Patient leaflet - Paracetamol 125 mg suppositories
What Paracetamol Suppositories are and what they are used for
Paracetamol Suppositories contain a medicine called paracetamol. Paracetamol is one of 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 babies and children from the age of I year. They are used by children who find it difficult to take paracetamol as tablets or syrup.
What you need to know before you give Paracetamol Suppositories to your child
Do not give your child these suppositories if:
- They are allergic to paracetamol or the other main ingredient which is called "hard fat".
Warnings and precautions
Talk to your child’s doctor or pharmacist before using these suppositories:
- If your child has liver or kidney problems.
Other medicines and Paracetamol Suppositories
Please tell your child's doctor or pharmacist if your child is taking, has recently taken or might take, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because the suppositories can affect the way some medicines work and some medicines can have an effect on Paracetamol 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 Paracetamol 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 whilst they are being given these suppositories.
- flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.
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
1 to 3 years: One suppository
4 to 6 years: Two suppositories
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
- If you forget to give your child a dose of Paracetamol 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) next time, to make up for a forgotten dose.
Patient Information Leaflet FOR RECTAL ADMINISTRATION ONLY Paracetamol 125mg Suppositories
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Ref:1819/171123/1/F If you give more Paracetamol Suppositories to your child than you should
- 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.
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.
Common (may affect up to 1 in 10 people)
- Redness or soreness in or around the back passage.
Rare (may affect up to 1 in 1,000 people) • Allergic reactions such as swelling of the face, lips tongue or throat.
- 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.
Very rare cases of serious skin reactions have been reported.
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.
Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Paracetamol Suppositories
- Keep out of the sight and reach of children. • Do not store above 25°C.
- Keep in outer carton in order to protect from light. • Do not remove the suppositories from the blister until immediately before use.
- Do not use Paracetamol Suppositories after the expiry date on the blister or carton. The expiry date refers to the last day of that month. • If your doctor tells you to stop using this medicine, take any remaining medicine back to your pharmacist for safe disposal. Only keep this medicine, if your doctor advises you to. • Do not use if the strip containing the suppositories is damaged.
- If the suppositories become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.
Contents of the pack and other information
What Paracetamol Suppositories contain:
The active ingredient is paracetamol.
Each suppository contains 125mg paracetamol. The other ingredient is witepsol S58.
What Paracetamol Suppositories look like and contents of the pack:
Paracetamol 125 mg Suppositories are white, torpedo-shaped suppositories with a smooth surface.
A suppository is a small, torpedo-shaped medicine which is inserted into the back passage (rectum). Each pack contains 10 suppositories.
Manufacturer and Licence Holder
Manufactured by PRZEDSIEBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK S.A., 51-131 Wroclaw, ul. Zmigrodzka 242 E, Poland and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
PL 15184/1819 Paracetamol 125mg
Suppositories
Revision date: 17/11/23
Blind or partially sighted? Is this leaflet hard to see or read? Phone
Lexon (UK) Limited, Tel: 01527 505414 to obtain the leaflet in a format suitable for you.
Ref: 1819/171123/1/B P
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