Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
codeine phosphate hemihydrate, Quantity: 5 mg/mL
iNova Pharmaceuticals (Australia) Pty Ltd
Oral Liquid
Excipient Ingredients: glycerol; propylene glycol; purified water; sucrose; methyl hydroxybenzoate
Oral
100 mL
Medicine Registered
(S8) Controlled Drug
Relief of unproductive, dry and intractable coughs associated with colds and flu Relief of unproductive, dry and intractable coughs associated with colds and flu.
Visual Identification: Clear, almost colourless liquid; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
1991-11-11
GOLD CROSS CODEINE LINCTUS G o l d C r o s s C o d e i n e L i n c t u s CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I USING GOLD CROSS CODEINE LINCTUS? Gold Cross Codeine Linctus contains the active ingredient codeine phosphate hemihydrate. Gold Cross Codeine Linctus is used to relieve unproductive, dry coughs associated with colds and flu. For more information, see Section 1. Why am I using Gold Cross Codeine Linctus? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE GOLD CROSS CODEINE LINCTUS? Do not use if you have ever had an allergic reaction to Gold Cross Codeine Linctus or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Gold Cross Codeine Linctus? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Gold Cross Codeine Linctus and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE GOLD CROSS CODEINE LINCTUS? • Adults: take 5 mL every 4 hours. More instructions can be found in Section 4. How do I use Gold Cross Codeine Linctus? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING GOLD CROSS CODEINE LINCTUS? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Gold Cross Codeine Linctus. • Tell your doctor if you become pregnant while taking Gold Cross Codeine Linctus. THINGS YOU SHOULD NOT DO • Do not take more than the recommended dose unless your doctor tells you to. • Do not use Gold Cross Codeine Linctus if you are breastfeeding. • Do not use Gold Cross Cod Olvassa el a teljes dokumentumot
1 AUSTRALIAN PRODUCT INFORMATION – GOLD CROSS CODEINE (CODEINE PHOSPHATE HEMIHYDRATE) LINCTUS 1 NAME OF THE MEDICINE Codeine phosphate hemihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Codeine phosphate hemihydrate 5 mg/mL Excipients with known effects: sucrose and methyl hydroxybenzoate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Gold Cross Codeine Linctus is a clear, almost colourless, oral liquid. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Relief of unproductive, dry and intractable coughs associated with colds and flu. 4.2 D OSE AND METHOD OF ADMINISTRATION Adults: 5 mL every four to six hours. (See also 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE – Paediatric Use.) WARNINGS _HAZARDOUS AND HARMFUL USE _ Gold Cross Codeine Linctus contains codeine and poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient’s risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see section 4.4SPECIAL WARNINGS AND PRECAUTIONS FOR USE). _LIFE THREATENING RESPIRATORY DEPRESSION _ Serious, life-threatening or fatal respiratory depression may occur with the use of Gold Cross Codeine Linctus. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see section 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE). _CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, _ _INCLUDING ALCOHOL _ Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimuthem required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patient Olvassa el a teljes dokumentumot