IBUPROFEN (ARGININE) VIR 600 mg ORAL SOLUTION GRANULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Read all of this 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Ibuprofeno (arginina) Vir and what is it 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, treatment of mild or moderate pain including migraine, treatment of arthritis (inflammation of the joints, including usually 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 that affects the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before you take Ibuprofen (arginine) Vir

Do not take Ibuprofen (arginine) Vir

• If you are allergic to the active substance or to other medicines of the non-steroidal anti-inflammatory drug group (NSAIDs), to aspirin, or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may be: skin rash with itching, swelling of the face, lips, or tongue, runny nose, difficulty breathing, or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines 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 severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions:

Ibuprofen has been reported to cause signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using ibuprofen immediately and contact your doctor or the emergency medical service immediately if you notice any of these signs.

Tell your doctor

• If you have edema (fluid retention).
• If you have or have had any heart disorder or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment with Ibuprofen (arginine) Vir as it may mask fever, which is an important sign of infection, making diagnosis 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 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, e.g. severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure as a consequence of dehydration.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by severe abdominal pain or persistent abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medication.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid.
• You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as ibuprofen-like medications can worsen these conditions.
• If you are being treated with diuretics (medicines to urinate) because your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria).
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• If you have an infection; see the "Infections" section below.
• It is possible that allergic reactions may occur with this medicine.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.

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

Infections

Ibuprofen (arginine) Vir may hide the signs of an infection, such as fever and pain. Consequently, Ibuprofen (arginine) Vir may delay the 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.

Skin reactions

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 of the symptoms related to these severe skin reactions described in section 4.

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

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 Ibuprofen (arginine) 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, have a family history of heart disease or stroke, or are a smoker.

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

Respiratory disorders

Ibuprofen should be used with caution when administered to patients who have or have had 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 kidney failure in dehydrated children and adolescents.

Ibuprofen (arginine) Vir is not recommended for use in children and 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 age

It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency 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 indicated 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 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 more than a few days, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that ibuprofen-like medications have been associated with decreased fertility.

Interference with laboratory tests

If you are going to have any diagnostic tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Use of ibuprofen with other medications

Tell your doctor or pharmacist if you are using or have recently used any other medication, even those purchased without a prescription.

Ibuprofen (arginine) Vir may affect or be affected by other medications. For example:

• Other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding
• Anticoagulant medications (e.g. to treat coagulation problems/prevent coagulation, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan)
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels such as ticlopidine)
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate. Your doctor may adjust the dose of this antimetabolite medication (slows down the growth of certain cells produced by the body).
• Mifepristone (abortion inducer).
• 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 with penicillin in infections).
• Antibiotics of the quinolone group such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (anti-HIV medication).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

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

You can take it alone or with food. In general, it is recommended to take it before meals to reduce the possibility of stomach upset. Consuming alcohol during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

You should not take ibuprofen during pregnancy, especially during the third trimester (see section precautions during pregnancy and in women of childbearing age).

Minimal amounts of ibuprofen and its degradation products are excreted in breast milk. As no adverse effects are known in the infant, it is not usually necessary to interrupt breastfeeding during short-term use at recommended doses.

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

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 only take one dose or take it for a short period, it is not necessary to take special precautions.

Ibuprofen (arginine) Vir contains aspartame and sucrose

This medication contains aspartame as an excipient. People with phenylketonuria should note that each sachet contains 16.8 mg of phenylalanine.

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

3. How to take Ibuprofeno (arginina) Vir

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the duration of treatment with Ibuprofeno. Do not suspend treatment beforehand, as the expected results will not be obtained. Similarly, do not use this medication 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 without delay 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), taking into account that the lowest effective dose should be administered.

Elderly patients:

In these patients, the dosage should be established by the doctor, as there may be a need to reduce the usual dose.

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 so, take the exact dose that your doctor has prescribed.

Use in children and adolescents:

The use of this medication is not recommended 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.

Adolescents over 14 years of age will follow adult dosage recommendations, but the maximum recommended daily dose in these patients is 1600 mg.

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

If gastric discomfort is detected after taking the medication, it should be administered together with milk or during meals.

If you take more Ibuprofeno (arginina) 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 or go to the nearest hospital immediately 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 packaging and the prospectus of the medication 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. 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 renal failure and liver damage may occur. Exacerbation of asthma in asthmatics is possible. Additionally, drops in blood pressure and respiratory alterations may occur.

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

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric lavage will be considered if significant amounts have been ingested and within 60 minutes after ingestion.

If you forgot to take Ibuprofeno (arginina) 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 of the next dose is very close, skip the forgotten dose and take the next dose at the usual time.

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

4. Possible adverse effects

Like all medications, Ibuprofeno (arginina) Vir may cause adverse effects, although not all people suffer from them.

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

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.

Infections and infestations

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

Note: If signs of infection or worsening occur during treatment with ibuprofen, it is recommended to go to the doctor immediately, in case it is necessary to initiate anti-infective/antibiotic therapy.

Gastrointestinal disorders

The most frequent adverse effects that occur with medications like ibuprofen are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Gastrointestinal disorders such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding that can cause anemia in exceptional cases have also been observed. Infrequent gastrointestinal ulcers, potentially with bleeding and perforation, stomatitis, exacerbation of colitis and Crohn's disease, gastritis.

Other adverse effects are: Frequent: skin rash. Infrequent: redness of the skin, itching or swelling of the skin, purpura (purple spots on the skin).

Very rare: hair loss, erythema multiforme (skin lesion), skin reactions due to light influence, inflammation of the blood vessels of the skin. Exceptionally, severe skin infections and soft tissue complications can 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 start of treatment (acute generalized exanthematous pustulosis), the skin becomes sensitive to light. Stop taking Ibuprofeno (arginina) Vir if you present these symptoms and seek medical attention immediately. See also section 2.

Cardiac and vascular disorders

Medications like ibuprofen may be associated with a moderate increase in the risk of suffering a heart attack or stroke.

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

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

Disorders of the skin and subcutaneous tissue

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

• Red patches, not elevated, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized rash, red and scaly, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Other adverse effects are:

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

Very rare: hair loss, erythema multiforme (skin lesion), skin reactions due to light influence, inflammation of the blood vessels of the skin. Exceptionally, severe skin infections and soft tissue complications can 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 start of treatment (acute generalized exanthematous pustulosis), the skin becomes sensitive to light. Stop taking Ibuprofeno (arginina) Vir if you present these symptoms and seek medical attention immediately. See also section 2.

Immune system disorders

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

Note: In the event of these symptoms, which can occur with the first use, immediate medical attention is required.

Nervous system disorders

Frequent: fatigue or drowsiness, headache, and dizziness or feeling of instability. Infrequent: headache, dizziness. Rare: paresthesia (sensation of numbness, tingling, etc., more frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered from some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric disorders

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

Ear and labyrinth disorders

Frequent: vertigo. Infrequent: ringing or buzzing in the ears. Rare: hearing difficulty.

Eye disorders

Infrequent: vision changes. 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 difficulty breathing and pale skin), decreased granulocytes (a type of white blood cell that can predispose to infections), pancytopenia (deficiency of red, white, and blood platelets), agranulocytosis (very large decrease in granulocytes), aplastic anemia (insufficiency of the bone marrow to produce different types of cells), or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, 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 can sometimes include kidney failure); kidney tissue damage (papillary necrosis), increased serum uric acid concentration.

Hepatobiliary disorders

Medications like ibuprofen may be associated, in rare cases, with liver damage. Other rare adverse effects are: hepatitis (inflammation of the liver), abnormal liver function, and jaundice (yellowing of the skin and eyes). Very rare: liver dysfunction, liver damage (particularly with long-term treatment), liver failure, acute hepatitis. Frequency unknown: liver failure (severe liver deterioration).

General disorders

Worsening of inflammation during infectious processes.

To date, no serious 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, intense and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

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).

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

• Allergic reactions such as skin rashes, swelling of the face, wheezing in the chest, or difficulty breathing.

Vomiting blood or coffee grounds-like vomit.

• Blood in the stool or bloody diarrhea.
• Severe stomach pain.
• Blistering or significant 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 type of adverse effect, consult your doctor or pharmacist, 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 Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofeno (arginina) Vir

Keep out of sight and reach of children.

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

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications that are no longer needed in the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that are no longer needed. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno (arginina) VirThe active ingredient is Ibuprofeno. Each sachet contains 600 mg of ibuprofen.

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

Appearance of the product and package contents

Sachets with granulate for oral solution. It is presented in the form of a white granulate with a characteristic mint flavor.

It is presented in packages 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 the last revision of this prospectus: November 2024

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