Ibuprofen (arginine) Cinfa 600 mg granules for oral solution EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

What Ibuprofen (arginine) cinfa is and what it is used for
What you need to know before taking Ibuprofen (arginine) cinfa
How to take Ibuprofen (arginine) cinfa
Possible adverse effects
How to store Ibuprofen (arginine) cinfa
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 known as non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used in adults and adolescents aged 14 years and older for the treatment of fever, moderate-intensity pain including migraine, arthritis (inflammation of the joints, usually affecting hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic condition causing damage to cartilage), 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) cinfa

Do not take Ibuprofeno (arginina) cinfa

If you are allergic to ibuprofen 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, bronchospasm 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 an active cerebral haemorrhage or any other active bleeding.
If you have bleeding or blood coagulation disorders, or are taking anticoagulant medicines (used to "thin" the blood). If it is necessary to use anticoagulants concomitantly, your doctor will perform blood coagulation tests.
If you have severe heart failure.
If you have severe dehydration caused by vomiting, diarrhoea or insufficient fluid intake.
If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before taking Ibuprofeno (arginina) cinfa.

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 have an infection;
Ibuprofeno (arginina) cinfa may mask signs of infection such as fever and pain. Therefore, this medicine 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 symptoms 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 long-term (more than 1–2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on the frequency of these checks.
If you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to kidney failure as a consequence of dehydration.
If you have had or develop a stomach or duodenal ulcer, bleeding or perforation. These 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 prolonged 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 coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of 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 (inflammation of the colon and rectum), as medicines like ibuprofen (arginina) may worsen these conditions.
If you are taking diuretics ("water pills"), because your doctor needs to monitor your kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect various 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—without bacterial cause) may occur.
If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine or liver disease), so your doctor can assess whether ibuprofen treatment is appropriate.
If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
If you experience vision disturbances during treatment with ibuprofen, stop treatment and consult your doctor for an ophthalmological examination.
Allergic reactions may occur with this medicine. Treatment must be discontinued if redness, inflammation or skin lesions 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), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen (arginina) treatment. Discontinue treatment with Ibuprofeno (arginina) cinfa 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 (arginina) and see a doctor immediately if you develop any skin rash, mucosal 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 closer monitoring if you receive ibuprofeno after major surgery.
It is advisable not to take this medicine if you have chickenpox.
Signs of allergic reaction to ibuprofen, such as breathing problems, swelling of the face and neck area (angioedema), or chest pain, have been reported. Stop using Ibuprofeno (arginina) cinfa immediately and contact your doctor or emergency medical services if you notice any of these signs.

It is important to use the lowest effective dose that relieves/controls your pain and not to take this medicine 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 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.

Discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary artery bypass surgery, peripheral arterial disease (circulation problems in 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 smoke.

Also, these types of medicines may cause fluid retention, especially 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 kidney failure in dehydrated children and adolescents.

The use of this medicine 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 dosing 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 your tendency and your baby's tendency to bleed and may delay or prolong labour more than expected. Do not take ibuprofen during the first 6 months of pregnancy unless strictly 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 dose for the shortest possible time.

From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that medicines like ibuprofen (arginina) have been associated with reduced fertility.

Interference with diagnostic tests

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

Other medicines and Ibuprofeno (arginina) cinfa

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

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

Anticoagulant medicines (e.g. to treat or prevent blood 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).

The following medicines may interact and therefore should not be taken together with ibuprofeno (arginina) 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 agents. Concomitant administration of ibuprofen and potassium-sparing diuretics may cause hyperkalaemia and increase the risk of kidney toxicity.
Antiplatelet agents (prevent blood clots in blood vessels) such as ticlopidine.
Anticoagulants (medicines used to "thin" the blood and prevent clots) such as warfarine.
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 (abortion-inducing agent).
Digoxin and cardiac glycosides (used to treat heart disorders).
Hydantoins such as phenytoin (used to treat epilepsy).
Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
Corticosteroids such as cortisone and prednisolone.
Pentoxifylline (used to treat intermittent claudication).
Probenecid (used in gout patients or with penicillin in infections).
Quinolone antibiotics such as norfloxacin.
Sulfinpyrazone (used to treat gout).
Sulfonylureas such as tolbutamide or insulin (for diabetes); dose adjustment may be necessary.
Certain antidepressants (serotonin reuptake inhibitors).
Tacrolimus or cyclosporine (used to prevent organ transplant rejection).
Zidovudine (an anti-HIV medicine).
Thrombolytics (medicines that dissolve blood clots).
Aminoglycoside antibiotics such as neomycin.
Herbal extracts: Ginkgo biloba.
CYP2C9 inhibitors (responsible for the metabolism of many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medicines may also affect or be affected by ibuprofeno (arginina) treatment. Therefore, always consult your doctor or pharmacist before using Ibuprofeno (arginina) cinfa with other medicines.

Taking Ibuprofeno (arginina) cinfa with food, drinks and alcohol

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

You may take it alone or with food. In general, it is recommended to take it during or immediately after meals to reduce the possibility of stomach discomfort. Alcohol consumption during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Ibuprofeno (arginina) 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 metabolites are excreted in breast milk. As no adverse effects in infants 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 using machines

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 of ibuprofeno (arginina) or use it for a short period, no special precautions are usually necessary.

Ibuprofeno (arginina) cinfa contains aspartame

This medicine contains 30 mg of aspartame per sachet.

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

Ibuprofeno (arginina) cinfa contains sucrose

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

Ibuprofeno (arginina) cinfa contains sodium

This medicine contains 85.4 mg of sodium (a main component of table/cooking salt) per sachet. This corresponds to 4.27% of the maximum daily sodium intake recommended for an adult.

3. How to take Ibuprofen (arginine) cinfa

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with ibuprofen (arginine). Do not stop treatment earlier, as this would prevent achieving the expected results. Likewise, do not use this medicine for longer than indicated by your doctor.

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

This medicine is administered orally. Immediately dissolve the contents of the sachet in half a glass of water and ingest right away.

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

Adults and adolescents aged 14 to 18 years

Dosage should be adjusted according to the severity of the condition and the patient's symptoms.

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

In some conditions, higher doses may be required; however, in all cases, 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 aged 14 to 18 years.

In rheumatoid arthritis, higher doses may be required; however, in all cases, 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 is achieved, with a maximum single dose 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 medicine 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 dosing in these patients.

Use in elderly patients

In these patients, dosage must be determined by the doctor, as a reduction from 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-than-usual dose. If so, take exactly the dose prescribed by your doctor.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you have taken more ibuprofen (arginine) 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 obtain advice on necessary measures.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), diarrhea, dizziness, spasms, hypotension, or signs of central nervous system depression (reduced consciousness), headache, tinnitus, confusion, and involuntary eye movements. Agitation, disorientation, or coma may also occur. 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 may be reported.

Additionally, prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors.

Rarely, more severe symptoms may occur, such as gastrointestinal bleeding, low blood pressure, seizures, and respiratory disturbances. Asthma exacerbation is possible in asthmatic patients. In cases of significant overdose, renal failure and liver damage may occur.

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 following ingestion.

If you forget to take Ibuprofen (arginine) cinfa

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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects of medicines such as ibuprofen (arginine) are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatments and when the daily dose is below the maximum recommended dose.

The observed adverse effects are described below according to their frequency of occurrence: 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), and frequency not known (cannot be estimated from available data).

The following adverse effects have been observed:

Infections and infestations

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

Note: If signs of infection appear or worsen during treatment with ibuprofen, consult a doctor immediately, as anti-infective/antibiotic therapy may be required.

Blood and lymphatic system disorders

Rare: Aplastic anemia (bone marrow failure to produce various types of cells).

Very rare: Decreased platelet count, decreased white blood cells (may present as frequent infections with fever, chills, or sore throat), decreased red blood cells (may present as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may increase susceptibility to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe reduction in granulocytes), 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. Prolonged bleeding time.

Immune system disorders

Uncommon: Allergic reaction, hypersensitivity reactions with skin rash and pruritus, as well as asthma attacks (possibly accompanied by 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, which may include potentially life-threatening shock).

Note: If these symptoms occur, even with first use, immediate medical attention is required.

Psychiatric disorders

Uncommon: Insomnia, anxiety, restlessness.

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

Nervous system disorders

Common: Fatigue or drowsiness, headache, dizziness, or feeling of instability.

Uncommon: Insomnia, excitement, irritability.

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 associated 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.

Eye disorders

Uncommon: Visual disturbances.

Rare: Abnormal or blurred vision.

Frequency not known: Papilledema (swelling of the optic nerve).

Ear and labyrinth disorders

Common: Vertigo.

Uncommon: Tinnitus (ringing or buzzing in the ears).

Rare: Hearing difficulty.

Cardiac disorders

Medicines such as ibuprofen (arginine) may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Very rare: Palpitations, cardiac failure.

Frequency not known: Heart failure, chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Vascular disorders

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatment using medicines like ibuprofen (arginine).

Very rare: Hypertension.

Frequency not known: Arterial thrombosis.

Respiratory, thoracic, and mediastinal disorders

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

Frequency not known: Throat irritation.

Gastrointestinal disorders

The most common adverse effects with medicines such as ibuprofen (arginine) are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients.

Common: Gastrointestinal discomfort such as pyrosis (acid reflux), abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding, which may exceptionally lead to anemia.

Uncommon: 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: Inflammation of the esophagus, pancreatitis, intestinal stenosis.

Frequency not known: Anorexia.

Hepatobiliary disorders

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

Skin and subcutaneous tissue disorders

Common: Skin rash.

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

Rare: Severe allergic reactions (anaphylactic shock).

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

Frequency not known: Skin becomes sensitive to light (photosensitivity), worsening of skin reactions.

A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell). Generalized red scaly rash with bumps under the skin and blisters primarily located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning 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 (presence of blood in urine).

Very rare: Edema (signs that may indicate kidney disease, which may sometimes include renal failure); renal 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 renal failure cannot be excluded.

General disorders

Very rare: Worsening of inflammation during infectious processes.

Frequency not known: Edema.

Additional investigations

Rare: Abnormal liver function tests.

Frequency not known: Abnormal kidney function tests.

To date, severe allergic reactions with ibuprofen (arginine) have not been reported, although they cannot be ruled out. Manifestations of such effects could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, angioedema, swelling of the face, tongue, and throat, breathing difficulty, asthma, palpitations, hypotension (decreased blood pressure), or shock.

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

Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
Vomiting blood or material resembling coffee grounds.
Blood in stool or bloody diarrhea.
Severe stomach pain.
Blisters or extensive peeling of the skin.
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.
Visual disturbances.
Flat, non-elevated red, target-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or 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 skin rash, high 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 exanthematous pustulosis).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can 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) cinfa

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofen (arginine) cinfa

The active substance 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 flavour, anhydrous colloidal silica, and sodium lauryl sulfate.

Appearance of the product and contents of the pack

White granules with a characteristic peppermint odour.

Presented in printed metallic complex sachets consisting of coated paper on one side + extruded polyethylene + aluminium + heat-seal resin.

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the most recent review of this leaflet: November 2024

Detailed information on this medicinal product 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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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