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POM 08977 / 0008

PATIENT INFORMATION LEAFLET FOR

IBUPROFEN TABLETS 200mg SUGAR COATED

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 Tablets 200mg.

What is in your medicine?

This medicine is Ibuprofen and each tablet contains 200mg of Ibuprofen. It also contains the inactive ingredients colloidal anhydrous silica, potato starch, povidone, croscarmellose sodium, microcrystalline cellulose, alginic acid, magnesium stearate, sodium lauryl sulphate, opaseal, sucrose, titanium dioxide (E171), erythrosine lake (E127), sodium benzoate, sodium starch glycollate and talc.

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 one of a group of substances known as 'non-steroidal anti-inflammatory drugs' (NSAID's).

Who makes this medicine?

The Marketing Authorisation Holder and manufacturer is:

Aspar Pharmaceuticals Ltd,

29-30 Capitol Way,

London NW9 0EQ.

P.L number 8977/0008 Pack Size

Ibuprofen 200mg 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 have or have ever had, peptic ulceration (ulcer in your stomach or duodenum) or bleeding in your digestive tract?

If you answer 'yes' to any of the following questions, or you are not sure, tell your doctor or pharmacist:

•    Have you ever experienced trouble after taking aspirin?

•    Do you have kidney, liver or heart problems?

•    Are you taking aspirin, other medicines for rheumatism, 'water tablets' or tablets to 'thin the blood', tablets for diabetes or quinolone antibiotics?

•    Are you pregnant or breast-feeding, or could you be?

•    Have you had asthma, or do you think you might be allergic to ibuprofen or to any other NSAID?

•    Are you taking any other medicines?

Ibuprofen may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Taking your medicine

Ibuprofen tablets should be taken with meals and swallowed with a drink of water.

The usual dose of Ibuprofen 200mg for adults is 1 or 2 tablet three times daily, but your doctor may have told you to take as many as 9 tablets daily; do not take more than 12 tablets in 24 hours; the dose for children varies with age and weight.

If you take an overdose, seek medical advice at once.

If you miss a dose, take your next dose at the usual time; do not take double the dose to 'make up'.

WARNING - DO NOT EXCEED THE MAXIMUM DOSE


If your symptoms persist for more than 3 days, consult your doctor or pharmacist.

Possible side-effects

If you experience any of the following, stop taking the medicine immediately and tell your doctor.

•    Nausea, indigestion or heartburn.

•    Headaches, abdominal pain (pains in your stomach) or other abnormal stomach symptoms, insomnia or drowsiness.

•    Unexplained wheezing, shortness of breath, skin rash, itching, bruising, facial swelling 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.

•    Rarely liver problems. Also headache, dizziness and ringing in the ears.

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.

Side effects will be minimised by taking the smallest possible dosage.

Storing the tablets

Do not store above 25°C. The tablets should be stored in the original packaging to protect them from moisture.

Do not allow children to see or reach them.

Do not use after the expiry date shown on the label.

Leaflet last revised: November 2004


Patient Intormation Leatlet for    | p | ^ASPA^^

Ibuprofen 200mg Tablets.

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 200mg 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 and talc.

The pink film coated tablets also contain hypromellose (E464), Glycerol, Carmine (E120) and titanium dioxide (E171).

The pink sugar coated tablets also contain erythrosine aluminium lake (E127), sodium benzoate, sucrose, opaseal and titanium dioxide (E171).

What is your 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 sizes

The tablets are available in blister packs of 24, 48 and 96 tablets.

Before Taking this 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 this 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 or 2 tablets 2 to 3 times daily. The dose should not be repeated more frequently than every 4 hours, and not more than 6 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, fltulence, 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 April 2005 m IBU-Combined FC/SC. P.

GSL vASPA]j

Patient Information Leaflet for


Ibuprofen 200mg Tablets.

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 200mg Tablets.

What is in your medicine?

The active ingredient in Ibuprofen tablets is ibuprofen. They may be either oblong and white in colour or round and pink.

The inactive ingredients are colloidal anhydrous silica, starch, povidone, croscarmellose sodium, microcrystalline cellulose, alginic acid, magnesium stearate, sodium lauryl sulphate,sodium starch glycollate and talc.

The pink film coated tablets also contain hypromellose (E464), Glycerol, Carmine (E120) and titanium dioxide (E171).

The pink sugar coated tablets also contain erythrosine aluminium lake (E127), sodium benzoate, sucrose, opaseal and titanium dioxide (E171).

What is your medicine for?

It is used to provide effective relief of mild to moderate pain including rheumatic and muscular pain, 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 sizes

The oblong white tablets are available in blister packs of 16. The round pink tablets are available in securitainers of 16’s and in blister packs of 12 and 16 tablets.

Before Taking this 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 this 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 or 2 tablets 2 to 3 times daily. The dose should not be repeated more frequently than every 4 hours, and not more than 6 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.

GSL


Date of preparation April 2005

IBU-Combined FC/SC&Cap GSL.