PROSPECTO: INFORMATION FOR THE USER

Dexketoprofeno VIR 25 mg film-coated tablets EFG

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus.See section 4.

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

2.What you need to know before starting to take Dexketoprofeno VIR

3.How to take Dexketoprofeno VIR

4.Possible adverse effects

5.Storage of Dexketoprofeno VIR

6.Contents of the package and additional information

Dexketoprofeno VIRis a pain reliever belonging to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild to moderate pain, such as muscle pain or joint pain, menstrual pain (dysmenorrhea), and toothache pain.

Do not takeDexketoprofenoVIR:

• If you are allergic (hypersensitive) to dexketoprofeno trometamol or to any of the other components of this medication (listed in section 6);
• If you are allergic to acetylsalicylic acid or to another nonsteroidal anti-inflammatory drug;
• If you have asthma or have had asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy formations in the interior of the nose due to allergy), urticaria (skin eruption), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs;
• If you have or have had in the past peptic ulcers, stomach or intestinal bleeding, or chronic digestive problems (for example, indigestion, stomach burning);
• If you have had in the past stomach or intestinal bleeding or perforation due to previous use of nonsteroidal 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 kidney failure, or severe liver failure;
• If you have bleeding disorders or blood clotting disorders;
• If you are in the last 3 months of pregnancy, as it could harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected. Do not take dexketoprofeno trometamol during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you must take the minimum dose for the shortest possible time. From week 20 of pregnancy, dexketoprofeno 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 a period longer than a few days, your doctor may recommend additional controls;
• If you are under 18 years old.

Warnings and precautions:

Consult your doctor or pharmacist before starting to takeDexketoprofenoVIR:

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or have had any of these diseases in the past;
• If you are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (for example, excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk of these conditions (for example, you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) consult this treatment with your doctor or pharmacist. Medications likeDexketoprofenoVIRmay be associated with a small increase in the risk of suffering heart attacks (“myocardial infarctions”) or strokes (“cerebral vascular accidents”). 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 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 (DexketoprofenoVIRmay reduce your fertility, so do not take it if you are planning to become pregnant or are undergoing fertility studies);
• If you have a disorder in blood production and blood cells;
• If you have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases 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 gastrointestinal or intestinal disorders;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), agents that prevent clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before takingDexketoprofenoVIR: your doctor may prescribe an additional medication to protect your stomach (for example, misoprostol or other medications that block stomach acid production).

Children and adolescents

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

Use of Dexketoprofeno VIR with other medications:

Inform 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 require a change in dose if taken together.

Inform your doctor, dentist, or pharmacist at all times if, in addition toDexketoprofenoVIR, you are taking any of the following medications:

Not recommended associations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medications used to prevent clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate, used to treat rheumatoid arthritis and cancer;
• Hydantoins and phenytoin, used to treat epilepsy;
• Sulfamethoxazole, used to treat bacterial infections;
• Associations that require 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 to treat diabetes;

Associations to consider:

• Quinolones (for example, ciprofloxacin, levofloxacin), used to treat bacterial infections;
• Ciclosporin or tacrolimus, used to treat autoimmune diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medications; that is, medications used to dissolve clots;
• Probenecid, used to treat gout;
• Digoxin, used to treat chronic heart failure;
• Mifepristone, used as an abortifacient (to interrupt pregnancy);
• SSRI antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and clot formation.

If you have any doubts about taking other medications withDexketoprofenoVIR, 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 to reduce the risk of experiencing adverse effects in the stomach or intestines. However, in the case of acute pain, take the tablets on an empty stomach; that is, at least 30 minutes before meals, as this facilitates the medication's action a little more quickly.

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 predisposition and that of your baby to bleed and delay or prolong delivery more than expected.

Do not take Dexketoprofeno during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you must take the minimum 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 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 a period longer than a few days, your doctor may recommend additional controls

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

Driving and using machines

Dexketoprofeno VIRmay affect your ability to drive and use machines slightly, as it may cause drowsiness or dizziness as adverse effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Consult your doctor.

Follow exactly the administration instructions forDexketoprofenoVIRprescribed by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Generally, it is recommended to take 1 tablet (25 mg of dexketoprofeno) every 8 hours, without exceeding 3 tablets per day (75 mg).

If you are an elderly patient or suffer from any 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 dexketoprofeno) ifDexketoprofenoVIRhas 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 eating) as they will be absorbed more easily (see section 2 “TakingDexketoprofenoVIRwith 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 service of your nearest hospital. Please remember to always carry the medication box or this 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 forgot to takeDexketoprofenoVIR:

Do not take a double dose to make up for the missed doses. Take the next dose when due (according to section 3 “How to takeDexketoprofenoVIR”).

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The 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).

Infrequent 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 discomfort.

Rare side effects:

Peptic ulcer, perforation of a peptic ulcer or bleeding (which may manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g., swelling of 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 renal insufficiency.

Muy rare:

Anaphylactic reaction (hypersensitivity reaction that may also lead to collapse), skin ulcers, mouth, eye, and genital area (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of the lips and throat (angioedema), respiratory difficulty due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis inflammation, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

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

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

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

Medicines likeDexketoprofeno VIRmay be associated with a small increase in the risk of suffering a heart attack (“myocardial infarction”) or stroke (“cerebrovascular accident”).

In patients with autoimmune disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory drugs may rarely cause fever, headache, and neck stiffness.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.

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

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

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and in the blister pack. The expiration date is the last day of the month indicated.

Do not store above 30°C. Store the blister packs in the original packaging to protect them from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Dexketoprofeno VIR:

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

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

The other components are: maize starch, microcrystalline cellulose, sodium carboxymethyl starch, glyceryl distearate, hypromellose, titanium dioxide, and macrogol 400.

Appearance of the product and contents of the packaging:

Dexketoprofeno VIR 25 mg coated tablets are presented in packaging containing 20 and 50 coated tablets.

Holder of the marketing authorization
Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70

Polígono Industrial Urtinsa II

28923 Alcorcón, Madrid

Spain

Responsible for manufacturing:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70

Polígono Industrial Urtinsa II

28923 Alcorcón, Madrid

Spain

Revision date of the textSeptember 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/