PATIENT INFORMATION LEAFLET

Ibuprofen (Arginine) Vir Pharma 600 mg powder for oral solution EFG

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

- Keep this leaflet as you may need to read it again.

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

- This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms, as it may harm them.

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

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

2. What you need to know before you start taking Ibuprofen (Arginine) Vir Pharma

3. How to take Ibuprofen (Arginine) Vir Pharma

4. Possible side effects

5. Storage of Ibuprofen (Arginine) Vir Pharma

6. Contents of the pack and additional information

Ibuprofeno (Arginina) Vir Pharmabelongs 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).

Do not take Ibuprofeno (arginina) Vir Pharma:

• If you are allergic to the active ingredient,to other nonsteroidal anti-inflammatory drugs (NSAIDs), to aspirinor to any of the other components of this medication (listed in section 6. The reactions that may be: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing or asthma.

• If you have a severe liver or kidney disease.

• If you have had a stomach or duodenal ulcer or bleeding, 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 or clotting disorders, or are taking anticoagulants (medicines used to "thin" the blood). If necessary, the doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

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 notice any of these signs.

Inform your doctor

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• If you are receiving treatment with Ibuprofeno (arginina) Vir Pharma as it may mask fever, an important sign of infection, making its diagnosis difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a long time (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done.
• If you experience symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluid and immediately contact your doctor, as ibuprofen in this case may cause kidney failure as a result of dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when high doses and prolonged treatment are used, especially in patients with a history of peptic ulcer disease and in the elderly. In these cases, your doctor may consider adding a stomach protector medication.
• If you are taking anticoagulants (medicines used to "thin" the blood) 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.

• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are taking diuretics (medicines to urinate) as your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic condition 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, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, blood in urine, or liver disease), so your doctor can assess the suitability of ibuprofen treatment.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform a more stringent check if you receive ibuprofen after major surgery.
• It is not recommended to take this medication if you have chickenpox.

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

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

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the 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 (arginina) Vir Pharma if:

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

These types of medications can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

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), generalized acute pustular psoriasis (GPP), have been reported in association with ibuprofen treatment. Stop using this medication immediately and seek medical attention if you notice any of these symptoms.

Respiratory Problems

Ibuprofen should be used with caution in patients who have or have had asthma, bronchial asthma, or allergic diseases, as it may cause bronchospasm, urticaria, or angioedema in these patients.

Children and Adolescents

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

This medication is not recommended for use in children or adolescents under 14 years old, as the dose of ibuprofen contained 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 predisposition to bleeding and delay or prolong labor more than expected. 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 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 checks.

For women of childbearing age, it is essential to note that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Interference with Diagnostic Tests

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

Taking Ibuprofeno (Arginina) Vir Pharma with Other Medications:

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

Ibuprofeno (arginina) Vir Pharma may affect or be affected by other medications. For example:

• Other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding.

• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Diuretics: NSAIDs may reduce the effect of diuretics and other antihypertensive substances. Concomitant administration of ibuprofen and potassium-sparing diuretics may cause hyperkalemia and increase the risk of renal toxicity.

• Antiplatelet agents (prevent the formation of blood clots in blood vessels) such as ticlopidine.
• Anticoagulants (medicines used to "thin" the blood) such as aspirin, warfarin, ticlopidine.
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.

• Metotrexate. Your doctor may adjust the dose of this antimetabolite (slows down the growth of certain cells produced by the body).
• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas such as tolbutamide (used to treat diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (medication used to treat HIV/AIDS).
• Fibrinolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: from the Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for metabolizing numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Taking Ibuprofeno (Arginina) Vir Pharma with Food, Drinks, and Alcohol

You can take it alone or with food. In general, it is recommended to take it during meals or immediately after eating to reduce the possibility of stomach discomfort. 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.

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

Minimal amounts of ibuprofen and its metabolites are excreted in breast milk. As no undesirable effects have been reported in the infant, it is usually not necessary to discontinue breastfeeding during short-term use at recommended doses.

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

Driving and Operating Machinery:

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, you should not drive or operate hazardous machinery. If you only take a single dose or take it for a short period, you do not need to take special precautions.

Ibuprofeno (arginina) Vir Pharma contains aspartame and saccharose:

People with phenylketonuria should note that each pack contains 16.8 mg of phenylalanine.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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 inform you of the duration of treatment with Ibuprofen. Do not discontinue treatment beforehand, as this will not yield the expected results. Similarly, do not use this medication for a longer period than indicated by your doctor.

It is essential to use the smallest dose that relieves or controls pain and should not take Ibuprofen (Arginina) Vir Pharma for a longer time than necessary to control your symptoms.

Adults:

The recommended average dose is 1 tablet (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 tablets), taking into account that the smaller dose considered effective should be administered.

Senior patients:

In these patients, the dosage should be established by the doctor, as it is possible that a reduction in the usual dose may be necessary.

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 that he has prescribed.

Use in children and adolescents:

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

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

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

If gastrointestinal discomfort is detected after ingesting the medication, it will be administered together with milk or during meals.

If you take more Ibuprofen (Arginina) Vir Pharma than you should

If you have taken more ibuprofen than you should or if a child has ingested the medication accidentally, 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, as well as blood in the urine, low potassium levels in the blood, chills, and breathing problems. 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 a severe intoxication has occurred, the doctor will take the necessary measures.

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

If you forget to take Ibuprofen (Arginina) Vir Pharma

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.

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

Like all medicines, Ibuprofeno (Arginina) Vir Pharma may cause side effects, although not everyone will experience them.

The side effects observed are described below according to the frequency of presentation:

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:

Infections and infestations

Very rare:Exacerbation ofinflammationsrelated to infection(e.g.,developmentof necrotizing fasciitis), coinciding withthe use ofnonsteroidal anti-inflammatory drugs*

Nota: If signs of infection or worsening occur during treatment with ibuprofen, it is recommended to see a doctor immediately, if necessary to initiate an anti-infective/antibiotic therapy.

Gastrointestinal disorders

The most common side effects that occur with medications such as ibuprofen are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Also, gastrointestinal discomfort such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding that may cause anemia in exceptional cases have been observed. Uncommon peptic ulcers, potentially with bleeding and perforation, oral ulcers, exacerbation of colitis and Crohn's disease, gastritis.

Other side effects are: Uncommon: mucosal inflammation of the mouth with ulcer formation. Rare: esophagitis, esophageal stricture (esophageal stenosis), exacerbation of intestinal diverticulitis, unspecified hemorrhagic colitis (gastroenteritis with bloody diarrhea). Very rare: esophagitis, pancreatitis, intestinal stenosis.

Cardiovascular and vascular disorders

Medications such as ibuprofen may be associated with a moderate increase in the risk of suffering a heart attack (“myocardial infarction”) or cerebral.

Also, edema (fluid retention), hypertension, and heart failure have been observed in association with treatments with ibuprofen-type medications.

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

Dermatological and subcutaneous tissue disorders

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

• Flat, red, circular, or target-shaped patches 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 symptoms similar to the flu [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Other side effects are:

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

Very rare: hair loss, erythema multiforme (skin lesion), light-sensitive skin reactions, inflammation of skin blood vessels.Exceptionally, severe skin infections and complications in soft tissue 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 pustular psoriasis). Stop taking Ibuprofeno (arginina) Vir Pharma if you experience these symptoms and seek immediate medical attention. See section 2.

Immune system disorders

Uncommon: hypersensitivity reactions with skin rash and pruritus, as well as asthma attacks (possibly accompanied by hypotension). Very rare: severe hypersensitivity reactions (these may be characterized by facial, tongue, and laryngeal swelling with bronchospasm, dyspnea, tachycardia, and hypotension that may include potentially fatal shock).

Nota: In the appearance of these symptoms, which may occur with the first use, immediate assistance from a doctor is required.

Nervous system disorders:

Common: fatigue or drowsiness, headache, and dizziness or feeling of instability.Uncommon: headache, dizziness.Rare: paresthesia (numbness, tingling, burning, 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 had 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:

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

Vestibular disorders

Common: vertigo. Uncommon: tinnitus or ringing in the ears. Rare: hearing difficulty.

Eye disorders:

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

Renal and urinary disorders:

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

Hepatobiliary disorders

Medications such as ibuprofen may be associated, in rare cases, to liver damage. Other rare side effects are: hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes).Very rare: liver dysfunction, liver damage (particularly in long-term treatment), liver insufficiency, acute hepatitis.Frequency unknown: liver insufficiency (severe liver deterioration).

General

Worsening of inflammation during infectious processes.

Up to the present, severe allergic reactions have not been reported with ibuprofen, although they cannot be ruled out. The manifestations of this type of reaction may be fever, skin rash, abdominal pain, severe headache, nausea, vomiting, facial, tongue, and throat swelling, respiratory difficulty, asthma, palpitations, hypotension, 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 side effects mentioned below appear, discontinue treatment and seek immediate medical attention:

· Allergic reactions such as skin rash, facial swelling, wheezing, or respiratory difficulty.

· Vomiting blood or coffee ground-like material.

· Blood in stool or diarrhea with blood.

· Severe stomach pain.

· Important blisters or peeling of the skin.

· Severe headache or persistent headache.

· Yellowing of the skin (jaundice).

· Signs of severe hypersensitivity (allergy) (see above in this same section).

· Swelling of the limbs or accumulation of fluid in the arms or legs.

Reporting of adverse reactions

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

Keep out of sight and reach of children.

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

Do not use this medication after the expiration date that appears on the packaging 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 the packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Ibuprofen (Arginine)Vir Pharma

The active ingredient is Ibuprofen. Each sachet contains 600 mg of Ibuprofen.

The other components are: Arginine, Aspartame (E-951), sucrose, sodium bicarbonate, sodium saccharin, sodium lauryl sulfate, peppermint aroma (10.86.4580), spearmint aroma (506041 TP0504) contains cornstarch, purified water.

Appearance of the product and contents of the packaging

Sachets with oral solution granules. It is presented in the form of a white granular substance with a characteristic peppermint odor.

It is presented in packaging with 20 or 40 sachets.

Holder of the marketing authorization and responsible for manufacturing

Holder

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-70. Polígono Industrial URTINSA II.

28923 – Alcorcón (Madrid)

Spain

Responsible for manufacturing

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 – Alcobendas

Madrid

Spain

or

LAMP S.PROSPERO S.P.A

Vía de la Pace, 25

41030 San Prospero (MO)

Italy

Last review date of this leaflet: November 2024

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/