Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
tapentadol hydrochloride, Quantity: 116.48 mg (Equivalent: tapentadol, Qty 100 mg)
Seqirus Pty Ltd
tapentadol hydrochloride
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; magnesium stearate; lactose monohydrate; iron oxide yellow; purified talc; povidone; titanium dioxide; iron oxide red; polyvinyl alcohol; microcrystalline cellulose; macrogol 3350; iron oxide black
Oral
30 tablet, 20 tablet, 14 tablets, 28 tablets, 10 tablet, 56 tablets, 40 tablet, 100 tablet, 5 tablets, 90 tablet, 50 tablet, 60 tablet
(S8) Controlled Drug
PALEXIA IR 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: Pale pink, round, biconvex, film-coated tablets, engraved with Grunenthal logo on one side and 'H8' on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2010-11-22
1 PALEXIA ® IR IMMEDIATE RELEASE TABLETS Tapentadol (as hydrochloride) _(TA-PEN-TA-DOL)_ CONSUMER MEDICINE INFORMATION (CMI) WARNING LIMITATIONS OF USE PALEXIA ® IR 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 PALEXIA ® IR 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 PALEXIA ® IR 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 PALEXIA ® IR 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 PALEXIA ® IR Using PALEXIA ® IR 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 PALEXIA ® IR. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PALEXIA ® IR. 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 having PALEXIA ® IR against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PAL Прочитайте повний документ
PALEXIA ® IR AUST R 165310, 165317, 165318 Page 1 of 30 AUSTRALIAN PRODUCT INFORMATION – PALEXIA ® IR (TAPENTADOL (AS HYDROCHLORIDE)) IMMEDIATE RELEASE TABLETS WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, PALEXIA ® IR 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 PALEXIA ® IR 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 PALEXIA ® IR. 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 PALEXIA ® IR. PALEXIA ® IR AUST R 165310, 165317, 165318 Page 2 of 30 1 NAME OF THE MEDICINE Tapentadol (as hydrochloride) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PALEXIA ® IR tablets contain 50, 75 or 100 mg tapentadol (as hydrochloride). Прочитайте повний документ