Package Insert: Information for the Patient

Ibuprofen Vir 600 mg Film-Coated Tablets

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

- Keep this package insert, as you may need to refer to it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4

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

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

3. How to take Ibuprofen Vir

4. Possible side effects

5. Storage of Ibuprofen Vir

6. Contents of the pack and additional information

Ibuprofeno Virbelongs to a group of medicines called nonsteroidal 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, including those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

It is essential to use the smallest effective dose to alleviate or control pain and not to take this medication for longer than necessary to manage your symptoms.

Do not take Ibuprofeno Vir

• If you are allergic to ibuprofen, or to any of the other components of this medication (listed in section 6).
• If you have a stomach or duodenal ulcer.
• If you have had a stomach or duodenal ulcer, or have experienced bleeding or perforation of the digestive tract.
• If you have severe heart failure.
• If you have a severe liver or kidney disease.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• If you have ulcerative colitis or Crohn's disease.
• If you are allergic to aspirin or other NSAIDs. Such reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you are in the third trimester of pregnancy (see section "Pregnancy, breastfeeding, and fertility").

Warnings and Precautions

Signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Stop using ibuprofen immediately and contact your doctor or emergency medical services if you observe any of these signs.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Discontinue treatment with this medication and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

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

• If you have had a stomach or duodenal ulcer.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms.
• This risk is higher when using high doses and in older adults. In these cases, your doctor will consider the possibility of associating a stomach protector medication.
• If you have kidney or liver disease.
• If you have edema (fluid retention).
• If you have heart disease or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you should inform your doctor of your ibuprofen treatment, as ibuprofen may mask fever, an important sign of infection, making its diagnosis more difficult.
• If you have heart, kidney, or liver disease, are over 60 years old, or need to take the medication for an extended period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you take anticoagulant medications, such as oral anticoagulants, antiplatelet agents like aspirin, or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you have an infection; see the "Infections" heading below.

Infections: Ibuprofeno Vir may mask the signs of an infection, such as fever and pain. Consequently, it may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Cardiovascular Precautions

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking Ibuprofeno Vir if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (circulation problems in the 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 are a smoker.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Other Medications and Ibuprofeno Vir

Taking Ibuprofeno Vir with other medications. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Ibuprofeno Vir may affect or be affected by other medications. For example:

• Other NSAIDs
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate. Your doctor may adjust the dose of this medication.
• Mifepristone.
• Digoxin and cardiac glycosides (used to treat heart failure).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).
• Corticosteroids such as prednisone and prednisolone.
• Diuretics.
• Fluconazole.
• Pentoxifylline.
• Probenecid.
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone.
• Sulfonylureas such as tolbutamide.
• Tacrolimus.
• Zidovudine.
• Anticoagulant medications (e.g., to prevent blood clotting, e.g., aspirin, warfarin, ticlopidine)
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan)

Other medications may also affect or be affected by Ibuprofeno Vir treatment. Therefore, you should always consult your doctor or pharmacist before using Ibuprofeno Vir with other medications.

Pregnancy, Breastfeeding, and Fertility

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

It may cause kidney and heart problems in your fetus. It may affect your and your baby's bleeding tendency and delay or prolong labor. Do not take ibuprofen 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 time possible. After 20 weeks of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may lead to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

For fertile women, it is essential to consider that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Driving and Operating Machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery.

If you only take a single dose of ibuprofen or take it for a short period, you do not need to take special precautions.

Ibuprofeno Vir contains Lactose, if your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

You should use the most effective dose 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).

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with ibuprofen. Do not discontinue treatment beforehand, as this will not yield the expected results. Similarly, do not use this medication for longer than indicated by your doctor.

This medication is administered orally. You must swallow the tablet whole with a little water.

If you have a sensitive stomach, take the medication with meals.

Adults

The dosage should be adjusted according to the severity of the disorder and the patient's discomfort.

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

In some cases, higher doses may be required, but 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

This medication is not recommended for use in children under 14 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in these patients.

Older patients

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

Patients with kidney and/or liver diseases

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

If you estimate that the action of this medication 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 medication, consult a doctor immediately or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement. It may also cause agitation, drowsiness, disorientation, or coma. Occasionally, patients develop seizures. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Blood in the urine, low potassium levels in the blood, chills, and breathing problems may also occur. Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. It is possible to exacerbate asthma in asthmatics. Furthermore, hypotension and respiratory disturbances may occur.

If you forgot to take Ibuprofeno Vir

Do not take a double dose to compensate for the missed doses.

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

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

The side effects of medicines like ibuprofen are more common in people over 65 years old.

The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

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

• Flat, red spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms [dermatitis exfoliativa, eritema poliforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).

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

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

The following side effects have been observed:

Gastrointestinal disorders

The most common side effects that occur with medicines like ibuprofen are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, mouth ulcers, worsening of ulcerative colitis, and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

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 secretion, and respiratory difficulty.

Rare: severe allergic reactions (anaphylactic shock).

Very rare: intense itching on the skin, sudden appearance of blisters on the skin, joint pain, and fever (lupus erythematosus), hair loss, skin reactions caused by light exposure. Medicines like ibuprofen can be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Frequency not known: skin sensitivity to light.

Nervous system disorders

Common: fatigue or drowsiness, headache, and dizziness or feeling unsteady.

Uncommon: insomnia, anxiety, restlessness, visual disturbances, 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 manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as respiratory difficulty and pale skin).

A severe skin reaction known as DRESS syndrome may occur. DRESS syndrome symptoms include: skin eruption, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Cardiovascular disorders

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

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with medicines of the ibuprofen type.

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

Renal and urinary disorders

Renal alterations or insufficiency.

Hepatobiliary disorders

Medicines like ibuprofen may be associated, in rare cases, with liver damage.

Other

Worsening of inflammation during infectious processes.

Until now, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. Manifestations of this type of reaction may include fever, skin rash, severe abdominal pain, intense and persistent headache, nausea, vomiting, facial swelling, tongue, and throat swelling, respiratory difficulty, asthma, palpitations, hypotension, or shock.

If any of the following side effects appear, stop treatment and seek immediate medical attention:

• Allergic reactions such as skin rash, facial swelling, chest tightness, or respiratory difficulty.
• Vomiting blood or coffee ground-like appearance.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Significant skin blisters or peeling.
• Intense headache or persistent headache.
• Yellow skin discoloration (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the extremities or fluid accumulation in the arms or legs.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30°C.

Store the blister pack in the outer packaging to protect it from light.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

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

Composition of Ibuprofeno Vir

• The active ingredient is Ibuprofeno.
• The other excipients are:

Core components: hypromellose, sodium croscarmellose, lactose, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate.

Coating components: hypromellose, titanium dioxide (E-171), talc, propylene glycol.

Appearance of the product and contents of the packaging

Ibuprofeno Vir is presented in the form of coated tablets. The tablets are oval, biconvex, and white. Each package contains 40 conditioned tablets in PVC-PVDC/aluminum blister.

Holder of the marketing authorization and responsible manufacturer

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

Laguna, 66-70. Industrial Park Urtinsa II

28923 Alcorcón (Madrid), Spain

Date of the last review of this leaflet: March 2025

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/