Patient Information

Ibuprofen MABO-FARMA 600 mg Film-Coated Tablets

Read this 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. Do not give it to others even if they have similar symptoms to yours, 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.

Contents of the pack and additional information

Ibuprofenbelongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for the treatment of fever, the treatment of mild to moderate pain including migraine, the treatment of arthritis (inflammation of the joints, including those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

Do not take Ibuprofeno MABO-FARMA:

• 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 active inflammatory bowel disease.
• if you have black stools or bloody diarrhea.
• if you have bleeding or clotting disorders, or are taking anticoagulants (blood thinners). If necessary, your doctor will perform blood clotting tests.
• if you have severe heart failure.
• if you are in the third trimester of pregnancy.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take ibuprofen:

• 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.
• inform your doctor if you are already receiving ibuprofen treatment, as it may mask fever, making it difficult to diagnose a possible infection.
• if you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done.
• if you experience symptoms of dehydration, such as severe diarrhea or vomiting, drink 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 or duodenal ulcer, bleeding, or perforation, which may manifest as intense or persistent 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 ulcer disease and in elderly patients. In these cases, your doctor may consider adding a stomach protector medication.

-if you take anticoagulant medications that alter blood clotting, 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 where 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 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, the membranes that protect the brain and spinal cord, not caused by bacteria).

• if you have porphyria (a metabolic disorder that affects your blood and can cause symptoms like red urine, bloody urine, or liver disease), so your doctor can assess the suitability of 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 recommended not 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 to 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 have been reported with Ibuprofeno MABO-FARMA. 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

Medications like Ibuprofeno may be associated with a moderate increase in the risk of heart attack or stroke, especially when used in high doses and prolonged treatment.Do not exceed the recommended dose or treatment duration.

If you have heart problems, a history of strokes, or think you may be at risk for these conditions (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker), consult this treatment with your doctor or pharmacist.

These types of medications can cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Signs of ibuprofen allergy, such as respiratory problems, facial and neck 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, bronchial asthma, or allergic diseases, as ibuprofen has been reported to 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 women of childbearing age

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 strictly necessary cases. 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 women of childbearing age, it is essential to consider that ibuprofen-type medications have been associated with a decrease in fertility.

Taking Ibuprofeno MABO-FARMA with other medications

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

The following medications may interact and should not be taken with Ibuprofeno MABO-FARMA without consulting your doctor:

• Other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Selective serotonin reuptake inhibitors (SSRIs) used in depression.
• Antiplatelet agents like ticlodipine.
• Anticoagulants like warfarin.
• 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 like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and trimethoprim (used to treat bacterial infections).
• Corticosteroids like prednisone and prednisolone.
• Diuretics (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 like norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas like tolbutamide (used to treat diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Antihypertensives: to lower high blood pressure.
• Trombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: from the Ginkgo biloba tree.
• Inhibitors of CYP2C9 (responsible for metabolizing numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).
• Cholestyramine (used to treat high cholesterol)

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)
• 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

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

Taking Ibuprofeno MABO-FARMA with food, drinks, and alcohol

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

Consuming alcohol during treatment may increase the risk of gastrointestinal side effects.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take ibuprofen during pregnancy, especially during the third trimester.

Breastfeeding

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

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, no special precautions are necessary.

Ibuprofeno MABO-FARMA contains lactose

If your doctor has told you that you have a certain sugar intolerance, 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 indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Do not discontinue treatment beforehand, as this will not yield the expected results. Similarly, do not use this medication for a longer period than indicated by your doctor.

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

Adults and adolescents

The recommended dose for adults and adolescents aged 14 to 18 years is one tablet (600 mg of ibuprofen) every 6 to 8 hours, depending on the severity of the condition and the response to treatment.

In some cases, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2400 mg in adults and 1600 mg in adolescents aged 12 to 18 years.

Use in children and adolescents

This medication is not recommended for use in children and adolescents under 14 years old, as the dose of ibuprofen contained is not suitable for the recommended dosage in this patient group.

Adolescents over 14 years old will follow adult dosage recommendations, but the maximum daily dose recommended for these patients is 1600 mg.

Older patients

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, the dose can only be increased once your doctor has confirmed that you tolerate the medication well.

Patients with kidney and/or liver diseases

If you have a kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose prescribed by your doctor.

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

Administration form

This medication is administered orally.

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

Patients with sensitive stomachs are recommended to take ibuprofen with food.

If you take moreIbuprofeno MABO-FARMAthan you should

If you have taken more Ibuprofeno MABO-FARMA than you should, or if a child has accidentally ingested the medication, consult a doctor or pharmacist immediately or contact the Toxicological Information Service, phone: 91 562 04 20, or go to the nearest hospital indicating the medication and the amount ingested, to inform yourself about the risk and ask for advice on the measures to be taken. It is recommended to bring the packaging 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,headache, ringing in the ears, confusion, and involuntary eye movement. It may also cause agitation, drowsiness, disorientation, or coma. Occasionally, patients develop seizures.

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

Additionally, the prothrombin time/INR may be prolonged due to interaction with circulating clotting factors. Gastrointestinal bleeding, acute renal failure, and liver damage may occur. Asthma exacerbation may occur in asthmatics. Hypotension and decreased respiration may also occur.

In rare cases, rapid involuntary eye movements, metabolic acidosis, decreased body temperature, kidney function impairment, stomach and intestinal bleeding, coma, transient loss of respiration (apnea), central nervous system and respiratory system depression have been reported. Cases of cardiovascular toxicity (hypotension, bradycardia, and tachycardia) have also been reported. If a severe overdose has occurred, renal failure and liver damage may occur. In these cases, the doctor will take the necessary measures.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric emptying will be considered if more than 400 mg/kg has been ingested and within 60 minutes of ingestion.

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 next dose is due soon, skip the missed dose and take the next dose at its usual time.

Like all medications,Ibuprofeno MABO-FARMAmay cause side effects, although not everyone will experience them.

The side effects of medications such asibuprofenoare more common in people over 65 years old.

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

Frequencies are established according to the following classification: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1000 people); very rare (may affect up to 1 in 10,000 people); frequency unknown (cannot be estimated from available data).

The following side effects have been observed:

Infections and infestations

Uncommon: nasal mucosa inflammation.

Very rare: Exacerbation of infections-related inflammation (e.g., necrotizing fasciitis) coinciding with the use of NSAIDs. If signs of infection or worsening occur during treatment with ibuprofen, seek medical attention immediately.

Gastrointestinal

Common: Digestive discomfort such as heartburn (dyspepsia), diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, bloody stools (melena), vomiting with blood (hematemesis), gastrointestinal bleeding. Uncommon: gastritis, duodenal ulcer, gastric ulcer, mucosal inflammation of the mouth with ulcer formation, gastrointestinal perforation.Very rare: pancreatitis.

Frequency unknown: Colitis and Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea).

Cardiovascular

Very rare: Heart failure, myocardial infarction, and hypertension.

Medications like Ibuprofeno may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with ibuprofen-type medications.

Frequency unknown: Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Dermatological

Common: Skin rash. Uncommon: Redness of the skin, itching or swelling of the skin, purpura (purple spots on the skin). Very rare: Severe blistering reactions such as 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 on mucous membranes and painful lesions with necrosis and detachment of the epidermis), hair loss, erythema multiforme (skin lesion), photosensitivity reactions, inflammation of skin blood vessels. Exceptionally, severe skin infections and complications in soft tissue may occur during varicella. Frequency unknown: 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.

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

Immune system:Uncommon: Transient edema in areas of the skin, mucous membranes, or sometimes in internal organs (angioedema), nasal mucosa inflammation, bronchospasm (spasm of the bronchi that prevents air from passing to the lungs).

Rare: Severe allergic reactions (anaphylactic shock).In case of severe generalized hypersensitivity reaction, swelling of the face, tongue, and larynx, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.

Very rare: Joint pain and fever (lupus erythematosus).

Central nervous system

Common: Headache and dizziness or feeling of instability. Uncommon: Paresthesia (numbness, tingling, prickling, etc., more common in hands, feet, arms, or legs), somnolence or drowsiness. Rare: Optic nerve inflammation (optic neuritis).

Very rare: 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 or other collagen diseases), which was a risk factor. Symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric

Uncommon: Insomnia, anxiety, restlessness.

Rare: Disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory

Uncommon: Ringing or buzzing in the ears, vertigo, hearing difficulty.

Ocular

Uncommon: Vision disturbances.

Rare: Retinal degeneration.

Hematologic

Rare: 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 pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red and white blood cells and platelets in the blood), agranulocytosis (very large decrease in granulocytes), aplastic anemia (insufficiency of the bone marrow to produce different types of cells) or 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, nasal and cutaneous hemorrhage.

Very rare: Prolonged bleeding time.

Renal

Uncommon: Interstitial nephritis (kidney disorder), nephrotic syndrome (characterized by protein in the urine and body swelling), and renal insufficiency (sudden loss of kidney function).

Hepatic

Rare: Liver damage (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes).

Frequency unknown: Liver insufficiency (severe deterioration of the liver).

General

Worsening of inflammation during infectious processes.

Until now, no severe allergic reactions have been reported with Ibuprofeno MABO-FARMA, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, severe abdominal pain, intense and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension, or shock.

Common: Fatigue.

If any of the following side effects occur, discontinue treatment and seek medical attention immediately:

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the national notification system included inwww.notificaRAM.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keepthis medication out of the sight and reach of children.

Do not store at a temperature above 30º.

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 in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ibuprofeno MABO-FARMA

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, white-coated tablets.

Presented in aluminum-PVC/PVDC blister packaging in a pack of 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

MABO-FARMA, S.A.

Vía de los Poblados, 3, Building 6

28033 Madrid,

Spain.

Responsible for manufacturing:

Farmalider, S.A,

Aragoneses Street, 2 28108

Alcobendas (Madrid)

Spain

FROSST IBÉRICA, S.A.,

Vía Complutense, 140, 28805

Alcalá de Henares, Madrid

Spain

PHARMALOOP, S.L.

Bolivia Street, 15 – Azque Industrial Estate

28806 Alcalá de Henares (Madrid)

Spain

TOLL MANUFACTURING SERVICES S.L.

Aragoneses Street, 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/