IBUPROFEN MABO FARMA 600 mg FILM-COATED TABLETS

Introduction

Prospective: patient information

Ibuprofen MABO-FARMA 600 mg film-coated tablets EFG

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the prospectus

1. What is Ibuprofen MABO-FARMA and what is it used for
2. What you need to know before starting to take Ibuprofeno MABO-FARMA
3. How to take Ibuprofeno MABO-FARMA
4. Possible adverse effects
5. Storage of Ibuprofeno MABO-FARMA

Package contents and additional information

1. What is Ibuprofen MABO-FARMA and what is it used for

Ibuprofen belongs to the group of medications called non-steroidal anti-inflammatory drugs (NSAIDs).

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

2. What you need to know before starting to 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 components of this medication (listed in section 6). Allergic reactions may include: 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 active inflammatory bowel disease.
• if you have black stools or bloody diarrhea.
• if you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medications 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.

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 heart problems or high blood pressure.
• if you have asthma or any other respiratory disorder.
• inform your doctor if you are already receiving treatment with ibuprofen, 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 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 contact your doctor immediately, as ibuprofen may cause kidney failure due to 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 symptoms. This risk is higher when using high doses and prolonged treatments, 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 aspirin type. 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 leads to bloody diarrhea) or ulcerative colitis, as medications like ibuprofen may worsen these conditions.
• if you are being treated with diuretics (medications 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 (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria).
• 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 medication.
• It is possible that allergic reactions may occur with this medication.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable 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/controls the 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 (non-steroidal anti-inflammatory drugs), 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, mucous 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue ibuprofen treatment and seek medical attention immediately if you experience any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular precautions

Medications like Ibuprofen may be associated with a moderate increase in the risk of heart attack or stroke, especially when used in high doses and prolonged treatments. 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), you should consult your doctor or pharmacist about this treatment.

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

Ibuprofen has been associated with signs of allergic reaction, such as respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop using ibuprofen immediately and contact your doctor or emergency medical services if you experience any of these signs.

Respiratory disorders

Ibuprofen should be used with caution when administered to patients who have or have had bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen may cause bronchospasm, urticaria, or angioedema in these patients.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, this medication 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 medication while having an infection and the symptoms of the infection persist or worsen, consult your doctor without delay.

Precautions during pregnancy and in women of childbearing age

Since the administration of medications like ibuprofen has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to take ibuprofen 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 medications like ibuprofen have been associated with a decrease in fertility.

Taking Ibuprofen MABO-FARMA with other medications

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

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

• Other non-steroidal anti-inflammatory drugs, such as aspirin, as they may increase the risk of stomach ulcers and bleeding.
• Selective serotonin reuptake inhibitors (used in depression).
• Antiplatelet agents (which prevent the formation of blood clots in blood vessels) such as ticlopidine.
• Anticoagulants (medications used to "thin" the blood and prevent the formation of clots) such as warfarin.
• Lithium (a medication 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 (an abortion inducer).
• Digoxin (cardiac glycosides) (used to treat heart disorders).
• Hydantoins, such as phenytoin (used to treat epilepsy).
• Sulfonamides, such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids, such as cortisone and prednisolone.
• Diuretics (medications used to increase urine production), as they may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics, such as norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonylureas, such as tolbutamide (used for diabetes), as they may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (a medication against the AIDS virus).
• Antihypertensives: to decrease high blood pressure.
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics, such as neomycin.
• Herbal extracts: from the Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).
• Colestyramine (a medication 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 discontinuing 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)
• Liver function tests: increased transaminase values

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

Taking Ibuprofen 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 adverse gastrointestinal reactions.

Pregnancy and breastfeeding

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

Pregnancy

Ibuprofen should not be taken 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 using machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or operate hazardous machinery. If you only take one dose of ibuprofen or for a short period, it is not necessary to take special precautions.

Ibuprofen MABO-FARMA contains lactose

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

Ibuprofen MABO-FARMA contains sodium

This medication 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 exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Do not stop treatment beforehand, as this will not achieve the expected results. Similarly, do not use this medication for longer than indicated by your doctor.

The lowest effective dose should be used 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).

Adults and adolescents

The recommended dose in adults and adolescents from 14 to 18 years old is one tablet (600 mg of ibuprofen) every 6 to 8 hours, depending on the intensity of the condition and 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 from 12 to 18 years old.

Use in children and adolescents

The use of this medication is not recommended in children and adolescents under 14 years old, as the dose of ibuprofen it contains is not suitable for the recommended dosage in this group of patients.

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

Elderly 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 checked that you tolerate the medication well.

Patients with kidney and/or liver disease

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

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

Method of administration

This medication is administered orally.

Take ibuprofeno with enough 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 recommended that patients with sensitive stomachs take ibuprofeno 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 the Toxicology Information Service, phone: 91 562 04 20, or go to the nearest hospital indicating the medication and the amount ingested, to find out about the risk and ask for advice on the measures to be taken. It is recommended to bring the packaging and the prospectus of the medication to the healthcare professional.

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

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), gastrointestinal bleeding (see also section 4), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement. Agitation, drowsiness, disorientation, or coma may also occur. 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 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 breathing may occur.

In rare cases, rapid involuntary eye movements, increased blood plasma acidity (metabolic acidosis), decreased body temperature, altered kidney function, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system depression, and respiratory system have been reported. Cardiovascular toxicity (decreased blood pressure, decreased heart rate, and increased heart rate) has also been produced. If severe poisoning has occurred, the doctor will take the necessary measures.

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

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 for the next dose is near, skip the forgotten dose and take the next dose at the usual time.

4. Possible adverse effects

Like all medications, Ibuprofeno MABO-FARMA can cause adverse effects, although not everyone will experience them.

Adverse effects of medications like ibuprofeno 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.

Frequencies are established according to the following classification: very frequent (may affect more than 1 in 10 people); frequent (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 not known (cannot be estimated from available data).

The following adverse effects have been observed:

Infections and infestations

Uncommon: nasal mucosa inflammation.

Very rare: Exacerbation of inflammation-related infections (e.g., development of necrotizing fasciitis) has been described coinciding with the use of NSAIDs. If signs of infection or worsening occur during treatment with ibuprofeno, it is recommended to go to the doctor immediately.

Gastrointestinal

Frequent: digestive disorders such as heartburn (dyspepsia), diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, bloody stools (melena), vomiting blood (hematemesis), gastrointestinal bleeding. Uncommon: gastritis, duodenal ulcer, gastric ulcer, inflammation of the oral mucosa with ulcer formation, gastrointestinal perforation. Very rare: pancreatitis.

Frequency not known: Colitis and Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces 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), arterial hypertension, and heart failure have also been observed in association with treatments with medications of the ibuprofeno type.

Frequency not known: Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Dermatological

Frequent: skin rash. Uncommon: skin redness, itching or skin swelling, purpura (purple spots on the skin). Very rare: severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes and purplish 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), skin reactions due to light influence, inflammation of the skin blood vessels. Exceptionally, severe skin infections and soft tissue complications can occur during chickenpox. Frequency not known: The 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 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.

Drug reaction with eosinophilia and systemic symptoms: A severe skin reaction known as DRESS syndrome can occur. The 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 viscera (angioedema), nasal mucosa inflammation, bronchospasm (bronchial spasm that prevents air from passing into the lungs).

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

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

Central nervous system

Frequent: headache and dizziness or feeling of instability. Uncommon: paresthesia (sensation of numbness, tingling, etc., more frequent in hands, feet, arms, or legs), drowsiness or drowsiness. Rare: optic neuritis (inflammation of the optic nerve).

Very rare: aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofeno, the patient suffered from some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. The 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 changes.

Rare: retinal degeneration.

Blood and lymphatic system

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 can predispose to infections), pancytopenia (deficiency of red, white blood cells, and platelets in the blood), agranulocytosis (very significant decrease in granulocytes), aplastic anemia (bone marrow failure 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, nosebleeds, and skin bleeding.

Very rare: prolonged bleeding time.

Renal and urinary disorders

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

Hepatic disorders

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

Frequency not known: liver failure (severe liver deterioration).

General disorders

Worsening of inflammation during infectious processes.

To date, no serious 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, abdominal pain, severe and persistent headache, nausea, vomiting, facial swelling, tongue and throat swelling, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

Frequent: fatigue.

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

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Blood vomiting or coffee grounds-like vomiting.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blistering.
• 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, non-raised, target-like, or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. 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 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national reporting system included in www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofeno MABO-FARMA

Keep this medication out of sight and reach of children.

Do not store at a temperature above 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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications that are no longer needed in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications that are no longer needed. This will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno MABO-FARMA

• The active ingredient is ibuprofeno. Each tablet contains 600 mg of ibuprofeno.
• The other components are:

Core

Croscarmellose sodium, 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 package contents

Oval, biconvex, white film-coated tablets.

It is presented in aluminum-PVC/PVDC blister packs in a package of 40 tablets.

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

PHARMALOOP, S.L.

c/ Bolivia, 15 – Polígono Industrial Azque

28806 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/