DEXKETOPROFEN VIR 12.5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dexketoprofen VIR 12.5 mg film-coated tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Dexketoprofen VIR and what is it used for
2. What you need to know before taking Dexketoprofen VIR
3. How to take Dexketoprofen VIR
4. Possible side effects
5. Storage of Dexketoprofen VIR
6. Package contents and additional information

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

Dexketoprofen VIR is a pain reliever belonging to the group of medications called non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild or moderate pain, such as muscle or joint pain, menstrual pain (dysmenorrhea), toothache.

2. What you need to know before taking Dexketoprofen VIR

Do not takeDexketoprofenoVIR:

• If you are allergic (hypersensitive) to dexketoprofen trometamol or any of the other components of this medication (listed in section 6);
• If you are allergic to acetylsalicylic acid or another non-steroidal anti-inflammatory medication;
• If you have asthma or have suffered from 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 medications;
• If you have or have had in the past peptic ulcer, stomach or intestinal bleeding, or chronic digestive problems (e.g., indigestion, heartburn);
• If you have suffered in the past from stomach or intestinal bleeding or perforation due to the use of non-steroidal anti-inflammatory medications (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 kidney failure, or severe liver 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 problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take dexketoprofen trometamol during the first 6 months of pregnancy unless it is clearly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, dexketoprofen trometamol may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional monitoring;
• If you are under 18 years old.

Warnings and precautions:

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

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), or fluid retention or have suffered from these diseases in the past;
• If you are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (e.g., due to excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk of suffering from these disorders (e.g., you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) you should consult your doctor or pharmacist about this treatment. Medications like Dexketoprofeno VIR may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration;
• If you are elderly, you may experience a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (Dexketoprofeno VIR may decrease your fertility, so you should not take it if you are planning to become pregnant or are undergoing fertility studies);
• If you have a blood disorder or blood coagulation disorder;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• If you have or have had in the past chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have or have had in the past stomach or intestinal disorders;
• If you are taking other medications that increase the risk of peptic ulcer or bleeding, such as oral corticosteroids, some antidepressants (e.g., selective serotonin reuptake inhibitors), agents that prevent clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking Dexketoprofeno VIR: your doctor may prescribe an additional medication to protect your stomach (e.g., misoprostol or other medications that block gastric acid production).

Children and adolescents

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

Using Dexketoprofeno VIR with other medications:

Tell your doctor or pharmacist if you are taking, have taken, or may need to take any other medication. There are some medications that should not be taken together, and other medications that may need a dose change if taken together.

Always inform your doctor, dentist, or pharmacist if, in addition to Dexketoprofeno VIR, you are taking any of the following medications:

Not recommended combinations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory medications;
• Warfarin, heparin, and other medications used to prevent clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate, used for rheumatoid arthritis and cancer;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections;
• Combinations that require caution:
• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used for high blood pressure and heart disorders;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycoside antibiotics, used for bacterial infections;
• Chlorpropamide and glibenclamide, used for diabetes;

Combinations to be taken into account:

• Quinolones (e.g., ciprofloxacin, levofloxacin) used for bacterial infections;
• Cyclosporin or tacrolimus, used to treat immune system diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medications, i.e., medications 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.

If you have any doubts about taking other medications with Dexketoprofeno VIR, consult your doctor or pharmacist.

Taking Dexketoprofeno VIR with food and drinks:

Take the tablets with a sufficient amount of water. Take the tablets with food, as this helps reduce the risk of experiencing side effects in the stomach or intestine. However, in case of acute pain, take the tablets on an empty stomach, i.e., at least 30 minutes before meals, as this will allow the medication to act a little faster.

Pregnancy, breastfeeding, and fertility

Do not take Dexketoprofeno VIR during pregnancy or breastfeeding.

It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected.

You should not take Dexketoprofeno during the first 6 months of pregnancy unless it is clearly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time.

From the 20th week of pregnancy, Dexketoprofeno may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, 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 medication.

Driving and using machines

Dexketoprofeno VIR may slightly affect your ability to drive and use machines, as it may cause drowsiness or dizziness as side effects of treatment. If you experience these effects, do not use machines or drive until they disappear. Ask your doctor for advice.

3. How to take Dexketoprofeno VIR

Follow exactly the administration instructions of Dexketoprofeno VIR indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

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

Generally, it is recommended to take 1 tablet (25 mg of dexketoprofen) every 8 hours, not 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 be increased later according to the general recommended dose (75 mg of dexketoprofen) if Dexketoprofeno VIR has been well tolerated.

If your pain is intense and you need quick relief, take the tablets on an empty stomach (at least 30 minutes before meals), as they will be absorbed more easily (see section 2 "Taking Dexketoprofeno VIR with food and drinks").

The tablet can be divided into equal doses.

If you take moreDexketoprofenoVIRthan you should:

If you have taken too much medication, inform your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to always carry the medication package or this package leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91562 04 20, indicating the medication and the amount ingested.

If you forget to takeDexketoprofenoVIR:

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Possible side effects are listed below according to their frequency. The following table indicates how many patients may experience these side effects:

Frequent side effects:

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

Uncommon side effects:

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

Rare side effects:

Peptic ulcer, perforation of peptic ulcer or bleeding (which may manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention, and peripheral edema (e.g., swelling of the ankles), laryngeal edema, 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 that can also lead to collapse), skin ulcers, mouth ulcers, eye ulcers, or genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or lip and throat swelling (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, blurred vision, tinnitus (ringing in the ears), sensitive skin, sensitivity to light, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Tell your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g., stomach pain or heartburn or bleeding), if you have previously experienced any of these side effects due to prolonged treatment with anti-inflammatory medications, and especially if you are elderly.

Stop taking Dexketoprofeno VIR immediately if you notice the appearance of a skin rash or any lesion inside the mouth or on the genitals, or any other sign of allergy.

During treatment with non-steroidal anti-inflammatory medications, cases of fluid retention and swelling (especially in ankles and legs), increased blood pressure, and heart failure have been reported.

Medications like Dexketoprofeno VIR may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident").

In patients with immune system disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medications can rarely cause fever, headache, and neck stiffness.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dexketoprofeno VIR

Keep out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging and blister. The expiration date is 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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content/Additional Information

Composition of Dexketoprofeno VIR:

Dexketoprofeno VIR 25 mg: coated tablets, white, biconvex and cylindrical, scored and marked with DT2 on one side. The tablet can be divided into equal doses.

The active ingredient is dexketoprofen trometamol (36.90 mg) corresponding to Dexketoprofeno (DCI) 25 mg.

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

Appearance of the product and packaging content:

Dexketoprofeno VIR 25 mg film-coated tablets are presented in packages containing 20 and 50 film-coated tablets.

Marketing Authorization HolderIndustria 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 revisionSeptember 2023

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