Ibufen 400 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ibufén 400 mg film-coated tablets

ibuprofen

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

Follow exactly the instructions for administration of this medicine provided in this leaflet or those given by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
• You must consult a doctor if fever worsens or does not improve after 3 days, or if pain does not improve after 5 days (3 days in children and adolescents).

Contents of the leaflet

1. What ibufén is and what it is used for
2. What you need to know before taking ibufén
3. How to take ibufén
4. Possible side effects
5. How to store ibufén
6. Contents of the pack and other information

1. What ibufén is and what it is used for

Ibufén contains ibuprofen as the active substance and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used for the symptomatic relief of mild to moderate occasional pain, such as headaches, dental pain, menstrual pain, muscle pain (cramps), or back pain (lumbago), as well as for feverish conditions.

2. What you need to know before taking ibufén.

Do not take ibufén:

• If you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6), or to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), or to aspirin. 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 diarrhoea.

• If you have bleeding or blood clotting disorders, or are taking anticoagulants (medicines used to "thin" the blood). If concomitant use of anticoagulants is necessary, your doctor will perform blood clotting tests.

• If you have severe dehydration (caused by vomiting, diarrhoea 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 taking ibufén if:

• You have oedema (fluid retention).
• You have or have had heart problems or high blood pressure.
• You have asthma or any other respiratory disorder.
• You are being treated with this medicine, as it may mask fever, an important sign of infection, thereby delaying diagnosis.
• 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), as your doctor may need to perform regular monitoring. Your doctor will advise you on how often these checks should be done.
• 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, 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.
• 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).
• You have Crohn’s disease (a chronic condition in which the immune system attacks the intestine, causing inflammation and usually bloody diarrhoea) or ulcerative colitis, as medicines like ibufén may worsen these conditions.
• You are taking diuretics (medicines to increase urine output), as your doctor needs to monitor your kidney function.
• 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 covering the brain and spinal cord—without bacterial infection) may occur.
• You have acute intermittent porphyria (a metabolic disorder affecting the blood, which may cause reddish urine, blood in urine, or liver disease), so your doctor can assess whether ibuprofen treatment is appropriate.
• You suffer from headaches after prolonged treatment and should not take higher doses of the medicine.
• You have an infection; see the section “Infections” below.
• Allergic reactions may occur with this medicine.
• Your doctor will monitor you more closely if you are receiving ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• Serious allergic reactions to ibuprofen, such as breathing problems, swelling of the face and neck region (angioedema), or chest pain, have been reported. Stop taking ibufén immediately and contact your doctor or emergency medical services right away if you notice any of these symptoms.

It is important to use the lowest effective dose that relieves or controls your pain and not to take this medicine longer than necessary to manage your symptoms.

Skin reactions

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

Stop taking ibufén and see a doctor immediately if you develop any skin rash, lesions on mucous membranes, blisters, or other signs of allergy, as these may be early signs of a serious skin reaction. See section 4.

Infections

Ibufén may mask signs of infection such as fever and pain. Therefore, ibufén may delay appropriate treatment of an 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 symptoms persist or worsen, consult a doctor without delay.

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 ibufén if:

• You have heart problems, including heart failure, angina (chest pain), 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 "mini-stroke" or transient ischaemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

Children and adolescents

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

Precautions during pregnancy and in women of childbearing age

Do not take ibufén during the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labour. Do not take ibuprofen during the first 6 months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, take the lowest effective 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) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

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

Taking ibufén with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Ibufén 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 ulceration and bleeding.
• Antiplatelet agents (prevent blood clot or thrombus formation in blood vessels) such as ticlopidine.
• Anticoagulant medicines (e.g. for treating or preventing blood clotting, e.g. acetylsalicilic acid, warfarin, ticlopidine).
• Cholestyramine (used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used for 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 (used to induce abortion).
• Digoxin and cardiac glycosides (used to treat heart disorders).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulphonamides 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 with penicillin for infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes), which may cause hypoglycaemia.
• 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 ibufén. Therefore, always consult your doctor or pharmacist before using ibufén with other medicines.

Taking ibuprofen may affect 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 ibufén with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

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

Ibufén should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing age).

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

Driving and using machines

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, you should not drive or operate 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.

ibufén contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially "sodium-free".

3. How to take ibufén.

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor, pharmacist, or nurse.

This medicine is taken orally.

The tablet may be divided into equal doses.

Take the medicine with food or milk, especially if you experience gastrointestinal discomfort. The tablet should be swallowed whole with a sufficient amount of liquid.

For occasional use only and for limited periods.

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

Recommended dose:

Adults and adolescents over 12 years of age (over 40 kg body weight):

Half a tablet (200 mg of ibuprofen) every 4–6 hours, if needed. If pain or fever does not respond to the half-tablet dose, one full tablet may be taken every 6–8 hours.

Do not exceed 3 tablets (1,200 mg of ibuprofen) per day (24 hours).

Use in children:

Children aged 8 to 12 years: Half a tablet (200 mg of ibuprofen) every 6–8 hours, without exceeding a total daily dose of 2 tablets (800 mg of ibuprofen).

Elderly population: Dosage should be determined by a physician, as a reduction from the usual dose may be necessary.

Patients with kidney, liver, or heart disease: Reduce the dose and consult your doctor.

If symptoms worsen, if fever persists for more than 3 days, or if pain lasts longer than 5 days (3 days in children and adolescents), consult a doctor.

This medicine should only be administered when pain or fever occurs. As symptoms subside, treatment should be discontinued.

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

If you take more ibufén than you should

If you have taken more medicine than recommended, or if a child has accidentally ingested the medicine, contact a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on necessary measures.

Symptoms of overdose typically occur 4 to 6 hours after taking ibuprofen.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. Bring this leaflet with you if possible.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), diarrhea, headache, tinnitus (ringing in the ears), confusion, involuntary eye movements, and lack of muscle coordination. Agitation or disorientation may also occur. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties may be reported. Additionally, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Rarely, cases of increased blood plasma acidity (metabolic acidosis), lowered body temperature, impaired kidney function, gastrointestinal bleeding, coma, transient cessation of breathing (apnea), central nervous system depression, and respiratory depression have been reported. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also occurred.

In cases of severe poisoning, kidney failure and liver damage may occur. In such cases, the doctor will take the necessary measures.

Asthma exacerbation is possible in asthmatic patients.

If you forget to take ibufén

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 the usual time.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

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

• Frequent adverse effects (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness or unsteadiness, fatigue.

• 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, paraesthesia (numbness, tingling, "pins and needles" sensations, 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, dyspnoea (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.

• Rare adverse effects (may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (ringing or noises in the ear), hearing disturbances, reversible toxic amblyopia, liver injury, oedema (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, dyspnoea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock), 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 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), agranulocytosis (severe decrease in neutrophils), aplastic anaemia (bone marrow failure to produce various types of blood cells), haemolytic anaemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, unexplained bleeding and bruising.

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

Exacerbation of infection-related inflammation has been observed coinciding with the use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to seek medical advice 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 produces bloody diarrhoea). Generalized red, scaly rash with bumps under the skin and blisters, primarily located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). The skin becomes sensitive to light. Stop taking ibufen if you experience these symptoms and seek immediate medical attention. See also section 2. Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes and elevated eosinophils (a type of white blood cell).

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

• Allergic reactions such as skin rashes, facial swelling, wheezing or breathing difficulties.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhoea.
• Severe stomach pain.
• Blisters or significant peeling of the skin.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in arms or legs.
• Flat, non-elevated, target-shaped or circular 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).
• Generalized, 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).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, 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 ibufen

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

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 empty containers and unused medicines at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibufén

The active substance in Ibufén is ibuprofen. Each tablet contains 400 mg of ibuprofen.

The other components are:

Core excipients: sodium croscarmellose (E-468), colloidal anhydrous silica, microcrystalline cellulose (E-460), stearic acid, talc (E-553 b).

Coating excipients: Opadry OYL 28900 (lactose monohydrate + HPMC 2910/hypromellose 15 cp + titanium dioxide + macrogol/PEG 4000), Opadry OYS 29019 (HPMC 2910/hypromellose 50 cp + macrogol/PEG 6000).

Appearance of Ibufén and contents of the pack

Film-coated white, oblong, biconvex tablets, scored on one side and marked with the letter “i” on the other. Each pack contains 10 or 20 film-coated tablets packed in PVC/PVDC-aluminum blister packs (alveolar packaging).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent revision 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/