Leaflet: information for the user

Ibuprofen Normon 400 mg film-coated tablets EFG

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

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

• Keep this leaflet as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms, 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.

6. Contents of the pack and additional information

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

This medicine is indicated for the treatment of fever, the treatment of mild to moderate pain including migraine, the treatment of arthritis (inflammation of the joints, including those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

Do not take Ibuprofeno Normon

• 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 (blood thinners). 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:

Consult your doctor, pharmacist, or nurse before starting this medication.

• 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 ibuprofen, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for an extended period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• 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 with 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 (blood thinners) or other medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents like aspirin, or corticosteroids and selective serotonin reuptake inhibitors (SSRIs). You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and SSRIs.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestines, causing inflammation that typically results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are receiving 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, 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 can cause symptoms such as red urine, bloody urine, or liver disease), so your doctor can assess the suitability of ibuprofen treatment.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible to experience allergic reactions with this medication.
• 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.
• If you have an infection: see the "Infections" section below.
• Signs of allergic reactions 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.

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.

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

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

NSAIDs, 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 treatment duration.

You should inform your doctor or pharmacist before taking ibuprofen if:

• Trouble with your heart, including heart failure, angina (chest pain), or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• Have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker. This type of medication may also cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Respiratory problems

Ibuprofen should be used with caution in patients who have or have had asthma, bronchial asthma, or allergic diseases, as it has been reported to cause bronchospasm, urticaria, or angioedema in these patients.

Precautions during pregnancy and in women of childbearing age

Due to the association of ibuprofen-type medications 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 will be limited to the minimum possible. It is believed that the risk increases with the dose and duration of treatment.

In the third trimester, the administration of ibuprofen is contraindicated.

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

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Therefore, it is possible that ibuprofen may delay the appropriate treatment of the infection, increasing 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, have used recently, or may need to use any other medication, including those purchased without a prescription.

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

• Other NSAIDs, such as aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent the formation of blood clots in blood vessels) such as ticlopidine.
• Anticoagulants (e.g., for treating blood clotting problems or preventing coagulation, e.g., 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 other 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 for gout).
• Sulfonylureas such as tolbutamide (used for 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).
• Fibrinolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• CYP2C9 inhibitors (responsible for the metabolism of many drugs 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.

Interference with laboratory tests

The use of ibuprofen may alter the following laboratory tests:

• Prothrombin time (may be prolonged for 1 day after stopping treatment).
• Blood glucose concentration (may decrease).
• Creatinine clearance (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Serum 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 test and are taking or have recently taken ibuprofen.

Taking Ibuprofeno Normon with food, drinks, and alcohol:

You can take it alone or with food. In general, it is recommended to take it with meals or with milk to reduce the possibility of stomach discomfort.Do not take alcohol, as it may increase the risk of gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility:

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

This medication should not be taken during pregnancy, especially during the third trimester.

Pregnancy

The use of this medication is not recommended in women who are trying to conceive.

Do not take ibuprofen if you are in the last 3 months of pregnancy (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 predisposition and that of your baby 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 conceive, 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). If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

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

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

Fertility

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

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.

This medication contains less than 1 mmol of sodium (23 mg) per ibuprofen tablet, which is essentially "sodium-free."

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

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

The effective dose should be used for the shortest necessary period to alleviate symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

This medication is administered orally.

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

The recommended dose is:

Adultsand adolescents 12 years or older (with a weight of ≥ 40 kg):

The recommended dose for adults and adolescents 12 years or older is one tablet (400 mg) every 6 to 8 hours, depending on the severity of the condition and the 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 2400 mg in adults and 1600 mg in adolescents 12 to 18 years old.

Use in children

This medication is not recommended for use in children, or adolescents weighing less than 40 kg or under 12 years old, as the dose of ibuprofen contained is not suitable for the recommended dosage in this group of patients.

Older adults

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, the dose can only be increased once your doctor has confirmed that you tolerate the medication well.

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.

Administration form

This medication is administered orally.

To achieve a faster onset of action, the dose can be taken on an empty stomach. Patients with sensitive stomachs should take ibuprofen with food.

Take ibuprofen with sufficient amounts of water. Tablets should be swallowed whole, without chewing, breaking, crushing, or sucking to avoid mouth discomfort and throat irritation.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more doses of Ibuprofeno Normon than you should

If you have taken more Ibuprofeno Normon than you should, or if a child has accidentally ingested the medication, consult a doctor or pharmacist immediately or 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. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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

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

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 have been reported. Blood in the urine, low potassium levels in the blood, chills, and breathing difficulties may also occur.

Additionally, the prothrombin time/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. Low blood pressure and reduced breathing may also occur.

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, and cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have been reported.

In case of ingestion of significant amounts, activated charcoal should be administered.

If you forgot 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 your usual time.

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

The side effects of medicines such as ibuprofen 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.

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

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

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

Disorientation or confusion, depression, irritability, nervousness, psychotic reaction, vertigo, tinnitus (golpes 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, may appear facial swelling, tongue and larynx 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 are thrombocytopenia, leukopenia (decrease in 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 (decrease in neutrophils) and agranulocytosis (very large decrease in neutrophils), aplastic anemia (bone marrow insufficiency to produce different types of cells), 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, bleeding and bruises of unknown cause.

• Very rare side effects(can affect up to 1 in 10,000 people): Pancreatitis, prolonged bleeding time, systemic lupus erythematosus (joint pain and fever), severe skin reactions including 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 skin detachment), erythema multiforme (skin lesion), hair loss, erythema multiforme. Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Liver failure (severe deterioration of the liver), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation related to infections coinciding with the use of NSAIDs has been observed. 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).

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

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). 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 beginning of treatment (generalized acute pustular exanthema). 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.
• Blood in 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 (allergy) (see above in this same section).
• Swelling of the limbs or accumulation of fluid in the arms or legs.
• Flat, red patches, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature and enlarged 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 exanthema).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, 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 Vigilance of Medicines 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 out of sight and reach of children.

No special storage conditions are required.

Do not usethis medicationafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ibuprofeno Normon 400 mg coated tabletswith EFG film coating

• The active ingredient is ibuprofen. Each tablet contains 400 mg of ibuprofen.
• The other components are:
• Core: microcrystalline cellulose, tricalcium phosphate, sodium croscarmellose, povidone, stearic acid, talc.

Coating components are: hypromellose, titanium dioxide (E-171), and macrogol 6000, talc.

Appearance of the product and content of the packaging

Ibuprofeno Normon 400 mg is presented in the form of coated tablets with a film.

The tablets are white or almost white, elongated, and biconvex.

Each package contains 30 tablets and clinical packages with 500 tablets, in a PVC-aluminum blister packaging.

Other presentations

Ibuprofeno Normon 600 mg coated tablets with EFG film coating

Ibuprofeno Normon 20 mg/ml oral suspension EFG

Ibuprofeno Normon 40 mg/ml oral suspension EFG

Marketing authorization holder and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos- Madrid (SPAIN)

Last review date of this leaflet:November 2024

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