Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
codeine phosphate hemihydrate, Quantity: 30 mg
Aspen Pharmacare Australia Pty Ltd
codeine phosphate hemihydrate
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; maize starch; magnesium stearate
Oral
100 tablets, 10, 20 tablets
(S8) Controlled Drug
Aspen Codeine tablets are indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.
Visual Identification: Plain white round biconvex tablet of diameter 7/32"; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2016-08-31
1 ASPEN CODEINE TABLETS CONSUMER MEDICINE INFORMATION WARNING LIMITATIONS OF USE Aspen Codeine tablets 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 Aspen Codeine tablets 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 Aspen Codeine tablets 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 Aspen Codeine tablets 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 ASPEN CODEINE TABLETS Using Aspen Codeine tablets 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 Aspen Codeine tablets. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Aspen Codeine tablets. It does not contain all of the available information about Aspen Codeine tablets. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Aspen Codeine tablets against the benefits he/she expect it will have. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need t Read the complete document
Aspen Codeine tablets - July 2020 1 AUSTRALIAN PRODUCT INFORMATION ASPEN CODEINE (CODEINE PHOSPHATE HEMIHYDRATE) TABLETS WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, Aspen Codeine 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 Aspen Codeine 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 Aspen Codeine 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 Aspen Codeine tablets. 1 NAME OF THE MEDICINE Codeine phosphate hemihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipient with known effect: Contains sugar as lactose For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Plain white rou Read the complete document