IBUPROFEN MABO-FARMA 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibuprofen Mabo-Farma 400 mg Film-Coated Tablets EFG

Read all of 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 have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Ibuprofen Mabo-Farma and what is it used for
2. What you need to know before you take 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 other information

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

Ibuprofen, the active substance in this medicine, acts by reducing pain and fever.

It is indicated in adults and adolescents from 12 years old and weighing more than 40 kg for the symptomatic relief of occasional mild or moderate pain, such as headache, dental, menstrual, muscular (cramps) or back (lumbago) pain, as well as in febrile conditions.

You should consult a doctor if it worsens or does not improve, if the fever persists for more than 3 days or the pain for more than 3 days in adolescents or 5 days in adults.

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

Do not take Ibuprofen Mabo-Farma

• If you are allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other ingredients of this medicine. Allergic reactions may be: skin rash with itching, swelling of the face, lips, or tongue, 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 have suffered a perforation of the digestive tract
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation 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 insufficient fluid intake).

Warnings and precautions

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

Inform your doctor:

• If you have edema (fluid retention)
• If you have or have had any heart disorder or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment with this medicine, as it may mask fever, which is an important sign of infection, making diagnosis 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 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, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure as a consequence of dehydration.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning signs. This risk is higher when high doses and prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as ibuprofen-like medications can worsen these conditions.
• If you are undergoing treatment with diuretics (medicines used to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease 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.
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medicine.
• It is possible that allergic reactions may occur with this medicine.
• Your doctor will perform stricter control if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection (see the "Infections" section below)

It is important that you use the smallest dose that relieves-controls the pain and do not take this medicine 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 have been reported in association with Ibuprofen Mabo-Farma treatment. Stop taking Ibuprofen Mabo-Farma and consult your doctor immediately if you experience any skin rash, lesions on the mucous membranes, 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 syndrome), and acute generalized exanthematous pustulosis (AGEP), 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

Anti-inflammatory/analgesic medications like 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 discuss your treatment with your doctor or pharmacist before taking this medicine if:

• You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems 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, have a family history of heart disease or stroke, or are a smoker.

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

Ibuprofen has been reported to cause allergic reactions to ibuprofen, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop using ibuprofen immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Respiratory disorders

Ibuprofen should be used with caution when administered to 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.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, this medicine may delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Precautions during pregnancy and in women of childbearing age

Because the administration of ibuprofen-like medications has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible. The risk is believed to increase with the dose and duration of treatment.

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

For women of childbearing age, it should be taken into account that ibuprofen-like medications have been associated with a decrease in fertility.

Adolescents

There is a risk of kidney damage in dehydrated adolescents.

Other medications and Ibuprofen Mabo-Farma

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

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

• Do not take this medicine if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, as it may increase the risk of stomach ulcers and gastrointestinal bleeding.
• Antiplatelet agents (which prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin (cardiac glycosides) (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Diuretics (medicines used to increase urine production).
• Corticosteroids such as cortisone and prednisolone, used in inflammatory processes.
• Selective serotonin reuptake inhibitors (SSRIs), used for depression.
• Pentoxifylline (for 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 decrease blood cholesterol levels).
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrine (used in the treatment of Alzheimer's disease).
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (a medication against the AIDS virus).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medications in the liver), such as voriconazole or fluconazole, used to treat fungal infections.
• Herbal extracts: Ginkgo biloba tree.

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

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

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

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

Taking Ibuprofen 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 drink alcohol while being treated with this medicine, you may be more prone to side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Fertility

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

Breastfeeding

Although only small amounts of the medicine pass into breast milk, it is recommended to consult a doctor in cases of long-term treatment or high doses during breastfeeding.

Driving and using machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medicine, you should not drive or use machinery.

If you only take one dose of ibuprofen or for a short period, it is not necessary 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 using machinery.

This applies to a greater extent to the combination with alcohol.

Ibuprofen Mabo-Farma contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Ibuprofen Mabo-Farma contains sodium

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

3. How to take Ibuprofeno Mabo-Farma

Follow the administration instructions for this medication contained in this prospectus or as indicated by your doctor. In case of doubt, ask your doctor, pharmacist, or nurse.

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

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

Take one tablet (400 mg) every 6 to 8 hours, if necessary. Do not take more than 3 tablets (1200 mg) within 24 hours.

Use in children and adolescents:

The use of this medication is not recommended in children or adolescents under 40 kg in weight, as the dose of ibuprofen it contains is not suitable for the recommended dosage in this group of patients.

Elderly patients (over 65 years):

The dosage should be established by the doctor, as there may be a need for a reduction in the usual dose. Elderly people are often more prone to adverse effects, so sometimes the dose needs to be reduced. Consult your doctor.

Patients with kidney, liver, and/or heart disease:

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.

Method of administration:

This medication is administered orally.

Patient with stomach upset should take the medication with milk and/or during meals.

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

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

If you think 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 Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount ingested. It is recommended to bring the package and the prospectus of the medication to the healthcare professional.

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

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

It is rare for more severe symptoms to appear, such as decreased body temperature, metabolic acidosis, convulsions, altered kidney function, coma, adult respiratory distress, and transient respiratory arrest in children (after ingesting large amounts). Agitation, somnolence, disorientation, or coma may also occur. Occasionally, patients develop convulsions.

At high doses, symptoms of somnolence, 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 is likely to be prolonged due to the interaction with circulating coagulation factors. Acute kidney failure and liver damage may occur. Exacerbation of asthma in asthmatics is possible. Additionally, hypotension and decreased respiration may occur.

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

If you forgot to take Ibuprofeno Mabo-Farma

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

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time of the next dose is very close, skip the forgotten dose and take the next dose at the usual time.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them.

Adverse effects of medications like ibuprofen are more common in people over 65 years old.

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

The following adverse effects have been observed:

• Frequent 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 stool, vomiting with blood, dizziness or feeling of instability, 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 spots on the skin), skin reactions due to light influence, hypersensitivity, paresthesia (sensation of numbness, tingling, or burning, more frequent in hands, feet, arms, or legs), and somnolence, insomnia, anxiety, hearing disorders, vision changes, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth sores), gastrointestinal perforations, hepatitis (liver inflammation), liver function anomalies, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and body swelling), and kidney failure. Acute kidney failure and papillary necrosis (especially with prolonged use) associated with increased urea.

• Rare adverse 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), hearing impairment, amblyopia (vision impairment), liver damage, 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, tachycardia, hypotension, anaphylaxis, or severe shock may occur), 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 suffered from 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 adverse effects are decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and skin pallor), neutropenia (decrease in neutrophils), and agranulocytosis (significant decrease in neutrophils), aplastic anemia (bone marrow failure to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudogripal symptoms, extreme fatigue, bleeding, and bruises of unknown cause.

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

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

Exacerbation of inflammation-related infections has been observed coinciding with the use of NSAIDs. If signs of infection or worsening of symptoms occur during the use of ibuprofen, it is recommended to consult 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 that usually produces diarrhea with blood). The skin becomes sensitive to light. Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno Mabo-Farma if you experience these symptoms and seek medical attention immediately. See also section 2.

Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

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

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee-ground-like material.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Severe skin blistering or peeling.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Red, target-like, or circular patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Reporting adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ibuprofeno Mabo-Farma

Keep this medication out of sight and reach of children.

Store below 30°C.

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno Mabo-Farma:

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

Appearance of the product and package contents

Oval, biconvex, white tablets.

They are presented in packages of 20 tablets in PVC/PVdC/Al blister packs.

Marketing authorization holder and manufacturer

Marketing authorization holder:

MABO-FARMA S.A.

Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer:

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

Date of the last revision of this prospectus:November2024

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