Ibuprofen Vir 600 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibuprofen Vir 600 mg film-coated tablets

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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ibuprofeno Vir is and what it is used for

Ibuprofeno Vir belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for the treatment of fever, the treatment of mild to moderate pain including migraine, the treatment of arthritis (inflammation of the joints, usually affecting the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic condition causing damage to cartilage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before starting to take Ibuprofen Vir

It is important that you use the smallest dose that relieves/controls your pain and that you do not take this medicine for longer than necessary to control your symptoms.

Do not take Ibuprofen Vir

• If you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• If you have a stomach or duodenal ulcer.
• If you have had a stomach or duodenal ulcer, gastrointestinal bleeding, or a perforation of the digestive tract.
• If you have severe heart failure.
• If you have severe liver or kidney disease.
• If you are vomiting blood.
• If you have black stools or bloody diarrhoea.
• If you have bleeding disorders or blood coagulation disorders, or if you are taking anticoagulants (medicines used to "thin" the blood). If anticoagulants must be used at the same time, your doctor will perform blood coagulation tests.
• If you have ulcerative colitis or Crohn's disease.
• If you are allergic to acetylsalicylic acid or to other NSAIDs. Such reactions may include skin rash with itching, swelling of the face, lips or tongue, runny nose, breathing difficulties, or asthma.
• If you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions

Allergic reactions to ibuprofen have been reported, including symptoms such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain. Stop taking ibuprofen immediately and contact your doctor or emergency medical services right away if you experience any of these symptoms.

Serious skin reactions have been reported in association with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). Discontinue treatment with this medicine and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Consult your doctor or pharmacist before starting to take Ibuprofen Vir:

• If you have had a stomach or duodenal ulcer.
• If you have had or develop an ulcer, bleeding, or perforation in the stomach or duodenum, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
• This risk is higher when high doses are used and in elderly individuals. In such cases, your doctor may consider prescribing a stomach-protective medication.
• If you have suffered from kidney or liver disease.
• If you have edema (fluid retention).
• If you have heart disease or high blood pressure.
• If you suffer from asthma or any other respiratory disorder.
• If you visit your doctor, inform them that you are taking ibuprofen, as ibuprofen may mask fever—an important sign of infection—making diagnosis more difficult.
• If you have heart, kidney, or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on how often these checks should occur.
• If you are taking medications that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn’s disease or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
• If you have an infection; see the section «Infections» below.

Infections: Ibuprofen Vir may mask signs of infection such as fever and pain. Therefore, treatment with Ibuprofen Vir may delay appropriate treatment of an infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and your infection symptoms persist or worsen, consult a doctor without delay.

Cardiovascular precautions

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen Vir if:

• You have heart problems, including heart failure, angina (chest pain), a history of heart attack, coronary artery bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").

• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

In addition, this type of medicine may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Other medicines and Ibuprofen Vir

Taking Ibuprofen Vir with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Ibuprofen Vir may interact with or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs)
• Lithium (a medicine used to treat depression). Your doctor may need to adjust the dose of this medicine.
• Methotrexate. Your doctor may need to adjust the dose of this medicine.
• Mifepristone.
• Digoxin and cardiac glycosides (used in the treatment of heart failure).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and co-trimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics.
• Fluconazole.
• Pentoxifylline.
• Probenecid.
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone.
• Sulfonylureas such as tolbutamide.
• Tacrolimus.
• Zidovudine.
• Anticoagulant medicines (e.g., to treat or prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)

Other medicines may also interact with or be affected by treatment with Ibuprofen Vir. Therefore, always consult your doctor or pharmacist before using Ibuprofen Vir with other medicines.

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.

Ibuprofen may cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and may delay or prolong labor beyond expected. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and specifically advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest effective dose should be used for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in the fetus if taken for more than a few days, which could 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 needed, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that medicines of the ibuprofen type have been associated with a reduced ability to conceive.

Driving and operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, you must not drive or operate dangerous machinery.

If you take only a single dose of ibuprofen, or take it for a short period, there is no need to take special precautions.

Ibuprofen Vir contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to use Ibuprofeno Vir

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Always follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will determine the duration of your treatment with ibuprofen. Do not stop treatment earlier, as this may prevent you from achieving the expected results. Likewise, do not use this medicine for longer than your doctor has prescribed.

This medicine is administered orally. Swallow the tablet whole with a little water.

If you have a sensitive stomach, take the medicine with food.

Adults

Dosage should be adjusted according to the severity of the condition and the patient's discomfort.

Generally, the recommended daily dose is 1200 mg of ibuprofen (2 tablets), divided into 2 doses.

In some conditions, higher doses may be required; however, in any case, it is recommended not to exceed the maximum daily dose of 2400 mg of ibuprofen (4 tablets).

Use in children and adolescents

The use of this medicine is not recommended in children under 14 years of age, as the dose of ibuprofen it contains is not suitable for the recommended dosage in these patients.

Elderly patients

If you are over 60 years old, your doctor may prescribe a lower than usual dose. If so, the dose may only be increased once your doctor has confirmed that you tolerate the medicine well.

Patients with kidney and/or liver disease

If you have kidney and/or liver disease, your doctor may prescribe a lower than usual dose. If so, take exactly the dose prescribed by your doctor.

If you think the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibuprofeno Vir than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medicine, contact a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4), diarrhea, headache, tinnitus, confusion, and involuntary eye movements. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients may develop seizures. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported. In addition, prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may be exacerbated in asthmatic patients. In addition, low blood pressure and respiratory disturbances may occur.

If you forget to take Ibuprofeno Vir

Do not take a double dose to make up for a missed dose.

If you forget to take your scheduled dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at your usual time.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects of medicines such as ibuprofen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

Stop treatment with ibuprofen and seek immediate medical attention if you notice any of the following symptoms:

• Flat red spots, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).

Generalized, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Frequencies are defined according to the following classification: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal disorders

The most common adverse effects associated with medicines such as ibuprofen are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, mouth ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Skin and subcutaneous tissue disorders

Common: skin rash.

Uncommon: skin redness, itching or swelling of the skin, swelling of the lips, face, or tongue, increased nasal discharge, and breathing difficulty.

Rare: severe allergic reactions (anaphylactic shock).

Very rare: sudden onset of intense itching or blisters on the skin, joint pain, and fever (lupus erythematosus), hair loss, skin reactions due to light exposure. Medicines such as ibuprofen may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Frequency not known: skin becomes sensitive to light.

Nervous system disorders

Common: fatigue or drowsiness, headache, dizziness, or feeling of instability.

Uncommon: insomnia, anxiety, restlessness, visual disturbances, tinnitus (ringing or buzzing in the ears).

Rare: disorientation or confusion, agitation, irritability or depression, abnormal or blurred vision, and hearing difficulty.

Very rare: aseptic meningitis.

Blood and lymphatic system disorders

Very rare: prolonged bleeding time, decreased white blood cells (may present as frequent infections with fever, chills, or sore throat), decreased red blood cells (may present as shortness of breath and pale skin).

A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

Cardiovascular disorders

Medicines such as ibuprofen may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatment using medicines of the ibuprofen type.

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

Renal and urinary disorders

Kidney dysfunction or kidney failure.

Hepatobiliary disorders

Medicines such as ibuprofen may, in rare cases, be associated with liver injury.

Other

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions to ibuprofen have been reported, although they cannot be ruled out. Manifestations of such reactions could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulty, asthma, palpitations, hypotension, or shock.

If any of the following adverse effects occur, stop treatment and consult your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulty.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Blisters or significant skin peeling.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen Vir 600 mg Tablets

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Keep the blister in the outer packaging to protect it from light.

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

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

6. Contents of the pack and other information

Composition of Ibuprofeno Vir

• The active substance is Ibuprofen.
• The other excipients are:

Components of the core: hypromellose, sodium croscarmellose, lactose, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, magnesium stearate.

Components of the film coating: hypromellose, titanium dioxide (E-171), talc, propylene glycol.

Appearance of the product and contents of the pack

Ibuprofeno Vir is presented as film-coated tablets. The tablets are oval, biconvex, and white. Each pack contains 40 tablets in PVC-PVDC/aluminum blisters.

Marketing Authorization Holder and Manufacturer

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

Laguna, 66-70. Poligono Industrial Urtinsa II

28923 Alcorcón (Madrid), Spain

Date of the most recent revision of this leaflet: March 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/