Patient Information

Ibuprofen Normon 600 mg Film-Coated Tablets

Read this 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 and you should not give it to others even if they have similar 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. Additional Information

Ibuprofenobelongs 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 takeIbuprofenNormon

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medicine.

• 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 medicine 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 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 adding a stomach protector medicine.
• If you are taking anticoagulants (blood thinners) or other medicines that affect blood clotting, such as aspirin, antiplatelet agents, corticosteroids, or selective serotonin reuptake inhibitors (SSRIs). You should also inform your doctor about the use of other medicines that may increase the risk of bleeding, such as corticosteroids and SSRIs.
• If you have Crohn's disease (a chronic condition where the immune system attacks the intestine, causing inflammation that often results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medicines may worsen these conditions.
• If you are taking diuretics (water pills), as your doctor needs to 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 porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, blood in 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 medicine.
• It is possible to experience allergic reactions with this medicine.
• Your doctor will perform more frequent checks if you receive ibuprofen after major surgery.
• It is recommended not to take this medicine if you have chickenpox.
• If you have an infection: see the "Infections" section below.
• Signs of allergic reactions to this medicine, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain, have been reported. Stop using Ibuprofen Normon immediately and contact your doctor or emergency medical services if you observe any of these signs.

It is essential to use the smallest effective dose to alleviate or control pain and not take this medicine 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 Ibuprofen 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 in high doses. Do not exceed the recommended dose or treatment duration.

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

• Trouble with your heart, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease, or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• High blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker. This type of medicine 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 medicines with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medicine 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. 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 medicines 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 or make the treatment of the infection more difficult, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult your doctor without delay.

Other medicines and Ibuprofen Normon

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, including those purchased without a prescription.

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

• Other NSAIDs, such as aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent blood clots in blood vessels) such as ticlopidine.
• Anticoagulants (blood thinners) 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 medicine.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (abortion inducer).
• 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 prednisone and prednisolone.
• Diuretics (water pills), 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).
• Sulfonureas 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).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Trombolytics (medicines 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 medicines may also affect or be affected by Ibuprofen Normon treatment. Therefore, always consult your doctor or pharmacist before using Ibuprofen Normon with other medicines.

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).
• Concentrations of urea nitrogen, creatinine, and potassium in the blood (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 taken ibuprofen recently.

Taking Ibuprofen Normon with food and drinks

You can take it alone or with food. Generally, it is recommended to take it before meals or with milk to reduce the possibility of stomach discomfort. Do not take alcohol, as it may increase gastrointestinal side effects.

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 medicine.

Pregnancy

The use of this medicine is not recommended for women 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 directed by your doctor. If you need treatment during this period or while trying to conceive, you should take the minimum dose for the shortest time possible.From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may result in low amniotic fluid levels (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 medicine pass into breast milk, it is recommended not to take ibuprofen for prolonged 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 medicines 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 medicine, do not drive or operate hazardous machinery. If you only take a single dose of ibuprofen or for a short period, you do not need to take special precautions.

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

Follow exactly the administration instructions foribuprofenprescribed by your doctor.

In case of doubt, consult your doctor or pharmacist again.

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

The most effective dose should be used for the shortest duration necessary 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).

Adverse effects can be minimized by taking the lowest effective dose for the shortest duration necessary to control symptoms.

Adults and adolescents 14 years or older:

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

In some cases, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2400 mg in adults and 1600 mg in adolescents 14 to 18 years old.

Children and adolescents under 14 years:

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

Senior patients:

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 are recommended to take ibuprofen with food.

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

If you estimate that the action ofthis medicationis too strong or too weak, inform your doctor or pharmacist.

If you take more doses ofIbuprofen Normonthan you should

If you have taken moreibuprofenthan you should or if a child has accidentally ingested the medication, consult a doctor or pharmacist immediately or contact the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingestedor 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-stained mucus), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, confusion, involuntary eye movement, 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, 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 clotting factors. Acute renal failure and liver damage may occur. It is possible that asthma exacerbation may occur in asthmatic patients. Low blood pressure and reduced breathing may also occur.

In rare cases, cases of increased plasma blood 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 takeIbuprofeno 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.

As with all medications,ibuprofenmay cause side effects, although not everyone will experience them.

Side effects of medications such asibuprofenare more common in people over 65 years old.

The incidence of side effects is lower in short-term treatments and when the daily dose is below the recommended maximum dose.

• Frequent 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.

• Less frequent side effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple skin spots), skin reactions caused by light exposure, hypersensitivity, paresthesia (numbness, tingling, or prickling sensations, 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 (liver inflammation), liver function abnormalities, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), and acute renal failure (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, irritability, nervousness, psychotic reaction, vertigo, tinnitus (ringing or buzzing in the ears), 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 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 protecting 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, may manifest as frequent infections with fever, chills, or sore throat), anemia (may manifest as difficulty breathing and pale skin), neutropenia (decreased neutrophils), 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, 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 purple lesions, 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 varicella. Liver failure (severe deterioration of the liver), 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 worsening of these symptoms occur during ibuprofen use, it is recommended to consult 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 on 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 rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or blood-like material.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Significant blisters or peeling of the skin.
• Intense or persistent headache.
• Yellowing 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, circular, or ring-shaped red spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed 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 medication.

Keep this medication out of the 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.

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

Composition of Ibuprofeno Normon 600 mg coated tabletswith EFG film coating

• The active ingredient is ibuprofen. Each tablet contains 600 mg of ibuprofen.
• The other components are:

Core: microcrystalline cellulose, tricalcium phosphate, sodium croscarmellose, povidone, stearic acid, talc.

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

Appearance of the product and contents of the packaging

Ibuprofeno Normon 600 mg is presented in the form of coated tablets with a film. The tablets are white or almost white, elongated and biconvex in shape.

Each package contains 40 tablets and clinical packages with 500 tablets, in a PVC-aluminum blister packaging and a leaflet.

Other presentations:

Ibuprofeno Normon 400 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

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/