Leaflet: information for the user

Ibuprofen Mabo-Farma 400 mg film-coated tablets EFG

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

- Keep this leaflet as you may need to read it again.

- If you are unsure about anything, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Ibuprofen Mabo-Farma and what it is used for

2. What you need to know before taking Ibuprofen Mabo-Farma

3. How to take Ibuprofen Mabo-Farma

4. Possible side effects

5. Storage of Ibuprofen Mabo-Farma

6. Contents of the pack and additional information

Theactive ingredient Ibuprofeno in this medication acts by reducing pain and fever.

It is indicated for adults and adolescents 12 years of age and older and weighing more than 40 kg for the symptomatic relief of occasional mild to moderate pain, such as headaches, toothaches, menstrual cramps, muscle pain (contractures) or back pain (lumbago), as well as in febrile states.

Consult a doctor if symptoms worsen or do not improve, if fever persists for more than 3 days or pain for more than 3 days in adolescents or 5 days in adults.

Do not take Ibuprofeno Mabo-Farma

• If you are allergic to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other components of this medication. 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 previous stomach 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 necessary, your doctor will perform blood clotting tests.
• If you have severe heart failure
• If you are in the third trimester of pregnancy
• If you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting this medication.

Inform your doctor:

• 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 an extended period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluids and immediately contact your doctor, as ibuprofen in this case may cause kidney failure due to dehydration.
• If you have had or develop a stomach ulcer, bleeding, or perforation, which may manifest as severe abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcers and the elderly. 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 often 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 must 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 meningitis.
• If you have porphyria (a metabolic disorder that affects your blood and can cause symptoms such as urine discoloration, blood in urine, or liver disease), as your doctor will evaluate the need for ibuprofen treatment.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform a more stringent check if you receive ibuprofen after major surgery.
• It is not recommended to take this medication if you have chickenpox.
• if you have an infection (see the "Infections" section below)

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

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

Skin reactions

Severe skin reactions associated with ibuprofen treatment have been reported. Stop taking Ibuprofeno Mabo-Farma and seek medical attention immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Discontinue ibuprofen treatment and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Cardiovascular precautions

NSAIDs, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking this medication if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation in the legs or feet due to narrowing or blockage of the 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 are a smoker.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Signs of an allergic reaction to ibuprofen, such as respiratory problems, facial swelling, and neck region swelling (angioedema), and chest pain have been reported. Stop using ibuprofen immediately and contact your doctor or emergency medical services if you observe any of these signs.

Respiratory problems

Ibuprofen should be used with caution in patients who have or have had asthma, chronic bronchitis, or allergic diseases, as it may cause bronchospasm, urticaria, or angioedema in these patients.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Therefore, it is possible that this medication 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 the infection symptoms persist or worsen, consult a doctor without delay.

Precautions during pregnancy and in fertile women

Due to the association of ibuprofen-type medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible. It is believed that the risk increases with the dose and duration of treatment.

In the third trimester, the administration of ibuprofen is contraindicated.

For fertile women, it should be noted that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Adolescents

There is a risk of kidney damage in dehydrated adolescents.

Other medications and Ibuprofeno Mabo-Farma:

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

The following medications may interact and should not be taken with ibuprofen without consulting your doctor:

• Do not take this medication if you are taking 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) such as ticlopidine.
• Anticoagulants (medications used to "thin" the blood) such as aspirin, warfarin.
• Blood pressure medications (inhibitors of the enzyme angiotensin-converting enzyme (ACE) such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Baclofen (used to treat involuntary muscle contractions).
• 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 (cardiotonic glucosides) (used to treat heart problems).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat bacterial infections).
• Diuretics (medications used to increase urine production).
• Corticosteroids such as cortisone and prednisolone, used in inflammatory processes.
• Selective serotonin reuptake inhibitors (SSRIs), used to treat depression.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Ion exchange resins such as cholestyramine (used to lower cholesterol levels in the blood).
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas such as tolbutamide (used to treat diabetes).
• Tacrine (used to treat Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Inhibitors of CYP2C9 (responsible for the metabolism of numerous medications in the liver), such as voriconazole or fluconazole, used to treat fungal infections.
• Herbal extracts: Ginkgo biloba.

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

Interference with laboratory tests:

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after discontinuing treatment).
• Blood glucose concentration (may decrease).
• Clearance of creatinine (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Serum concentrations of urea nitrogen, creatinine, and potassium (may increase).
• With liver function tests: increased values of transaminases.

If you are to undergo any diagnostic test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Taking Ibuprofeno Mabo-Farma with food, drink, and alcohol

You can take it alone or with food. In general, it is recommended to take it during meals to reduce the possibility of stomach discomfort.

If you take alcohol while on this medication, you may be more prone to adverse effects.

Ibuprofeno Mabo-Farma contains lactose

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

Ibuprofeno Mabo-Farma contains sodium

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

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

This medication should be used at the most effective dose for the shortest time 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 40 kg of weight) from 12 years old:

One tablet (400 mg) will be taken every 6 to 8 hours, if necessary. Do not take more than 3 tablets (1,200 mg) in 24 hours.

Use in children and adolescents:

This medication is not recommended for use in children or adolescents weighing less than 40 kg, as the ibuprofen dose contained is not suitable for the recommended dosage in this patient group.

Older patients (>65 years):

The dosage should be established by the doctor, as it may be necessary to reduce the usual dose. Older people are more prone to adverse effects, so the dose may need to be reduced at times. Consult your doctor.

Patients with kidney, liver and/or heart diseases:

In patients with mild or moderate disease, the dose should be reduced. Ibuprofen should not be used in patients with severe renal, hepatic or cardiac insufficiency.

Administration form:

This medication is administered orally.

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

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

It is essential to use the smallest dose that relieves/controls pain and not to take ibuprofen for longer than necessary to control symptoms.

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

If you take more Ibuprofeno Mabo-Farma than you should

If you have taken more ibuprofen than you should or if a child has accidentally ingested the contents of the package, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested. It is recommended to bring the package and the medication leaflet to the healthcare professional.

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

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), gastrointestinal bleeding (see also section 4), diarrhea, indifference, sleepiness, headache, ringing in the ears, confusion, muscle coordination and involuntary eye movements.

It is rare for more severe symptoms to appear, such as decreased body temperature, metabolic acidosis, convulsions, renal function alteration, coma, adult respiratory distress and transient cessation of breathing in children (after ingesting large quantities). It may also cause agitation, drowsiness, disorientation or coma. Occasionally, patients develop convulsions.

At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in the urine, low potassium levels in the blood, chills and breathing problems have been reported.

Additionally, the prothrombin time/INR may be prolonged due to interaction with circulating clotting factors. Acute renal failure and liver damage may occur. It is possible to exacerbate asthma in asthmatics. Additionally, hypotension and decreased respiration may occur.

If a severe intoxication has occurred, the doctor will take the necessary measures.

If you forgot to take Ibuprofeno Mabo-Farma

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

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

The side effects of medications such as ibuprofen are more common in people over 65 years old.

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

The following side effects have been observed:

• Frequent side effects(may affect up to 1 in 10 people):Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, stomach pain, bloody stools, vomiting with blood, dizziness or feeling of instability, fatigue.

Rare 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), skin reactions caused by light exposure, hypersensitivity, paresthesia (numbness, tingling, burning, etc. more common 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), and renal insufficiency (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

• Very rare side effects(may affect up to 1 in 1,000 people):

Disorientation or confusion, depression, irritability, nervousness, psychotic reaction, vertigo, tinnitus (ringing 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 include facial swelling, tongue swelling, laryngeal swelling, dyspnea, tachycardia, hypotension, anaphylaxis, angioedema, or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes 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 include thrombocytopenia, leukopenia (decreased white blood cells, may manifest as frequent infections with fever, chills, or sore throat), anemia (may manifest as difficulty breathing and pale skin), neutropenia, and agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow insufficiency to produce different types of cells), and hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, unexplained bleeding, and hematomas.

• Extremely rare side effects(may affect up to 1 in 10,000 people):

Pancreatitis, prolonged bleeding time, lupus erythematosus (joint pain and fever), severe skin reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and epidermal detachment), erythema multiforme (skin lesion), hair loss, erythema multiforme. Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Liver failure (severe deterioration of the liver), heart failure, myocardial infarction, hypertension.

Exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that produces diarrhea with blood) has been observed. The skin becomes sensitive to light. 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). Stop taking Ibuprofeno Mabo-Farma if you experience these symptoms and seek medical attention immediately. See 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: generalized skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

If any of the following side effects appear, discontinue treatment and seek immediate medical attention:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or blood-like material.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Significant blisters or peeling of the skin.
• Intense or persistent headache.
• Yellow discoloration of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this same section).
• Swelling of the limbs or accumulation of fluid in the arms or legs.
• Flat, red patches, often with blisters in the center, on the trunk, usually accompanied by fever and flu-like symptoms [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The 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, pharmacist, or nurse, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Store below 30°C.

Do not use this medication after 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 in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ibuprofeno Mabo-Farma:

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

• The other components (excipients) are; Core: sodium croscarmellose, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate, purified water. Coating: Hypromellose, titanium dioxide (E-171), talc, purified water, and propylene glycol.

Appearance of the product and content of the packaging

Oval, biconvex tablets, white in color.

Presented in packs of 20 tablets in PVC/PVdC/Al blister

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Responsible for manufacturing:

Farmalider, S.A,

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

FROSST IBÉRICA, S.A.,

Vía Complutense, 140,

28805 Alcalá de Henares, Madrid

Spain

TOLL MANUFACTURING SERVICES S.L.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet:November2024

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