국가: 뉴질랜드
언어: 영어
출처: Medsafe (Medicines Safety Authority)
Paracetamol 500mg;
Ipca Pharma (NZ) Pty Limited
500 mg
Tablet
Active: Paracetamol 500mg Excipient: Magnesium stearate Sodium metabisulfite Starch
Prescription
For the temporary relief of pain and discomfort in headaches, colds and flu symptoms, rheumatic muscular and neuralgic conditions and dental pain. Assist in reducing fever.
Package - Contents - Shelf Life: Blister pack, Al foil/PVC coating - 1000 tablets - 60 months from date of manufacture stored at or below 25°C protect from light and moisture. Protect from Heat
2019-02-28
NEW ZEALAND DATA SHEET Page 1 of 7 1. PRODUCT NAME Pacimol, paracetamol 500 mg, uncoated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient : Paracetamol (BP) 500 mg/tablet Excipient(s) with known effect For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White, capsule shaped, biconvex uncoated tablet with break line on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the temporary relief of pain & discomfort, in headaches, colds and flu symptoms, rheumatic. muscular and neuralgic conditions and dental pain. Assist in reducing fever. 4.2 DOSE AND METHOD OF ADMINISTRATION Adults and children aged 12 years and over: 1 to 2 tablets every four to six hours as required. Maximum of 8 tablets in 24 hours. Maximum daily dose: 4000 mg. Children 7 to 11 years: ½ to 1 tablet every four to six hours as required. Maximum of 4 tablets in 24 hours. Do not exceed the stated dose. Adults: Do not take this medicine for longer than a few days at a time unless advised by a doctor. Children and Adolescence: Do not take this medicine for longer than 48 hours at a time unless advised by a doctor. Not suitable for children under seven years of age. Take orally with water or other fluid. The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment. Should not be used with other paracetamol‐containing products. Minimum dosing interval: 4 hours. 4.3 CONTRAINDICATIONS These products are contraindicated in patients with a previous history of hypersensitivity to paracetamol or any of the excipients. NEW ZEALAND DATA SHEET Page 2 of 7 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Contains paracetamol. Do not use with any other paracetamol‐ containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Paracetamol should be used with caution in patients with: Impaired liver function: Underlying liver 전체 문서 읽기