Ibuprofen Normon 600 mg film-coated tablets EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ibuprofeno Normon 600 mg Film-coated Tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as 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 should not be given to others, even if they have the same symptoms, as it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

What Ibuprofeno Normon is and what it is used for
What you need to know before taking Ibuprofeno Normon
How to take Ibuprofeno Normon
Possible adverse effects
How to store Ibuprofeno Normon
Further information

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

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

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

2. What you need to know before taking Ibuprofeno Normon

Do not take Ibuprofeno Normon

If you are allergic (hypersensitive) to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other components of this medicine (listed in section 6). Signs of allergy may include itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties, or asthma.
If you have severe liver or kidney disease.
If you have had a stomach or duodenal ulcer, gastrointestinal bleeding, or a perforation of the digestive tract.
If you are vomiting blood.
If you have black stools or bloody diarrhea.
If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulant treatment is necessary, your doctor will perform blood coagulation tests.
If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
If you have severe heart failure.
If you are in the third trimester of pregnancy.

Warnings and precautions

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

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 are being treated with ibuprofen, as it may mask fever—a key 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 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on how often these checks should be done.
If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
This risk is higher when high doses or long-term treatment are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.
If you are taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines 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 and usually bloody diarrhea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
If you are taking diuretics (medicines to increase urine production), because your doctor needs to monitor your kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can involve vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria—may occur).
If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether ibuprofen treatment is appropriate.
If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
Allergic reactions to this medicine may occur.
Your doctor will perform closer monitoring if you receive ibuprofen after major surgery.
It is advisable not to take this medicine if you have chickenpox.
If you have an infection: see the section “Infections” below.
Allergic reactions to ibuprofen, including breathing problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop taking Ibuprofeno Normon immediately and contact your doctor or emergency medical services right away if you experience any of these symptoms.

It is important to use the lowest effective dose that relieves or controls your pain and to avoid taking this medicine longer than necessary to manage your symptoms.

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.

Serious adverse cutaneous reactions (SACRs)

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

Cardiovascular precautions

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

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofeno Normon if:

You have heart problems, including heart failure, angina (chest pain), a history of heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack, TIA).
You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke. These medicines may also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

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

Precautions during pregnancy and in women of childbearing potential

Because administration of medicines like ibuprofen has been associated with an increased risk of congenital malformations or miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration of treatment should be kept to a minimum. The risk is believed to increase with higher doses and longer treatment duration.

Administration of ibuprofen is contraindicated during the third trimester of pregnancy.

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

Infections

Ibuprofen may mask signs of infection such as fever and pain. Therefore, ibuprofen may delay appropriate treatment of an infection, increasing the risk of complications. This has been observed in bacterial pneumonia and skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.

Other medicines and Ibuprofeno Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

Other non-steroidal anti-inflammatory drugs such as aspirin, as this may increase the risk of gastrointestinal ulceration and bleeding.
Antiplatelet agents (which prevent blood clot formation in blood vessels), such as ticlopidine.
Anticoagulant medicines (e.g., used to treat coagulation disorders or prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).
Cholestyramine (a medicine used to treat high cholesterol).
Selective serotonin reuptake inhibitors (used in depression).
Lithium (a medicine used to treat depression). Your doctor may need to adjust the dose of this medicine.
Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medicine.
Mifepristone (an abortion-inducing agent).
Digoxin and other cardiac 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 to treat certain bacterial infections).
Corticosteroids such as cortisone and prednisolone.
Diuretics (medicines used to increase urine output), as they may increase the risk of kidney toxicity.
Pentoxifylline (used to treat intermittent claudication).
Probenecid (used in gout patients or together with penicillin for infections).
Quinolone antibiotics such as norfloxacin.
Sulfinpyrazone (for gout).
Sulfonylureas such as tolbutamide (for diabetes), which may cause hypoglycemia.
Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
Zidovudine (an anti-HIV medication).
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
Thrombolytics (medicines that dissolve blood clots).
Aminoglycoside antibiotics such as neomycin.
Herbal extracts: Ginkgo biloba.
CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medicines may also interact with or be affected by Ibuprofeno Normon. Therefore, always consult your doctor or pharmacist before using Ibuprofeno Normon with other medicines.

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

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

Inform your doctor if you are scheduled for clinical testing and are taking or have recently taken ibuprofen.

Taking Ibuprofeno Normon with food and drinks

You may take it with or without food. In general, it is recommended to take it before meals or with milk to reduce the risk of stomach discomfort. Avoid alcohol, as it may increase gastrointestinal adverse effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

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 potential), 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 tendency to bleed and may delay or prolong labor more than expected. Do not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose should be taken 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, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

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

Fertility

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

Driving and using machines

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, do not drive or operate dangerous machinery. If you take only a single dose of ibuprofen or use it for a short period, special precautions are generally not necessary.

Ibuprofen may slow your reaction time, which should be considered before engaging in activities requiring heightened alertness, such as driving or operating machinery.

This is particularly important when combined with alcohol.

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

3. How to take Ibuprofen Normon

Follow exactly the ibuprofen dosing instructions provided by your doctor.

If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the duration of treatment with ibuprofen. Do not stop treatment prematurely, as this may prevent the expected results. Likewise, do not use ibuprofen for longer than prescribed by your doctor.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor promptly if symptoms (such as fever and pain) persist or worsen (see section 2).

Adverse effects can be minimized by using the lowest effective dose for the shortest time needed to control symptoms.

Adults and adolescents aged 14 years and older:

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

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

Children and adolescents under 14 years of age:

The use of this medicine is not recommended in children or adolescents under 14 years of age, as the ibuprofen dose it contains is not suitable for the recommended dosing regimen in this patient group.

Elderly patients:

If you are over 60 years old, your doctor may prescribe a lower than usual dose. If so, the dose should 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 than usual dose. If so, take exactly the dose prescribed by your doctor.

Method of administration

This medicine is administered orally.

To achieve a faster onset of action, the dose may be taken on an empty stomach. However, patients with a sensitive stomach are advised to take ibuprofen with food.

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

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibuprofen Normon than you should

If you have taken more ibuprofen than prescribed, or if a child has accidentally ingested the medicine, contact a doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested, or go to the nearest hospital to assess the risk and obtain advice on necessary measures. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

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

Symptoms of overdose may include stomach pain, nausea, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, tinnitus (ringing in the ears), confusion, involuntary eye movements, and lack of muscle coordination.

Nervousness, drowsiness, disorientation, or coma may also occur. Occasionally, patients may develop seizures. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

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

Rarely, cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, transient cessation of breathing (apnea), depression of the central nervous and respiratory systems have been reported. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also been observed.

In cases of ingestion of large amounts, activated charcoal should be administered.

If you forget to take Ibuprofen Normon

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

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

4. Possible adverse effects

Like all medicines, ibuprofen may cause adverse effects, although not everyone experiences them.

Adverse effects of medicines such as ibuprofen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

Common adverse effects (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness or feeling unsteady, and fatigue have also been observed.
Uncommon adverse effects (may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, urticaria, purpura (purple skin spots), photosensitivity reactions (skin reactions due to light exposure), hypersensitivity, paresthesia (numbness, tingling, "pins and needles" sensations, more frequent in hands, feet, arms, or legs), somnolence, insomnia, anxiety, auditory disturbances, vision disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth ulcers), 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 (disorder characterized by protein in urine and body swelling), renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea levels have also been observed.
Rare adverse effects (may affect up to 1 in 1,000 people):

Disorientation or confusion, depression, irritability, nervousness, psychotic reaction, vertigo, tinnitus (ringing or noises in the ear), hearing disturbances, reversible toxic amblyopia, liver injury, edema (swelling due to fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, swelling of the face, tongue and larynx, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock) may occur), aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria). In most reported cases of aseptic meningitis associated with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which represented a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other adverse effects include 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), neutropenia (decreased neutrophils), agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow failure to produce various types of blood cells), and hemolytic anemia (premature destruction of red blood cells). Early symptoms include: fever, sore throat, superficial mouth ulcers, pseudoinfluenza-like symptoms, extreme fatigue, unexplained bleeding and bruising.

Very rare adverse effects (may affect up to 1 in 10,000 people): Pancreatitis, prolonged bleeding time, erythema multiforme (skin lesion), lupus erythematosus (joint pain and fever), very severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purplish lesions, mainly on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and detachment of the epidermis), hair loss, erythema multiforme. Rarely, serious skin infections and complications in soft tissues may occur during chickenpox. Hepatic failure (severe liver impairment), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation associated with infections has been observed during use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to consult a doctor promptly.

Frequency not known (cannot be estimated from available data):

Exacerbation of colitis and Crohn's disease (chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea).

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

A serious skin reaction known as DRESS syndrome (an acronym in English) may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell). Widespread red, scaly rash with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofen Normon if you experience these symptoms and seek immediate medical attention. See also section 2.

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

Allergic reactions such as skin rashes, facial swelling, wheezing or breathing difficulty.
Vomiting blood or material resembling coffee grounds.
Blood in stools or bloody diarrhea.
Severe stomach pain.
Blisters or extensive skin peeling.
Severe or persistent headache.
Yellowing of the skin (jaundice).
Signs of severe hypersensitivity (allergy) (see above in this section).
Swelling of the limbs or fluid accumulation in arms or legs.
Flat, non-elevated red spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Generalized skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen Normon

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofen Normon 600 mg film-coated tablets EFG

The active substance 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), macrogol 6000, talc.

Appearance of the product and contents of the pack

Ibuprofen Normon 600 mg is presented as film-coated tablets. The tablets are white or almost white, elongated and biconvex in shape.

Each pack contains 40 tablets and clinical packs with 500 tablets, in PVC-aluminum blister packs, together with a package leaflet.

Other presentations:

Ibuprofen Normon 400 mg film-coated tablets EFG

Ibuprofen Normon 20 mg/ml oral suspension EFG

Ibuprofen Normon 40 mg/ml oral suspension EFG

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos - Madrid (SPAIN)

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

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

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/65251/P_65251.html