Ibuprofen 400mg Tablets Bp
THIS LEAFLET PROVIDES A SUMMARY OF THE INFORMATION AVAILABLE ON YOUR MEDICINE; PLEASE READ IT CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE. IF YOU HAVE ANY QUESTIONS OR ARE NOT SURE OF ANYTHING ASK YOUR DOCTOR OR PHARMACIST.
WHAT IS IN THIS MEDICINE?
Ibuprofen tablets 200 mg: Pink, circular, sugar coated tablets. Each tablet contains 200 mg of ibuprofen.
Ibuprofen tablets 400 mg: Pink, circular, sugar coated tablets. Each tablet contains 400 mg of ibuprofen.
The tablets also contain the inactive ingredients lactose monohydrate, maize starch, methylcellulose, sodium starch glycollate, magnesium stearate, colloidal anhydrous silica, talc, calcium carbonate, acacia, sucrose, titanium dioxide (E171), Opalux AS 1305 and Opalux 6000P.
Unsuitable for people with a lactase insufficiency, galactosaemia or glucose/galactose malabsorption syndrome.
Lactose content per tablet: 200 mg tablet - 96.5mg, Sucrose content - 239 mg Lactose content per tablet: 400 mg tablet - 110mg, Sucrose content - 240 mg
Pack sizes: 84, 100, 250 and 500 tablets
WHAT IS IBUPROFEN?
Ibuprofen is one of a group of medicines called non-steroidal anti-inflammatory drugs. It causes a reduction in the levels of prostaglandins, substances believed to be responsible for causing pain and inflammation. Ibuprofen also reduces fever.
MA holder: Medley Pharma Limited, Unit 2A, Olympic Way, Sefton Business Business Park, Liverpool L30 1RD.
Distributed by: Zanza Laboratories Ltd, Liverpool, UK.
WHAT IS THIS MEDICINE FOR?
Ibuprofen is used for the relief of mild to moderate pain and inflammation in a number of conditions affecting the joints and muscles.
WHAT DO YOU NEED TO KNOW BEFORE TAKING THIS MEDICINE?
If the answer to any of the following questions is YES, DO NOT take this medicine without consulting your doctor.
• Have you had an allergic reaction (wheezing, skin rash, itchy or runny nose) after taking ibuprofen, aspirin or any
other medicines used to treat painful conditions?
• Are you allergic to any of the other ingredients? (See 'WHAT IS IN THIS MEDICINE?' above.)
• Have you been told by your doctor that you have an intolerance to some sugars?
• Are you pregnant, planning to become pregnant or breast feeding?
• Do you have or have you ever had a stomach or duodenal ulcer, or long term indigestion?
If the answer to any of the following questions is YES, tell your doctor or pharmacist.
• Have you ever had stomach pains, felt like being sick or heartburn after taking aspirin or any other medicines used to
treat painful conditions?
• Do you have asthma or other allergic condition?
• Do you have liver, kidney or heart trouble?
• Do you have high blood pressure?
ARE YOU TAKING ANY OTHER MEDICINES?
You should consult your doctor BEFORE taking any other medicine including:
• Diuretics (water tablets) and other drugs used to treat high blood pressure (e.g. frusemide and indapamide).
• Medicines used for heart trouble (e.g. digoxin).
• Ibuprofen may enhance the effect of lithium, a treatment for depression.
• Methotrexate, a drug used in cancer therapy.
• Cyclosporin, a drug used following organ transplants.
• Mifepristone, a drug used for terminating pregnancy.
• Other non-steroidal anti-inflammatory drugs (e.g. piroxicam).
• Corticosteroids, which are used to treat allergic and inflammatory diseases and immune reactions (e.g. prednisolone).
• Medicines used to thin the blood (anticoagulants, e.g. warfarin).
• Quinolone antibiotics, which are used to treat bacterial infections (e.g. ciprofloxacin).
HOW MUCH OF THIS MEDICINE SHOULD YOU TAKE
You should take your medicine as directed by your doctor. The pharmacist’s label should tell you how much to take and how often. If it does not or you are not sure ask your doctor or pharmacist.
Adults
The usual dose is 200 - 400 mg 3 or 4 times daily.
Do not exceed 12 of the 200 mg tablets or 6 of the 400 mg tablets in a 24 hour period.
Children
If this medicine is prescribed for a child make sure that the tablets are taken as stated on the pharmacist’s label. The dosage for children is worked out on the basis of the child’s weight in kilograms. The usual dose is
20 mg per kg body weight daily. For children weighing under 30 kg do not exceed 500 mg in a 24 hour period.
• If you are elderly you may be more sensitive to the effects of ibuprofen tablets.
• Swallow the tablets with a drink of water or milk. It is best to take ibuprofen tablets after food.
WHAT IF YOU HAVE TAKEN TOO MANY TABLETS?
If you or anyone else has swallowed a lot of the tablets all together contact your nearest hospital casualty department or doctor immediately.
If you forget to take a dose, take it as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Then go on as before.
WHAT UNWANTED EFFECTS CAN THIS MEDICINE HAVE?
This medicine, like most other medicines may cause side effects in some people.
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.
You should tell your doctor as soon as possible if you notice any of the following side effects after taking this medicine.
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• Yellowing of your skin or the whites of your eyes |
• Vomiting blood or passing black coloured motions |
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• Heartburn or stomach pain for the first time or worse than normal |
• Difficulty in passing urine |
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• Eye pain or blurred vision |
• Hallucinations |
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• Sore mouth |
• Swollen ankles |
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• Your skin may become more sensitive to light |
• Anaemia |
The following side effects are often mild and may wear off after a few days treatment. If they are severe or last more than a few days, tell your doctor.
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• Stomach discomfort |
• Headaches |
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• Nausea |
• A ringing in the ears (tinnitus) |
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• Vomiting |
• Feeling unwell |
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• Diarrhoea |
• Drowsiness or tiredness |
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• Indigestion |
• Pins and needles |
Other rare side effects include confusion, depression, dizziness, and vertigo (spinning sensation).
Ibuprofen can reduce the number of certain types of blood cells. If you have any blood tests carried out, remember to tell the doctor that you are taking ibuprofen.
If you experience any of the above or are concerned about anything or you notice anything unusual contact your doctor.
HOW SHOULD YOU STORE THIS MEDICINE?
This medicine should not be used after the expiry date stated on the pack.
Store this medicine below 25°C in a dry place and protect from light.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
REMEMBER: This medicine has been prescribed for you. Do not give it to anybody else even if their symptoms appear to be the same as yours, since it may be harmful to them.
Marketing authorisation numbers:
Ibuprofen Tablets 200 mg: PL 43870/0021 Ibuprofen Tablets 400 mg: PL 43870/0022
Medley Pharma Ltd, Unit 2A, Olympic Way, Date leaflet last revised: October 2014
Sefton Business Park, Liverpool L30 1RD, UK