IBUPROFEN 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ibuprofeno Vir 600 mg film-coated tablets

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 doubts, consult your doctor or pharmacist.
• 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

This medication is indicated for the treatment of fever, pain of mild or moderate intensity, including migraine, 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 condition that causes cartilage damage), ankylosing spondylitis (inflammation that affects the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before taking Ibuprofeno Vir

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

Do not take Ibuprofeno Vir

• If you are allergic to ibuprofen or 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, bleeding, or perforation, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
• If you have severe heart failure.
• If you have severe liver or kidney disease.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood coagulation problems, or are taking anticoagulants (medications used to "thin" the blood). If it is necessary to use anticoagulant medications 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 other NSAIDs. Such reactions could be: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you are in the third trimester of pregnancy (see section "Pregnancy, breastfeeding, and fertility").

Warnings and Precautions

Allergic reactions to this medication, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen. Stop using ibuprofen immediately and contact your doctor or the emergency medical service immediately 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with this medication and seek medical attention immediately if you notice any 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 developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense 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 these cases, your doctor will consider the possibility of associating a stomach-protecting medication.
• If you have had 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 visit your doctor, inform them of your treatment with ibuprofen, as ibuprofen may mask fever, which is 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 medication for an extended period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medications like ibuprofen may worsen these conditions.
• If you have an infection; see the "Infections" section below.

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

Cardiovascular Precautions

Anti-inflammatory/analgesic medications 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 discuss your treatment with your doctor or pharmacist before taking Ibuprofeno Vir if:

• You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the 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.

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

Other Medications and Ibuprofeno Vir

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

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

• Other non-steroidal anti-inflammatory drugs (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 like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids like cortisone and prednisolone.
• Diuretics.
• Fluconazole.
• Pentoxifylline.
• Probenecid.
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone.
• Sulfonylureas like tolbutamide.
• Tacrolimus.
• Zidovudine.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II antagonists like losartan)

Other medications may also affect or be affected by treatment with Ibuprofeno Vir. 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 ability to bleed and delay or prolong labor more than expected. You should 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 possible time. From the 20th week of pregnancy, ibuprofen 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 you need treatment for more than a few days, your doctor may recommend additional checks.

For female patients of childbearing age, it should be noted that medications like ibuprofen have been associated with a decrease in fertility.

Driving and Using Machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or operate hazardous machinery.

If you take only one 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 told you that you have an intolerance to certain sugars, consult them before taking this medication.

3. How to Use Ibuprofeno Vir

The effective lowest dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. 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 stop treatment before this, as the expected results will not be achieved. Similarly, do not use this medication for longer than indicated by your doctor.

This medication is administered orally. You should 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

The use of this medication is not recommended in children under 14 years old, 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 dose than usual. If this is the case, the dose can only be increased once your doctor has checked that you tolerate the medication well.

Patients with Kidney and/or Liver Disease

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

If you think the effect 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 find out about the risk and ask for advice on the measures to be taken, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package and package leaflet of the medication 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, ringing in the ears, confusion, and involuntary eye movement. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients develop seizures. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported. Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute kidney failure and liver damage may occur. Exacerbation of asthma in asthmatics is possible. Furthermore, hypotension and respiratory changes may occur.

If You Forget to Take Ibuprofeno Vir

Do not take a double dose to make up for forgotten doses.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

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

• Reddish, non-raised spots, target-shaped or circular on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).

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

Frequencies are established according to the following classification: very frequent (may affect more than 1 in 10 patients); frequent (may affect up to 1 in 10 patients); infrequent (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 adverse effects have been observed:

Gastrointestinal Disorders

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

Disorders of the Skin and Subcutaneous Tissue

Frequent: skin rash.

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

Rare: severe allergic reactions (anaphylactic shock).

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

Frequency not known: skin becomes sensitive to light.

Nervous System Disorders

Frequent: fatigue or drowsiness, headache, and dizziness or feeling of instability.

Infrequent: insomnia, anxiety, restlessness, vision changes, 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, decrease in white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decrease in red blood cells (may manifest as difficulty breathing and skin paleness).

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

Cardiovascular Disorders

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

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

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

Renal and Urinary Disorders

Kidney changes or failure.

Hepatobiliary Disorders

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

Others

Worsening of inflammation during infectious processes.

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

If any of the following adverse effects appear, stop treatment and go immediately to your doctor:

• Allergic reactions such as skin rashes, swelling of the face, wheezing, or difficulty breathing.
• Blood vomiting or coffee grounds-like vomiting.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Severe blisters or 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Ibuprofeno Vir 600 mg Tablets

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

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

Do not use this medicine after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibuprofeno Vir

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

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

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

Appearance of the Product and Package Contents

Ibuprofeno Vir is presented in the form of film-coated tablets. The tablets are oval, biconvex, and white. Each package contains 40 tablets packaged 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 Last Revision of this Prospectus: March 2025

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