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Patient Information Leaflet for

PARACETAMOL CAPLETS 500 mg

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 Paracetamol Caplets 500 mg.

1. What THESE CAPLETS DO

These caplets contain paracetamol and are used to treat mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pain, flu, fever, aches and pains including muscles pains, back ache and rheumatic aches and pains.

2. Check BEFORE YOU TAKE

Do not take these caplets if you:

■    Are allergic to Paracetamol or any of the other ingredients listed in section 6 (see section 4 - possible side effects)

■    If you are taking other medicines containing paracetamol Take special care and tell your doctor if you:

■    Suffer from liver or kidney problems

■    Have heart disease

■    Suffer from G6PD deficiency Suffer from alcohol dependency

Suffer from mild arthritis and need to take painkillers every day

■    Are pregnant or breast feeding

Tell you doctor or pharmacist if you are already taking any of the following medicines:

■    Blood thinning medicines such as Warfarin

■    Metoclopramide and Domperidone (for sickness and digestive disorders)

■    Colestyramine (to help control cholesterol levels)

■    Any drugs that affect the liver

■    Any other anti-inflammatory drugs e.g. aspirin

Dosage in adults and children over 12 years:

Take 2 caplets every 4 hours as needed. Do not take more than 8 caplets in any 24 hours. Swallow the caplets with a glass of water.

Dosage in children aged 6 to 12 years:

Take half to 1 caplet every 4 hours as needed but do not give more than 4 doses in 24 hours. Do not give the caplets to children aged under 6 years unless told to by your doctor.

Do not give for more than 3 days at a time unless your doctor tells you to.

When taking this medicine, it is important to remember the following:

Wait at least 4 hours between doses

■    Do not exceed the stated dose

■    Do not drink alcohol or take other Paracetamol containing products whilst taking this medicine

■    If your symptoms continue or your headache becomes persistent, see your doctor.

If you take more Paracetamol caplets than you should:

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.

If you forget to take Paracetamol caplets:

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Paracetamol can cause side effects but not everybody gets them.

If you experience any of the symptoms below after taking this medicine go to the nearest hospital IMMEDIATELY.

Serious side effects

■    Skin rashes and itching

■    Difficulty breathing Swollen face

■    Unusual bruising or bleeding, throat and mouth ulcers or bleeding gums accompanied by tiredness and flu like symptoms

Other side effects

■    Blood problems including anaemia Pain in the lower back and groin

■    Changes in your urine Pancreatitis

■    Hepatitis

Very rare cases of serious skin reactions have been reported. If you experience any of these or any other side effects and they become serious, contact your doctor or pharmacist. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard or fill in a paper form available from your local pharmacy.

5. Storing your medicine

Keep your medicine in a safe place where children cannot see or reach it.

Do not store above 25°C. Store in the original packaging to protect from light and moisture. Do not use this medicine after the expiry date printed on the packaging.

*    6. More about your medicine

The active ingredient in these caplets is paracetamol 500 mg. They are white and capsule shaped with a break line marked ap/500. The inactive ingredients are Potato Starch, Pregelatinised Starch, Magnesium Stearate, Povidone, Stearic Acid and Talc.

Marketing Authorisation Holder and Manufacturer:

Aspar pharmaceuticals Ltd., Capitol Way, London NW9 0EQ

PL 08977/0014

Available in packs of 8, 12, 16, 24, 32, 48, 50, 96, 100 caplets.

Text Revised: June 2014