Leaflet: information for the user

Ibufen 400 mg film-coated tablets

Ibuprofen

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

Follow exactly the administration instructions contained 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 side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if the fever worsens or does not improve after 3 days or the pain after 5 days (3 days in children and adolescents).

1. What isIbufenand what it is used for

2. What you need to know before starting to takeIbufen

3. How to takeIbufen

4. Possible side effects

5. Storage ofIbufen

6. Contents of the pack and additional information

Ibufén contains ibuprofen as the active ingredient and belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medication is used for the symptomatic relief of occasional mild to moderate pains, such as headaches, toothaches, menstrual cramps, muscle contractions, or back pain (lumbago), as well as fever states.

Do not take ibufén:

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6)or to other nonsteroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Allergic reactions may include:skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.

• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood). If you need to take anticoagulants at the same time as ibuprofen, your doctor will perform blood clotting tests.
• If you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to take ibufén

• 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 this medication as it may mask fever, an important sign of infection, making its diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication 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 or persistent 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 associating a stomach protector medication.
• If you are taking anticoagulants (medications used to "thin" the blood) such as oral anticoagulants, antiplatelet agents like aspirin, or other medications 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 that usually results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are taking diuretics (medications used to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic condition that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have intermittent acute porphyria (a metabolic disorder that affects your blood and can cause symptoms such as reddish urine, bloody urine, or liver disease), so your doctor can assess the need for ibuprofen treatment.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• If you have an infection; see the "Infections" section later.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform more stringent monitoring if you receive ibuprofen after undergoing major surgery.
• It is recommended not to take this medication if you have chickenpox.
• Signs of severe allergic reactions to ibuprofen, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using ibufén immediately and contact your doctor or emergency medical services if you observe any of these signs.

It is essential to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

Skin reactions:

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 ibufén treatment.Stop taking ibufén and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Stop taking ibufén and see a doctor immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Infections:

Ibufén may mask the signs of an infection, such as fever and pain. Consequently, it may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and your symptoms persist or worsen, consult a doctor without delay.

CARDIOVASCULAR PRECAUTIONS:

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the 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 ibufén if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease, 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 are a smoker.

Children and adolescents:

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

Pregnancy, lactation, and fertility:

Do not take ibufen if you are in the last 3 months of pregnancy, 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 tendency and that of your baby to bleed and delay or prolong delivery more than expected. Do not take ibuprofen during the first 6 months of pregnancy unless it is strictly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, 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 cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

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

Combination with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• Other nonsteroidal anti-inflammatory drugs (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 (medications used to "thin" the blood) 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 medication.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).
• Corticosteroids such as prednisone and prednisolone.
• Diuretics (medications used to increase urine production), as it may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonureas such as tolbutamide (used for diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for metabolizing many medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medications may also affect or be affected by ibufén treatment. Therefore, always consult your doctor or pharmacist before using ibufén with other medications.

Ibufén may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose levels (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Urea nitrogen levels, serum creatinine, and potassium levels (may increase)
• With liver function tests: increased transaminase values

Inform your doctor if you are to undergo a clinical analysis and are taking or have recently taken ibuprofen.

Combination with food, drinks, and alcohol:

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

Pregnancy, lactation, and fertility:

The use of this medication is not recommended for women trying to become pregnant. If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take ibufén 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 medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Driving and operating machinery:

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery. If you only take a single dose of ibuprofen or for a short period, 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 greater vigilance, such as driving and operating machinery. This applies to a greater extent when combined with alcohol.

Ibufén contains lactose and sodium:

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

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor, pharmacist, or nurse.

This medication isadministeredby mouth.

The tablet can be divided into equal doses.

Take the medication with meals or with milk, especially if digestive discomfort is noted. The tablet should be swallowed whole with a sufficient amount of liquid.

Only for occasional use 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).

The recommended dose is:

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

half tablet (200 mg of ibuprofen) every 4-6 hours, if necessary. If pain or fever does not respond to the half-tablet dose, 1-tablet doses can be used every 6-8 hours.

No more than 3 tablets (1,200 mg of ibuprofen) should be taken per day (24 hours).

Use in children:

Children from8 to12 years:half tablet (200 mgof ibuprofen) every 6-8 hours, not exceeding the total daily dose of 2 tablets (800 mgof ibuprofen).

Geriatric population:The dosage should be established by the doctor, as there may be a need for a reduction in the usual dose.

Patients with kidney, liver, or heart diseases:reduce the dose and consult the doctor.

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

The administration of this medication is subject to the appearance of pain or fever. As these disappear, the medication should be discontinued.

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

If you take more ibufén than you should

If you have taken more medication than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

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

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

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-tinged mucus), diarrhea, headache, ringing in the ears, confusion, involuntary eye movementand muscle coordination failure. It may also cause agitation or disorientation. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported.Blood in the urine, low potassium levels in the blood, chills, and breathing difficulties may also occur.Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors.In rare cases, cases of metabolic acidosis, decreased body temperature, kidney function impairment, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system and respiratory system depression have been reported.Toxicity to the cardiovascular system (low blood pressure, decreased heart rate, and increased heart rate) has also been reported.

If a severe overdose has occurred, renal insufficiency and liver damage may occur. In these cases, the doctor will take the necessary measures.

Exacerbation of asthma is possible in asthmatics.

If you forget to takeibufén

Do not take a double dose to compensate for the missed doses.

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

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

• Common 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.

• Uncommon side effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple patches on the skin), light-induced skin reactions, hypersensitivity, paresthesia (numbness, tingling, burning, etc. more frequent in hands, feet, arms, or legs) and somnolence, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellow discoloration of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing).

Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

• Rare side effects(may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (golpes or sounds in the ear), auditory disturbances, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, may appear facial swelling, tongue, and larynx, dyspnea, tachycardia, hypotension, anaphylaxis, angioedema, or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other side effects are thrombocytopenia, leukopenia (decrease in white blood cells, may manifest as frequent infections with fever, chills, or sore throat), anemia (may manifest as difficulty breathing and pale skin), neutropenia, and agranulocytosis (severe decrease in neutrophils), aplastic anemia (insufficiency of the bone marrow 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, severe blistering 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 epidermal detachment), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during varicella. Liver failure, heart failure, myocardial infarction, hypertension.

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

• Unknown frequency(cannot be estimated from available data): Exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that produces diarrhea with blood). Generalized red scaly rash, with bumps under the skin and localized blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). The skin becomes sensitive to light.Stop taking ibufen if you experience these symptoms and seek medical attention immediately. See also section 2. Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

If any of the following side effects appear, interrupt treatment and seek medical attention immediately:Reactions such as skin rashes, facial swelling, chest tightness, or difficulty breathing.

• Vomiting blood or coffee grounds-like material.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Significant blisters or peeling of the skin.
• Intense or persistent headache.
• Yellow discoloration of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this same section).
• Swelling of the extremities or fluid accumulation in the arms or legs.
• Reddish patches that are not elevated, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, 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 skin rash, elevated body temperature, and hypertrophied 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 (generalized acute pustular exanthema).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of 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 medicine.

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

Do not store at a temperature above 30°C.

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

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

Composition of ibufen

The active ingredient of ibufen is ibuprofen. Each tablet contains 400 mg of ibuprofen.

The other components are:

Core excipients: sodium croscarmellose (E-468), anhydrous colloidal 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 Ibufen and content of the packaging

Coated tablets with a white film coating, oblong, biconvex, scored on one side and with the code “i” on the other. Each package contains 10 or 20 coated tablets acondicionadosin an alveolar packaging (blister) of PVC/PVDC-Aluminum.

Only some package sizes may be commercially marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:November 2024

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