국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
paracetamol, Quantity: 500 mg; codeine phosphate hemihydrate, Quantity: 10 mg; doxylamine succinate, Quantity: 5.1 mg
Pharmacor Pty Ltd
codeine phosphate hemihydrate,doxylamine succinate,Paracetamol
Tablet, uncoated
Excipient Ingredients: crospovidone; lactose monohydrate; stearic acid; magnesium stearate; maize starch; ethanol; povidone; microcrystalline cellulose
Oral
10, 36, 24, 12, 40, 30, 20
(S4) Prescription Only Medicine
For the temporary relief of acute moderate pain and fever.
Visual Identification: White capsule shaped, biconvex, bevel edged, uncoated tablet with break line on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2013-11-26
Trust Analgesic Calmative (V – 05) 1 TRUST ANALGESIC CALMATIVE _Paracetamol 500mg, codeine phosphate 10mg and doxylamine succinate 5.1mg_ CONSUMER MEDICINE INFORMATION (CMI) WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, TRUST ANALGESIC CALMATIVE 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 _HAZARDOUS AND HARMFUL USE _ TRUST ANALGESIC CALMATIVE 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 _LIFE THREATENING RESPIRATORY DEPRESSION _ Serious, life-threatening or fatal respiratory depression may occur with the use of TRUST ANALGESIC CALMATIVE. 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 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 TRUST ANALGESIC CALMATIVE. Please read this information before you start taking this medicine. WHAT IS IN THIS CMI This leaflet answers some common questions about Trust Analgesic Calmative. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of taking this m 전체 문서 읽기
Trust Analgesic Calmative (V – 06) Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION – TRUST ANALGESIC CALMATIVE (PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE, DOXYLAMINE SUCCINATE) TABLETS WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, TRUST ANALGESIC CALMATIVE 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 _ TRUST ANALGESIC CALMATIVE 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 TRUST ANALGESIC CALMATIVE. 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 TRUST ANALGESIC CALMATIVE. 1 NAME OF THE MEDICINE Paracetamol, codeine phosphate hemihydrate, and doxylamine succinate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains para 전체 문서 읽기