Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Tramadol hydrochloride 100mg
Seqirus (NZ) Ltd
Tramadol hydrochloride 100 mg
100 mg
Modified release tablet
Active: Tramadol hydrochloride 100mg Excipient: Colloidal silicon dioxide Hypromellose Lactose monohydrate Macrogol 6000 Magnesium stearate Microcrystalline cellulose Propylene glycol Purified talc Titanium dioxide
Blister pack, Al PVC/PVDC or Al/PP, sample pack, 4 tablets
Prescription
Class C2 Controlled Drug
Proto Chemicals AG
Relief of moderate to severe pain.
Package - Contents - Shelf Life: Blister pack, Al PVC/PVDC or Al/PP, sample pack - 4 tablets - 60 months from date of manufacture stored at or below 30°C - Blister pack, Al PVC/PVDC or Al/PP - 20 tablets - 60 months from date of manufacture stored at or below 30°C - Blister pack, Al PVC/PVDC or Al/PP - 60 tablets - 60 months from date of manufacture stored at or below 30°C
1999-07-07
New Zealand Consumer Medicine Information TRAMAL ® SR Tramadol hydrochloride Sustained Release Tablets WARNING Limitations of use TRAMAL ® SR 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 TRAMAL ® SR 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 TRAMAL ® SR 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 TRAMAL ® SR 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 TRAMAL ® SR Using TRAMAL ® SR 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 TRAMAL ® SR. What is in this leaflet? This leaflet answers some common questions about TRAMAL ® SR. It does not contain all the available information. It does not replace talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking TRAMAL ® against the benefits this medicine is expected to have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet. You may need to read it again. What is TRAMAL ® SR used for TRAMAL ® SR is used to reliev Leggi il documento completo
1 NEW ZEALAND DATA SHEET TRAMAL ® CAPSULES TRAMAL ® SOLUTION FOR INJECTION TRAMAL ® SR TABLETS 1. PRODUCT NAME Tramal ® (tramadol hydrochloride) immediate release capsules 50 mg Tramal ® (tramadol hydrochloride) solution for injection 50 mg/mL, 100 mg/2mL Tramal ® SR tablets (tramadol hydrochloride) sustained release tablets) 50 mg, 100 mg, 150 mg, 200 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TRAMAL ® 50 MG CAPSULES ARE YELLOW-YELLOW CAPSULES CONTAINING: 50 mg tramadol hydrochloride. TRAMAL ® 50 MG AND 100 MG INJECTIONS CONTAIN: tramadol hydrochloride 50 mg/mL. TRAMAL ® SR SUSTAINED RELEASE TABLETS CONTAIN: tramadol hydrochloride in the following dose strengths: 50, 100, 150 and 200 mg. For full list of excipients, see section 6.1 LIST OF EXCIPIENTS. Tramal ® capsules, Tramal ® solution for injection, and Tramal ® SR tablets contain tramadol hydrochloride which is ( +) - _cis_-2-(dimethylaminomethyl)-1-(3-methoxyphenyl)-cyclohexanol hydrochloride. Tramadol hydrochloride is an odourless, white to off-white crystalline powder WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, Tramal ® 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 Tramal ® 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 Tramal ® . 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 ( Leggi il documento completo