Aspar

IBUPROFEN 600 Label

200 x 45

Version 4

25.10.06

Illustrator 10

Each Tablet contains 600mg Ibuprofen

KEEP0UT0FTHE REACH AND SIGHT OF CHILDREN

IBUPROFEN

600mg TABLETS

IBL008

Read the enclosed leaflet before taking this medicine

For Oral use

To be taken as directed by your doctor

Do not store above 25°C and keep the container tightly closed.

Manufactured by the Product Licence Holder 08977/0010

Aspar Pharmaceuticals Ltd., 2930 Capitol Way, Colindale, London NW9 0EQ

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PATIENT INFORMATION LEAFLET FOR

IBUPROFEN 600mg TABLETS FILM COATED

Please read this leaflet carefully before you start 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 600mg Tablets. What is in your medicine?

This medicine is Ibuprofen and each tablet contains 600mg of Ibuprofen. It also contains the inactive ingredients

collodial anhydrous silica, povidone, croscarmellose sodium, potato starch microcrystalline cellulose, alginic acid, sodium lauryl sulphate, magnesium sterate, sodium starch glycollate, titanium dioxide (E171), carmine (E120), glycerol and methyl cellulose.

Ibuprofen 600mg are capsule shaped, pink tablets. They are supplied in blister packs of 84 and 100 and in plastic containers of 84 and 100.

What is this medicine for?

Ibuprofen is used for many conditions including the following:

Mild to moderate pain such as dysmenorrhoea, dental and postoperative 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 antiinflammatory 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

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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? ■ If you have or have ever had stomach ulcers, or have 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 breastfeeding, 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 a history of gastrointestinal bleeding, 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. patch varnish

The usual dose of Ibuprofen 600mg    ^

for adults is 1 tablet two or three times

daily, but your doctor may have told

you to take as many as 4 tablets daily;

do not take more than 4 in 24 hours;

the dose for children varies with age

and weight, and this particular size

tablet is rarely used for them.

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. If these tablets make you feel drowsy do not drive or operate machinery

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. ■ Tinnitus (ringing in the ears), vertigo, dizziness, blurred or disturbed vision,or seeing/hearing strange things.

■ Oedema, depression, drowsiness, sleeplessness.

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.

Keep container tightly closed to protect from moisture.

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

Date of preparation October 2006

adhesive deadener