Mandafen 400 Mg Tablets
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Read all of this leaflet carefully because it contains important information for you.
Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advice.
1. WHAT MANDAFEN TABLETS ARE AND WHAT THEY ARE USED FOR
Mandafen Tablets contain ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Mandafen 400mg Tablets are used to treat painful and feverish conditions such as headache, migraine, toothache, colds, influenza, sore throat period pains, muscular aches and pains, non-serious arthritis, neuralgia and rheumatic pain.
2. BEFORE YOU TAKE MANDAFEN TABLETS Do NOT take Mandafen Tablets If:
• you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• you have had an allergic reaction to aspirin or other NSAIDs (e.g. asthma, runny nose, swelling of the nose or throat or skin rash)
• you have or have ever had a stomach ulcer, perforation or bleeding from the stomach
• you have severe heart, kidney or liver failure
• you are in the last 3 months of pregnancy
• you are taking other NSAIDs or aspirin with a daily dose above 75mg.
Talk to your doctor or pharmacist before you take this medicine if:
• you have systemic lupus erythematous (SLE) or connective tissue disease
• you have kidney or liver problems
• you have a history of heart failure or high blood pressure
• you have asthma or have a history of asthma or allergic disease
• you have a history of stomach or bowel disorders (e.g. ulcerative colitis, Crohn's disease)
• you are in the first 6 months of pregnancy or are trying to become pregnant
• you are breast-feeding.
Warning: Medicines such as Mandafen 400mg Tablets may be associated with a small increased risk of heart attack ('myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (10 days).
If you have heart problems, previous stroke or think you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
Taking other medicines
Talk to your doctor or pharmacist before you take Mandafen if you are taking, or have recently taken, any of the following:
• medicines for high blood pressure (ACE inhibitors e.g. captopril, beta blockers, angiotensin II antagonists) or heart failure, such as diuretics (water tablets)
• medicines for thinning the blood (anti-coagulants e.g. warfarin, acetylsalicylic acid/aspirin, ticlopidin)
• medicines for depression such as SSRls or lithium
• corticosteroids
• certain antibiotics (quinolones e.g. ciprofloxacin)
• other NSAIDs, low dose aspirin (less than 75mg per day) or other painkillers
• methotrexate (used to treat some cancers, psoriasis or arthritis)
• ciclosporin and tacrolimus (used to prevent rejection of organ transplants)
• mifepristone (used to induce abortion)
• zidovudine (used to treat viral infection)
• aminoglycosides (a type of antibiotic)
• Ginkgo biloba (a herbal medicine).
Some medicines may affect or be affected by Mandafen.
Seek the advice of a doctor before you use Mandafen with other medicines. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast feeding
Mandafen Tablets contain ibuprofen which belongs to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that Mandafen, used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.
Driving and using machines
Mandafen may make you feel tired, dizzy or drowsy, or your vision may be affected. You should not drive or operate machinery if you experience any of these side effects.
Important information about some of the ingredients of this medicine
This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE MANDAFEN TABLETS
Ask your doctor or pharmacist if you are not sure how to take these tablets.
The tablets should be swallowed with a drink of water or milk, with or after food.
Adults (including the elderly) and children over 12 years:
• Take 1 tablet every 4-6 hours after food.
• Do not take more than 3 tablets in any 24-hour period.
• For short term use only. Do not take for longer than 10 days unless your doctor tells you to.
• Always use the lowest dose for the shortest time necessary to relieve your symptoms.
• If symptoms persist or worsen consult your doctor.
Mandafen 400 mg Tablets should not be given to children under 12 years of age.
If you or anyone else takes too many Mandafen 400mg Tablets
Contact your doctor immediately or go to your local hospital casualty department. Please take this leaflet, any remaining tablets and the container with you.
If you forget to take a tablet take one as soon as you remember, unless it is nearly time to take the next dose. Do not take a double dose to make up for a forgotten dose and do not take more than the maximum dose per day.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mandafen can cause side effects, although not everybody gets them.
The incidence of side effects may be greater in the elderly.
STOP TAKING the tablets and seek immediate medical help if you experience any of the following:
• Stomach irritation or bleeding with any of the following symptoms:
- pass blood in your faeces (stools/motions)
- pass black tarry stools
- vomit any blood or dark particles that look like coffee grounds
• Allergic reactions with any of the following symptoms:
- asthma, worsening of asthma, wheezing or difficulty breathing; skin rashes or itching; swelling of the lips, tongue or face; fast heart rate, low blood pressure, collapse
• Severe skin reactions.
STOP TAKING the tablets and tell your doctor if you experience:
• Indigestion or heartburn
• Stomach pains or other abnormal stomach symptoms.
Medicines such as Mandafen 400mg Tablets may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
Other side effects:
• nausea, vomiting, diarrhoea, flatulence, constipation
• inflammation of the pancreas causing severe stomach and back pain
• blood disorders (symptoms may include unusual bleeding or bruising, sore throat, fever, exhaustion or anaemia)
• liver problems such as hepatitis and jaundice (yellowing of the skin or whites of the eyes)
• kidney problems and swelling caused by fluid retention, very rarely kidney failure
• high blood pressure and heart failure
• headache, visual disturbances, ringing in the ears
• depression, confusion, hallucination
• skin rashes or rarely severe skin reactions and blistering
• numbness or tingling of the hands or feet vertigo. dizziness, tiredness, drowsiness, malaise
• sensitivity of the skin to the sun
• single cases of aseptic meningitis have been reported
• worsening of symptoms of colitis or Crohn's disease.
If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, stop taking the tablets and tell your doctor or pharmacist.
5. HOW TO STORE MANDAFEN TABLETS Keep out of the reach and sight of children.
Do not store above 25oC
Do not use after the expiry date printed on the pack.
6. FURTHER INFORMATION
What Mandafen 400mg Tablets contain:
• The active ingredient in each tablet is ibuprofen 400mg.
• The other ingredients are maize starch, cellulose microcrystalline, sodium starch glycollate, povidone, alginic add, silica colloidal anhydrous, magnesium stearate, croscarmellose sodium, sodium lauryl sulphate.
• The tablet coating contains opadry, sucrose, titanium dioxide (E171), erythrosine lake (E127), sodium benzoate (E211), white beeswax and carnauba wax.
What Mandafen 400mg Tablets look like and contents of the pack:
They are pink, round sugar-coated tablets.
They are available in blister packs of 12, 16, 24, 32, 36, 48,
60, 72, 84 and 96 tablets.
Marketing Authorisation Holder and Manufacturer:
M&A Pharmachem Ltd, Bolton, BL5 2AL, UK.
Date of last revision: May 2013
PP2324