IBUPROFEN (ARGININE) CINFA 600 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

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

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

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

This medicine is used in adults and adolescents from 14 years of age for the treatment of fever, treatment of 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) cinfa

Do not take Ibuprofen (arginine) cinfa

• If you are allergic to ibuprofen or 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, nasal discharge, difficulty breathing, bronchospasm or asthma.
• If you have a 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 an active cerebral hemorrhage or other active bleeding.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulant 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 severe heart failure.
• If you have severe dehydration caused by vomiting, diarrhea, or insufficient fluid intake.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofen (arginine) cinfa.

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 have an infection;
• Ibuprofen (arginine) cinfa may hide the signs of an infection, such as fever and pain. Therefore, it is possible that this medicine may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.
• 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 in this specific case could cause kidney failure as a consequence of dehydration.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum. It may manifest as severe abdominal pain or persistent pain and/or black stools, or even without previous warning symptoms. This risk is higher when high doses are used and prolonged treatments, in patients with a history of peptic ulcer and in the elderly population. In these cases, your doctor will consider the possibility of associating a stomach protective medication.
• If you take medications that alter blood coagulation, such as oral anticoagulants or antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that could increase the risk of such bleeding, such as corticosteroids and antidepressants that are selective inhibitors of serotonin reuptake.
• 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 (inflammation of the colon and rectum), as ibuprofen-type medications may worsen these diseases.
• If you are being treated with diuretics (medicines to urinate) because your doctor must 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, you should not take higher doses of the medicine.
• If you experience vision changes during treatment with ibuprofen, stop treatment and consult your doctor for an ophthalmological examination.
• It is possible that allergic reactions may occur with this medicine. Treatment should be discontinued if redness and inflammation or skin injury appear.
• Skin reactions: Serious skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen (arginine) treatment. Discontinue ibuprofen (arginine) cinfa treatment and seek immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.
• Stop taking ibuprofen (arginine) and go to the doctor immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.
• Your doctor will perform stricter control if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• With ibuprofen, signs of allergic reaction to this medicine have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibuprofen (arginine) cinfa immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

It is important that you use the smallest dose that relieves-controls the pain and do not take this medicine for longer than necessary to control your symptoms. Avoid concomitant administration with other NSAIDs, including COX-2 inhibitors.

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 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 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 if you 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 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.

This medicine is not recommended for use 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 age

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect you and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is strictly necessary and as your doctor indicates. 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 the fluid that surrounds 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 should be noted that ibuprofen-type medications have been associated with a decrease in fertility.

Interference with analytical tests

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

Other medicines and Ibuprofen (arginine) cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• 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).

The following medications may interfere and should not be taken with ibuprofen (arginine) without first consulting your doctor:

• Acetylsalicylic acid or other anti-inflammatory/analgesic agents increase the risk of gastrointestinal ulcers and bleeding.
• Antihypertensives (beta-blockers, ACE inhibitors, and angiotensin II antagonists) and 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 or thrombi in blood vessels) such as ticlopidine.
• Anticoagulants (medicines used to "thin" the blood and prevent the formation of clots) such as warfarin.
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate. Your doctor may adjust the dose of this antimetabolite medicine (slows down the growth of certain cells produced by the body).
• Mifepristone (abortion inducer).
• Digoxin and cardiotonic 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 (to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group such as norfloxacin.
• Sulfinpyrazone (for the treatment of gout).
• Sulfonylureas such as tolbutamide or insulin (for diabetes), may need to adjust the dose.
• Certain antidepressants (selective serotonin reuptake inhibitors).
• Tacrolimus or cyclosporin (used to prevent organ transplant rejection).
• Zidovudine (a medicine against the AIDS virus).
• Thrombolytics (medicines that eliminate blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medicines in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

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

It is recommended to take the ibuprofen (arginine) sachets with a sufficient amount of water or other liquid.

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 upset. Alcohol consumption during treatment may increase the risk of adverse gastrointestinal reactions.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Ibuprofen (arginine) should not be taken during pregnancy, especially during the third trimester (see section "precautions during pregnancy and in women of childbearing age").

Breastfeeding

Minimal amounts of ibuprofen and its degradation products are excreted in breast milk. As no adverse effects are known in the breastfed 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 medicine, you should not drive or use hazardous machinery. If you only take one dose of ibuprofen (arginine) or take it for a short period, you do not need to take special precautions.

Ibuprofen (arginine) cinfa contains aspartame

This medicine contains 30 mg of aspartame in each sachet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Ibuprofen (arginine) cinfa contains saccharose

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

Ibuprofen (arginine) cinfa contains sodium

This medicine contains 85.4 mg of sodium (the main component of table salt) in each sachet. This is equivalent to 4.27% of the maximum daily sodium intake recommended for an adult.

3. How to take Ibuprofen (arginine) cinfa

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

Your doctor will indicate the duration of treatment with ibuprofen (arginine). Do not suspend treatment beforehand, as this will not achieve the expected results. 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 your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

This medication is administered orally. Take immediately after dissolving the contents of the sachet in half a glass of water.

Patients with stomach discomfort should take the medication with milk or during/after meals.

Adults and adolescents from 14 to 18 years old

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

In adults and adolescents from 14 to 18 years old, the recommended dose is one sachet (600 mg of ibuprofen) every 6 to 8 hours, depending on the intensity of the symptoms and the response to treatment.

In some processes, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg (4 sachets) in adults and 1,600 mg of ibuprofen in adolescents from 14 to 18 years old.

In rheumatoid arthritis, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg (4 sachets of granules) of ibuprofen.

In primary dysmenorrhea, a daily dose of 600 mg of ibuprofen is recommended until pain relief, with a maximum dose per intake of 600 mg of ibuprofen and a maximum daily dose of 1,200 mg (2 sachets).

Use in children and adolescents

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

Use in elderly 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.

Use in 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.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have taken more ibuprofen (arginine) than you should, or if a child has accidentally ingested the medication, consult immediately with a doctor or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), diarrhea, dizziness, spasms, hypotension, or depression of the nervous system (reduced consciousness), headache, ringing in the ears, confusion, and involuntary eye movement. Agitation, disorientation, or coma may also occur. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (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.

Rarely, more severe symptoms such as gastrointestinal bleeding, low blood pressure, convulsions, and respiratory disorders may appear. Exacerbation of asthma is possible in asthmatics. In case of significant overdose, renal failure and liver damage may occur.

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

If you forget to take Ibuprofen (arginine) cinfa

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.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

The adverse effects of medications like ibuprofen (arginine) 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.

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), and unknown frequency (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 medications.

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

Blood and lymphatic system disorders

Rare: Aplastic anemia (insufficiency of the bone marrow to produce different types of cells).

Very 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 paleness of the skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red, white, and platelet cells in the blood), agranulocytosis (very large decrease in granulocytes), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudo-flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding. Prolongation of bleeding time.

Immune system disorders

Infrequent: Allergic reaction, hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly along with a drop in blood pressure).

Rare: Anaphylaxis (generalized allergic reaction).

Very rare: Severe hypersensitivity reactions (these may be characterized by swelling of the face, tongue, and larynx with bronchospasm, dyspnea, tachycardia, and hypotension that may include potentially fatal shock).

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

Psychiatric disorders

Infrequent: Insomnia, anxiety, restlessness.

Rare: Psychotic reaction, nervousness, irritability, depression, confusion, disorientation.

Nervous system disorders

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

Infrequent: Insomnia, excitement, irritability.

Rare: Paresthesia (sensation of numbness, tingling, prickling, 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.

Eye disorders

Infrequent: Vision disturbances.

Rare: Abnormal or blurred vision.

Unknown frequency: Papilledema (inflammation of the optic nerve).

Ear and labyrinth disorders

Frequent: Vertigo.

Infrequent: Ringing or buzzing in the ears.

Rare: Hearing difficulty.

Cardiac disorders

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

Very rare: Palpitations, heart failure.

Unknown frequency: Cardiac failure, chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Vascular disorders

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

Very rare: Hypertension.

Unknown frequency: Arterial thrombosis.

Respiratory, thoracic, and mediastinal disorders

Infrequent: Asthma, worsening of asthma, bronchospasm, dyspnea (breathing difficulty).

Unknown frequency: Throat irritation.

Gastrointestinal disorders

The most frequent adverse effects that occur with medications like ibuprofen (arginine) are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients.

Frequent: Gastrointestinal disorders such as heartburn (acidity, reflux), abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding that can cause anemia in exceptional cases.

Infrequent: Gastrointestinal ulcers, potentially with bleeding and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, melena (blood in stool), gastritis.

Rare: Vomiting blood.

Very rare: Esophageal inflammation, pancreatitis, intestinal stenosis.

Unknown frequency: Anorexia.

Hepatobiliary disorders

Rare: Liver damage, hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes).

Skin and subcutaneous tissue disorders

Frequent: Skin rash.

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

Rare: Severe allergic reactions (anaphylactic shock).

Very rare: Medications like ibuprofen (arginine) may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes and purplish lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and detachment of the epidermis). Hair loss, erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox.

Unknown frequency: The skin becomes sensitive to light (photosensitivity), worsening of skin reactions.

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). Generalized red scaly rash, with bumps under the skin and blisters located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking ibuprofen (arginine) if you experience these symptoms and seek immediate medical attention. See also section 2.

Renal and urinary disorders

Rare: Hematuria (blood in the urine).

Very rare: Edema (signs that may indicate kidney disease, which may include kidney failure); kidney tissue damage (papillary necrosis), increased serum uric acid concentration. Based on experience with non-steroidal anti-inflammatory drugs in general, cases of interstitial nephritis, nephrotic syndrome, and kidney failure cannot be ruled out.

General disorders

Very rare: Worsening of inflammation during infectious processes.

Unknown frequency: Edema.

Investigations

Rare: Alteration of liver function tests.

Unknown frequency: Alteration of renal function tests.

To date, no serious allergic reactions have been reported with ibuprofen (arginine), although they cannot be ruled out. The manifestations of this type of effect could be fever, skin rash, abdominal pain, intense and persistent headache, nausea, vomiting, angioedema, swelling of the face, tongue, and throat, breathing difficulty, asthma, palpitations, hypotension (decrease in blood pressure), or shock.

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

• Allergic reactions such as skin rashes, swelling of the face, wheezing in the chest, or breathing difficulty.
• Vomiting blood or coffee-ground-like material.
• Blood in the stool or bloody diarrhea.
• Severe stomach pain.
• Blisters or significant 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.
• Vision disturbances.
• Reddish, non-elevated, target-like, or circular spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nose ulcers, genital ulcers, and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized red scaly rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

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 Ibuprofen (arginine) cinfa

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

This medication does not require special storage conditions.

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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofen (arginine) cinfa

• The active ingredient is ibuprofen. Each sachet contains 600 mg of ibuprofen as ibuprofen (arginine).
• The other components (excipients) are: L-Arginine, aspartame (E-951), sucrose, sodium saccharin (E-954), sodium hydrogen carbonate (E-500), peppermint flavor, colloidal anhydrous silica, and sodium lauryl sulfate.

Appearance of the product and package contents

White granules with a characteristic peppermint odor.

It is presented in sachets of a metallic complex printed with a coating on one side + extruded polyethylene + aluminum + thermofusible resin.

Each package contains 20, 40, or 500 (clinical package) sachets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the last revision of this prospectus:November 2024

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67939/P_67939.html

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