Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
codeine phosphate hemihydrate,doxylamine succinate,paracetamol
Cipla Australia Pty Ltd
codeine phosphate hemihydrate,doxylamine succinate,Paracetamol
Registered
Maxydol 1 MAXYDOL 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 MAXYDOL? Maxydol contains the active ingredient paracetamol, codeine phosphate hemihydrate and doxylamine succinate. Maxydol is used for temporary relief of acute moderate pain when other analgesics have proven not to be effective. For more information, see Section 1. Why am I using Maxydol? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE MAXYDOL? Do not use if you have ever had an allergic reaction to Maxydol 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. You may develop addiction, dependence, and tolerance. For more information, see Section 2. What should I know before I use Maxydol? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Maxydol 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 MAXYDOL? The standard dose for adults is 1 or 2 tablets for severe pain, taken every 4 to 6 hours if necessary. More instructions can be found in Section 4. How do I use Maxydol? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING MAXYDOL ? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist when you visit that you are using Maxydol. • Talk to your doctor or pharmacist if this medicine is not relieving your pain. • Tell your doctor or pharmacist, if you become pregnant while you are taking this medicine. THINGS YOU SHOULD NOT DO • Do not take more than the recommended dose, unless your doctor tells you to. Do not take more than 8 tablets a day. • Do not give this medicine to children under 12 Lesen Sie das vollständige Dokument
1 AUSTRALIAN PRODUCT INFORMATION-MAXYDOL (PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE, AND DOXYLAMINE SUCCINATE) TABLETS WARNINGS _Limitations of use _ Because of the risks associated with the use of opioids, Maxydol 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 _ Maxydol 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 Maxydol. 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 Maxydol. 1 NAME OF THE MEDICINE Paracetamol, Codeine phosphate hemihydrate and Doxylamine succinate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains paracetamol 500mg, codeine phosphate hemihydrate 10mg, and doxylamine succinate 5.1mg. For the full list of excipients, see Section 6.1 List of Lesen Sie das vollständige Dokument