देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
Sigma Pharmaceuticals Plc
N02BE01
Paracetamol
240mg
Suppository
Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100
PACKAGE LEAFLET: INFORMATION FOR THE USER PARACETAMOL SUPPOSITORIES 240MG Paracetamol 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 The active ingredient Paracetamol is a medicine with pain relieving properties. Paracetamol Suppositories are used: • for the relief of mild to moderate pain • for the relief of a high temperature (fever) • if you are unable to take paracetamol orally e.g. after an operation or if you are feeling or being sick. 2. BEFORE YOU USE PARACETAMOL SUPPOSITORIES YOUR CHILD SHOULD NOT TAKE PARACETAMOL SUPPOSITORIES IF: • they are allergic (hypersensitive) to paracetamol or to any of the If this applies to your child please tell your doctor before taking this medicine. TAKE SPECIAL CARE WITH PARACETAMOL SUPPOSITORIES IF: • • your child is dependent on alcohol If your child’s symptoms persist you should consult your doctor. Do not use Paracetamol Suppositories with other medicines that contain paracetamol. Do not exceed the recommended dose. TAKING OTHER MEDICINES Please tell your doctor, nurse or pharmacist if your child is taking, or has recently taken, any other medicine including medicines obtained without prescription. Please tell your doctor if your child is taking any of the following medicines: • medicines used to thin your blood (anticoagulants) e.g. warfarin • medicines used to stop you feeling or being sick such as metoclopramide and domperidone • colestyramine, a medicine used to prevent coronary heart disease and diarrhoea caused by certain disorders If you have any doubts as to whether Paracetamol Suppositories are suitable for your child please consult your doctor. PREGNANCY AND BREAST-FEEDING If necessary, Paracetamol Suppositories 240mg can be used during pregnancy. You should use the lowest possible dose पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol or Paralink Suppositories 240mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains Paracetamol Ph.Eur. 240mg 3 PHARMACEUTICAL FORM White, tapered, cylindrical suppositories with a smooth surface and rounded head, containing 240mg Paracetamol Ph.Eur. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of mild to moderate pain and pyrexia. The suppositories may be particularly 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 Children 5 – 12 years (18 – 39kg): 1 – 2 suppositories; maximum of 2g in 24 hours Dose may be repeated every 4 – 6 hours with a maximum of 4 doses in 24 hours. The dose should be based on age and weight i.e. 5 years (18 kg) – (240mg) 1 suppository 12 years (39 kg) – (480mg) 2 suppositories 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol or any of the other constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Do not exceed the recommended dose. Patients should be advised not to take other paracetamol-containing products concurrently. If symptoms persist, consult your doctor. Keep out of the sight and reach of children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. The rate of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by coleystyramine. 4.6 FERTILITY, PREGNANCY AND LACTATION Pregnancy A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. पूरा दस्तावेज़ पढ़ें