Ibuprofen Mabo Farma 600 mg film-coated tablets EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Ibuprofeno MABO-FARMA is and what it is used for
- 2. What you need to know before taking Ibuprofeno MABO-FARMA
- 3. How to take Ibuprofen MABO-FARMA
- 4. Possible adverse effects
- 5. Storage of Ibuprofen MABO-FARMA
- 6. Contents of the container and additional information
- **Composition of Ibuprofen MABO-FARMA**
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ibuprofen MABO-FARMA 600 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as 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 others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Ibuprofen MABO-FARMA is and what it is used for
- What you need to know before taking Ibuprofen MABO-FARMA
- How to take Ibuprofen MABO-FARMA
- Possible adverse effects
- How to store Ibuprofen MABO-FARMA
Pack contents and other information
1. What Ibuprofeno MABO-FARMA is and what it is used for
Ibuprofen belongs to a group of medicines called non-steroidal 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, usually affecting the hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic condition causing damage to cartilage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).
2. What you need to know before taking Ibuprofeno MABO-FARMA
Do not take Ibuprofeno MABO-FARMA:
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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 components of this medicine (listed in section 6). Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, nasal discharge, breathing difficulties, or asthma.
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if you have severe liver or kidney disease.
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if you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
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if you are vomiting blood.
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if you have active inflammatory bowel disease.
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if you have black stools or bloody diarrhoea.
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if you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants concomitantly, your doctor will perform blood coagulation tests.
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if you have severe heart failure.
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if you are in the third trimester of pregnancy.
Warnings and precautions:
Talk to your doctor or pharmacist before taking ibuprofen:
- if you have oedema (fluid retention).
- if you have or have previously 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 diagnosis of a possible infection more 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 1–2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks should be done.
- if you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to renal failure as a consequence of 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 treatments 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 other medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about 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 and usually bloody diarrhoea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
- if you are taking diuretics (medicines to increase urine output), because your doctor must monitor your kidney function.
- if you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—without bacterial cause) 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 titled “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 may be fatal.
Skin reactions
Severe 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 very serious 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 treatment with ibuprofen and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.
Cardiovascular precautions
Medicines such as ibuprofen may be associated with a moderate increase in the risk of heart attack or stroke, especially when used at high doses or for prolonged periods. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, a history of stroke, or think you may be at risk for these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoking), consult your doctor or pharmacist about this treatment.
Also, these types of medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).
Signs of allergic reaction to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop taking 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 the 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 the symptoms persist or worsen, consult a doctor without delay.
Pregnancy and fertility precautions
Because administration of medicines like ibuprofen has been associated with an increased risk of congenital malformations or miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration of treatment should be kept to a minimum. The risk is believed to increase with dose and duration of treatment.
In the third trimester, administration of ibuprofen is contraindicated.
For women of childbearing age, it should be noted that medicines like ibuprofen have been associated with a reduced ability to conceive.
Taking Ibuprofeno MABO-FARMA with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
The following medicines may interact and therefore should not be taken together with Ibuprofeno MABO-FARMA without first consulting your doctor:
- Other non-steroidal anti-inflammatory drugs such as aspirin, as this may increase the risk of gastrointestinal ulceration and bleeding.
- Selective serotonin reuptake inhibitors (used for depression).
- Antiplatelet agents (prevent blood clots or thrombi in blood vessels) such as ticlopidine.
- Anticoagulants (medicines used to "thin" the blood and prevent clots) such as warfarin.
- Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
- Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
- Mifepristone (an abortion-inducing agent).
- Digoxin (cardiac glycosides) (used to treat heart disorders).
- Hydantoins such as phenytoin (used to treat epilepsy).
- Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
- Corticosteroids such as cortisone and prednisolone.
- Diuretics (medicines used to increase urine output), as they may increase the risk of renal toxicity.
- Pentoxifylline (used to treat intermittent claudication).
- Probenecid (used in gout patients or together with penicillin in infections).
- Quinolone antibiotics such as norfloxacin.
- Sulfinpyrazone (for gout).
- Sulfonylureas such as tolbutamide (for diabetes), as this may cause hypoglycaemia.
- Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
- Zidovudine (an anti-HIV drug).
- Antihypertensives: to reduce high blood pressure.
- Thrombolytics (medicines that dissolve clots).
- Aminoglycoside antibiotics such as neomycin.
- Herbal extracts: Ginkgo biloba.
- Inhibitors of CYP2C9 (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).
- Cholestyramine (a medicine used to treat high cholesterol).
Interference with laboratory tests
Taking ibuprofen may alter the following laboratory tests:
- Bleeding time (may be prolonged for up to 1 day after stopping treatment)
- Blood glucose concentration (may decrease)
- Creatinine clearance (may decrease)
- Haematocrit or haemoglobin (may decrease)
- Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase)
- Liver function tests: increased transaminase values
Inform your doctor if you are scheduled for clinical testing and are taking or have recently taken ibuprofen.
Taking Ibuprofeno MABO-FARMA with food, drinks, and alcohol
You may 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 adverse 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 medicine.
Pregnancy
Ibuprofen should not be taken during pregnancy, especially during the third trimester.
Breastfeeding
Although only small amounts of the medicine 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 use of machines
If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you take only a single dose or use ibuprofen for a short period, no special precautions are usually necessary.
Ibuprofeno MABO-FARMA contains lactose
If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.
Ibuprofeno MABO-FARMA contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially "sodium-free".
3. How to take Ibuprofen MABO-FARMA
Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Do not stop treatment prematurely, as otherwise the expected results will not be achieved. Likewise, do not use this medicine for longer than indicated by your doctor.
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).
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 symptoms and response to treatment.
In some conditions, higher doses may be required; however, 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
The use of this medicine is not recommended in children and adolescents under 14 years of age, as the ibuprofen dose it contains is not suitable for the recommended dosage regimen in this patient group.
Adolescents over 14 years of age should follow adult dosing 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 than usual dose. If so, the dose may only be increased once your doctor has confirmed that you tolerate the medicine well.
Patients with kidney and/or liver disease
If you have kidney and/or liver disease, your doctor may prescribe a lower than usual dose. If so, take exactly the dose prescribed by your doctor.
If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
Method of administration
This medicine is administered orally.
Take ibuprofen with a sufficient amount of water. The tablets must be swallowed whole with a glass of water, without chewing, breaking, crushing, or sucking, to avoid mouth discomfort and throat irritation.
Patients with a sensitive stomach are advised to take ibuprofen with food.
If you take more Ibuprofen MABO-FARMA than you should
If you have taken more Ibuprofen MABO-FARMA than you should, or if a child has accidentally ingested the medicine, contact a doctor or pharmacist immediately, call the Toxicology Information Service at telephone number: 91 562 04 20, or go to the nearest hospital. Indicate the medicine and the amount ingested, to obtain information about the risk and advice on the measures to be taken. It is recommended to bring the medicine’s packaging 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, headache, tinnitus, confusion, and involuntary eye movements. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients may experience 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 potassium levels in the blood, 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. In addition, hypotension and respiratory depression may occur.
Rarely, cases of rapid involuntary eye movements, increased acidity of blood plasma (metabolic acidosis), decreased body temperature, impaired kidney function, bleeding from the stomach and intestine, coma, transient loss of breathing (apnea), central nervous system and respiratory depression have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also occurred. If severe poisoning has occurred, renal failure and liver damage may develop. In such cases, the doctor will take the necessary measures.
In case of ingestion of large amounts, activated charcoal should be administered. Gastric lavage should be considered if more than 400 mg/kg has been ingested and within 60 minutes of ingestion.
If you forget to take Ibuprofen 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 your usual time.
4. Possible adverse effects
Like all medicines, Ibuprofeno MABO-FARMA can produce 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 treatments and when the daily dose is below the maximum recommended dose.
Frequencies are defined 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 1,000 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: inflammation of the nasal mucosa.
Very rare: Exacerbation of inflammation associated with infections (e.g., development of necrotizing fasciitis) has been described during use of NSAIDs. If signs of infection occur or worsen during treatment with ibuprofen, immediate medical attention is recommended.
Gastrointestinal
Common: gastrointestinal discomfort 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 condition 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.
Medicines such as ibuprofen may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.
Edema (fluid retention), arterial hypertension, and heart failure have also been observed in association with treatments using ibuprofen-type medicines.
Frequency not known: Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
Dermatological
Common: 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 two or more mucous membranes and purple-colored lesions, primarily on the trunk), toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis), hair loss, erythema multiforme (skin lesions), photosensitivity reactions, inflammation of blood vessels in the skin. Rarely, severe skin infections and soft tissue complications may occur during chickenpox.
Frequency not known: Skin becomes sensitive to light. Generalized red, scaly rash with bumps under the skin and blisters, primarily located in skin folds, trunk, and upper extremities, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Discontinue taking Ibuprofeno MABO-FARMA if you experience these symptoms and seek immediate medical attention. See also 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, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).
Immune system disorders:
Uncommon: transient swelling in areas of skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of the nasal mucosa, bronchospasm (spasm of the bronchi restricting airflow to the lungs).
Rare: severe allergic reactions (anaphylactic shock). In cases of severe generalized hypersensitivity reactions, swelling of the face, tongue, and larynx, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.
Very rare: joint pain and fever (drug-induced lupus erythematosus).
Central nervous system
Common: headache, dizziness, or sensation of unsteadiness.
Uncommon: paresthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms, or legs), somnolence or drowsiness.
Rare: optic neuritis (inflammation of the optic nerve).
Very rare: aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria). In most reported cases of aseptic meningitis with ibuprofen, the patient had an underlying autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which represented a risk factor. Symptoms observed included neck stiffness, headache, nausea, vomiting, fever, or disorientation.
Psychiatric
Uncommon: insomnia, anxiety, restlessness.
Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.
Auditory
Uncommon: tinnitus (ringing or buzzing in the ears), vertigo, hearing difficulty.
Ocular
Uncommon: visual disturbances.
Rare: retinal degeneration.
Blood and lymphatic system
Rare: decreased platelet count, decreased white blood cell count (may present as frequent infections with fever, chills, or sore throat), decreased red blood cell count (may present as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may increase susceptibility to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe reduction in granulocytes), aplastic anemia (failure of bone marrow to produce various blood cells), or hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding.
Very rare: prolonged bleeding time.
Renal
Uncommon: interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in urine and body swelling), and renal failure (sudden loss of kidney function).
Hepatic
Rare: liver injury (liver inflammation), abnormal liver function tests, and jaundice (yellowing of the skin and eyes).
Frequency not known: liver failure (severe deterioration of liver function).
General
Worsening of inflammation during infectious processes.
To date, no severe allergic reactions have been reported with Ibuprofeno MABO-FARMA, although they cannot be ruled out. Manifestations of such reactions could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulty, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.
Common: fatigue.
If any of the following adverse effects occur, stop treatment immediately and consult your doctor:
- Allergic reactions such as skin rash, facial swelling, wheezing, or breathing difficulty.
- Vomiting blood or material resembling coffee grounds.
- Blood in the stool 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, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions 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 swollen 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 effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system at 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 sight and reach of children.
Do not store above 30ºC.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the container and additional information
Composition of Ibuprofen MABO-FARMA
- The active substance is ibuprofen. Each tablet contains 600 mg of ibuprofen.
- The other components are:
Core
Sodium croscarmellose, hypromellose, monohydrate lactose, microcrystalline cellulose, pregelatinized maize 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 contents of the container
White, oval-shaped, biconvex coated tablets.
Presented in aluminum-PVC/PVDC blisters within a 40-tablet pack.
Marketing Authorization Holder and Manufacturing Responsible Party
Marketing Authorization Holder:
MABO-FARMA, S.A.
Calle Vía de los Poblados, 3, Edificio 6
28033 Madrid,
Spain.
Manufacturing Responsible Parties:
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 most recent review of this leaflet: November 2024
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/