Ibuprofen Normon 400 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofen Normon 400 mg film-coated tablets EFG

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

Follow exactly the instructions for use provided 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 questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

What Ibuprofen Normon is and what it is used for
What you need to know before taking Ibuprofen Normon
How to take Ibuprofen Normon
Possible side effects
How to store Ibuprofen Normon
Contents of the pack and other 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, mild to moderate pain (including migraine), arthritis (inflammation of the joints, usually affecting hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder 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 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 skin rash with itching, 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 or bleeding, or have experienced a perforation of the gastrointestinal 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 medicines must be used together, 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 suffer from 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 occur.
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 adding 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 mention the use of other medicines that could 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 urination), because your doctor needs to monitor your kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may 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—without bacterial cause) 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 have been reported, including breathing problems, facial or neck swelling (angioedema), and chest pain. Stop taking Ibuprofeno Normon immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

It is important to use the lowest dose that relieves/controls your pain and not to take this medicine longer than necessary to control 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 skin adverse reactions (SSARs)

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 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 duration of treatment.

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

You have heart problems, including heart failure, angina (chest pain), a previous 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.

Pregnancy and fertility precautions

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 considered 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 infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with 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

Tell your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Ibuprofen may interact with 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 ulcer and bleeding.
Antiplatelet agents (prevent blood clot or thrombus formation in blood vessels) such as ticlopidine.
Anticoagulant medicines (e.g., to treat or prevent blood clotting problems, 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 adjust the dose of this medicine.
Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
Mifepristone (an abortion-inducing agent).
Digoxin and other cardiac glycosides (used to treat heart disorders).
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 (medicines used to increase urine output), as they may increase the risk of renal toxicity.
Pentoxifylline (used to treat intermittent claudication).
Probenecid (used in patients with gout 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 medicine).
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, 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 many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medicines may also interact with or be affected by ibuprofen treatment. Therefore, always consult your doctor or pharmacist before using ibuprofen 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, serum creatinine, and potassium levels (may increase).
Liver function tests: increased transaminase values.

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

Taking Ibuprofeno Normon with food, drinks, and alcohol:

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

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.

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

Pregnancy

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 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 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, take the lowest possible 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, 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 age, it should be noted that medicines like ibuprofen have been associated with reduced fertility.

Driving and use of 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 required.

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

This is especially 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 instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with ibuprofen. Do not stop treatment earlier, as the expected results may not be achieved. Likewise, do not use ibuprofen for longer than prescribed by your doctor.

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

This medicine is administered orally.

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

Recommended dose:

Adults and adolescents aged 12 years and older (with weight ≥ 40 kg):

The recommended dose for adults and adolescents aged 12 years and older is one tablet (400 mg) every 6 to 8 hours, depending on the severity of symptoms and response to treatment.

In some conditions, 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 aged 12 to 18 years.

Use in children

The use of this medicine is not recommended in children or adolescents weighing less than 40 kg or under 12 years of age, as the ibuprofen dose contained is not suitable for the recommended dosing 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 may only be increased once your doctor has confirmed that you tolerate the medicine 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, without chewing, breaking, crushing, or sucking, to avoid mouth irritation and throat irritation.

If you think 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 Normon than you should, or if a child has accidentally ingested the medicine, contact a doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital to obtain information about the risk and advice on the measures to be taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Symptoms of overdose usually 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, indifference, headache, tinnitus, 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 (mainly 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, probably 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, increased blood plasma acidity (metabolic acidosis), decreased body temperature, temporary cessation of breathing (apnea), central nervous system and respiratory depression have been reported. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also occurred.

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 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 the usual time.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 maximum recommended 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" sensation, more frequent in hands, feet, arms, or legs), somnolence, insomnia, anxiety, auditory disturbances, visual 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 the 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.
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 impairment, reversible toxic amblyopia, liver injury, edema (swelling caused by 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) has also been reported. In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. 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 shortness of breath and pale skin), neutropenia (decreased neutrophils) and agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow failure to produce various types of blood cells), hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, bleeding and unexplained bruising.

Very rare adverse effects (may affect up to 1 in 10,000 people): Pancreatitis, prolonged bleeding time, 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, preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion), hair loss, erythema multiforme. Rarely, serious skin infections and soft tissue complications may occur during chickenpox. Hepatic failure (severe liver deterioration), heart failure, myocardial infarction, hypertension.

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

Frequency not known (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, usually resulting 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 from English) may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes and elevated eosinophils (a type of white blood cell). Generalized 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 Ibuprofeno Normon if you experience these symptoms and seek medical attention immediately. See also section 2.

If any of the following adverse effects occur, stop treatment and consult your doctor immediately:

Allergic reactions such as skin rashes, facial swelling, wheezing or difficulty breathing.
Vomiting blood or material resembling coffee grounds.
Blood in stools or diarrhea with blood.
Severe stomach pain.
Blisters or significant peeling of the skin.
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, target-shaped or circular, 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).
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 exanthematous pustulosis).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if they are possible adverse effects 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 out of the 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 drains or household waste. Unused containers and unwanted medicines should be returned to the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofen Normon 400 mg film-coated tablets EFG

The active substance 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: hypromellose, titanium dioxide (E-171), macrogol 6000, talc.

Appearance of the product and contents of the pack

Ibuprofen Normon 400 mg is presented as film-coated tablets.

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

Each pack contains 30 tablets and clinical packs with 500 tablets, in PVC-aluminum blister packaging.

Other presentations

Ibuprofen Normon 600 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 latest review of this leaflet: November 2024

Detailed and up-to-date information on this medicine 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 leaflet and packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/65250/P_65250.html