Leaflet: information for the user

Ibuprofen Normon 40 mg/ml oral suspension EFG

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor, pharmacist or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days in case of fever or 5 days (3 days in children from 6 months) in case of pain. In the case of children from 3 to 5 months, you should consult a doctor if symptoms worsen or persist after 24 hours.

1. What is Ibuprofen Normon and what it is used for

2. What you need to know before starting to take Ibuprofen Normon

3. How to take Ibuprofen Normon

4. Possible side effects

5. Storage of Ibuprofen Normon

6. Contents of the pack and additional information

Ibuprofeno belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used in children from 3 months old, adolescents, and adults for the symptomatic relief of occasional mild to moderate pain, as well as in febrile states.

Do not take Ibuprofeno Normon

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

Warnings and precautions

Inform your doctor:

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• If you are receiving treatment with this medication, as it may mask fever, an important sign of infection, making its diagnosis more difficult.
• 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 tell you how often these checks should be done.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms.
• This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease, and in elderly patients. In these cases, your doctor may consider associating a stomach protector medication.
• If you are taking anticoagulants (medications used to "thin" the blood) or antiplatelet medications (such as aspirin), or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that produces, usually, bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are taking diuretics (medications to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic condition 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 disorder that affects your blood and may cause symptoms such as urine discoloration, bloody urine, or liver disease), so your doctor can assess the advisability or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• Signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibuprofeno Normon immediately and contact your doctor or emergency medical services if you observe any of these signs..
• Allergic reactions may occur with this medication.
• Your doctor will perform a more stringent check if you receive ibuprofen after undergoing major surgery.
• It is not recommended to take this medication if you have chickenpox.
• If you have an infection: see the "Infections" heading below.

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.

Severe cutaneous adverse reactions (SCARs)

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 treatment. Discontinue Ibuprofeno Normon treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular precautions

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increased 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 Ibuprofeno Normon 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.

Children and adolescents

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

Precautions during pregnancy and in women of childbearing age

Due to the association of ibuprofen administration with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, unless strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

In the third trimester, administration of this medication is contraindicated.

For women of childbearing age, it should be noted that ibuprofen-type medications have been associated with a decrease in fertility.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Therefore, it is possible that ibuprofen may delay or complicate the treatment of an 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 having an infection and the infection symptoms persist or worsen, consult your doctor without delay.

Other medications and Ibuprofeno Normon

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

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

• Other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet medications (which prevent the formation of blood clots in blood vessels) such as ticlopidine.
• Anticoagulants, such as aspirin, warfarin, ticlopidine.
• Colestiramine (used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (SSRIs) used in depression.
• Lithium (used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (used to increase urine production), as it may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas such as tolbutamide (used to treat diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Trombolytics (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 treatment. Therefore, always consult your doctor or pharmacist before using ibuprofen with other medications.

Ibuprofen may alter the following laboratory tests:

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

Inform your doctor if you are to undergo a clinical analysis and are taking or have recently taken ibuprofen.

Taking Ibuprofeno Normon with food, drinks, and alcohol

It is recommended to take this medication with milk or with food, or immediately after eating, to reduce the possibility of stomach discomfort. Do not take alcohol, as it may increase gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

The use of this medication is not recommended in women trying to become pregnant.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. Do not take ibuprofen during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing age), 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 and your baby's predisposition to bleeding and delay or prolong delivery more than expected.

Do not take ibuprofen during the first 6 months of pregnancy unless it is clearly 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.

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Driving and operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery. If you only take a single dose of ibuprofen or for a short period, no special precautions are necessary.

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require increased vigilance, such as driving and operating machinery.

This applies to a greater extent when combined with alcohol.

Ibuprofeno Normon contains saccharose, sodium benzoate (E-211), and yellow orange S (E-110)

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

Patients with diabetes mellitus should note that this medication contains 0.44 g of saccharose per milliliter.

It may cause tooth decay.

This medication contains 2.5 mg of sodium benzoate in each dose unit.

Sodium benzoate may increase the risk of jaundice (yellow discoloration of the skin and eyes) in newborns (up to 4 weeks old).

This medication may cause allergic reactions because it contains yellow orange S (E-110) dye. It may cause asthma, especially in patients allergic to aspirin.

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

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor, pharmacist or nurse. If in doubt, ask your doctor, pharmacist or nurse.

Only for occasional use and for limited periods.

The 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).

The administration of the medication is subject to the appearance of pain or fever. As these disappear, the medication should be discontinued.

Adults and adolescents over 12 years (≥40 kg):

The recommended dose is 5-10 ml (200-400 mg of ibuprofen) at intervals not less than 4 hours, if necessary and while symptoms persist, without exceeding 1200 mg of ibuprofen in 24 hours.

The maximum dose per dose should not exceed 400 mg of ibuprofen. More than 400 mg in a single dose does not provide better analgesic effect.

The interval between doses will depend on the evolution of symptoms, but will never be less than 4 hours.

In adults and adolescents, consult a doctor if this medication needs to be used for more than 3 days in case of fever or 4 days in case of pain or if symptoms worsen.

Children 3 months to 12 years:

The recommended dose of ibuprofen depends on the age and weight of the child. Generally, for children 3 months to 12 years, the recommended daily dose is 20-30 mg per kg of body weight depending on the intensity of symptoms and is divided into three doses.

The use of this medication in children under 2 years will always be by medical prescription.

As a guide, the following doses can be followed:

The suspension can also be dosed following a regimen of 4 daily doses. In that case, the maximum daily doses (see last column of the previous table) should not be exceeded. The dose to be administered in each dose every 6 hours will be recalculated/reduced proportionally.

This medication should not be used in children under 3 months or weighing less than 5 kg.

??Over 65 years: the dosage should be established by the doctor, as there is a possibility that a reduction in the usual dose may be needed.

??Patients with kidney, liver or heart disease: they should reduce the dose and consult a doctor. Ibuprofen should not be used in patients with severe cardiac, renal and hepatic insufficiency.

Adults and adolescents should consult a doctor if symptoms worsen or do not improve after 3 days in case of fever or 5 days in case of pain.

Children 6 months to 12 years should consult a doctor if symptoms worsen or do not improve after 3 days.

Children 3 to 5 months should consult a doctor if symptoms worsen or persist after 24 hours.

Administration form:

Ibuprofen Normon is a suspension for oral administration. It can be administered directly or diluted in water.

1.Shake the container before use.

2.Insert the syringe into the perforated cap.

3.Invert the bottle and remove the necessary dose.

4.Administer the syringe contents directly into the mouth or in a spoon.

5.The syringe should be washed after each dose and can be sterilized by boiling it in water or by immersing it in the sterilizing solution used for bottles.

A burning sensation in the mouth or throat may occur with ibuprofen oral suspension; ensure that the bottle has been shaken well before administering the medication.

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

If you take more Ibuprofeno Normon than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested or go to the nearest hospital for information on the risk and advice on the measures to be taken.

Normally, symptoms of overdose occur 4 to 6 hours after taking ibuprofen.

The symptoms of overdose may include: nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, confusion, involuntary eye movement, and muscle coordination failure.

They may also produce nervousness, drowsiness, disorientation or coma. 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 problems have been reported.

It may also prolong the time of protrombina/INR, probably due to interference with the action of circulating coagulation factors. Gastrointestinal bleeding, acute renal failure, and liver damage may occur. It is possible that asthma exacerbation may occur in asthmatic patients. There is also a possibility of low blood pressure and reduced breathing.

In rare cases, cases of increased plasma acidity (metabolic acidosis), decreased body temperature, transient loss of breathing (apnea), depression of the central nervous system and respiratory system have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also been reported.

If you forget to take Ibuprofeno 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 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, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

The frequencies shown below refer to the short-term use of maximum daily doses of up to 1,200 mg of oral ibuprofen:

• Common side effects(may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, stomach pain, bloody stools, vomiting with blood, headache, dizziness or feeling of instability, fatigue.

• Uncommon side effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple patches on the skin), light-induced skin reactions, hypersensitivity, paresthesia (numbness, tingling, burning, etc., more common in hands, feet, arms, or legs), somnolence, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), oral mucosa inflammation with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (liver inflammation), liver function abnormalities, jaundice (yellow discoloration of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Acute kidney injury, nephrotic syndrome (characterized by proteinuria and body swelling), and renal insufficiency (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

• Rare side effects(may affect up to 1 in 1,000 people):

Disorientation or confusion, depression, vertigo, tinnitus (ringing or sounds in the ear), auditory disturbances, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, signs may include facial swelling, tongue swelling, laryngeal swelling, dyspnea, tachycardia, hypotension, anaphylaxis, angioedema, or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other side effects include thrombocytopenia, leukopenia (decreased white blood cells, which may manifest as frequent infections with fever, chills, or sore throat), anemia (may manifest as difficulty breathing and pale skin), neutropenia, and agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow insufficiency to produce different types of cells), and 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, unexplained bleeding, and hematomas.

• Very rare side effects(may affect up to 1 in 10,000 people): Pancreatitis, severe blistering reactions, including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purple lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and epidermal detachment), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during varicella. Liver failure, heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection or these worsen during ibuprofen use, it is recommended to see a doctor as soon as possible.

• Unknown frequency(cannot be estimated from available data): Exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that produces diarrhea with blood).

A severe skin reaction known as DRESS syndrome (by its English acronym) may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Generalized red scaly rash, with bumps under the skin and localized blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular exanthema) and skin sensitivity to light.Stop taking Ibuprofeno Normon if you experience these symptoms and seek medical attention immediately. See section 2.

If any of the following side effects appear, interrupt treatment and seek medical attention immediately:

• Allergic reactions such as skin rash, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee ground-like material.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Significant blisters or peeling of the skin.
• Severe headache or persistent headache.
• Yellow discoloration of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this same section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Flat, red patches, often with blisters in the center, on the trunk, which may be accompanied by fever and flu-like symptoms [dermatitis exfoliativa, 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. Symptoms usually appear at the beginning of treatment (acute generalized 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 the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: 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.

No special storage conditions are required.

Do not use this medication after 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. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Ibuprofeno Normon 40 mg/ml oral suspension EFG:

• The active ingredient is ibuprofen.
• The other components are: xanthan gum, hypromellose, sodium benzoate (E-211), citric acid, sucrose, glycerol (E-422), yellow-orange colorant S (E-110), peach flavor and purified water.

Ibuprofeno Normon 40 mg/ml oral suspension is presented in a 150 ml bottle in a cardboard box. Each ml contains 40 mg of ibuprofen.

Appearance of the product and contents of the packaging

Ibuprofeno Normon is a viscous suspension, orange in color and with a peach flavor.

It is presented in 150 ml containers. It includes a dosing syringe and a dropper plug for the syringe.

Other available presentations

Ibuprofeno Normon 20 mg/ml oral suspension EFG

Ibuprofeno Normon 400 mg coated tablets EFG

Ibuprofeno Normon 600 mg coated tablets EFG

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

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

Last review date of this prospectus:November 2024

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/.