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Paralink 500mg Suppositories

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Document: leaflet MAH BRAND_PLPI 10383-1863 change

Paralink® 500mg Suppositories Paracetamol 500mg Suppositories

(paracetamol)

Your medicine is known by any of the above names, but will be referred to as Paracetamol Suppositories throughout this:

Patient Information Leaflet

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


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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 Paracetemol Suppositories on driving or using machines.

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, 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 up to a maximum of 4 doses in 24 hours. The dose should be based on age and weight i.e.12 years (39 kg) - (500 mg) 1 suppository, adults and the elderly (1 g) 2 suppositories.

Who makes and repackages your medicine?

Your medicine is manufactured by Ricesteele Manufacturing Limited, Cookstown Industrial Estate, Tallaught, Dublin 24, Ireland. Procured from within the EU and repackaged by the Product Licence holder: Primecrown Ltd., 28, Sarum Complex, Uxbridge, Middlesex UB8 2RZ

You must not exceed the stated dose.

Leaflet date: 09.02.2011.

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.

Paralink® is a trade mark of Rice Steele and Company Limited, Tallaght, County Dublin, Republic of Ireland

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 all medicines out of the reach and sight of children

•    Do not use after the expiry date shown on this pack

•    Do not store above 25°C. Protect from heat.

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

•    If your medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

•    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 contains

•    The active ingredient is paracetamol 500mg.

•    The other ingredients are hard fat and macrogol ester.

What Paracetamol Suppositories looks like and contents of the pack

Paracetamol Suppositories are smooth, white suppositories supplied in a plastic cavity in strips of 5. Each pack contains 10 suppositories..

PL 10383/1863 Paracetamol 500mg Suppositories/

Paralink 500mg Suppositories P