Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
Accord-UK Ltd
N02BE01
Paracetamol
500mg
Suppository
Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5012617023353
Information for the user FOR RECTAL ADMINISTRATION ONLY PARACETAMOL 500MG SUPPOSITORIES Your medicine is known by the above name, but will be referred to as Paracetamol Suppositories throughout the following leaflet. This medicine is available in other strength (250mg). 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 children from the age of 6 years. 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 Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paraserts 500mg Suppositories Paracetamol 500mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains Paracetamol 500mg 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 10 years – 12 years (30-40kg): 1 suppository every 4 to 6 hours up to a maximum of 4 suppositories in 24 hours. Adults + Children 12 years and over: 1 -2 suppositories every 4 to 6 hours up to a maximum of 8 suppositories in 24 hours. Dosages should be based on the child’s age and weight. 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 (analgetic 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 Olvassa el a teljes dokumentumot