Dexketoprofen ViatriS 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Dexketoprofen Viatis 25 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking 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, ask 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 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 Dexketoprofeno Viatris is and what it is used for
2. What you need to know before taking Dexketoprofeno Viatris
3. How to take Dexketoprofeno Viatris
4. Possible adverse effects
5. How to store Dexketoprofeno Viatris
6. Contents of the pack and other information

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

Dexketoprofeno Viatris is an analgesic belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild to moderate pain, such as muscle or joint pain, menstrual pain (dysmenorrhoea), and dental pain.

2. What you need to know before taking Dexketoprofeno Viatris

Do not take Dexketoprofeno Viatris:

• 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 experienced stomach or intestinal 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;
• 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:

Consult your doctor or pharmacist before taking Dexketoprofeno Viatris:

• 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 conditions, a history of stroke, or think you may be at risk of such conditions (e.g., 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 these occur, consult your doctor immediately;
• If you are a woman with fertility problems (this medicine 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 anticoagulants like acetylsalicylic acid (aspirin) or 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 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.

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

Infections

Dexketoprofen may mask signs of infection, such as fever and pain. Therefore, this medicine may delay appropriate treatment of the 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 without delay.

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

Children and adolescents

This medicine 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.

Other medicines and Dexketoprofeno Viatris:

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription. Some medicines should not be taken together, and others may require dose adjustments when used 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 NSAIDs;
• Warfarin, heparin, and other medicines used to prevent blood clotting;
• Lithium, used to treat certain mood disorders;
• Methotrexate (a cancer and immunosuppressive drug), 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 drugs—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 Selective Serotonin Reuptake Inhibitor (SSRI) type;
• 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 Dexketoprofeno Viatris, consult your doctor or pharmacist.

Taking Dexketoprofeno Viatris with food and drink:

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 cases of acute pain, take the tablets on an empty stomach—i.e., at least 30 minutes before meals—since this allows the medicine to act slightly faster.

Pregnancy, breastfeeding, and fertility

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

Do not take this medicine during the last three months of pregnancy or while breastfeeding. 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 this medicine 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 become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, this medicine 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 is needed for longer than a few days, your doctor may recommend additional monitoring.

The use of this medicine is not recommended when trying to conceive or while undergoing infertility evaluation. 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 drowsiness or dizziness as adverse effects of treatment. If you experience these effects, do not operate machinery or drive until these symptoms resolve. Seek advice from your doctor.

Dexketoprofeno Viatris contains sodium

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

3. How to take Dexketoprofeno Viatris

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

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

The lowest effective dose should be used for the shortest duration 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 tablet can be divided into equal doses by breaking it along the score line.

In general, the recommended dose is half a tablet (12.5 mg) every 4–6 hours or one tablet (25 mg) every 8 hours, without exceeding 3 tablets per day (75 mg).

If you are an elderly patient or suffer from 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 the 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 Viatris with food and drink").

Use in children and adolescents

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

If you take more Dexketoprofeno Viatris 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 pack or this leaflet with you. You may also call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount taken.

If you forget to take Dexketoprofeno Viatris

Do not take a double dose to make up for forgotten doses. Take the next dose as scheduled (according to section 3 "How to take Dexketoprofeno Viatris").

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:

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

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

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

Spinning sensation (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, 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 (may affect up to 1 in 10,000 people):

Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), skin, mouth, eye, and 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, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, photosensitivity, itching, kidney problems. Decrease in white blood cell count (neutropenia), decrease in platelet count (thrombocytopenia).

Frequency not known (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

An 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 the affected areas may also occur, which may persist after healing. Drug-induced fixed 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 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 lesions in the mouth or genital area, or any other sign 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 this one 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.

After administration, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, and exacerbation 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the national reporting system included in the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexketoprofen Viatris

Keep out of the sight and reach of children.

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

Do not store above 30°C. Keep the blisters in the original packaging to protect them from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please 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 Dexketoprofeno Viatris

The active substance is dexketoprofen (as dexketoprofen trometamol). Each film-coated tablet contains 25 mg of dexketoprofen. The other components are: maize starch, microcrystalline cellulose, sodium carboxymethyl starch from potato, glycerol distearate, hypromellose, titanium dioxide, macrogol 400 (see section 2: Dexketoprofeno Viatris contains sodium).

Appearance of Dexketoprofeno Viatris and pack contents
Film-coated, scored, white, biconvex, cylindrical tablets marked with DT2 on one side.

Presented in packs containing 20 and 50 film-coated tablets in continuous blisters and single-dose perforated blisters.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

Manufacturer

Galenicum Health, S.L.U.
Sant Gabriel, 50
08950 - Esplugues de Llobregat, Barcelona
Spain

or

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