Paracetamol 125mg Suppositories
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PARACETAMOL 125MG SUPPOSITORIES
Paracetamol
Read all of this leaflet carefully because it contains important information for you.
This medicine is av ailable w ithout pres cription. How ever, y ou still need to use Paracetamol 125mg Suppositories carefully to get the best results from them.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if symptoms worsen or do not improve after 3 days.
- If any of the listed side effects get serious, or if you notice any side effects which are not listed in this leaflet, please tell your doctor or pharmacist.
- Your product is called Paracetamol 125 mg Suppos itories but will be referred to as Paracetamol Suppositories throughout this leaflet.
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
Paracetamol Suppositories contain a medicine called paracetamol. This belongs to a group of medicines called pain-killers (analgesics). A suppository is a small, torpedo-shaped, medicine which is inserted into the back passage (rectum).
Paracetamol Suppositories are used to treat pain and high temperature (fever) in children from 1 to 5 years of age. They can be used in children who find it difficult to take paracetamol as tablets or syrup.
2. BEFORE YOU USE PARACETAMOL SUPPOSITORIES Do not give Paracetamol Suppositories to your child if:
• your child is allergic (hypersensitive) to paracetamol, soya, peanuts or any of the other ingredients of Paracetamol Suppositories (listed in Section 6 at the end of this leaflet).
Take special care with the use of Paracetamol Suppositories and talk to your pharmacist or doctor if:
• your child has problems with their liver or kidneys.
Taking other medicines
Please tell your child’s doctor or pharmacist if your child is taking, or has recently taken, any other medicines, including medicines obtained without a prescription and herbal medicines. This is because Paracetamol Suppositories can have an affect on the way some medicines work and some medicines can have an affect on how Paracetamol Suppositories work.
In particular tell your child’s doctor or pharmacist if your child is taking any of the following:
• Other medicines containing paracetamol - do not give your child Paracetamol Suppositories at the same time
• Medicines to treat nausea (feeling sick) and vomiting (being sick), such as metoclopramide and domperidone
• Colestyramine, used to reduce the level of cholesterol (fat) in the blood
• Medicines called anticoagulants, such as warfarin, used for treating blood clots
• Medicines called anticonvulsants used for treating epilepsy or fits (e.g. phenytoin, carbamazepine)
• The antibiotic rifampicin.
3. HOW TO USE PARACETAMOL SUPPOSITORIES
This medicine is for rectal use only. 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 are not sure, ask the doctor or pharmacist.
How many Paracetamol Suppositories to give your child:
|
Age |
Number of Suppositories |
Minimum Length of time between doses |
Maximum number of suppositories in 24 hours |
|
1 year (10kg) |
1 |
4 - 6 hours |
4 |
|
Over 1 year to 5 years (20kg) |
1 or 2 |
4 - 6 hours |
4-8 |
Do not give your child more suppositories than stated above.
Consult your child’s doctor if symptoms get worse or do not improve within 3 days.
How to use the suppositories:
• 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
• It may be easier to give your child the suppository if they are lying on their front or side on a bed
• Wash you hands. Then peel the wrapping apart to take out the suppository. Do not break the suppository before use
• Gently push the suppository into you child’s back passage with the pointed end first. To make it easier to give the suppository you may warm it slightly between your hands beforehand
• Try to keep your child still for a minute or two and then wash your hands
• If you need to give another suppository, then follow the above procedure again.
If you have given more Paracetamol Suppositories to your baby than you should:
• Immediate medical advice should be sought in the event of an overdose, even if your child seems well, because of the risk of delayed, serious liver damage.
If you have any further questions regarding the use of this medication, please ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol Suppositories can cause side effects, although not everybody gets them.
Stop giving Paracetamol Suppositories to your child immediately and call your doctor if you notice your child has any signs of allergic reaction.
Signs of an allergic reaction include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
The following side effects can happen with this medicine.
Common side effects (affects more than 1 in 100 people taking this medicine):
• Redness or soreness in and around the back passage.
Rare side effects (affects less than 1 in 1000 people taking this medicine):
• Blood problems. If these happen, your child may bruise or bleed more easily than usual, be more susceptible to get infections, or get a high temperature (fever) and ulcers in the mouth and throat
• Liver problems, symptoms may includejaundice (yellowing of the skin or whites of the eyes).
If your child gets any of the side effects mentioned above, or gets any side effect not mentioned in this leaflet, talks to your child’s doctor or pharmacist.
5. HOW TO STORE PARACETAMOL SUPPOSITORIES
Keep out of reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and on the blister strip. The expiry date refers to the last day of that month.
Do not store over 30°C.
6. FURTHER INFORMATION
What Paracetamol Suppositories contains:
The active substance is paracetamol. Each suppository contains 125mg of paracetamol.
The other ingredients are: hydrogenated fat, soyabean lecithin.
What Paracetamol Suppositories look like and contents of the pack:
Cream coloured, torpedo shaped suppository, available in packs of 10 suppositories.
Marketing authorisation holder:
Amdeepcha Limited 85 Yarmouth Road
Blofield, Norwich, Norfolk, NR13 4LQ, UK Manufacturer:
Dr. R. Pfleger Chemische Fabrik GmbH,
D-96045 Bamberg,