Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
codeine phosphate hemihydrate, Quantity: 15 mg; paracetamol, Quantity: 500 mg
Sigma Company Limited
codeine phosphate hemihydrate,Paracetamol
Tablet, uncoated
Excipient Ingredients: magnesium stearate; lactose monohydrate; colloidal anhydrous silica; povidone; ethanol; purified water; potato starch; docusate sodium
Oral
20, 40
(S4) Prescription Only Medicine
For the temporary relief of acute moderate pain in patients over the age of 12 years (see also CONTRAINDICATIONS and Paediatric Use).
Visual Identification: White to off white capsule shaped uncoated tablets plain on one side and breakline on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2014-07-28
Consumer Medicine Information (CMI) CODASIG CMI‐0621 v04 1 CONSUMER MEDICINE INFORMATION (CMI) CODASIG (AUST R 226290) Please read this information before you start taking this medicine WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, Codasig tablets should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). _HAZARDOUS AND HARMFUL USE _ Codasig tablets 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 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE). _LIFE THREATENING RESPIRATORY DEPRESSION _ Serious, life-threatening or fatal respiratory depression may occur with the use of Codasig tablets. 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 minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking Codasig tablets. Consumer Medicine Information (CMI) CODASIG CMI‐0621 v04 2 WHAT IS IN THIS LEAFLET? This leaflet answers some IF YOU WANT MORE INFORMATION, ASK YOUR DOCTOR. Do not take CODASIG tablets during labou Lestu allt skjalið
Product Information CODASIG PI0321 v04 1 AUSTRALIAN PRODUCT INFORMATION CODASIG paracetamol 500 mg and codeine phosphate hemihydrate 15 mg tablets blister pack (AUST R 226290) WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, Codasig tablets should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). _HAZARDOUS AND HARMFUL USE _ Codasig tablets 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 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE). _LIFE THREATENING RESPIRATORY DEPRESSION _ Serious, life-threatening or fatal respiratory depression may occur with the use of Codasig tablets. 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 minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking Codasig tablets. Product Information CODASIG PI0321 v04 2 1. NAME OF THE MEDICINE CODASIG paracetamol 500 mg and codeine phosphate hemihydrate 15 mg tablets blister pack 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVES: Each Lestu allt skjalið