Leaflet: information for the user

Ibuprofen (arginine)cinfa 600 mg granulated powder for oral solution EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

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

Ibuprofeno (arginina) belongs to the group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs).

This medicine is used in adults and adolescents aged 14 years and above for the treatment of fever, the treatment of moderate to severe pain including migraine, the treatment of arthritis (inflammation of the joints, including those in the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic condition causing cartilage damage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

Do not take Ibuprofeno (arginina) cinfa

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6). Allergic reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, 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 experienced gastrointestinal bleeding.
• 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 or clotting disorders, or are taking anticoagulant medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you have severe dehydration caused by vomiting, diarrhea, or inadequate fluid intake.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofeno (arginina) cinfa.

Inform your doctor

• If you have edema (fluid retention).
• If you have or have had any heart problems or have high blood pressure.
• If you have asthma or any other respiratory problems.
• If you have an infection;
• Ibuprofeno (arginina) cinfa may mask the signs of an infection, such as fever and pain. Consequently, it may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication 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 medication 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 fluid and contact your doctor immediately, 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. It may manifest by intense 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 disease, and in the elderly population. In these cases, your doctor will consider the possibility of associating a stomach protector medication.
• If you take anticoagulant medications that alter blood clotting, such as oral anticoagulants or antiplatelet agents like aspirin. You should also inform your doctor about the use of 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 disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis (inflammation of the colon and rectum), as ibuprofen (arginina) type medications may worsen these conditions.
• If you are taking diuretics (medications to urinate) because your doctor needs to 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, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have intermittent acute porphyria (a metabolic disease that affects your blood and can cause symptoms such as red urine, blood in urine, or liver disease) so that your doctor can evaluate the advisability or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• If you experience visual disturbances during ibuprofen treatment, discontinue treatment and consult your doctor for an eye examination.
• It is possible to experience allergic reactions with this medication. You should discontinue treatment if you develop skin redness and inflammation or skin lesions.
• Severe 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 (PEGA), have been reported in association with ibuprofen (arginina) treatment. Discontinue ibuprofen (arginina) cinfa treatment and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.
• Stop taking ibuprofen (arginina) and seek medical attention 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 severe skin reaction. See section 4.
• Your doctor will perform a more stringent control if you receive ibuprofen after undergoing major surgery.
• It is recommended not to take this medication if you have chickenpox.
• Signs of allergic reaction to ibuprofen have been reported, such as respiratory problems, facial swelling, and neck region swelling (angioedema), and chest pain. Discontinue use of Ibuprofeno (arginina) cinfa immediately and contact your doctor or emergency medical services if you observe any of these signs.

It isimportantthatyouusethesmallestdosethatalleviates/controlsthepainanddonottakethismedication for longer than necessary to control your symptoms. Avoid concurrent administration withotherAINEs, includingthosedenominatedinhibitors ofCOX-2.

Precautions in elderly patients

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

Cardiovascular precautions

NSAIDs, such as 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 ibuprofen if:

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

Respiratory problems

Ibuprofen should be used with caution when administered to patients who have or have had asthma, bronchial asthma, or allergic diseases, as ibuprofen has been reported to 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 ibuprofen dose contained 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 your tendency and that of your baby to bleed and delay or prolong delivery more than expected. Do not take ibuprofen during the first 6 months of pregnancy unless it is strictly 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 week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

For women of childbearing age, it should be noted that ibuprofen (arginina) 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.

Other medications and Ibuprofeno (arginina) cinfa

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

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

• Anticoagulant medications (e.g. to treat bleeding problems/prevent bleeding, e.g. aspirin, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).

The following medications may interfere and should not be taken together with ibuprofeno (arginina) without consulting your doctor:

• Aspirin or other anti-inflammatory/analgesic agents increase the risk of gastrointestinal ulcers and bleeding.
• Anti-hypertensive medications (beta-blockers, ACE inhibitors, and angiotensin II receptor antagonists) and diuretics: NSAIDs may reduce the effect of diuretics and other anti-hypertensive substances. Concurrent administration of ibuprofen and potassium-sparing diuretics may cause hyperkalemia and increase the risk of renal toxicity.
• Antiplatelet agents (prevent blood clots from forming in blood vessels) like ticlopidine.
• Anticoagulant medications (used to "thin" the blood) like warfarin.
• Lithium (used to treat depression). Your doctor may adjust your lithium dose.
• Methotrexate. Your doctor may adjust your methotrexate dose, an 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 like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids like prednisone and prednisolone.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas like tolbutamide or insulin (used to treat diabetes), may need to adjust the dose.
• Some antidepressants (selective serotonin reuptake inhibitors).
• Tacrolimus or cyclosporine (used to prevent organ transplant rejection).
• Zidovudine (used to treat HIV/AIDS).
• Trombolytics (used to eliminate blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba tree.
• Inhibitors of CYP2C9 (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) treatment. Therefore, you should always consult your doctor or pharmacist before using ibuprofeno (arginina) with other medications.

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

It is recommended to take the ibuprofeno (arginina) 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 discomfort. The consumption of alcohol during treatment may increase the risk of gastrointestinal side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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 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 ofibuprofeno (arginina)or take it for a short period, no special precautions are necessary.

Ibuprofeno (arginina) cinfa contains aspartame

This medication contains 30 mg of aspartame in each sachet.

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

Ibuprofeno (arginina) cinfa contains saccharose

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

Ibuprofeno (arginina) cinfa contains sodium

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

Follow exactly the administration instructions of this medication 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 (arginina). Do not discontinue treatment beforehand, as the expected results will not be obtained. Similarly, do not use this medication for a longer period than indicated by your doctor.

The effective dose should be used for the shortest time necessary to alleviate 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 medication is administered orally. Swallow immediately after dissolving the contents of the packet in a half glass of water.

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

Adults and adolescents aged 14 to 18 years

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

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

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

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 packets 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 dose per administration of 600 mg of ibuprofen and a maximum daily dose of 1,200 mg (2 packets).

Use in children and adolescents

This medication is not recommended for use in children or adolescents under 14 years old, as the ibuprofen dose contained 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 may be necessary to reduce the usual dose.

Use in 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 prescribed by your doctor.

If you take more Ibuprofeno (arginina) cinfa than you should

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

If you have taken more ibuprofen (arginina) than you should, or if a child has accidentally ingested the medication, 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.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), diarrhea, dizziness, spasms, hypotension, or depression of the nervous system (reduced consciousness), headache, ringing in the ears, confusion, and involuntary eye movement. It may also cause agitation, disorientation, or coma. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties may occur.

Rarely, more severe symptoms such as gastrointestinal bleeding, low blood pressure, seizures, and respiratory disturbances may appear. Asthma exacerbation is possible in asthmatics. In case of significant overdose, renal insufficiency and liver damage may occur.

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 forgot to take Ibuprofeno (arginina) cinfa

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 next dose is due soon, skip the missed dose and take the next dose at its usual time.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects of medicines like ibuprofen (arginine) are more common in people over 65 years old.

The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

The observed side effects 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) and unknown frequency (cannot be estimated from available data).

The following side effects have been observed:

Infections and infestations

Very rare: Exacerbation of infections-related inflammation (for example, the development of necrotizing fasciitis), coinciding with the use of nonsteroidal 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.

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 pale 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, pseudogripal symptoms, extreme fatigue, nasal and cutaneous 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 that may include potentially fatal shock).

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

Mental disorders

Uncommon: Insomnia, anxiety, restlessness.

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

Nervous system disorders

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

Uncommon: Insomnia, excitement, irritability.

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 suffered 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

Uncommon: Vision disturbances.

Rare: Abnormal or blurred vision.

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

Ear and labyrinth disorders

Common: Dizziness.

Uncommon: Ringing or buzzing in the ears.

Rare: Hearing difficulty

Cardiac disorders

Medicines 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 severe allergic reaction called Kounis syndrome.

Vascular disorders

Also, edema (fluid retention), high blood pressure, and heart failure have been observed in association with treatments with ibuprofen (arginine) type medicines.

Very rare: High blood pressure.

Unknown frequency: Arterial thrombosis.

Respiratory, thoracic, and mediastinal disorders

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

Unknown frequency: Irritation of the throat.

Gastrointestinal disorders

The most common side effects that occur with medicines like ibuprofen (arginine) are gastrointestinal: Peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients.

Common: Gastrointestinal disturbances such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding that may cause anemia in exceptional cases.

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

Rare: Vomiting with blood.

Very rare: Inflammation of the esophagus, pancreatitis, intestinal stenosis.

Unknown frequency: Anorexia.

Hepatobiliary disorders

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

Skin and subcutaneous tissue disorders

Common: Skin rash.

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

Rare: Severe allergic reactions (anaphylactic shock).

Very rare: Medicines like ibuprofen (arginine) may be associated, in very rare cases, with severe bullous reactions such as Stevens-Johnson syndrome (disseminated erosions affecting the skin and two or more mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and detachment of the epidermis). Hair loss, erythema multiforme (skin lesion). Exceptionally, severe cutaneous infections and complications in the soft tissue 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 on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking ibuprofen (arginine) if you experience these symptoms and seek medical attention immediately. See section 2.

Renal and urinary disorders

Rare: Hematuria (blood in urine).

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

General disorders

Very rare: Exacerbation of inflammation during infectious processes.

Unknown frequency: Edema.

Complementary examinations

Rare: Alteration of liver function tests.

Unknown frequency: Alteration of renal function tests.

Until now, no severe allergic reactions have been reported with ibuprofen (arginine), although they cannot be ruled out. The manifestations of this type of effect may be fever, skin rash, abdominal pain, severe headache, nausea, vomiting, angioedema, facial swelling, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension (low blood pressure), or shock.

If any of the following side effects occur, discontinue treatment and seek immediate medical attention:

• Allergic reactions such as skin rash, facial swelling, chest tightness, or difficulty breathing.
• Vomiting blood or coffee grounds-like appearance.
• Blood in stool or diarrhea with blood.
• Severe abdominal pain.
• Significant blisters or peeling of the skin.
• Severe headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this same section).
• Swelling of the limbs or accumulation of fluid in the arms or legs.
• Visual disturbances.
• Red spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin reactions 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 and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conditions for conservation.

Do not usethis medicationafter 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 disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE collection pointof the pharmacy. In case of doubt,ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition ofIbuprofen (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 aroma, anhydrous colloidal silica, and sodium lauryl sulfate.

Appearance of the product and contents of the packaging

White granule with a characteristic peppermint odor.

It is presented in sachets of a composite metal container composed of a printed coating on one side + extruded polyethylene + aluminum + heat-fusible resin.

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

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

LCinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:November 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your 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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