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The product code for this leaflet is: PL 17901/0096

 

Alvedon Suppositories 125mg

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AstraZeneca UK Limited


Horizon Place600 Capability GreenLutonBedfordshireLU1 3LU
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P023883

PACKAGE LEAFLET: INFORMATION FOR THE USER

FOR RECTAL ADMINISTRATION ONLY

Alvedon® Suppositories 125 mg

paracetamol

Read all of this leaflet carefully before you give this medicine to your child.

This medicine is available without prescription. However, you still need to use it carefully to get the best results from it.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • You must contact your child's doctor if your child's symptoms get worse or do not improve.
  • If your child gets any side effects after being given this medicine, please tell a doctor or pharmacist.

In this leaflet:

  • 1. What Alvedon Suppositories are and what they are used for
  • 2. Before you give Alvedon Suppositories to your child
  • 3. How to give Alvedon Suppositories to your child
  • 4. Possible side effects
  • 5. How to store Alvedon Suppositories
  • 6. Further information
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1. What Alvedon Suppositories are and what they are used for

A suppository is a small, cone-shaped medicine which is inserted into the back passage (rectum).

Alvedon Suppositories contain a medicine called paracetamol. This belongs to a group of medicines called pain-killers (analgesics).

Alvedon Suppositories are used to treat pain and high temperature (fever) in children from 1 to 5 years of age. They are used by children who find it difficult to take paracetamol as tablets or syrup.

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2. Before you give Alvedon Suppositories to your child

Do not give Alvedon Suppositories to your child if:

  • They are allergic (hypersensitive) to paracetamol or to the other ingredient which is called 'hard fat'.

Take special care with Alvedon Suppositories

Check with a doctor or pharmacist before using these suppositories if:

  • Your child has liver or kidney problems.

Taking other medicines

Please tell your child's doctor or pharmacist if your child is taking, or has recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Alvedon Suppositories can affect the way some medicines work and some medicines can have an effect on Alvedon Suppositories.

In particular, tell your child's doctor or pharmacist if your child is taking any of the following:

  • Other medicines that contain paracetamol - do not give your child Alvedon Suppositories at the same time.
  • Barbiturates (a type of sedative).
  • Medicines for epilepsy or fits (also called 'anti-convulsants').
  • Medicines such as warfarin for treating blood clots.

Do not give your child alcohol, or any medicines containing alcohol, while they are being given these suppositories.

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3. How to give Alvedon Suppositories to your child

If your child's doctor or pharmacist has told you how to use this medicine, do exactly as they have told you. Otherwise, follow the instructions below. If you do not understand the instructions, or you are not sure, ask the doctor or pharmacist.

How many Alvedon Suppositories to give your child

  • Alvedon Suppositories are for children aged from 1 to 5 years.
  • The number of suppositories to give your child depends on their age and weight.
  • The usual dose is one or two suppositories.
  • You should ask your child's doctor or pharmacist for advice on how many suppositories to give.

You can give your child up to 4 doses in 24 hours. You must leave at least 4 hours between each dose.

If you are not sure how many suppositories to give your child, don't guess. Ask your child's doctor or pharmacist for advice.

Do not give your child more suppositories than stated above.

Contact your child's doctor if your child's symptoms get worse or do not improve.

How to use Alvedon Suppositories

  • 1. Your child's bowels need to be empty when you give them this medicine. If your child needs to go to the toilet, make sure that they do it before you give them the suppository.
  • 2. You may find it easier to give your child the suppository if they are lying on their front or side on a bed. Do whichever is more comfortable for your child.
  • 3. Wash your hands. Then peel the wrapping apart to take out the suppository. Do not break the suppository before use.
  • 4. Gently push the suppository into your child's back passage (rectum) with the pointed end first. Then wash your hands.
  • 5. Try to keep your child still for a minute or two.
  • 6. If your child needs to be given another suppository, remove another one from the wrapper. Then insert it into your child's back passage as before. Once again you should try to keep your child still for a minute or two. Then wash your hands.

If you give too many Alvedon Suppositories to your child

  • Do not give your child more suppositories than stated overleaf (in the section called "How many Alvedon Suppositories to give your child").
  • Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage.

If you forget to give Alvedon Suppositories to your child

  • If you forget to give your child a dose of Alvedon Suppositories, give it to them as soon as you remember.
  • However, if it is almost time for the next dose, skip the missed dose.
  • Do not give your child a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your child's doctor or pharmacist.

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4. Possible side effects

Like all medicines, Alvedon Suppositories can cause side effects, although not everybody gets them. The following side effects can happen with this medicine. Tell your doctor if any of these happen to your child.

Common (affects more than 1 in 100 people)

  • Redness or soreness in or around the back passage.

Rare (affects less than 1 in 1,000 people)

  • Allergic reactions.
  • Skin problems such as a rash or itching.
  • Blood problems. If these happen, your child may bruise or bleed more easily, get infections more easily, or get a high temperature (fever) and ulcers in the mouth and throat.
  • Liver problems.

If your child gets any of the side effects mentioned above, or gets any side effects not mentioned in this leaflet, talk to your child's doctor or pharmacist.

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5. How to store Alvedon Suppositories

  • Keep this medicine out of the reach and sight of children.
  • Store this medicine in a cool, dry place (below 25°C) and out of direct sunlight.
  • Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
  • Return any unused suppositories to the pharmacist, unless your child's doctor has told you to keep them.
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6. Further information

What Alvedon Suppositories contain

The active substance is paracetamol. Each suppository contains 125 mg of paracetamol.

The other ingredient is hard fat (Witepsol H12).

What Alvedon Suppositories look like and contents of the pack

Alvedon Suppositories are cone-shaped and come in packs of 10.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Alvedon Suppositories is held by

AstraZeneca UK Ltd
600 Capability Green
Luton
LU1 3LU
UK

Alvedon Suppositories are manufactured by

AstraZeneca UK Ltd
Silk Road Business Park
Macclesfield
Cheshire
SK10 2NA
UK

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Alvedon Suppositories 125 mg

Reference number 17901/0096

This is a service provided by the Royal National Institute of Blind People.

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Leaflet prepared: September 2008

© AstraZeneca 2008

Alvedon is a trade mark of the AstraZeneca group of companies.

PAI 08 0062


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