PACKAGE LEAFLET: INFORMATION FOR THE USER    D00474

Paracetamol 60mg Suppositories BP

Paracetamol

Read all of this leaflet carefully before you or your child starts taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, please ask your doctor, or pharmacist.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

3.How to use Paracetamol 60mg Suppositories BP

For rectal use only.

Always use Paracetamol 60mg Suppositories BP exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

In this leaflet:

1.    What Paracetamol 60mg Suppositories BP are and what they are used for

2.    Before you or your child use Paracetamol 60mg Suppositories BP

3.    How to use Paracetamol 60mg Suppositories BP

4.    Possible side effects

5.    How to store Paracetamol 60mg Suppositories BP

6.    Further information

1. What Paracetamol 60mg Suppositories BP are and what they are used for

Paracetamol belongs to a group of medicines called analgesics. An analgesic is a medicine that relieves pain.

Paracetamol 60mg Suppositories BP are used in the treatment of mild to moderate pain or fever for children aged 1 to 2 years.

2. Before you or your child use Paracetamol 60mg Suppositories BP

You should not use Paracetamol 60mg Suppositories BP 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 using this medicine.

Take special care with Paracetamol 60mg Suppositories BP if you or your child:

•    suffer from kidney problems

•    suffer from liver problems, including those caused by alcoholism

•    have an infection

If symptoms persist you should consult your doctor.

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:

•    warfarin, a medicine used to thin the blood. Regular use of paracetamol and warfarin together may increase the risk of bleeding; occasional use has no effect

•    metoclopramide (a medicine used to stop you feeling, or being, sick)

•    domperidone (a medicine used to stop you feeling, or being, sick)

•    cholestyramine (a medicine used to treat high cholesterol levels)

•    medicines used to treat epilepsy or fits, such as phenobarbitone

Do not use Paracetamol 60mg Suppositories BP with other medicines that contain paracetamol.

If you have any doubts as to whether Paracetamol 60mg Suppositories BP are suitable for you or your child please consult your doctor.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding you should ask your doctor for advice before taking Paracetamol 60mg Suppositories BP

Driving and using machines

There are no known effects of taking Paracetamol 60mg Suppositories BP on driving or using machines.

Continued overleaf

•    If you need to empty your bowels, this should be done before inserting the suppository

•    Wash your hands

•    Peel the wrapping apart and remove the suppository from its plastic wrapping by grasping the two halves of the wrapping at the tip of the suppository and pulling them gently apart.

•    Moisten the suppository tip before insertion

•    Push the suppository as high as possible into the rectum (back passage)

•    If you are unsure about how to use the suppositories, please consult your doctor or pharmacist

How much to use

ick    Peel back

5. How to Store Paracetamol 60mg Suppositories BP

Keep out of the reach and sight of children.

Do not store above 25° C. Keep the blister strip in the outer carton

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 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 60mg Suppositories BP contain

The active ingredient is paracetamol 60mg The other ingredients are hard fat and Polyoxyl 40 Ester

Children 1-2 years

The usual dose for children aged 1-2 years (body weight 8-11 kg) is 2 suppositories. The dose may be repeated every 4-6 hours up to a maximum of 4 doses in 24 hours. The dose will be based on age and weight, your doctor or pharmacist will advise you of this.

You must not exceed the stated dose.

If you use more Paracetamol 60mg Suppositories BP than you should

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

4.Possible Side Effects

Like all medicines Paracetamol 60mg Suppositories BP can cause side effects, although not everybody gets them.

Side effects that may occur include:

•    a rash or itching initially

•    soreness in or around the back passage

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.

What Paracetamol 60mg Suppositories BP look like and contents of the pack:

Paracetamol 60mg Suppositories BP are smooth, white suppositories supplied in a plastic cavity in strips of 6. Each pack contains 12 suppositories.

Marketing Authorisation Holder

Martindale Pharmaceuticals Ltd Bampton Road, Romford, RM3 8UG

Manufacturer:

Macarthys Laboratories Ltd T/A Martindale Pharmaceuticals Bampton Road, Romford, RM3 8UG Product Licence Number:

PL 00156/0099

This leaflet was last approved in: March 2009

MARTINDALE

Pharmaceuticals

Bampton Road, Harold Hill ^ Romford, RM3 8UG Ic United Kingdom 8

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