Ibucalm 400mg Tablets
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PATIENT INFORMATION LEAFLET FOR
IBUPROFEN TABLETS 400mg
Please read this leaflet carefully before taking your medicine. It does not contain all the information about your medicine that you may need to know, so please ask your doctor or pharmacist if you have any questions. This leaflet only applies to Ibuprofen 400mg Tablets.
What is in your medicine?
The active ingredient in Ibuprofen tablets is Ibuprofen. They are round and pink in colour.
The inactive ingredients are colloidal anhydrous silica, starch, povidone, croscarmellose sodium, microcrystalline cellulose, alginic acid, magnesium stearate, sodium lauryl sulphate,sodium starch glycollate, talc, hypromellose (E464), Glycerol, Carmine (E120) and titanium dioxide (E171).
What is this medicine for?
It is used to provide effective relief of mild to moderate pain including rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, period pains and feverishness. For relief from the symptoms of cold and flu.
Ibuprofen is a 'non-steroidial anti-inflammatory drug' (NSAID). It relieves mild to moderate pain, reduces inflammation and lowers temperature when you have a fever.
Who makes this medicine?
The Product Licence holder and manufacturer responsible for release is: Aspar Pharmaceuticals Ltd.,
29-30 Capitol Way,
Colindale,
London NW9 0EQ
Pack Size
The tablets are available in blister packs of 24, 48 and 96 tablets.
Before you take your medicine
Do not take if you are taking aspirin at doses of above 75mg daily. If you are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take Ibuprofen.
If you answer 'yes' to any of the following questions, or if you are not sure, tell your doctor or pharmacist:
• Are you allergic to any of the ingredients in the tablets as listed above?
• Have you ever had stomach ulcers, or have you ever had trouble after taking aspirin?
• Do you suffer from high blood pressure?
• Do you have kidney, liver or heart problems?
• Are you pregnant or breast-feeding, or could you be?
• Do you have asthma, or other breathing difficulties or have previously suffered from rhinitis or urticaria?
• Do you suffer from ulcerative colitis, Crohns disease or SLE (increased risk of aseptic meningitis)?
• Are you taking any of the following medicines?
- diuretics (such as furosemide and triamterene) or beta blockers (such as atenolol and propranolol) for high blood pressure.
- Warfarin to prevent blood clotting.
- Anti-biotics called quinolones (such as ciprofloxacin).
- lithium,corticosteroids, methotrexate or cyclosporin.
- Zidovudine (for alleviating aids symptoms)
- Any other inflammatory pain killers.
• Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect 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
Taking your medicine
Adults, the elderly and children over 12 years: This product is 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 for longer than 10 days. If symptoms persist or worsen consult your doctor, who may instruct you to continue taking the medicine.
Unless otherwise directed by a doctor, adults. the elderly and children over 12 years should take 1 tablet up to 3 times daily. The dose should not be repeated more frequently than every 8 hours, and not more than 3 tablets should be taken in any 24 hours.
Do not give to children under 12 years old except on the advice of a doctor.
Ibuprofen tablets should be taken with meals and swallowed with a drink of water.
If you miss a dose, do not take a double dose to 'make up'.
If symptoms persist or worsen consult your doctor.
WARNING - DO NOT EXCEED THE MAXIMUM DOSE
You should seek medical attention immediately if you accidentally take too many tablets.
Possible side-effects
Side effects may be minimised by taking the smallest possible dosage.
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
If you experience any of the following, stop taking the medicine immediately and tell your doctor.
• Stomach pain, indigestion, nausea or heartburn and occasionally peptic ulcer and bleeding in the stomach.
• Unexplained wheezing, shortness of breath, skin rash, hives, itching, bruising, facial swelling and very rarely skin peeling.
• Rarely changes in the blood which may lead to unexpected bruising.
• Blood in urine, kidney damage or kidney failure has been reported.
• High or low blood pressure or fluid retention e.g. swollen ankles.
• Yellowing of the eyes and/or skin.
• Severe sore throat with a high fever.
• Diarrhoea, flatulence, constipation and headache.
• Blurred or disturbed vision, or seeing / hearing strange things.
If you experience any other unusual symptoms whilst taking your tablets, tell your doctor or pharmacist.
Storing the tablets
Keep your medicine in a safe place where children cannot see or reach it.
Do not store above 25°C. The tablets should be stored in the original packaging to protect them from moisture.
Do not use after the 'expiry' date shown on the carton / label.
Date of preparation August 2005
IBU 400.P.FC
PATIENT INFORMATION LEAFLET FOR
IBUPROFEN TABLETS 400mg
Please read this leaflet carefully before taking your medicine. It does not contain all the information about your medicine that you may need to know, so please ask your doctor or pharmacist if you have any questions. This leaflet only applies to Ibuprofen 400mg Tablets.
What is in your medicine?
The active ingredient in Ibuprofen tablets is Ibuprofen. They are round and pink in colour.
The inactive ingredients are colloidal anhydrous silica, starch, povidone, croscarmellose sodium, microcrystalline cellulose, alginic acid, magnesium stearate, sodium lauryl sulphate,sodium starch glycollate, talc, hypromellose (E464), Glycerol, Carmine (E120) and titanium dioxide (E171).
What is this medicine for?
Ibuprofen is used for many conditions including the following:
Mild to moderate pain such as dysmenorrhoea, dental and post-operative pain and for the symptomatic relief of headache, including migraine headache.
Rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease)
Ankylosing spondylitis Osteoarthritis
Sero-negative arthropathies
Pain relief of peri-articular disorders such as frozen shoulder (capsulitis), bursitis, tendinitis, tenosynovitis, low-back pain, and soft tissue injuries such as sprains and strains.
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID). It relives mild to moderate pain, reduces inflammation and lowers temperature when you have a fever.
Who makes this medicine?
The Product Licence holder and manufacturer responsible for release is: Aspar Pharmaceuticals Ltd.,
29-30 Capitol Way,
Colindale,
London NW9 0EQ
Pack Size
Ibuprofen 400mg is packed in dispensing containers and your pharmacist will have counted out the number prescribed by your doctor.
Before you take your medicine
Do not take if you are taking aspirin at doses of above 75mg daily. If you are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take Ibuprofen.
If you answer 'yes' to any of the following questions, or if you are not sure, tell your doctor or pharmacist:
• Are you allergic to any of the ingredients in the tablets as listed above?
• Have you ever had stomach ulcers, or have you ever had trouble after taking aspirin?
• Do you suffer from high blood pressure?
• Do you have kidney, liver or heart problems?
• Are you pregnant or breast-feeding, or could you be?
• Do you have asthma, or other breathing difficulties or have previously suffered from rhinitis or urticaria?
• Do you suffer from ulcerative colitis, Crohns disease or SLE (increased risk of aseptic meningitis)?
• Are you taking any of the following medicines?
- diuretics (such as furosemide and triamterene) or beta blockers (such as atenolol and propranolol) for high blood pressure.
- Warfarin to prevent blood clotting.
- Anti-biotics called quinolones (such as ciprofloxacin).
- lithium,corticosteroids, methotrexate or cyclosporin.
- Zidovudine (for alleviating aids symptoms)
- Any other inflammatory pain killers.
• Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect 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
Taking your medicine
Ibuprofen should be taken with meals and swallowed with a drink of water.
The usual dose of Ibuprofen 400mg for adults is 1 tablet three or four times daily, but your doctor may have told you to take 5 or 6 tablets daily; do not take more than 6 tablets in 24 hours; the dose for children varies with age and weight.
If you miss a dose, do not take a double dose to 'make up'.
If symptoms persist or worsen consult your doctor.
WARNING - DO NOT EXCEED THE STATED DOSE
You should seek medical attention immediately if you accidentally take too many tablets.
Possible side-effects
Side effects may be minimised by taking the smallest possible dosage.
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
If you experience any of the following, stop taking the medicine immediately and tell your doctor.
• Stomach pain, indigestion, nausea or heartburn and occasionally peptic ulcer and bleeding in the stomach.
• Unexplained wheezing, shortness of breath, skin rash, hives, itching, bruising, facial swelling and very rarely skin peeling.
• Rarely changes in the blood which may lead to unexpected bruising.
• Blood in urine, kidney damage or kidney failure has been reported.
• High or low blood pressure or fluid retention e.g. swollen ankles.
• Yellowing of the eyes and/or skin.
• Severe sore throat with a high fever.
• Diarrhoea, flatulence, constipation and headache.
• Blurred or disturbed vision, or seeing / hearing strange things.
If you experience any other unusual symptoms whilst taking your tablets, tell your doctor or pharmacist.
Storing the tablets
Keep your medicine in a safe place where children cannot see or reach it.
Do not store above 25°C. The tablets should be stored in the original packaging to protect them from moisture.
Do not use after the 'expiry' date shown on the carton / label.
Date of preparation August 2005
IBU 400.POM.FC
D: PIL / 08977/0017 (Ibu 400mg FC POM)