Country: New Zealand
Lingwa: Ingliż
Sors: Medsafe (Medicines Safety Authority)
Codeine phosphate hemihydrate 8mg equivalent to 5.92 mg codeine; Paracetamol 500mg;
Viatris Limited
Codeine phosphate hemihydrate 8 mg (= 5.92 mg codeine)
Tablet
Active: Codeine phosphate hemihydrate 8mg equivalent to 5.92 mg codeine Paracetamol 500mg Excipient: Maize starch Potassium sorbate Povidone Purified talc Starch Stearic acid
Blister pack, PVC/Al, 100 tablets
Prescription
Prescription
Sun Pharmaceuticals Industries (Australia) Pty Ltd
For adults and children aged 12 years and above for effective, temporary relief of pain and discomfort associated with: · headache · migraine headache · tension headache · period pain · back pain · muscle pain · arthritis · toothache · dental procedures · neuralgia · cold and flu symptoms in adults only (18 years and older) · sore throat Paracetamol + Codeine tablets also help reduce fever. Paracetamol + Codeine is suitable for asthmatics sensitive to aspirin and NSAIDs.
Package - Contents - Shelf Life: Blister pack, PVC/Al - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 1000 tablets - 24 months from date of manufacture stored at or below 25°C
2008-07-04
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION PARACETAMOL + CODEINE _PARACETAMOL 500 MG, CODEINE PHOSPHATE 8 MG TABLETS_ WARNINGS _LIMITATIONS OF USE_ Paracetamol + Codeine 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_ Paracetamol + Codeine 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_ Paracetamol + Codeine can cause life-threatening or fatal breathing difficulties (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 Paracetamol + Codeine 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. _CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING _ _ALCOHOL_ Using Paracetamol + Codeine 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 Paracetamol + Codeine. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Paracetamol + Codeine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Paracetamol + Codeine against the benefits he/she expects it will have for you. IF YOU HAVE AN Aqra d-dokument sħiħ
Page 1 of 14 NEW ZEALAND DATA SHEET PARACETAMOL + CODEINE WARNINGS _LIMITATIONS OF USE_ Because of the risks associated with the use of opioids, Paracetamol + Codeine 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 (refer to _section 4.4 _ _Special Warnings and Precautions for Use_). _HAZARDOUS AND HARMFUL USE_ Paracetamol + Codeine 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 (refer to _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 Paracetamol + Codeine. 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 (refer to _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 Paracetamol + Codeine. 1. PRODUCT NAME Paracetamol + Codeine, 500 mg + 8 mg, tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Paracetamol + Codeine contains 500 mg of paracetamol and 8 mg of codeine phosphate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Paracetamol + Code Aqra d-dokument sħiħ