Ibuprofen 400mg Tablets
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Ibuprofen 400 mg Tablets BP
Please read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or pharmacist.
The name of this medicine is Ibuprofen 400 mg Tablets BP.
Each coated tablet contains Ibuprofen 400 mg as the active substance.
Other ingredients are Lactose monohydrate. Potato Starch, Hypromellose, Sodium Starch Glycolate Type A, Colloidal Anhydrous Silica, Magnesium Stearate, Sucrose, Talc. Titanium Dioxide (E171). Maize Starch and Pregelatinised Starch.
The Marketing Authorisation Holder is:
Aurobindo Pharma Limited.
Ares, Odyssey Business Park,
West end road, South Ruislip HA4 6QD,
United Kingdom.
Manufacturer:
Aurex Generics Limited,
Ares. Odyssey Business Park,
West End Road, South Ruislip HA4 6QD,
United Kingdom.
1) What are Ibuprofen 400 mg Tablets and what are they used for?
The tablets are white and sugar coated. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAJDs). It relieves pain, reduces inflammation and lowers temperature when you have a fever.
The tablets are available in packs containing 6, 12, 24, 25, 48, 84, 96 or 250 tablets (not all packs marketed). The larger packs are for use by your pharmacist to provide you with the required number of tablets when they have been prescribed by your doctor. Ibuprofen tablets are used for the relief of rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain and period pains. They are also for the relief of feverishness, colds and influenza.
2) Before you use Ibuprofen 400 mg Tablets Do not take Ibuprofen 400 mg Tablets if
You have or ever had stomach ulcers, perforation or bleeding.
You are allergic to ibuprofen, aspirin or any other painkillers, or to any of the other ingredients contained in these tablets. (An allergic reaction may be recognized as shortness of breath, blocked nose, rash, itching or swollen face or lips). If you are taking other NSAID painkillers, or aspirin at doses of above 75 mg daily. If you are on low dose aspirin (upto 75 mg daily) speak to your doctor or pharmacist before you take Ibuprofen Tablets.
You are in the last three months of pregnancy.
Take special care with Ibuprofen 400 mg Tablets if:
You suffer from asthma, heart, liver, kidney or bowel problems
You are pregnant or breast feeding
You are taking drugs to thin the blood (anticoagulants); drugs which increase the volume of urine (diuretics); drugs for high blood pressure or heart disease; the drugs lithium, methotrexate or zidovudine.
You have been told that you have an intolerance to some sugars, check with your doctor before taking this medicine.
Please speak to your doctor or pharmacist before taking these tablets if any of the above statements applies to you.
Ibuprofen belongs to a group of medicines which may impair fertility in woman. This is reversible on stopping the medicine. It is unlikely that ibuprofen used occasionally will affect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant.
3) How to use Ibuprofen 400 mg Tablets?
The tablets should be swallowed with a drink of water, preferably with or after food. Adults, the elderly and the children over 12 years: take 400 mg (one tablet) up to 3 times a day, or as instructed by your doctor. Leave at least 4 hours between doses and do not take more than 1200 mg (3 tablets) in any 24 hour period.
Ibuprofen tablets are intended for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. You should not take Ibuprofen tablets for longer than 10 days unless your doctor tells you to.
If symptoms persist or worsen consult your doctor. who may instruct you to continue taking this medicine.
Do not give to children under 12 years of age.
If these tablets were prescribed by your doctor the dose may be slightly different to the usual dose given above; always follow your doctors instructions for taking medicines.
Do not exceed the stated dose.
Side effects may be minimized by using the lowest effective dose for the shortest possible duration.
If you take more tablets than you should:
Speak to your doctor or pharmacist straightaway.
If you forget to take a dose of Ibuprofen tablets:
Do not take a double dose to make up for the missed dose.
4) Possible side effects
Like all medicines, Ibuprofen 400 mg Tablets may sometimes cause side effects, and those which may occur include:
• Stomach pain, nausea, indigestion or heart burn.
• Occasionally, stomach ulcer and stomach bleeding.
• Allergic reactions such as skin rashes, itching, red or swollen skin, difficulty breathing and very rarely skin peeling.
• Rarely, changes in blood which can lead to bruising.
• Blood in urine, kidney damage or kidney failure.
• Rarely, liver problems; also headache, dizziness and ringing in the ears.
If you do notice any side effects, including any not mentioned in this leaflet, please inform your doctor or pharmacist.
If you suffer from any of the following at any time during your treatment. STOP TAKING THE MEDICINE and seek immediate medical help:
• Pass blood in your faeces (stools / motions).
• Pass black tarry stools.
• Vomit any blood or dark particles that look like coffee grounds.
STOP TAKING the medicine and tell your doctor if you experience
Indigestion or heart bum
Abdominal pain (pain in your stomach) or other abnormal stomach symptoms.
5) Storing Ibuprofen 400 mg Tablets
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package. Keep the container (bottle) tightly closed to protect from moisture.
Do not use the tablets after the expiry date shown on the label or carton.
This leaflet was approved in_
6) Further information
For any information about this medicinal product, please contact:
AURQB1NDO
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