Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
codeine phosphate hemihydrate, Quantity: 8 mg; aspirin, Quantity: 300 mg
Viatris Pty Ltd
Tablet, dispersible
Excipient Ingredients: citric acid; wheat starch; purified talc; saccharin sodium; calcium carbonate; disodium edetate; sodium lauryl sulfate
Oral
20 tablets, 40 tablets
Medicine Registered
(S4) Prescription Only Medicine
For the temporary relief of acute moderate pain, inflammation and fever
Visual Identification: A round white tablet flat with bevelled edges one face plain one engraved FM having a diameter of 17/32".; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1991-08-30
ASPALGIN _aspirin and codeine phosphate hemihydrate_ CONSUMER MEDICINE INFORMATION WARNING LIMITATIONS OF USE ASPALGIN 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 ASPALGIN 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 ASPALGIN 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 ASPALGIN 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 ASPALGIN USING ASPALGIN WITH OTHER MEDICINES THAT CAN MAKE YOU FEEL DROWSY SUCH AS SLEEPING TABLETS (E.G. BENZODIAZE- PINES), OTHER PAIN RELIEVERS, ANTIHISTAMINES, ANTIDEPRESSANTS, ANTIPSYCHOTICS, GABAPENTINOIDS (E.G. GABAPENTIN AND PRE- GABALIN), 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 ASPALGIN. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ASPALGIN. 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 has weighed the risks of you taking ASPALGIN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ASPALGIN IS USED FOR This medicine is used for the temporary relief of acute moderate p Preberite celoten dokument
AUSTRALIAN PRODUCT INFORMATION ASPALGIN _aspirin and codeine phosphate hemihydrate dispersible tablets _ WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, ASPALGIN 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 _ ASPALGIN 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 ASPALGIN. 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 ASPALGIN. 1 NAME OF THE MEDICINE Aspirin and codeine phosphate hemihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ASPALGIN dispersible tablet contains 300 mg aspirin and 8 mg codeine phosphate hemihydrate as the active ingredients. Excipients of known effect: gluten, saccharin. For the full list of excipients, Preberite celoten dokument