Dexketoprofeno Vir 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dexketoprofen VIR 25 mg film-coated tablets EFG

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, pharmacist, or nurse.
• This medicine has been prescribed only for you and you must 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, pharmacist, or nurse, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Dexketoprofen VIR 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 (dysmenorrhoea), and dental pain.

2. What you need to know before taking Dexketoprofeno VIR

Do not take Dexketoprofeno VIR:

• If you are allergic (hypersensitive) to dexketoprofen trometamol 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 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 non-steroidal anti-inflammatory drugs;
• If you currently have or have previously had peptic ulcer, gastrointestinal bleeding, or intestinal bleeding, or if you have 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) 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 failure, or severe hepatic failure;
• If you have bleeding disorders or blood coagulation disorders;
• If you are in the last 3 months of pregnancy, as it may harm the fetus or cause complications during childbirth. 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 beyond expected duration. You should not take dexketoprofen trometamol 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 become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, dexketoprofen trometamol 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). If treatment for longer than a few days is required, your doctor may recommend additional monitoring;
• If you are under 18 years of age.

Warnings and precautions:

Consult your doctor or pharmacist before taking Dexketoprofeno VIR:

• If you are allergic or have previously had allergic reactions;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), or 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., 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 smoking), discuss this treatment with your doctor or pharmacist. Medicines like Dexketoprofeno VIR 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 likely to experience adverse effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (Dexketoprofeno VIR 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 and 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 blood clotting such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In such cases, consult your doctor before taking Dexketoprofeno VIR: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other medicines that block gastric acid production).
  • Allergic reactions to dexketoprofen, including respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Immediately discontinue treatment with [product name] and contact your doctor or nearest emergency service if you experience any of these symptoms.

Children and adolescents

Do not take Dexketoprofeno VIR if you are under 18 years of age.

Taking Dexketoprofeno VIR with other medicines:

Inform your doctor or pharmacist if you are 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 Dexketoprofeno VIR, you are taking any of the following medicines:

Combinations not recommended:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent blood 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 to control 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;
• Chlorpropamide and glibenclamide, used for diabetes;

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 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 VIR, consult your doctor or pharmacist.

Taking Dexketoprofeno VIR 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 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, breastfeeding, and fertility

Do not take Dexketoprofeno VIR during 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 beyond expected duration.

You should not take Dexketoprofeno 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 become pregnant, you should take the lowest possible dose for the shortest possible time.

From week 20 of pregnancy, Dexketoprofeno 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 required, your doctor may recommend additional monitoring.

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

Driving and using machines

Dexketoprofeno VIR 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 have resolved. Seek advice from your doctor.

3. How to take Dexketoprofeno VIR

Follow exactly the administration instructions for Dexketoprofeno VIR given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

In general, 1 tablet (25 mg of dexketoprofen) every 8 hours is recommended, 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 therapy 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 Dexketoprofeno VIR 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 a meal), as they will be absorbed more easily (see section 2 "Taking Dexketoprofeno VIR with food and drink").

The tablet may be divided into equal doses.

If you take more Dexketoprofeno VIR 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 package or this leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dexketoprofeno VIR:

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 VIR").

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:

Sensation of spinning (vertigo), dizziness, somnolence, sleep disturbances, nervousness, headache, palpitations, hot flushes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish feeling 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, 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, 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 airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, inflammation of 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).

Inform your doctor immediately 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 anti-inflammatory drugs, and particularly if you are elderly.

Stop taking Dexketoprofen VIR immediately if you notice the appearance of 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 VIR 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.

Unknown frequency

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

Drug eruption (fixed drug eruption)

An 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 may persist after healing. Fixed drug eruption usually reappears in the same location or locations if the medicine is taken again.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet.

You can also report them directly via the national reporting system included in 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 Dexketoprofen VIR

Keep 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. 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 unused medicines and their containers at the SIGRE collection point at 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. Package contents/Additional information

Composition of Dexketoprofen VIR:

Dexketoprofen VIR 25 mg: film-coated, white, biconvex, cylindrical tablets, scored on one side with the mark DT2. The tablet can be divided into equal doses.

The active substance is dexketoprofen trometamol (36.90 mg), equivalent to dexketoprofen (INN) 25 mg.

The other components are: maize starch, microcrystalline cellulose, sodium carboxymethyl starch from potato, glycerol distearate, hypromellose, titanium dioxide, macrogol 400.

Appearance of the product and pack contents:

Dexketoprofen VIR 25 mg film-coated tablets are available in packs containing 20 and 50 film-coated tablets.

Marketing Authorization Holder: Industria Química y Farmacéutica VIR, S.A.
C/ Laguna 66-70
Polígono Industrial Urtinsa II
28923 Alcorcón, Madrid
Spain

Manufacturer: Industria Química y Farmacéutica VIR, S.A.
C/ Laguna 66-70
Polígono Industrial Urtinsa II
28923 Alcorcón, Madrid
Spain

Date of text revision: September 2025

Detailed and up-to-date 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/