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Paracetamol 500mg Suppositories Ref:0136/281114/1/F

Patient Information Leaflet

Read all of this leaflet carefully before you start

using this medicine.

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

-    If you have any further questions, ask your doctor 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

Q What Paracetamol Suppositories are and what they are used for

Q Before you use Paracetamol Suppositories

Q How to use Paracetamol Suppositories

Q Possible side effects

Q How to store Paracetamol Suppositories

Q Further information

Q 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.

A 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 lealfet.

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.

Q 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 in to 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.

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.

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.

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.

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 with a smooth surface and rounded head. Each pack contains 10 suppositories.

Manufacturer and Licence Holder

This medicine is manufactured by Ricesteele Manufacturing Ltd, Dublin 24, Ireland and procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road East Moons Moat, Redditch, Worcestershire B98 0RE. Repackaged by Lexon (UK) Limited, B98 ORE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

Possible side effects


P


PL 33723/0136


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

Side effects that may occur include:

• a skin rash

Revision date: 28/11/14

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Lexon (UK) Limited,

Tel: 01527 505414 for help

Ref: 0136/281114/1 /B

(paracetamol)

Patient Information Leaflet

Read all of this leaflet carefully before you start

using this medicine.

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

-    If you have any further questions, ask your doctor 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

Q What Paralink Suppositories are and what they are used for

Q Before you use Paralink Suppositories

Q How to use Paralink Suppositories

O Possible side effects

Q How to store Paralink Suppositories

Q Further information

Q What Paralink Suppositories are and what they are used for

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

Paralink 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 paralink orally e.g. after an operation or if you are feeling or being sick.

Do not use Paralink Suppositories with other medicines that contain paralink.

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 Paralink 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 Paralink Suppositories.

Driving and using machines

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

Q Before you use Paralink Suppositories

You or your child should not take Paralink

Suppositories if:

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

If this applies to you or your child please tell your

doctor before taking this medicine.

Take special care with Paralink Suppositories if:

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

•    you or your child suffer from alcoholism

Q How to use Paralink Suppositories

Always use Paralink 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.

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


P


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 in to 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.

You must not exceed the stated dose.

If you use more Paralink 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.

Possible side effects

Like all medicines Paracetemol 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.

Keep out of the reach and sight of children.

Do not use Paralink 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.

Further Information

What Paralink Suppositories contain

The active ingredient is paralink 500mg

The other ingredients are hard fat and Macrogol

Ester

What Paralink Suppositories look like and contents of the pack:

White, tapered cylindrical suppository with a smooth surface and rounded head. Each pack contains 10 suppositories.

Manufacturer and Licence Holder

This medicine is manufactured by Ricesteele Manufacturing Ltd, Dublin 24, Ireland and procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road East Moons Moat, Redditch, Worcestershire B98 0RE. Repackaged by Lexon (UK) Limited, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

PL 15184/0136

Paralink is a registered trademark of Ricesteele.

Leaflet revision date: 28/11/14

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Lexon (UK) Limited,

Tel: 01527 505414 for help

Ref: 0136/281114/2/B