Ibuprofen Mabo-Farma 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofen Mabo-Farma 400 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Ibuprofen Mabo-Farma is 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 adverse effects
5. How to store Ibuprofen Mabo-Farma
6. Contents of the pack and other information

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

Ibuprofen, the active ingredient in this medicine, works by reducing pain and fever.

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

You should consult a doctor if symptoms worsen or do not improve, if fever persists for more than 3 days in adolescents or more than 5 days in adults, or if pain lasts longer than 3 days in adolescents or 5 days in adults.

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

Do not take Ibuprofeno Mabo-Farma

• If you are allergic to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other ingredients of this medicine. Allergic reactions 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 previously had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
• If you are vomiting blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If concomitant use of anticoagulant medicines is necessary, 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 heart disorders or high blood pressure.
• If you suffer from asthma or any other respiratory disorder.
• If you are being treated with this medicine, as it may mask fever—an important sign of infection—making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on how often these checks should occur.
• If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to renal failure due to dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is higher when high doses or prolonged treatment are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine.
• If you are taking concomitant medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such 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 medicines may worsen these conditions.
• If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis may occur.
• If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• Allergic reactions may occur with this medicine.
• Your doctor will perform closer monitoring if you receive ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection (see the section “Infections” below).

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

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal.

Skin reactions

Serious skin reactions have been reported with Ibuprofeno Mabo-Farma. Stop taking Ibuprofeno Mabo-Farma and see a doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a serious skin reaction. See section 4.

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 in association with ibuprofen treatment. Discontinue ibuprofen treatment and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Cardiovascular precautions

Medicines such as ibuprofen (anti-inflammatory/analgesic) 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 this medicine if:

• You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

These types of medicines may also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Allergic reactions to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. 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 in patients who have or have a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in such patients.

Infections

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

Pregnancy, fertility, and breastfeeding

Pregnancy

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

Due to the association of ibuprofen-type medicines with an increased risk of congenital malformations or miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible. The risk is believed to increase with higher doses and longer treatment duration.

Administration of ibuprofen is contraindicated during the third trimester.

Fertility

The use of this medicine is not recommended in women attempting to conceive, as ibuprofen-type medicines have been associated with reduced fertility.

Breastfeeding

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

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 slow 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.

Ibuprofeno Mabo-Farma contains lactose

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

Ibuprofeno Mabo-Farma contains sodium

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

3. How to take Ibuprofeno Mabo-Farma

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

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 (weighing over 40 kg) from 12 years of age:

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

Use in children and adolescents:

This medicine is not recommended for use in children or adolescents weighing less than 40 kg, as the ibuprofen dose it contains is not suitable for the recommended dosing regimen in this patient group.

Elderly patients (>65 years):

Dosage should be determined by the physician, as a reduction from the usual dose may be required. Elderly individuals are often more susceptible to adverse effects, so the dose may sometimes need 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 must not be used in patients with severe renal, hepatic, or cardiac insufficiency.

Method of administration:

This medicine is administered orally.

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

Take ibuprofen with a sufficient amount of water. The tablets should be swallowed whole with a glass of water, without chewing, splitting, crushing, or sucking, to avoid mouth irritation and throat irritation.

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

If you consider that the effect of this medicine 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 5620420, indicating the medicine and the amount ingested. It is recommended to bring the medicine package and leaflet to the healthcare professional.

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

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding (see also section 4), diarrhea, indifference, drowsiness, headache, tinnitus, confusion, lack of muscle coordination, and involuntary eye movements.

More severe symptoms are rare but may include decreased body temperature, metabolic acidosis, seizures, impaired kidney function, coma, adult respiratory distress, and transient cessation of breathing in children (after ingestion of large quantities). Agitation, somnolence, disorientation, or coma may also occur. Occasionally, patients may develop seizures.

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

In addition, prothrombin time/INR may be prolonged due to interaction with circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may be exacerbated in asthmatic patients. Hypotension and reduced respiration may also occur.

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

If you forget to take Ibuprofeno Mabo-Farma

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 or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects of medicines such as ibuprofen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the maximum recommended dose.

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 stools, vomiting blood, dizziness or feeling unsteady, fatigue have also been observed.

• Uncommon adverse effects (may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, urticaria, purpura (purple spots on the skin), skin reactions due to light exposure, hypersensitivity, paresthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms or legs), somnolence, insomnia, anxiety, hearing disorders, vision disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth ulcers), gastrointestinal perforations, hepatitis (liver inflammation), liver function abnormalities and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing), tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in urine and body swelling), renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea levels.

• Rare adverse effects (may affect up to 1 in 1,000 people):

Disorientation or confusion, depression, irritability, nervousness, psychotic reaction, dizziness, tinnitus (ringing or noises in the ear), hearing impairment, reversible toxic amblyopia, liver injury, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, swelling of the face, tongue and larynx, dyspnea (shortness of breath), tachycardia, hypotension may occur (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 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 represented 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 anemia (bone marrow failure to produce various types of blood cells), hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, unexplained bleeding and bruising.

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

Exacerbation of inflammation associated with infections has been observed during 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 disease in which the immune system attacks the intestine causing inflammation, usually resulting in bloody diarrhea). Skin becomes sensitive to light. Generalized red, scaly rash with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno Mabo-Farma 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 and consult your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing or difficulty breathing.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Blisters or extensive skin 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 arms or legs.
• Flat, non-elevated red spots, target-shaped or circular, on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• Generalized, red, 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 effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen Mabo-Farma

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

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and empty containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Ibuprofen Mabo-Farma:

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

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

Appearance of the medicinal product and content of the container

White, oval-shaped, biconvex tablets.

Packaged in PVC/PVdC/Al blisters containing 20 tablets.

Marketing Authorization Holder and Manufacturing Responsible

Marketing Authorization Holder:

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturing Responsible:

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 most recent review of this leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/