Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
A A H Pharmaceuticals Ltd
N02BE01
Paracetamol
125mg
Suppository
Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5025903084884
Information for the user FOR RECTAL ADMINISTRATION ONLY PARACETAMOL 125MG SUPPOSITORIES Your medicine is known by the above name, but will be referred to as Paracetamol Suppositories throughout the following leaflet. 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. IN THIS LEAFLET: 1. WHAT PARACETAMOL SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU GIVE PARACETAMOL SUPPOSITORIES TO YOUR CHILD 3. HOW TO ADMINISTER PARACETAMOL SUPPOSITORIES TO YOUR CHILD 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. 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 1 year. They are used by children who find it difficult to take paracetamol as tablets or syrup. 2. BEFORE YOU GIVE PARACETAMOL SUPPOSITORIES TO YOUR CHILD DO NOT GIVE YOUR CHILD THESE SUPPOSITORIES IF: • They are allergic to paracetamol or to the other main ingredient which is called 'hard fat'. TAKE SPECIAL CARE WITH PARACETAMOL SUPPOSITORIES Check with your 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 ha Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paraserts 125mg Suppositories Paracetamol 125mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains Paracetamol 125mg For excipients, see 6.1 3 PHARMACEUTICAL FORM Suppositories 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of mild to moderate pain and fever. Paraserts/Paracetamol Suppositories may be especially useful in patients unable to take oral forms of paracetamol, e.g. post-operatively or with nausea and vomiting. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: Rectal Children: 1year – 5 years: 1-2 suppositories every 4 to 6 hours Dosages should be based on the child’s age and weight i.e. 1 year (10kg) – 125mg (1 suppository) 5 years (20kg) – 250mg (2 suppositories) These doses may be repeated up to a maximum of 4 times in 24 hours. The dose should not be repeated more frequently than every 4 hours. The recommended dose should not be exceeded. Higher doses do not produce any increase in analgesic effect. The product should not be used for more than 3 days, except on the advice of a doctor. Only whole suppositories should be administered – do not break the suppository before administration 4.3 CONTRAINDICATIONS Hypersensitivity to either paracetamol, soy, peanuts or any of the other ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Paraserts/Paracetamol Suppositories should not be combined with other analgesic medications that contain paracetamol. Paracetamol should be given with care to patients with impaired kidney or liver function. In general, the habitual use of painkillers, especially with combinations of more than one pain killing active ingredient, can lead to permanent kidney damage with the risk of liver failure (analgesic nephropathy). Label and Leaflet will state the following warnings: Label : “Immediate medical advice should be sought in the event of an overdose, even if the child seems well”. “Do not give with any other Paracetam Прочитайте повний документ