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Paracetamol 500mg Suppositories

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Document: leaflet MAH BRAND_PLPI 21828-0318 change

Paracetamol 500mg Suppositories


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, nurse or pharmacist.

■    This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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



PACKAGE LEAFLET: INFORMATION FOR THE USER

In this leaflet:

1.    What Paracetamol 500mg Suppositories are and what they are used for

2.    Before you use Paracetamol 500mg Suppositories

3.    How to use Paracetamol 500mg Suppositories

4.    Possible side effects

5.    How to store Paracetamol 500mg Suppositories

6.    Further information

1. What Paracetamol 500mg Suppositories are and what they are used for

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

Paracetamol 500mg 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 500mg Suppositories

You or your child should not take Paracetamol 500mg 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 500mg 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 500mg 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 500mg 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 500mg Suppositories.

Driving and using machines

There are no known side effects of taking Paracetamol 500mg Suppositories on driving or using machines.

3. How to use Paracetamol 500mg Suppositories

Always use Paracetamol 500mg 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

Adults, the elderly and children 12-18 years

The usual dosage for adults, elderly and children 12-18 years is 1 or 2 suppositories every 4-6 hours up 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 500mg 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 500mg Suppositories can cause side effects, although not everybody gets them.

Side effects that may occur include:

■ a skin rash

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.    How to store Paracetamol 500mg Suppositories

Keep out of the sight and reach of children.

Do not use the Paracetamol 500mg 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.

Store in a dry place and protect from heat.

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

If your doctor decides to stop treatment, return any left over medicine to the pharmacist. Only keep them if the doctor tells you to.

If your medicine appear to be discoloured or shown any other signs of deterioration, take them back to your pharmacist who will advise you.

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 500mg Suppositories contain

The active ingredient in Paracetamol 500mg suppositories is paracetamol.

Each suppository contains 500mg of paracetamol.

Paracetamol 500mg Suppositories contains the following inactive substances: hard fat and Macrogol Ester.

What Paracetamol 500mg Suppositories look like and the content of the pack

Paracetamol 500mg Suppositories are bullet-shaped, semi-solid and white which are packed individually in plastic cavities.

There are five suppositories in each strip.

Each box contains 10 Paracetamol 500mg Suppositories.

Manufacturer

Paracetamol 500mg Suppositories are manufactured by:

Rice Steele Manufacturing Limited, Tallaght, Dublin 24, Ireland.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0318    [p]

Leaflet revision and issue date (ref): 11.02.15

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