PHOENIX LABS

Information for the user

FOR RECTAL ADMINISTRATION ONLY

Paracetamol 250mg Suppositories Paracetamol 500mg Suppositories

Read all of this leaflet carefully because it contains important information for you and 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.

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Paracetamol 500mg Suppositories

Children aged 10 to 12 years (30 - 40kg) - one 500 mg suppository Children aged 12 years and older - one to two 500 mg suppositories The dosage should be based on your child's age and weight.

These doses may be repeated up to a maximum of 4 times in 24 hours.

Suppositories should not be given more often than every 4 hours.

If you are not sure how many suppositories to give your child, don’t guess, ask your child’s doctor or a pharmacist. Do not give your child this medicine for more than 3 days, without speaking to your child’s doctor.

Do not give your child more suppositories than stated above.

How to use Paracetamol 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 they do so 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. Do whichever is more comfortable for your child.

3.    Wash your hands. Then peel the wrapping apart to remove the suppository. Do not break the suppository before use.

4.    Gently push the suppository into your child's back passage, 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 forget to give Paracetamol Suppositories to your child

•    Give them as soon as you remember, then go on as before.

•    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) next time, to make up for a forgotten dose.

If you give too many Paracetamol Suppositories to your child

•    Do not give your child more suppositories than stated in the section called “How many Paracetamol 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

4.    Possible side effects

Like all medicines, Paracetamol Suppositories can cause side effects, although not everybody gets them. The following side effects can happen with this medicine.

•    Redness or soreness in or around the back passage are common.

•    Allergic reactions.

•    Skin problems, such as a rash or itching.

•    Blood problems. If these happen, your child may bruise or bleed more easily, get infection 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.

5.    How to store Paracetamol Suppositories

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

•    Do not store above 25°C and keep the blister strips in the outer carton.

•    Do not use this medicine after the expiry date which is stated on the carton and blister. 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.

6.    Further Information

What Paracetamol Suppositories contain - The active substance is paracetamol. The other ingredients are hard fat, macrogol cetostearyl ether and glyceryl ricinoleate.

What Paracetamol Suppositories look like and the contents of the pack - A suppository is a small, torpedo shaped medicine which is inserted into the back passage (rectum). Each pack contains 10 white suppositories, each containing either 250mg or 500mg paracetamol.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation is held by Phoenix Labs, Suite 12 Bunkilla Plaza, Bracetown Business Park, Clonee,

Co. Meath, Ireland.

Paracetamol Suppositories are manufactured by RRF.Hasco-LekS.A., 51-131 Wroclaw, Poland This medicinal product is authorized in the member states of the EEA under the following names:

UK Paracetamol 250mg Suppositories / Paracetamol 500mg Suppositories Ireland Paracetamol 250mg Suppositories / Paracetamol 500mg Suppositories Leaflet Prepared: June 2013 © Phoenix Labs

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