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Paracetamol Capsules 500mg

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Document: leaflet MAH GENERIC_PL 12762-0434 change

PATIENT INFORMATION LEAFLET KEEP THIS LEAFLET AND READ IT BEFORE YOU TAKE YOUR MEDICINE Paracetamol Capsules 500mg

YOUR MEDICINE:

These capsules are called Paracetamol Capsules 500mg. Each capsule contains the active ingredient Paracetamol BP 500.00mg. Each capsule also contains Maize Starch, Lactose, Povidone, Sodium Starch Glycollate, Magnesium Stearate (E572), Titanium Dioxide (E171), Gelatin, Erythrosin (E127) and Indigotine (E132). The ink is composed of Shellac,

Propylene Glycol, Strong Ammonia Solution, Potassium Hydroxide, Black Iron Oxide, Dehydrated Alcohol, Isopropyl Alcohol and Butyl Alcohol.

The capsules are available in blister packs of 12, 16, 24, 32, 48 and 96 and in containers of 16, 20, 50, 100, 250, 500 and 1000 capsules.

WHO MAKES IT?

The product licence is held by the manufacturers,

Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK WHAT IS IT FOR?

Paracetamol Capsules 500mg are taken orally and used for the relief from the symptoms of headache, toothache, period pains, rheumatic pains, colds and influenza. They are also used to reduce fever.

WARNING:

Do not take these capsules if you are allergic to Paracetamol or to any of the above listed ingredients.

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

Tell your doctor or pharmacist before taking these capsules if:

1.    You are pregnant or breast-feeding.

2.    You suffer from liver or kidney disease.

3.    You drink a lot of alcohol regularly.

OTHER MEDICINES:

Advise your doctor of all other medicines you are taking for example barbiturates (used to treat sleeplessness and epilepsy), tricyclic anti-depressants (for example Amitriptyline and Impiramine - used to treat depression in adults and bed-wetting in children), anticoagulants

(for example, Warfarin - used to thin the blood), Cholestyramine (used to treat diarrhoea, to reduce cholesterol levels and to relieve itching), Metoclopramide and Domperidone (both used to treat nausea and vomiting). These and other medicines may interfere with the action of Paracetamol.

TAKING YOUR CAPSULES:

To be taken orally.

Adults: 1 to 2 capsules every four to six hours to a maximum of 8 capsules daily.

Children 6 - 12 years: 1 capsule. Repeat the dose every 4 to 6 hours when necessary. Not

more than 4 capsules a day.

These capsules are not suitable for children under 6 years.

Do not exceed the stated dose.

NOTE:

You should never take other Paracetamol containing products at the same time.

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.

Please inform your doctor if your symptoms persist.

SIDE EFFECTS:

With prolonged use or overdosage, liver disease, inflammation of the pancreas (marked by feeling sick, vomiting and stomach pain) and kidney problems such as blood in the urine, reduced production of urine or kidney failure may occur.

At normal doses, side effects of Paracetamol are rare. However blood disorders such as unexplained bruising or bleeding more easily than usual or increased susceptibility to infection may occur very rarely. Skin rashes and other allergic reactions such as itching and shortness of breath occur occasionally. If you notice these or any other side effects consult your doctor or pharmacist at once for advice.

STORING YOUR CAPSULES:

These capsules should be stored in a cool dry place and out of the reach and sight of children. Keep these capsules in the pack that they came in - do not transfer them to another container. Do not take these capsules after the expiry date shown on the label or carton.

Revised on: March 2014

This leaflet is a summary of information about your capsules. It does not contain all the information - if you have any questions, ask your doctor or pharmacist.