Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
tramadol hydrochloride, Quantity: 37.5 mg; paracetamol, Quantity: 325 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; stearic acid; hyprolose; croscarmellose sodium; titanium dioxide; iron oxide yellow; macrogol 8000; hypromellose; povidone; pregelatinised maize starch
Oral
6, 8, 10 Tablets
(S4) Prescription Only Medicine
Tramadol/paracetamol is 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: Yellow, capsule shaped, biconvex, film-coated tablet. Engraved APO on one side and 37.5 - 325 on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-02-22
APO-TRAMADOL/PARACETAMOL 37.5/325 TABLETS 1 APO- TRAMADOL/PARACETAMOL 37.5/325 TABLETS _Tramadol hydrochloride and paracetamol _ CONSUMER MEDICINE INFORMATION WARNINGS LIMITATIONS OF USE Tramadol/Paracetamol 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 Tramadol/Paracetamol 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 Tramadol/Paracetamol 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 Tramadol/Paracetamol 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 TRAMADOL/PARACETAMOL TABLETS Using Tramadol/Paracetamol 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 Tramadol/Paracetamol tablets. _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 using this medicine against the benefits Olvassa el a teljes dokumentumot
1 AUSTRALI AN PRODUCT INFORMATION – APO- TRAMADOL/PARACETAMOL 37.5/325 (TRAMADOL HYDROCHLORIDE, PARACETAMOL) TABLETS WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, tramadol/paracetamol 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 Tramadol/paracetamol 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 tramadol/paracetamol 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 tramadol/paracetamol tablets. 1 NAME OF THE MEDICINE Tramadol hydrochloride and paracetamol. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol, as the active ingredients. LIST OF EX Olvassa el a teljes dokumentumot