Paracetamol 125mg Suppositories
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Title: |
Paracetamol 125mg Suppositories |
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Ref: |
PIL - Patient Information Leaflet |
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Date: |
05/01/16 |
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Size (mm): |
265 (W) x 360(H) |
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Modified: |
01/03/16 |
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V |
Colours
(Printed)
Black
Process
Colours (Non printed)
TRIM
REFERENCE
PERF
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Paracetamol 125mg Suppositories
Paracetamol
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If the patient gets any side effects, talk to a doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- You must contact a doctor if the patient does not feel better or if the patient feels worse after 3 days.
- Your product is called Paracetamol 125mg Suppositories but will be referred to as Paracetamol Suppositories throughout this leaflet.
What is in this leaflet
1. What Paracetamol Suppositories are and what they are used for
2. What you need to know before you use Paracetamol Suppositories
3. How to use Paracetamol Suppositories
4. Possible side effects
5. How to store Paracetamol Suppositories
6. Contents of the pack and other 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.
You must talk to a doctor if the patient does not feel better or if the patient feels worse after 3 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL SUPPOSITORIES
Do not give Paracetamol Suppositories to the patient:
• if the patient is allergic to paracetamol, soya, peanuts or any of the other ingredients of this medicine (listed in Section 6). Warnings and precautions
Talk to a doctor or pharmacist before using Paracetamol Suppositories.
Take special care with the use of Paracetamol Suppositories and talk to your pharmacist or doctor if:
• the patient has problems with their liver or kidneys.
Other medicines and Paracetamol Suppositories
Tell the patient's doctor or pharmacist if the patient is taking, has recently taken or might take any other 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 the patient's doctor or pharmacist if the patient is taking any of the following:
• Other medicines containing paracetamol - do not give the patient 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 or “thinning the blood”
• 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. Always use this medicine exactly as described in this leaflet or as the patient's doctor or pharmacist have told you. Check with the patient's doctor or pharmacist if you are not sure.
The recommended dose is:
|
Age |
Number of Suppositories |
Minimum Length of time between doses |
Maximum number of suppositories in 24 hours |
|
1 year (1 Okg) |
1 |
4-6 hours |
4 |
|
Over 1 year to 5 years (20kg) |
1 or 2 |
4-6 hours |
4-8 |
Do not give the patient more suppositories than stated above.
How to use the suppositories:
• The patient's bowels need to be empty when you give them this medicine. If the patient needs to go to the toilet, make sure that they do it before you give them the suppository.
• It may be easier to give the patient the suppository if they are lying on their front or side on a bed.
• Wash your hands. Then peel the wrapping apart to take out the suppository. Do not break the suppository before use.
• Gently push the suppository into the patient'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 the patient 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 the patient 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.
If you forget to give Paracetamol Suppositories to the patient
Do not give a double dose to make up for a forgotten dose.
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, this medicine can cause side effects, although not everybody gets them.
Stop giving Paracetamol Suppositories to the patient immediately and call your doctor if you notice the patient 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, the patient may bruise or bleed more easily than usual, be more susceptible to infections, or get a high temperature (fever) and ulcers in the mouth and throat
• Liver problems. Symptoms may include jaundice (yellowing of the skin or whites of the eyes).
Reporting of side effects
If the patient gets any side effects, talk to a doctor or pharmacist. 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.
5. HOW TO STORE PARACETAMOL SUPPOSITORIES
Keep this medicine out of the sight and reach 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Paracetamol Suppositories contain:
- The active substance is paracetamol. Each suppository contains 125mg of paracetamol.
- The other ingredients are hydrogenated fat and 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 and Manufacturer
Marketing authorisation holder: Amdeepcha Limited, 85 Yarmouth Road, Blofield, Norwich, Norfolk NR13 4LQ, UK. Manufacturer: Dr. R. Pfleger Chemische Fabrik GmbH, D-96045 Bamberg,