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PARA-SUPPS PARACETAMOL 250 MG SUPPOSITORIES - patient leaflet, side effects, dosage

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Patient leaflet - PARA-SUPPS PARACETAMOL 250 MG SUPPOSITORIES

Contents of this leaflet:

  • 1. What Para-Supps Paracetamol 250 mg Suppositories are and what they are used for

  • 2. Before you use Para-Supps Paracetamol 250 mg Suppositories

  • 3. How to use Para-Supps Paracetamol 250 mg Suppositories

  • 4. Possible side effects

  • 5. How to store Para-Supps Paracetamol 250 mg Suppositories

  • 6. Further information

1. WHAT PARA-SUPPS PARACETAMOL 250 MG SUPPOSITORIES ARE AND

Para-Supps Paracetamol 250 mg Suppositories contain paracetamol which belongs to a group of medicines called anti-inflammatory painkillers.

A suppository is a small, torpedo-shaped medicine which is inserted in to the back passage (rectum). These may be useful in children who find it difficult to take tablets or syrup.

Para-Supps Paracetamol 250 mg Suppositories can be used to relieve mild to moderate pain and fever in children from 6 to 12 years of age. For children over 12 years’ old Para-Supps Paracetamol 500 mg Suppositories should be used.

2. before you use para-supps paracetamol 250 mg

SUPPOSITORIES

Do not use Para-Supps Paracetamol 250 mg Suppositories

  • – if your child is allergic (hypersensitive) to paracetamol or any of the other ingredients in this medicine.

Take special care with Para-Supps Paracetamol 250 mg Suppositories

  • – if your child has liver or kidney problems

Taking other medicines

Do not use any other products that contain paracetamol while using Para-Supps Paracetamol 250 mg Suppositories.

Tell your doctor or pharmacist if your child is taking any of the following medicines:

  • – medicines used as sedatives, such as barbiturates

  • – warfarin or other coumarins, which are medicines used to thin the blood

  • – medicines used to treat epilepsy or fits, such as carbamazepine, phenobarbital or phenytoin

Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription.

If you have any doubts about whether your child should take this medicine, then talk to your doctor or pharmacist.

Pregnancy and breast-feeding

If your child is pregnant or breast-feeding you should ask your doctor for advice before taking Para-Supps Paracetamol 250 mg Suppositories.

3. how to use para-supps paracetamol 250 mg suppositories

For rectal use only.

The dosage schedule given below should be followed, unless otherwise directed by your doctor.

The number of suppositories to give your child depends on their age and weight.

The usual dose is 250–500 mg (1–2 suppositories) up to 4 times a day. Ask your doctor or pharmacist for advice on how many suppositories to give.

Do not give more than 4 doses in any 24-hour period. Leave at least 4 hours between doses. Only use whole suppositories.

Para-Supps Paracetamol 250 mg Suppositories are designed to be inserted in the back passage (rectum).

  • – Always wash your hands before and after using the suppositories.

  • – If your child needs to empty their bowels, this should be done before inserting the

suppository.

  • – It may be easier to do if your child lies on a bed on their front or side.

  • – The blister should be opened immediately before use. Remove one suppository from

the mould. Do not break the suppository.

  • – Moisten the tip of the suppository with a little water before insertion.

  • – Using one finger, slide the suppository as high up into the rectum as it can go without

pushing or applying force.

  • – Try to keep your child still for a minute or two.

If you need to insert more than one suppository, insert them one at a time – there is no need to wait between insertions for the previous suppository to melt – there is plenty of room in the rectum.

Please refer to the diagram, which shows the insertion procedure. If you have any concerns you should seek advice from your doctor or pharmacist.

Do not give more medicine than the label tells you to. If your child does not get better, talk to your doctor or pharmacist.

Do not give more suppositories than the recommended dose given Section 3 of this leaflet. Do not use for longer than three days without consulting your doctor.

If a dose is missed, administer the normal dose as soon as possible. Do not give a double dose. Then allow at least 4 hours before the next dose.

If you use more than you should: Talk to a doctor at once if your child takes too much of this medicine even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage.

4. possible side effects

Like all medicines Para-Supps Paracetamol 250 mg Suppositories can have some side effects although not everyone gets them. Side effects that may occur are listed below.

Common side effects (affecting less than 1 in 10 people)

  • Redness or soreness in or around the back passage (rectum)

Rare side effects (affecting less than 1 in 1,000 people)

  • Allergic reactions
  • Skin rashes or itching
  • Blood problems. If these happen your child may get a high temperature/fever, ulcers in the mouth and throat, a tendency to bleed or bruise easily or to get infections.
  • Liver problems

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.

5.


HOW TO STORE PARA-SUPPS PARACETAMOL 250 MG SUPPOSITORIES

Keep this medicine out of the sight and reach of children.

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

Do not use this medicine after the expiry date on the carton or blister strip.

Do not use a suppository that is damaged or shows signs of deterioration.

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

  • 5. FURTHER INFORMATION

What Para-Supps Paracetamol 250 mg Suppositories contain:

Each suppository contains:

Active ingredient: 250 mg of paracetamol

Other ingredient: hard fat

What Para-Supps Paracetamol 250 mg Suppositories look like and contents of the pack:

Para-Supps Paracetamol 250 mg Suppositories are white to ivory-coloured, torpedo-shaped suppositories that are available in packs of 10 packed in plastic-coated aluminium blister strips.

Manufactured by:

bene Arzneimittel GmbH, Herterichstrasse 1, D-81479 Munich, Germany

Marketing authorisation holder:

Amdeepcha Ltd., 85, Yarmouth Road, Blofield, Norwich, Norfolk NR13 4LQ, UK

This leaflet was last revised in: December 2012