Ibuprofen (arginine) Vir 600 mg granules for oral solution EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibuprofen (arginine) Vir 600 mg granules for oral solution EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be passed on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Ibuprofen (arginine) Vir is and what it is used for

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

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

2. What you need to know before taking Ibuprofeno (arginina) Vir

Do not take Ibuprofeno (arginina) Vir

• If you are allergic to the active substance or to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or to any of the other ingredients of this medicine (listed in section 6). Signs of allergy may include itchy rash, swelling of the face, lips, or tongue, runny nose, breathing difficulties, or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract.
• If you are vomiting blood.
• If you have black stools or bloody diarrhoea.
• If you have bleeding disorders or blood coagulation problems, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulant medicines must be used at the same time, your doctor will perform blood coagulation tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions:

Allergic reactions to ibuprofen, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop using ibuprofen immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Inform your doctor

• If you have oedema (fluid retention).
• If you have or have had heart problems or high blood pressure.
• If you suffer from asthma or any other respiratory disorder.
• If you are being treated with Ibuprofeno (arginina) Vir, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks should be done.
• If you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this specific case could lead to renal failure as a consequence of dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, 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 and long-term treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine.
• If you are taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid.
• You should also inform your doctor about using other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
• If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can involve vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) may occur.
• If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in the urine, or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate.
• If you suffer from headaches after prolonged treatment, you should not take higher doses of the medicine.
• If you have an infection; see the section titled «Infections» below.
• Allergic reactions may occur with this medicine.
• Your doctor will carry out closer monitoring if you are receiving ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.

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

Infections

Ibuprofeno (arginina) Vir may mask signs of infection, such as fever and pain. Therefore, Ibuprofeno (arginina) Vir may delay appropriate treatment of the infection, 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 infection symptoms persist or worsen, consult a doctor without delay.

Skin reactions

Serious skin reactions have been reported with ibuprofen, 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.

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal.

Cardiovascular precautions

Anti-inflammatory/analgesic 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 Ibuprofeno (arginina) Vir if:

you have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary bypass surgery, peripheral arterial 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 ischaemic 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, these types of medicines may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

Ibuprofen should be used with caution in patients who have or have a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in such patients.

Children and adolescents

There is a risk of renal failure in dehydrated children and adolescents.

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

Precautions during pregnancy and in women of childbearing potential

This medicine may cause kidney and heart problems in your unborn baby. It may affect your tendency and your baby's tendency to bleed, and may delay or prolong labor beyond what is expected. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. Starting from week 20 of pregnancy, ibuprofen may cause kidney problems in your unborn baby 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 required, your doctor may recommend additional monitoring.

For women of childbearing potential, it should be noted that medications such as ibuprofen have been associated with a reduced ability to conceive.

Interference with diagnostic tests

If you are scheduled to undergo any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Use of ibuprofen with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Ibuprofeno (arginine) Vir may affect or be affected by other medicines. For example:

• Other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding
• Anticoagulant medicines (e.g., those used to treat coagulation disorders or prevent clotting, such as acetylsalicylic acid, warfarin, ticlopidine)
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin-II receptor antagonists such as losartan)
• Antiplatelet agents (prevent blood clots in blood vessels, such as ticlopidine)
• 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 antimetabolite medicine (which slows the growth of certain body cells).
• Mifepristone (used to induce abortion)
• Digoxin and cardiac glycosides (used in the treatment of heart disorders)
• Hydantoins such as phenytoin (used in the treatment of epilepsy)
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections)
• Corticosteroids such as cortisone and prednisolone
• Pentoxifylline (for intermittent claudication)
• Probenecid (used in patients with gout or together with penicillin in infections)
• Quinolone antibiotics such as norfloxacin
• Sulfinpyrazone (for gout)
• Sulfonylureas such as tolbutamide (for diabetes)
• Tacrolimus (used in organ transplantation to prevent rejection)
• Zidovudine (an anti-HIV medication)
• Thrombolytics (medicines that dissolve blood clots)
• Aminoglycoside antibiotics such as neomycin
• Herbal extracts: Ginkgo biloba
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections)

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

Taking Ibuprofen (arginine) Vir with food, drinks, and alcohol

You may take this medicine with or without food. In general, it is recommended to take it before meals to reduce the possibility of stomach discomfort. Alcohol consumption during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section: Precautions during pregnancy and in women of childbearing potential).

Minimal amounts of ibuprofen and its metabolites are excreted in breast milk. As no adverse effects in the infant are known, breastfeeding usually does not need to be interrupted during short-term use at recommended doses.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and use of machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you take only a single dose or use the medicine for a short period, special precautions are generally not required.

Ibuprofen (arginine) Vir contains aspartame and sucrose

This medicine contains aspartame as an excipient. Patients with phenylketonuria should be aware that each sachet contains 16.8 mg of phenylalanine.

Each sachet of Ibuprofen (arginine) Vir contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Ibuprofen (arginine) Vir

Follow exactly the administration instructions for this medicine as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will determine the duration of treatment with Ibuprofen. Do not stop treatment earlier, as otherwise the expected results may not be achieved. Likewise, do not use this medicine for longer than indicated by your doctor.

The lowest effective dose should be used for the shortest time 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).

Adults:

The recommended average dose is 1 sachet (600 mg of ibuprofen) every 12 hours. In rheumatoid arthritis, higher doses may be required, but in any case, it is recommended not to exceed the daily dose of 2,400 mg of ibuprofen (4 sachets), keeping in mind that the lowest effective dose should be administered.

Elderly patients:

In these patients, dosage must be determined by the doctor, as a reduction from the usual dose may be necessary.

Patients with kidney and/or liver disease:

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

Use in children and adolescents:

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

Adolescents over 14 years of age should follow adult dosing recommendations, but the maximum recommended daily dose in these patients is 1,600 mg.

This medicine is administered orally. Dissolve the contents of one sachet in half a glass of water and shake.

If gastric discomfort occurs after taking the medicine, it should be taken together with milk or during meals.

If you take more Ibuprofen (arginine) Vir than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medicine, consult a doctor immediately or go to the nearest hospital to assess the risk and receive advice on necessary measures, 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’s 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 (mainly 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 circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may worsen in asthmatic patients. In addition, hypotension and respiratory disturbances may occur.

If a severe poisoning has occurred, the doctor will take the necessary measures.

In case of ingestion of large quantities, activated charcoal should be administered. Gastric emptying should be considered if large amounts have been ingested and within 60 minutes of ingestion.

If you forget to take Ibuprofen (arginine) Vir

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

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.

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

4. Possible adverse effects

Like all medicines, Ibuprofeno (arginina) Vir can produce adverse effects, although not everyone will experience them.

The adverse effects observed are described below according to their frequency of occurrence:

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.

Infections and infestations

Very rare: Exacerbation of inflammation related to infection (e.g., development of necrotizing fasciitis), coinciding with the use of non-steroidal anti-inflammatory drugs*

Note: If signs of infection appear or worsen during treatment with ibuprofen, it is recommended to see a doctor immediately, in case anti-infective/antibiotic therapy is required.

Gastrointestinal disorders

The most common adverse effects associated with medicines such as ibuprofen are gastrointestinal: peptic ulcers, gastrointestinal hemorrhage, perforations (in some cases fatal), especially in elderly patients. Gastrointestinal discomfort has also been observed, such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and minor gastrointestinal bleeding, which may exceptionally lead to anemia. Uncommon: gastrointestinal ulcers, potentially with hemorrhage and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis.

Other adverse effects include: Uncommon: inflammation of the oral mucosa with ulcer formation. Rare: esophagitis, esophageal narrowing (esophageal stricture), exacerbation of intestinal diverticular disease, nonspecific hemorrhagic colitis (gastroenteritis with bloody diarrhea). Very rare: esophagitis, pancreatitis, intestinal stricture.

Cardiac and vascular 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), hypertension, and heart failure have also been observed in association with treatments using medicines of the ibuprofen type.

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

Skin and subcutaneous tissue disorders

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

• Non-elevated 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 skin rash, high body temperature, and enlarged 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).

Other adverse effects are:

Common: skin rash. Uncommon: skin redness, itching or swelling of the skin, purpura (purple spots on the skin).

Very rare: hair loss, erythema multiforme (skin lesion), photosensitivity reactions, inflammation of blood vessels in the skin. Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox.

Frequency not known: Generalized red, scaly rash with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis), skin becomes light-sensitive. Stop taking Ibuprofeno (arginina) Vir if you experience these symptoms and seek immediate medical attention. See also section 2.

Immune system disorders

Uncommon: hypersensitivity reactions with skin rash and pruritus, as well as asthma attacks (possibly together with a drop in blood pressure). Very rare: severe hypersensitivity reactions (these may be characterized by swelling of the face, tongue, and larynx, bronchospasm, dyspnea, tachycardia, and hypotension, which may include potentially fatal shock).

Note: if these symptoms occur, even with first use, immediate medical assistance is required.

Nervous system disorders

Common: fatigue or drowsiness, headache, dizziness, or feeling of instability. Uncommon: headache, dizziness. Rare: paresthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis. In most reported cases of aseptic meningitis with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. Symptoms observed included neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric disorders

Uncommon: insomnia, anxiety, restlessness. Rare: disorientation or confusion, nervousness, irritability. Very rare: psychotic reactions, depression.

Ear and labyrinth disorders

Common: dizziness. Uncommon: tinnitus (ringing or buzzing in the ears). Rare: hearing difficulty.

Eye disorders

Uncommon: visual disturbances. Rare: abnormal or blurred vision.

Blood and lymphatic system disorders

Rare: decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe decrease in granulocytes), aplastic anemia (bone marrow failure to produce various types of blood cells), or hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding. Very rare: prolonged bleeding time.

Renal and urinary disorders

Very rare: edema (signs that may indicate kidney disease, which may sometimes include renal failure); kidney tissue damage (papillary necrosis), increased serum uric acid concentration.

Hepatobiliary disorders

Medicines such as ibuprofen may rarely be associated with liver injury. Other rare adverse effects include: hepatitis (liver inflammation), liver function abnormalities, and jaundice (yellowing of the skin and eyes). Very rare: hepatic dysfunction, liver damage (particularly with long-term treatment), liver failure, acute hepatitis. Frequency not known: liver failure (severe liver impairment).

General

Worsening of inflammation during infectious processes.

To date, severe allergic reactions with ibuprofen have not 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 difficulties, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

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

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulties.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or diarrhea with blood.
• Severe stomach pain.
• Blisters or extensive skin peeling.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (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, consult your doctor or pharmacist, 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 (arginine) Vir

Keep out of sight and reach of children.

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

No special storage conditions are required. Keep in the original packaging to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofeno (arginine) Vir
The active substance is Ibuprofen. Each sachet contains 600 mg of ibuprofen.

• The other components are: arginine, aspartame (E951), compressible sugar (sucrose), sodium bicarbonate, sodium saccharin, sodium lauryl sulfate, menthol flavour (10.86.4580), peppermint flavour (506041 TP0504 contains maize starch) and purified water.

Appearance of the product and contents of the pack

Sachets containing granules for oral solution. It is presented as white granules with a characteristic peppermint odour.

Packaged in packs of 20 or 40 sachets.

Marketing Authorization Holder

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
C/Laguna 66-70. Polígono Industrial URTINSA II
28923 – Alcorcón (Madrid)
Spain

Manufacturer

Toll Manufacturing Services, S.L.
C/ Aragoneses, 2
28108 – Alcobendas
Madrid
Spain

or

Lamp San Prospero, S.P.A.
Via della Pace 25/A, 41030
San Prospero S/S, Modena, Italy

or

LABORATORIO FCO BIOCENTURY
Ctra N-II Km 714
17242 Quart - Gerona
Spain

Date of latest revision of this leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/