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PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol 500mg Suppositories

In this leaflet:

1.    What Paracetamol Suppositories are and what they are used for

2.    Before you use Paracetamol Suppositories

3.    How to use Paracetamol Suppositories

4.    Possible side effects

5.    How to store Paracetamol Suppositories

6.    Further information

1.    What Paracetamol Suppositories are and what they are used for

The active ingredient Paracetamol is a medicine with pain relieving properties.

Paracetamol Suppositories are used:

•    for the relief of mild to moderate pain

•    for the relief of a high temperature (fever)

•    if you are unable to take paracetamol orally e.g. after an operation or if you are feeling or being sick.

2.    Before you use Paracetamol Suppositories

You or your child should not take Paracetamol Suppositories if:

•    you or your child are allergic (hypersensitive) to paracetamol or to any of the ingredients listed in section 6 of this leaflet

If this applies to you or your child please tell your doctor before taking this medicine.

Take special care with Paracetamol Suppositories if:

•    you or your child suffer from severe liver or kidney problems

•    you or your child suffer from alcoholism

If your's or your child's symptoms persist you should consult your doctor.

Do not use Paracetamol Suppositories with other medicines that contain paracetamol.

Do not exceed the recommended dose.

Taking other medicines

Please tell your doctor, nurse or pharmacist if you or your child are taking, or have recently taken, any other medicine including medicines obtained without prescription.

Please tell your doctor if you or your child are taking any of the following medicines:

•    medicines used to thin your blood (anticoagulants) e.g. warfarin

•    medicines used to stop you feeling or being sick such as metoclopramide and domperidone

•    colestyramine, a medicine used to prevent coronary heart disease and diarrhoea caused by certain disorders

If you have any doubts as to whether Paracetamol Suppositories are suitable for you or your child please consult your doctor.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding you should ask your doctor for advice before taking Paracetamol Suppositories.

Driving and using machines

There are no known side effects of taking Paracetamol Suppositories on driving or using machines.

continued overleaf

3. How to use Paracetamol Suppositories

Always use Paracetamol Suppositories exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

1. If your child needs to empty their bowels this should be done before inserting the suppository.2. Wash hands before opening individual packaging. If the suppository is too soft, it may be chilled in the refrigerator or under cold running water before unwrapping

3. To remove a suppository, tear one from the strip along the perforations then peel it from the plastic wrapping by grasping the two halves of the wrapping at the tip of the suppository and pulling them gently apart. The tip should be moistened with a little cold water to aid insertion

4.    Using your index finger or middle finger, whichever you find easier, gently push the suppository into the rectum (back passage), making sure the rounded end of the suppository is inserted first.

5.    The suppository should be inserted as far as possible, pushing the end of the suppository sideways to ensure contact with the wall of the bowel.

How much to use

The usual dose for adults, elderly and children 12-18 years is 1 or 2 suppositories every 4 to 6 hours to a maximum of 4 doses in 24 hours.

The dose should be based on age and weight i.e. 12 years (39kg) - (500mg) 1 suppository, adults and the elderly (1g) 2 suppositories.

You must not exceed the stated dose.

If you use more Paracetamol Suppositories than you should

Immediate medical advice should be sought in the event of an overdose, even if you or the child seems well, because of the risk of delayed, serious liver damage.

If these suppositories are swallowed contact your doctor or nearest casualty unit immediately taking the carton, any leftover suppositories and this leaflet with you.

4.    Possible Side Effects

Like all medicines Paracetamol Suppositories can cause side effects, although not everybody gets them.

Side effects that may occur include:

• a skin rash

If any of these side effects gets serious, or you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    How to Store Paracetamol Suppositories

Keep out of the reach and sight of children.

Do not use Paracetamol Suppositories after the expiry date on the carton label. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not use if the strip containing the suppositories is damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further Information

What Paracetamol Suppositories contain

The active ingredient is paracetamol 500mg. The other ingredients are hard fat and Macrogol Ester

What Paracetamol Suppositories look like and contents of the pack:

White, tapered, cylindrical suppository, approximately 30mm in length with 10mm diameter supplied in a plastic cavity of 5 strips. Each pack contains 10 suppositories.

This product is made by Ricesteele Manufacturing Limited, Cookstown Industrial Estate, Tallaght, Dublin 24, Ireland and procured from the EU by the product licence holder:

Millsdale Pharmaceuticals, Warrington, Cheshire. WA2 7UB.

PL 08811/0028

This leaflet was prepared 03/08/2010.