Leaflet: information for the user

Ibuprofen (Arginine) Normon 600 mg powder for oral solution EFG

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

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

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

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

Ibuprofeno (Arginina) Normonbelongs to a group of medicines called 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 and primary dysmenorrhea (painful menstruation), 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 spine joints), and non-rheumatic inflammation.

Do not take Ibuprofeno (Arginina) Normon

• 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 bleeding, or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have an active cerebral hemorrhage or other active bleeding.
• If you have bleeding disorders or coagulation disorders, or are taking anticoagulants (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

Inform your doctor, pharmacist, or nurse before starting to take Ibuprofeno (Arginina) Normon:

• 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) Normon may mask the signs of an infection, such as fever and pain. Consequently, this medication 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 in bacterial 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 present symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluid and immediately contact your doctor, as ibuprofen in this case may cause kidney failure as a result of dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest 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 elderly patients. In these cases, your doctor will consider the possibility of associating a stomach-protective medication.

• If you take ibuprofen simultaneously with medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. 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, as ibuprofen (arginine) type medications may worsen these conditions.
• If you are being treated with diuretics (medications for urination) 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, 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 may cause symptoms such as reddish urine, blood in urine, or liver disease), so 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 a doctor for an eye examination.
• It is possible to experience allergic reactions with this medication. Discontinue treatment if you notice redness, inflammation, or skin lesions.
• Cutaneous reactions: Severe cutaneous reactions associated with ibuprofen (arginine) treatment have been reported. Discontinue ibuprofen (arginine) and seek medical attention immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe cutaneous reaction. See section 4.
• Your doctor will perform a more stringent check 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, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Discontinue use of Ibuprofeno (Arginina) Normon immediately and contact your doctor or emergency medical services immediately if you observe any of these signs.

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

Avoid concurrent administration with other NSAIDs, including those called COX-2 inhibitors.

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially bleeding and gastrointestinal 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.

Inform your doctor or pharmacist before taking ibuprofen (arginine) if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease, or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.

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

Respiratory disorders

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.

Cutaneous adverse reactions

Severe cutaneous reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular exanthema (PEGA), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno (Arginina) Normon and seek medical attention immediately if you notice any of the symptoms related to these severe cutaneous reactions described in section 4.

Children and adolescents

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

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

Precautions during pregnancy and in women of childbearing age

Due to the administration of ibuprofen (arginine) type medications being associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of ibuprofen (arginine) is contraindicated.

For women of childbearing age, it should be noted that ibuprofen (arginine) type medications have been associated with a decrease in the ability to conceive.

Interference with analytical tests

• Bleeding time (may be prolonged for 1 day after discontinuing treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen concentrations, serum creatinine, and potassium concentrations (may increase)
• With liver function tests: increased values of transaminases.

Other medications and Ibuprofeno (Arginina) Normon

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

Ibuprofeno (arginine) may affect or be affected by other medications. 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 together with ibuprofen (arginine) without consulting your doctor:

• Acetylsalicylic acid 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 diuretics that save potassium may cause hyperkalemia and increase the risk of renal toxicity.
• Antiplatelet agents (prevent the formation of blood clots in blood vessels) such as ticlopidine.
• Anticoagulants (medications used to "thin" the blood) such as warfarin.

• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate. Your doctor may adjust the dose of this antimetabolite (slows down the growth of certain cells produced by the body).
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used in the treatment of heart problems).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide or insulin (for diabetes), may need to adjust the dose.
• Some antidepressants (selective serotonin reuptake inhibitors).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (medication against HIV/AIDS).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: from the Ginkgo biloba tree.
• Inhibitors of CYP2C9 (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Taking Ibuprofeno (Arginina) Normon with food, drinks, and alcohol

It is recommended to take the granulated ibuprofen (arginine) sachets with water or another liquid. You can take them alone or with food. In general, it is recommended to take it during meals or immediately after eating, to reduce the possibility of stomach discomfort. Consuming alcohol during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy and breastfeeding

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

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

Small 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 of ibuprofen (arginine) or take it for a short period, no special precautions are necessary.

Ibuprofeno (Arginina) Normon contains aspartame, glucose, sucrose, and sodium

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.

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

May harm teeth.

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

May harm teeth.

This medication contains less than 1 mmol of sodium (23 mg) per sachet; it is essentially "sodium-free."

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.This medication should be taken exactly as directed by your doctor or pharmacist. Do not take more or less of the medication than prescribed.

Your doctor will indicate the duration of treatment with ibuprofen. Do not stop treatment before, as this will not produce the expected results. Similarly, do not use this medication for a longer period 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 immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

This medication is administered orally.The contents of a sachet should be dissolved in a glass of water and ingested after preparing the corresponding solution.

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

Adults

The recommended dose for adults and adolescents 14 to 18 years old is one sachet (600 mg of ibuprofen) every 6 to 8 hours, depending on the severity of the condition and response to treatment.

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 in adults and 1,600 mg in adolescents 14 to 18 years old.

Use in children and adolescents

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

Use in elderly patients

The dosage should be established by the doctor in elderly patients, 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 moreIbuprofeno (Arginina) Normonthan you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately or contact the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.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, nausea, vomiting (which may contain blood in the sputum),gastrointestinal bleeding (see also section 4 below), diarrhea, dizziness, spasms, hypotension, neurological depression (reduction of consciousness) headache, ringing in the ears, confusion, and involuntary eye movement.

Other symptoms may include nervousness, drowsiness, disorientation, or coma. Occasionally, patients develop seizures.

At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported.

Additionally, the time of protrombina/INR may be prolonged, probably due to interference with the action of circulating clotting factors. Acute renal failure and liver damage may occur. It is possible that asthma may worsen in asthmatic patients. There is also a possibility of low blood pressure, reduced breathing.

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 60 minutes of ingestion.

If you forget to takeIbuprofeno (Arginina) Normon

Do not take a double dose to compensate for the missed dose.

If you forget to take your dose, take it as soon as you remember. However, if the next scheduled dose is almost due, skip the missed dose and take the next dose at its usual time.

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

Like all medications,this medicationmay cause side effects, although not everyone will experience them.

The side effects of medications such as 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.

Frequencies are established according to the following classification:very common (may affect more than 1 in 10 patients); Common (may affect up to1 in 100 patients); Uncommon (may affect up to1 in 1000 patients); Rare (may affect up to1 in 10,000 patients); Very rare (may affect up to1 in 10,000 patients);frequency unknown (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 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, dizziness or sensation 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 from some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases) which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Eye disorders

Uncommon: Vision disturbances.

Rare: Abnormal or blurred vision.

Frequency unknown: Papilledema (inflammation of the optic nerve).

Ear and labyrinth disorders

Common: Dizziness.

Uncommon: Ringing or buzzing in the ears.

Rare: Hearing difficulty.

Cardiac disorders

Medications such as 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.

Frequency unknown: Cardiac 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 treatments with ibuprofen (arginine) type medications.

Very rare: Hypertension.

Frequency unknown: Arterial thrombosis.

Respiratory, thoracic, and mediastinal disorders

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

Frequency unknown: Irritation of the throat.

Gastrointestinal disorders

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

Common: Gastrointestinal discomfort 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 ulcerosa, 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.

Frequency unknown: 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: Anaphylactic reaction.

Very rare: Medications such as ibuprofen (arginine) may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread 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 skin infections and complications in soft tissue during chickenpox may occur.

Frequency unknown: Photosensitivity reactions, 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 and scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Renal and urinary disorders

Rare: Hematuria (blood in urine).

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

Based on experience with nonsteroidal anti-inflammatory drugs in general, cases of interstitial nephritis, nephrotic syndrome, and renal insufficiency cannot be ruled out.

General disorders and administration site conditions

Very rare: Worsening of inflammation during infectious processes.

Frequency unknown: Edema.

Investigations

Rare: Alteration of liver function tests.

Frequency unknown: Alteration of renal function tests.

Until now, severe allergic reactions have not been reported with ibuprofen (arginine), although they cannot be ruled out. The manifestations of this type of side effect could be fever, skin rash, abdominal pain, severe headache, nausea, vomiting, angioedema, facial swelling, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension(decreased blood pressure) or shock.

If any of the side effects listed below appear, discontinue treatment and seek immediate medical attention:

• Allergic reactions such as skin rash, facial swelling, chest tightness, or difficulty breathing.
• Vomiting blood or coffee ground-like material.
• Blood in stool or diarrhea with blood.
• Severe abdominal pain.
• Significant blisters or peeling of the skin.
• Severe headache or persistent 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, non-elevated spots, in the shape of a target or circles 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 [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized red and scaly 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. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Reporting of adverse reactions:

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

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

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

Do not use this medication after the expiration date that appears on the packagingafterCAD. 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 you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Ibuprofeno (Arginina) Normon

• The active ingredient is ibuprofen. Each sachet contains 600 mg of ibuprofen.
• The other components (excipients) are: arginine, aspartame (E-951), sucrose, sodium hydrogen carbonate, sodium saccharin, sodium lauryl sulfate, orange essence (contains glucose in maltodextrin from corn and other excipients) and purified water.

Appearance of Ibuprofeno (Arginina) Normon and contents of the packaging

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

It is presented in packaging with 20, 40 and 500 sachets.

Holder of the marketing authorization and responsible for manufacturing

NORMON, S.A. Laboratories

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of thisleaflet:November2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.