Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
codeine phosphate hemihydrate, Quantity: 12.8 mg; ibuprofen, Quantity: 200 mg
Soul Pattinson Manufacturing Pty Ltd
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; colloidal anhydrous silica; pregelatinised maize starch; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400
Oral
24, 30, 15, 20, 10, 12
(S4) Prescription Only Medicine
For the temporary relief of acute moderate pain and inflammation
Visual Identification: White to off white coloured, caplet shaped film coated tablets plain on both sides.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2019-05-30
Product Information Medco Ibuprofen 200 & Codeine phosphate 12.8 V1220 Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION – MEDCO IBUPROFEN 200 & CODEINE PHOSPHATE 12.8 (IBUPROFEN & CODEINE PHOSPHATE HEMIHYDRATE) WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, Medco Ibuprofen 200 & Codeine Phosphate 12.8 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 _ Medco Ibuprofen 200 & Codeine Phosphate 12.8 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 Medco Ibuprofen 200 & Codeine Phosphate 12.8. 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 Medco Ibuprofen 200 & Codeine Phosphate 12.8. 1. NAME OF THE MEDICINE Ibuprofen 200mg/Codeine phosphate 12.8m Przeczytaj cały dokument