Km 36, San Agustin de Guadalix,

28750 Madrid

Spain

GALENICUM HEALTH S.L.

Calle De San Gabriel 50 Poligono Industrial Esplugues De Llobregat

08950 Esplugues De Llobregat (Barcelona)

Spain

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

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