País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Codeine phosphate hemihydrate 15mg; ; ; ;
Noumed Pharmaceuticals Limited
Codeine phosphate hemihydrate 15 mg
15 mg
Tablet
Active: Codeine phosphate hemihydrate 15mg Excipient: Lactose monohydrate Magnesium stearate Maize starch
Bottle, glass, 100 tablets
Class C2 Controlled Drug
Class C2 Controlled Drug
Sun Pharmaceuticals Industries (Australia) Pty Ltd
Codeine phosphate is indicated for: The relief of mild to moderate pain (including pain associated with terminal illness, post-operative pain and headache), The relief of symptoms of diarrhoea (except diarrhoea caused by poisoning),
Package - Contents - Shelf Life: Blister pack, - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, glass, - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, glass, - 500 tablets - 36 months from date of manufacture stored at or below 25°C protect from light
1969-12-30
NEW ZEALAND CONSUMER MEDICINE INFORMATION CODEINE PHOSPHATE TABLETS (NOUMED) _Codeine Phosphate Hemihydrate BP _ _ _ Tablet, uncoated 15 mg, 30 mg & 60 mg WARNINGS LIMITATIONS OF USE Codeine Phosphate Tablets (Noumed) should only be used when your doctor decides that other treatment options are not able to effectively manage your pain, or you cannot tolerate them. HAZARDOUS AND HARMFUL USE Codeine Phosphate Tablets (Noumed) poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment. LIFE THREATENING RESPIRATORY DEPRESSION Codeine Phosphate Tablets (Noumed) can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing), even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting Codeine Phosphate Tablets (Noumed) and after a dose increase, if you are older, or have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate. USE OF OTHER MEDICINES WHILE USING CODEINE PHOSPHATE TABLETS (NOUMED) Codeine Phosphate Tablets (Noumed) with other medicines that can make you feel drowsy such as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using Codeine Phosphate Tablets (Noumed). WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Codeine Phosphate Tablets (Noumed). This leaflet answers some common questions about Codeine Phosphate Tablets (Noumed). 1 NEW ZEALAND CONSUMER MEDICINE INFORMATION 2 It does not contain all the available information. It does not take the place of talking to your docto Llegiu el document complet
NEW ZEALAND DATA SHEET New Zealand Data Sheet Page 1 of 14 1. PRODUCT NAME Codeine Phosphate Tablets (Noumed) 15 mg, 30 mg & 60 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Name and strength of the active substance Codeine Phosphate Hemihydrate BP 15 mg Codeine Phosphate Hemihydrate BP 30 mg Codeine Phosphate Hemihydrate BP 60 mg Codeine phosphate hemihydrate is obtained from opium or made by methylating morphine. It occurs as odourless colourless crystals or white crystalline powder. The molecular formula of codeine phosphate is C 18 H 21 NO 3 ,H 3 PO 4 .½H 2 O and the molecular weight 406.4. Excipient(s) with known effect Contains sugars as lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral – tablet, uncoated Presentation Codeine Phosphate Tablets (Noumed) are white to cream, biconvex circular tablets. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Codeine phosphate is indicated for: • the relief of mild to moderate pain (including pain associated with terminal illness, post-operative pain, headache), • the relief of symptoms of diarrhoea (except diarrhoea caused by poisoning). 4.2 Dose and method of administration _Adults _ Codeine phosphate may be given orally in doses of 15 mg – 60 mg every 4 – 6 hours as needed. If these doses fail to relieve pain, larger doses rarely succeed and may give rise to restlessness and excitement. NEW ZEALAND DATA SHEET New Zealand Data Sheet Page 2 of 14 The maximum daily dose in adults should not exceed 300 mg. _Paediatric _ Do not use in children aged less than 12 years (see sections 4.3 and 4.4). The usual paediatric dose is 0.5 mg per kg of body weight, every 4 to 6 hours as needed. The total dose should not exceed 240 mg in 24 hours. The duration of treatment should not normally exceed 3 days. 4.3 Contraindications Codeine phosphate is contraindicated in: • Known hypersensitivity to codeine, other opioids, or any component of the tablets • Acute respiratory depression, especially in the presence of cyanosis a Llegiu el document complet