IBUPROFEN (ARGININE) NORMON 600 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Ibuprofen (Arginine) Normon 600 mg Granules for Oral Solution EFG

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

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

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

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

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

Contents of the Package Leaflet

1. What is Ibuprofen (Arginine) Normon and what is it used for
2. What you need to know before taking Ibuprofen (Arginine) Normon
3. How to take Ibuprofen (Arginine) Normon
4. Possible side effects
5. Storage of Ibuprofen (Arginine) Normon
6. Package Contents and Additional Information

1. What is Ibuprofen (Arginine) Normon and what is it used for

Ibuprofen (Arginine) Normon belongs to a group of medications called non-steroidal anti-inflammatory drugs (NSAIDs).

This medication is used in adults and adolescents from 14 years of age for the treatment of fever, moderate pain including migraine and primary dysmenorrhea (painful menstruation), treatment of arthritis (inflammation of the joints, including hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic condition that causes cartilage damage), ankylosing spondylitis (inflammation that affects 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 any of the other components of this medication (listed in section 6). Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, bronchospasm, or asthma.
• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have an active cerebral hemorrhage or other active bleeding.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medications used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• If you have severe heart failure.
• If you have severe dehydration caused by vomiting, diarrhea, or insufficient fluid intake.
• If you are in the third trimester of pregnancy.

Warnings and Precautions

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

• If you have edema (fluid retention).
• If you have or have had heart problems or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you have an infection: Ibuprofen (Arginine) Normon can hide the signs of an infection, such as fever and pain. Therefore, this medication may delay the proper treatment of the infection, which can increase the risk of complications. This has been observed in bacterial pneumonia and 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 experience symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen in this specific case could cause kidney failure due to dehydration.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous 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 these cases, your doctor will consider the possibility of associating a stomach-protecting medication.

• If you take medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss with your doctor the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as medications of the type of ibuprofen (arginine) may worsen these conditions.
• If you are being treated with diuretics (medications to urinate) because your doctor must monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria).
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• If you experience vision changes during treatment with ibuprofen, discontinue treatment and consult your doctor for an ophthalmological examination.
• It is possible that allergic reactions may occur with this medication. Treatment should be discontinued if redness and inflammation or skin injury appear.
• Skin reactions: Serious skin reactions have been reported in association with ibuprofen (arginine) treatment. Stop taking ibuprofeno (arginina) and go to the doctor immediately if you present any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• Signs of allergic reaction to this medication, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibuprofeno (Arginina) Normon immediately and contact your doctor or the emergency medical service immediately if you observe any of these signs.

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

Avoid concomitant administration with other NSAIDs, including COX-2 inhibitors.

Precautions in Elderly Patients

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

Cardiovascular Precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

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

• You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

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

Respiratory Disorders

Ibuprofen should be used with caution when administered to patients who have or have a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in these patients.

Severe Adverse Skin Reactions (SASR)

Severe 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 Ibuprofeno (Arginina) Normon and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children and Adolescents

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

The use of this medication 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 Age

Since the administration of medications of the type of ibuprofen (arginine) has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless 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 taken into account that medications of the type of ibuprofen (arginine) have been associated with a decrease in fertility.

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 concentrations of urea nitrogen and serum creatinine and potassium (may increase)
• With liver function tests: increased transaminase values.

Other Medications and Ibuprofen (Arginine) Normon

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

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

• Anticoagulant medications (e.g., to treat coagulation problems/avoid coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).

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

• Acetylsalicylic acid or other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding.
• Antihypertensives (beta-blockers, ACE inhibitors, and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effect of diuretics and other antihypertensive substances. Concomitant administration of ibuprofen and potassium-sparing diuretics may cause hyperkalemia and increase the risk of renal toxicity.
• Antiplatelet agents (prevent the formation of thrombi or blood clots in blood vessels) such as ticlopidine.
• Anticoagulants (medications used to "thin" the blood and prevent the formation of clots) 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 medication (slows down the growth of certain cells produced by the body).
• Mifepristone (abortion inducer).
• Digoxin and cardiotonic glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide or insulin (for diabetes), may need to adjust the dose.
• Certain antidepressants (selective serotonin reuptake inhibitors).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).
• Thrombolytics (medications that dissolve clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree.
• CYP2C9 inhibitors (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 treatment with ibuprofen (arginine). Therefore, you should always consult your doctor or pharmacist before using ibuprofen (arginine) with other medications.

Taking Ibuprofen (Arginine) Normon with Food, Drinks, and Alcohol

It is recommended to take the sachets of ibuprofen (arginine) granules together 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. 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Minimal amounts of ibuprofen and its degradation products are excreted in breast milk. As no adverse effects are known in the infant, it is not usually necessary to interrupt breastfeeding during short-term use at recommended doses.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and Using Machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or use hazardous machinery. If you only take one dose of ibuprofen (arginine) or take it for a short period, it is not necessary to take special precautions.

Ibuprofen (Arginine) 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 case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

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

It may harm teeth.

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

It may harm teeth.

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

3. How to take Ibuprofen (Arginine) Normon

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

Your doctor will indicate the duration of treatment with ibuprofen. Do not stop treatment beforehand, as this will not achieve the expected results. Similarly, do not use this medication for longer than indicated by your doctor.

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult 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 are 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

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

Use in children and adolescents

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

Use in elderly patients

In elderly patients, the dosage should be established by the doctor, as there may be a need to reduce the usual dose.

Use in patients with kidney and/or liver disease

If you have kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose prescribed by your doctor.

If you take moreIbuprofen (Arginine) Normonthan you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist or the Toxicology Information Service immediately, telephone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, nausea, vomiting (which may contain bloody sputum), gastrointestinal bleeding (see also section 4 below), diarrhea, dizziness, spasms, hypotension, depression of the nervous system (reduced consciousness), headache, ringing in the ears, confusion, and involuntary eye movement.

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

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

Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the action of circulating coagulation factors. Acute kidney 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 and reduced breathing.

In case of ingestion of significant amounts, activated charcoal should be administered. Stomach emptying will be considered if significant amounts have been ingested and within 60 minutes following ingestion.

If you forget to takeIbuprofen (Arginine) Normon

Do not take a double dose to make up for forgotten doses.

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time for the next dose is near, skip the forgotten dose and take the next dose at the usual time.

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

4. Possible adverse effects

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

Adverse effects of medications like ibuprofen (arginine) are more common in people over 65 years old.

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

Frequencies are established according to the following classification: very frequent (may affect more than 1 in 10 patients); frequent (may affect up to 1 in 100 patients); uncommon (may affect up to 1 in 1,000 patients); rare (may affect up to 1 in 10,000 patients); very rare (may affect up to 1 in 10,000 patients); unknown frequency (cannot be estimated from available data).

The following adverse effects have been observed:

Infections and infestations

Very rare: Exacerbation of inflammation-related infections (e.g., development of necrotizing fasciitis) coinciding with the use of non-steroidal anti-inflammatory drugs.

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

Blood and lymphatic system disorders

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

Very rare: Decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and pale skin), decreased granulocytes (a type of white blood cell that can predispose to infections), pancytopenia (deficiency of red, white, and platelet cells in the blood), agranulocytosis (very significant decrease in granulocytes), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, nasal and skin bleeding. Prolongation of bleeding time.

Immune system disorders

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

Rare: Anaphylaxis (generalized allergic reaction).

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

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

Psychiatric disorders

Uncommon: Insomnia, anxiety, restlessness.

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

Nervous system disorders

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

Uncommon: Insomnia, excitement, irritability.

Rare: Paresthesia (sensation of numbness, tingling, prickling, etc., more frequent in hands, feet, arms, or legs).

Very rare: Aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Eye disorders

Uncommon: Vision disturbances.

Rare: Abnormal or blurred vision.

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

Ear and labyrinth disorders

Frequent: Vertigo.

Uncommon: Ringing or buzzing in the ears.

Rare: Hearing difficulty.

Cardiac disorders

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

Very rare: Palpitations, heart failure.

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

Vascular disorders

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

Very rare: Hypertension.

Unknown frequency: Arterial thrombosis.

Respiratory disorders

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

Unknown frequency: Throat irritation.

Gastrointestinal disorders

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

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

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: Esophageal inflammation, pancreatitis, intestinal stenosis.

Unknown frequency: Anorexia.

Hepatobiliary disorders

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

Skin and subcutaneous tissue disorders

Frequent: Skin rash.

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

Rare: Anaphylactic reaction.

Very rare: Medications like ibuprofen (arginine) may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes and purple-colored lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis).

Hair loss, erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications can occur during chickenpox.

Unknown frequency: Photosensitivity (skin reactions due to light influence), worsening of skin reactions. A severe skin reaction known as DRESS syndrome can occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

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

Renal and urinary disorders

Rare: Hematuria (presence of blood in the urine).

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

Based on experience with non-steroidal anti-inflammatory drugs in general, cases of interstitial nephritis, nephrotic syndrome, and kidney failure cannot be excluded.

General disorders

Very rare: Worsening of inflammation during infectious processes.

Unknown frequency: Edema.

Investigations

Rare: Abnormal liver function tests.

Unknown frequency: Abnormal kidney function tests.

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

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

• Allergic reactions such as skin rashes, swelling of the face, wheezing in the chest, or breathing difficulties.
• Vomiting blood or coffee grounds-like material.
• Blood in the stool or bloody diarrhea.
• Severe stomach pain.
• Blistering or significant skin peeling.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Visual disturbances.
• Red, target-like, or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofen (Arginine) Normon

Keep this medication 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 medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

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

Appearance of Ibuprofen (Arginine) Normon and package contents

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

It is presented in packages with 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 last revision of thisleaflet:November 2024

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69679/P_69679.html