Ibuprofen Tablets Bp 600mg
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IBUPROFEN 600mg TABLETS
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 IBUPROFEN TABLETS ARE AND WHAT THEY ARE USED FOR
Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen 600 mg Tablets are used to treat mild to moderate pain including period pains, headache, migraine and toothache; pain after operations; rheumatoid arthritis (including juvenile arthritis or Still's disease) and other muscle or bone disorders.
2. BEFORE YOU TAKE IBUPROFEN TABLETS Do NOT take Ibuprofen Tablets If:
• you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• you have a history of allergy to aspirin, ibuprofen or NSAIDs, which includes attacks of asthma, swelling of the nose and throat, skin rash or runny nose
• you have an active or history of recurrent peptic ulcers (more than two)
• you have a history of stomach bleeding or perforation related to the use of NSAIDs
• you have severe heart, kidney or liver failure
• you are in the last 3 months of pregnancy.
Talk to your doctor or pharmacist before you take this medicine if:
• you have systemic lupus erythematous (SLE) or connective tissue disease
• you have heart, kidney or liver problems
• you have a history of heart failure or high blood pressure
• you have asthma or have a history of asthma
• 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
• Ibuprofen 600 mg Tablets may make it more difficult to become pregnant. Tell your doctor if you have problems becoming pregnant
• you are breast-feeding.
Warning: Medicines such as Ibuprofen 600 mg 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.
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 ibuprofen if you are taking, or have recently taken, any of the following:
• medicines for high blood pressure or heart failure, such as diuretics (water tablets)
• medicines for thinning the blood (anti-coagulants e.g. warfarin)
• medicines for depression such as SSRls or lithium
• corticosteroids
• certain antibiotics (quinolones e.g. ciprofloxacin)
• other NSAIDs, aspirin 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).
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Driving and using machines
Side effects such as dizziness, drowsiness, tiredness and visual disturbances are possible after taking NSAIDs. If affected, you should not drive or operate machinery.
Important information about some of the ingredients of this medicine
This medicine contains lactose monohydrate. 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 IBUPROFEN TABLETS
Your doctor has carefully chosen the correct dosage for you. Always follow your doctor's instructions and those on the pharmacy label. Ask your doctor or pharmacist if you are not sure.
The tablets should be swallowed with a drink of water or milk, with or after food.
The usual doses are given below:
Adults: initially 2 to 3 tablets daily in divided doses; increased if necessary to a maximum of 4 tablets daily. A maintenance dose of 1 to 2 tablets daily may be adequate. Elderly: a lower dose should be considered and the patient should be monitored for gastro-intestinal bleeding for 4 weeks after starting the tablets.
Children: 20 mg per kg body weight daily, in divided doses. For juvenile rheumatoid arthritis, up to 40 mg per kg daily, in divided doses. Children under 30 kg must not receive more than 500 mg per day even in divided doses.
• Always use the lowest dose for the shortest time necessary to relieve your symptoms
• If symptoms persist or worsen contact your doctor
If you or anyone else takes too many Ibuprofen 600 mg Tablets
Contact your doctor immediately or go to your nearest 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, ibuprofen can cause side effects, although not everybody gets them.
Side effects will be minimised by using the lowest dose for the shortest time necessary to control your symptoms. The incidence of gastro-intestinal 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 reaction with blistering and peeling.
STOP TAKING the tablets and tell your doctor if you experience:
• Indigestion or heartburn
• Stomach pains or other abnormal stomach symptoms. Medicines such as Ibuprofen 600 mg 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
• 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 IBUPROFEN 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 Ibuprofen 600mg Tablets contain:
• The active ingredient in each tablet is ibuprofen 600mg.
• The other ingredients are maize starch, cellulose microcrystalline, sodium starch glycolate (type A), povidone, alginic add, silica colloidal anhydrous, magnesium stearate, croscarmellose sodium, sodium lauryl sulphate.
• The tablet coating contains lactose monohydrate, hypromellose, titanium dioxide (E171), Macrogol 4000 and erythrosine lake (E127).
What Ibuprofen 600mg Tablets look like and contents of the pack:
They are pink, oval shaped, film-coated tablets with “M” and “A” either side of a break line on one side and “600” on the other.
They are available in plastic containers of 7, 12, 14, 16, 24,
28, 32, 48, 50, 56, 60, 72, 84, 96, 100, 250 and 500 tablets.
Marketing Authorisation Holder and Manufacturer:
M&A Pharmachem Ltd, Bolton, BL5 2AL, UK.
Date of last revision: May 2013
PP 2331