국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paracetamol
KOMEDIC SDN BHD
Paracetamol
20 Suppositories; 100 Suppositories
MEDOCHEMIE LTD (COGOLS FACILITY)
_Consumer Medication Information Leaflet (RiMUP) _ ARFEN SUPPOSITORY Paracetamol (125mg, 250mg) 1 IN THIS LEAFLET : 1. What ARFEN SUPPOSITORY is used for 2. How ARFEN SUPPOSITORY works 3. Before you use ARFEN SUPPOSITORY 4. How to use ARFEN SUPPOSITORY 5. While you were using it 6. Side effects 7. Storage and disposal of ARFEN SUPPOSITORY 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ARFEN SUPPOSITORY IS USED FOR A suppository is a small, torpedo- shaped medicine which is inserted into the back passage (rectum). These suppositories are used to treat pain and fever in children. They are used by children who find it difficult to take paracetamol as tablets or syrup. Suppositories are also useful in patients who are unable to take oral forms of paracetamol (post-operatively or with nausea and vomiting). HOW ARFEN SUPPOSITORY WORKS ARFEN suppositories contain a medicine called paracetamol. This belongs to a group of medicines with analgesic (painkiller) and anti-pyretic (reduce fever) activity. BEFORE YOU USE ARFEN SUPPOSITORY _When you must not use it _ DO NOT USE ARFEN: - If your child is allergic (hypersensitive) to paracetamol or to the other ingredients in the suppository _Before you start to use it _ Before taking any of this medicine, tell the doctor: - if your child has renal or hepatic problems - if your child is taking other medicines which can affect their liver _Taking other medicines _ Please tell the doctor or pharmacist if your child is taking or have recently taken any other medicines, including medicines obtained without a prescription, including: - Medicines that contain paracetamol – DO NOT give your child ARFEN 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. - Rifampicin and St. John’s wort. - Probenecid acid (for gout treatment) - Chloramphenicol (a medicine used to treat bacterial infection) - Cholestyramine (bile aci 전체 문서 읽기
PACKAGE INSERT – ARFEN 1. NAME OF THE MEDICINAL PRODUCT Arfen 125 mg, suppositories Arfen 250 mg, suppositories 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Arfen 125mg: Each suppository contains 125mg paracetamol. Arfen 250mg: Each suppository contains 250mg paracetamol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suppository Arfen 125mg and 250mg suppositories are creamy, smooth homogenous and torpedo shaped. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the treatment of mild to moderate pain and pyrexia in children: Arfen 125 mg is indicated in children aged 1 to 5 years. Arfen 250 mg is indicated in children aged 6 to 12 years. Arfen 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 Posology _Paediatric population _ CHILDREN 1 TO 5 YEARS (125 MG SUPPOSITORIES) The dosage should be based on age and weight i.e. 1 year (10 Kg) 125mg (1 suppository) 5 years (20 Kg) 250mg (2 suppositories) CHILDREN 6 TO 12 YEARS (250 MG SUPPOSITORIES) The dosage should be based on age and weight i.e. 6 years (20 Kg) 250mg (1 suppository) 12 years (40 Kg) 500mg (2 suppositories) Method of administration Intrarectal use. 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. Only whole suppositories should be administered – do not break suppository before administration. 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Arfen should not be combined with other analgesic medications that contain paracetamol (e.g. combination drugs). Paracetamol should be given with care to patients with impaired kidney or liver function. Doses higher than those recomme 전체 문서 읽기