Galpharm Extra Power Pain Reliever Caplets

Document: leaflet MAH BRAND_PL 16028-0147 change

Galpharm Extra Power Pain Reliever Caplets

Paracetamol, Aspirin, Caffeine

Patient Information Leaflet

Read all of this leaflet carefully before you take this medicine because it contains important information you need to know.

This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice.

1.    What is this medicine and what is it used for?

This medicine contains:

   paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever

   aspirin which is a pain reliever (analgesic) and helps to reduce swelling

   caffeine which helps to increase the pain relief from paracetamol and makes you more alert.

These tablets are for the relief of mild to moderate pain including headache, migraine, toothache, nerve pain, sore throat and period pains. They are also for symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness, flu, feverishness and feverish colds.

2.    Is this medicine suitable for you?

Do not take this medicine if you:

•    are allergic to paracetamol, aspirin, caffeine or any of the other ingredients

•    have, or have ever had, a stomach ulcer

•    have haemophilia or any other blood clotting disorder

•    are pregnant or breast feeding

•    are under 16 years old

•    are taking medicines called anti-coagulants, to stop your blood from clotting.

Please see your doctor or pharmacist before taking this medicine if you:

•    suffer from kidney or liver problems, including alcoholic liver disease

•    have asthma

•    have an intolerance to some sugars.

If you are taking any of the following

medicines please see your doctor:

•    medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as colestyramine

•    medicines to control feeling sick or being sick such as metoclopramide or domperidone

•    medicines called anti-coagulants, which are used to thin the blood such as warfarin and other coumarins - you may take occasional doses of paracetamol but should consult your doctor if you need to take it on a regular basis

•    other anti-coagulant medicines such as heparin and phenindione

•    adsorbents, used as a stomach treatment, such as kaolin, or antacids, such as calcium carbonate

•    medicines used to control seizures in epilepsy such as phenytoin or sodium valproate

   methotrexate, used for cancer therapy or to t reat pso ri asis

•    mifepristone

•    spironolactone, used to treat heart disease and fluid retention

•    medicines to treat gout such as colchicine, allopurinol, probenecid and sulphinpyrazone.

Contains paracetamol and aspirin.

Do not take with any other paracetamol-containing products.

Please turn over W

2.    Is this medicine suitable for you? (continued)

Information about some of the ingredients in this medicine:

Contains sorbitol (E420). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.    How to take this medicine

Swallow the tablets whole with water. Do not chew.

Adults, the elderly and young persons over 16 years: 1 or 2 tablets every 4 hours as required. Do not take more than 6 tablets in any 24 hour period. Do not take more often than every 4 hours.

Do not give to children under 16 years.

There is a possible association between aspirin and Reye's Syndrome when given to children. Reye's Syndrome is a very rare disease, which can be fatal. For this reason aspirin should not be given to children aged under 16 years, unless on the advice of a doctor.

Do not exceed the stated dose.

If your symptoms persist or worsen, you must see a doctor or pharmacist.

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

4.    Possible side effects

Most people do not have any side effects while taking this medicine. However, if you experience any of the following side effects, or anything else unusual happens, stop taking the medicine immediately, and see your doctor or pharmacist.

Rare side effects are:

•    allergic type reactions such as skin rash, cough, wheezing and tightness of the chest

•    asthma or gout, brought on by aspirin

•    bleeding in the stomach or bowel lining, which can be seen as black, tarry stools when you go to the toilet or blood in vomit which may look like coffee grounds when you are being sick.

More rarely, the following side effects can happen:

•    you may take longer to stop bleeding after a cut or injury

•    you may become more prone to bleeding, bruising, fever and infections, such as sore throat and ulcers, due to changes in your blood.

5.    How to store your medicine

Keep all medicines out of the reach and sight of children.

Do not use this medicine after the expiry date printed on the pack.

6.    What is in this medicine?

Each tablet contains the active ingredients: paracetamol 200 mg, aspirin 300 mg and caffeine 45 mg. The other ingredients are: maize starch, methyl cellulose, microcrystalline cellulose, sorbitol (E420), sodium lauryl sulphate, hydrogenated cotton seed oil, methylhydroxy-propylcellulose and polyethylene glycol.

This product is available in a pack size of 16 tablets.

7. Who makes this medicine?

The Marketing Authorisation holder is Galpharm Healthcare Ltd., Dodworth, South Yorkshire S75 3SP The manufacturer is Wrafton Laboratories Ltd., Braunton, Devon, EX33 2DL, UK.

Text Revised: January 2009. PL 16028/0147