Patient Information Leaflet

Ibuprofen 400mg Tablets BP

Please read this leaflet carefully before you start to take Ibuprofen Tablets. If you have any questions or if you do not understand anything, please ask your doctor or pharmacist.

What does the active ingredient do?

Ibuprofen is one of a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDs. It relieves pain, reduces inflammation and lowers temperature when you are feverish.

What is it used for?

Ibuprofen Tablets are used to provide relief of headache, migraine, dental pain, backache, rheumatic and muscular pains, neuralgia, period pain, feverishness and the symptoms of cold and flu.

Do not take this medicine if:

•    You are allergic to ibuprofen, aspirin or any other painkillers or to any of the other ingredients contained in the tablets. An allergic reaction may be recognised as a rash, itching, swollen face or lips, or shortness of breath.

•    You are or have been suffering from a stomach or duodenal ulcer or other stomach disorders.

•    You are taking aspirin or any other non-steroidal anti-inflammatory drugs (NSAIDs).

Can you take Ibuprofen Tablets wth other medicines?

Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine), some medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-ll receptor antagonists such as losartan), and other medicines may affect or be affected by treatment with ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you take ibuprofen with other medicines.

See your doctor before you take Ibuprofen Tablets if:

•    You suffer from asthma or hives.

•    You have been prescribed drugs to thin the blood (anticoagulants), for high blood pressure or heart disease, lithium (used in the treatment of mania) or diuretics (water tablets).

•    You are taking corticosteroids (used to treat hormone problems, inflammation or allergic conditions), cyclosporin (used following organ transplants), mifepristone (used to induce abortion), or antibiotics called quinolones (such as ciprofloxacin).

•    You have liver, kidney or heart problems.

•    You are pregnant or breast-feeding.

•    You have a history of heart problems or high blood pressure.

•    If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

If you are elderly you may be more prone to side effects so you should take just enough to make you feel better.

The colouring includes sunset yellow (E110), which can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

This product also contains lactose and 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.

Medicines such as Ibuprofen 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.

How to take Ibuprofen Tablets:

They are suitable for adults, the elderly and children over 12 years old:

Dose for Ibuprofen Tablets BP 400mg:

•    Take one tablet with water to start with, with or after food, followed by one tablet every four hours if necessary.

•    Do not take more than three tablets in any twenty four hour period.

Do not continue to use for longer than three days without consulting your pharmacist or doctor. The side effects may be minimised by using the lowest effective dose for the shortest possible time.

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Do not give to children under 12 years old.

Consult your doctor immediately if you have taken too many tablets.

If you have missed a dose, do not double up on a dose to make up for the one you have missed.

Possible side effects:

In most cases, taking Ibuprofen Tablets does not cause any problems.

If you experience any of the following, stop taking the medicine immediately and tell your doctor: unexplained wheezing, shortness of breath, skin rash, itching, bruising or facial swelling.

Other side effects that could occur include:

*    Sickfeeling, nausea, digestive problems such as stomach pain, heartburn and peptic ulcer and occasionally stomach bleeding may occur (signs of this can be black tarry stools or vomiting).

*    Allergic reactions such as skin rashes, itching, runny nose difficulty breathing and, very rarely, skin peeling.

*    Rarely changes in the blood which may lead to bruising.

*    Blood in urine, kidney damage or kidney failure has been reported.

*    Swelling of the heart.

*    Rarely liver problems. Also headache, dizziness, vertigo, ringing in the ears, sensitivity to light, visual disturbances, 'pins and needles', depression, confusion, hallucinations, tiredness, drowsiness and vertigo.

*    A worsening of a previous asthmatic condition.

*    Medicines such as Ibuprofen Tablets may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

If you experience these or any other unusual side effects, stop taking this medicine and tell your doctor or pharmacist at once.

TELL YOUR PHARMACIST OR YOUR DOCTOR IF YOU ARE ALREADY TAKING OTHER MEDICINES

How to store Ibuprofen Tablets:

*    Store below 25°C.

*    Blister packaging: Store in the original package.

Securitainer/Pharmapac bottles: Keep the bottle tightly closed.

*    Do not use after the expiry date shown on the package.

Further information:

What does each tablet contain?

Each tablet contains the active ingredient Ibuprofen BP 400 mg.

The tablets also contain: lactose, sucrose, starch, methyl cellulose, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, talc, titanium dioxide (E171), erythrosine (E127), sunset yellow (E110) and sodium benzoate (E211).

What is in the pack?

This product contains pink round sugar coated tablets.

Ibuprofen Tablets BP400mg are available in blister packs of 6,12,24,48,84 and 96 tablets. The product is also available in pots of 12 or 250 tablets.

Who supplies Ibuprofen Tablets?

Product Licence Holder:

Intrapharm Laboratories Limited, Kidwells Park House, Kidwells Park Drive, Maidenhead, Berkshire, SL6 8AQ Manufacturer:

Norbrook Laboratories Limited, Newry, Co. Down, Northern Ireland.

KEEP OUT OF THE REACH OF CHILDREN

Leaflet prepared:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800198 5000 (UK Only).

Please be ready to give the following information:

Product name: Ibuprofen 400mg Tablets BP

Reference number: PL 17509/0058

This is a service provided by the Royal National Institute of the Blind.