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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

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

Leaflet contents

What Ibuprofen (Arginine) Normon is and what it is used for
What you need to know before taking Ibuprofen (Arginine) Normon
How to take Ibuprofen (Arginine) Normon
Possible side effects
How to store Ibuprofen (Arginine) Normon
Contents of the pack and other information

1. What Ibuprofeno (Arginina) Normon is and what it is used for

Ibuprofeno (Arginina) Normon belongs to a group of medicines called 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 pain including migraine and primary dysmenorrhea (painful menstruation), the treatment of 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), and non-rheumatic inflammation.

2. What you need to know before taking Ibuprofen (Arginine) Normon

Do not take Ibuprofen (Arginine) Normon

If you are allergic to ibuprofen or to any of the other components of this medicine (listed in section 6). Signs of allergy may include: itchy skin 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 active cerebral haemorrhage or any other active bleeding.
If you suffer from bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulant medicines must be used at the same time, your doctor will perform blood coagulation tests.
If you have severe heart failure.
If you have severe dehydration caused by vomiting, diarrhoea or insufficient fluid intake.
If you are in the third trimester of pregnancy.

Warnings and precautions

Inform your doctor, pharmacist or nurse before starting to take Ibuprofen (Arginine) Normon:

If you have oedema (fluid retention).
If you suffer or have suffered from heart problems or have high blood pressure.
If you have asthma or any other respiratory disorder.
If you have an infection: Ibuprofen (Arginine) Normon 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 the 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 renal failure due to dehydration.
If you have had or develop a stomach or duodenal ulcer, bleeding or perforation, which may manifest as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

This risk is higher when high doses are used, during prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.

If you are taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor if you are taking other medicines that could increase the risk of 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, as medicines like ibuprofen (arginine) may worsen these conditions.
If you are taking diuretics (medicines to increase urine production), because your doctor should monitor your kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect 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—not caused by bacteria) 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 treatment with ibuprofen is appropriate.
If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
If you experience visual disturbances during treatment with ibuprofen, stop taking the medicine and consult your doctor for an ophthalmological examination.
Allergic reactions may occur with this medicine. Discontinue treatment if you develop redness, swelling or skin lesions.
Skin reactions: Serious skin reactions have been reported with ibuprofen (arginine). Stop taking ibuprofen (arginine) and contact your doctor immediately if you develop any skin rash, mucosal lesions, blisters or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.
Your doctor will carry out stricter monitoring if you receive ibuprofen 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 Ibuprofen (Arginine) Normon immediately and contact your doctor or emergency medical services immediately 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.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen (arginine) if:

You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary 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 are a smoker.

In addition, these 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.

Serious skin adverse reactions (SSARs)

Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofen (Arginine) Normon and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Children and adolescents

There is a risk of renal 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 dosage in these patients.

Precautions during pregnancy and in women of childbearing potential

Because administration of medicines like ibuprofen (arginine) has been associated with an increased risk of congenital abnormalities or miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless considered strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration of ibuprofen (arginine) is contraindicated during the third trimester.

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

Interference with laboratory tests

Bleeding time (may be prolonged for up to 1 day after stopping treatment)
Blood glucose concentration (may decrease)
Creatinine clearance (may decrease)
Haematocrit or haemoglobin (may decrease)
Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase)
Liver function tests: increased transaminase values.

Other medicines and Ibuprofen (Arginine) Normon

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

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

Anticoagulant medicines (e.g. to treat or prevent blood clotting, e.g. 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 ibuprofen (arginine) without first consulting your doctor:

Acetylsalicylic acid or other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding.
Antihypertensives (beta-blockers, ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effect of diuretics and other antihypertensive agents. Concomitant administration of ibuprofen and potassium-sparing diuretics may cause hyperkalaemia and increase the risk of renal toxicity.
Antiplatelet agents (prevent formation of blood clots) such as ticlopidine.
Anticoagulants (medicines used to "thin" the blood and prevent clot formation) such as warfarin.
Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
Methotrexate. Your doctor may adjust the dose of this antimetabolite medicine (slows the growth of certain body cells).
Mifepristone (an abortion-inducing agent).
Digoxin and cardiac glycosides (used in the treatment of heart disorders).
Hydantoins such as phenytoin (used in the treatment of epilepsy).
Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
Corticosteroids such as cortisone and prednisolone.
Pentoxifylline (for intermittent claudication).
Probenecid (used in gout patients or together with penicillin in infections).
Quinolone antibiotics such as norfloxacin.
Sulfinpyrazone (for gout).
Sulfonylureas such as tolbutamide or insulin (for diabetes), dose adjustment may be necessary.
Some antidepressants (serotonin reuptake inhibitors).
Tacrolimus or cyclosporine (used in organ transplants to prevent 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 numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Taking Ibuprofen (Arginine) Normon with food, drinks and alcohol

It is recommended to take the ibuprofen (arginine) granule sachets with water or another liquid. You may take them alone or with food. In general, it is advisable to take them 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.

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

Minimal amounts of ibuprofen and its metabolites are excreted in breast milk. As no adverse effects in the infant 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 use of 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 ibuprofen (arginine) or use it for a short period, special precautions are generally not required.

Ibuprofen (Arginine) Normon contains aspartame, glucose, sucrose and sodium

This medicine contains 30 mg of aspartame per sachet.

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

This medicine contains glucose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

May be harmful to teeth.

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

May be harmful to teeth.

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

3. How to take Ibuprofen (Arginine) Normon

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

Your doctor will determine the duration of treatment with ibuprofen. Do not stop treatment earlier, as the expected results would not be achieved. Likewise, do not use this medicine for longer than indicated by your doctor.

The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. 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. Dissolve the contents of one sachet in a glass of water and take after preparing the corresponding solution.

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

Adults

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 the severity of symptoms and response to treatment.

Higher doses may be required in some conditions; however, it is recommended not to exceed the maximum daily dose of 2,400 mg in adults and 1,600 mg in adolescents aged 14 to 18 years.

Use in children and adolescents

This medicine is not recommended for use in children or adolescents under 14 years of age, as the ibuprofen dose it contains is not suitable for the recommended dosing in these patients.

Use in elderly patients

In elderly patients, dosage should 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) Normon than you should

In case of overdose or accidental ingestion, immediately consult a doctor or pharmacist or contact the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital to learn about the risks and receive advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, nausea, vomiting (which may contain blood-stained material), gastrointestinal bleeding (see also section 4 below), diarrhea, dizziness, spasms, hypotension, nervous system depression (reduced consciousness), headache, tinnitus, confusion, and involuntary eye movements.

Nervousness, drowsiness, disorientation, or coma may also occur. Occasionally, patients may develop seizures.

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 have been reported.

Additionally, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may worsen in patients with asthma. Low blood pressure and reduced breathing may also occur.

In cases of ingestion of large amounts, 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) Normon

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 the time for your next dose is approaching, skip the missed dose and take the next dose at the 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 will experience 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 treatment and when the daily dose is below the recommended maximum dose.

Frequencies are defined according to the following classification: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 100 people); uncommon (may affect up to 1 in 1,000 people); rare (may affect up to 1 in 10,000 people); very rare (may affect up to 1 in 100,000 people); 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), coinciding with the use of non-steroidal anti-inflammatory drugs (NSAIDs).

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 blood cells).

Very rare: Decreased platelets, 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 fatal 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 unsteady.

Uncommon: Insomnia, excitement, irritability.

Rare: Paresthesia (numbness, tingling, "pins and needles" sensation, more commonly in hands, feet, arms, or legs).

Very rare: Aseptic meningitis. In most reported cases of aseptic meningitis 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: Dizziness.

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 serious allergic reaction known as Kounis syndrome.

Vascular disorders

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

Very rare: Hypertension.

Frequency not known: Arterial thrombosis.

Respiratory 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 heartburn (acid reflux), abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and minor 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, purpura (purple spots on the skin).

Rare: Anaphylactic reaction.

Very rare: Medicines such as ibuprofen (arginine) may very rarely 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, mainly 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, serious skin infections and soft tissue complications may occur during chickenpox.

Frequency not known: Skin reactions due to light exposure (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 mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking ibuprofen 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 sometimes may include renal failure); kidney tissue damage (papillary necrosis), increased serum uric acid concentration.

Based on experience with non-steroidal anti-inflammatory drugs in general, cases of interstitial nephritis, nephrotic syndrome, and 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, no severe allergic reactions have been reported with ibuprofen (arginine), 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 (low blood pressure), or shock.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulty.
Vomiting blood or material resembling coffee grounds.
Blood in stool or bloody diarrhea.
Severe stomach pain.
Blisters or extensive skin peeling.
Severe or persistent headache.
Yellowing of the skin (jaundice).
Signs of severe hypersensitivity (see above in this section).
Swelling of the limbs or fluid accumulation in the arms or legs.
Visual disturbances.
Flat, non-elevated red spots, target-like or circular rashes 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 effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect 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) Normon

Keep this medicine out of sight and reach of children.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Ibuprofen (Arginine) Normon

The active substance 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 flavour (containing glucose in maltodextrin derived from maize and other excipients), and purified water.

Appearance of Ibuprofen (Arginine) Normon and contents of the pack

Granules for oral solution in sachets. It is presented as white granules with a characteristic orange odour.

Available in packs containing 20, 40, and 500 sachets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.

You can access detailed and updated 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/69679/P_69679.html