Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Codeine phosphate hemihydrate 8mg; Paracetamol 500mg (As 521mg paracetamol DC 727N);
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Codeine phosphate hemihydrate 8 mg
500mg/8mg
Tablet
Active: Codeine phosphate hemihydrate 8mg Paracetamol 500mg (As 521mg paracetamol DC 727N) Excipient: Gelatin Magnesium stearate Microcrystalline cellulose Purified talc Wheat starch
Blister pack, PVC/Al, 50 tablets
Prescription
Prescription
GlaxoSmithKline Australia Pty Ltd
For the temporary relief of pain and discomfort associated with migraine, earache, period pain, and rheumatic pain. Reduces fever.
Package - Contents - Shelf Life: Blister pack, PVC/Al - 50 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al - 100 tablets - 24 months from date of manufacture stored at or below 30°C
2011-04-18
Page 1/11 NEW ZEALAND DATA SHEET 1 PRODUCT NAME CODALGIN TABLETS PARACETAMOL 500 MG, CODEINE PHOSPHATE 8 MG 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Codalgin tablets contain the following Active ingredients – Paracetamol 500 mg, codeine phosphate hemihydrate 8 mg. It also contains the following Inactives - gelatin, magnesium stearate, microcrystalline cellulose, purified talc, wheat starch 3 PHARMACEUTICAL FORM Tablet - 12.7mm round, flat bevelled edge, white, with a break-bar on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the temporary relief of pain and discomfort associated with migraine, earache, period pain and rheumatic pain. Reduces fever. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN OVER 12 YEARS: One to two tablets to be taken every four to six hours as necessary. The maximum dosage of tablets in 24 hours is 8 tablets._ _ CHILDREN 7 - 12 YEARS:_ _Half to one tablet to be taken every four to six hours as necessary. The maximum dosage of tablets in 24 hours is 4 doses. Codalgin should not be given to children under 7 years of age. 4.3 CONTRAINDICATIONS Paracetamol should not be used in patients with active alcoholism as chronic excessive alcohol ingestion predisposes patients to paracetamol hepatotoxicity. Paracetamol should not be used in patients with a history of intolerance to the drug. Page 2/11 Codeine should not be used in cases of acute respiratory depression (eg acute asthma, acute exacerbations of chronic obstructive pulmonary disease) since codeine may exacerbate the condition. Codalgin should not be used in patients with a past history of allergic reactions to codeine. Hypersensitivity to any of the tablet excipients. Due to codeine’s structural similarity to morphine and oxycodone, patients experiencing systemic allergy (generalised rash, shortness of breath) to these drugs should not receive codeine. Codeine is contraindicated in patients with diarrhoea caused by poisoning, until the toxic substance has been eliminated from th Olvassa el a teljes dokumentumot