Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
tramadol hydrochloride, Quantity: 50 mg
Arrotex Pharmaceuticals Pty Ltd
Capsule, hard
Excipient Ingredients: magnesium stearate; titanium dioxide; iron oxide yellow; colloidal anhydrous silica; microcrystalline cellulose; Gelatin; sodium starch glycollate; sodium lauryl sulfate
Oral
6 capsules, 8 capsules, 10 capsules, 20 capsules
(S4) Prescription Only Medicine
Zydol capsules are 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: Oblong, yellow/yellow, shiny hard gelatin capsules size 4 with snap fit closure; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2001-11-23
ZYDOL 1 ZYDOL ™ _tramadol hydrochloride_ _ _ CONSUMER MEDICINE INFORMATION (CMI) FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WARNING LIMITATIONS OF USE ZYDOL 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 ZYDOL 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 ZYDOL 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 ZYDOL 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 ZYDOL USING ZYDOL WITH OTHER MEDICINES THAT CAN MAKE YOU FEEL DROWSY SUCH AS SLEEPING CAPSULE (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 ZYDOL. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Zydol capsules. 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 Zydol against the benefits this medicine is expected to have for you. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. KEEP THIS LEAFLET. You may need to read it again. WHAT ZYDOL IS USED FOR ZYDOL is used to relieve severe pain which Прочитать полный документ
1 AUSTRALIAN PRODUCT INFORMATION – ZYDOL ™ (TRAMADOL HYDROCHLORIDE) CAPSULE WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, Zydol 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 Zydol 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 Zydol. 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 Zydol. 2 1 NAME OF THE MEDICINE Tramadol hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zydol 50 mg capsules contain 50 mg of the active ingredient, tramadol hydrochloride. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Oblong, yellow/yellow, shiny hard gelatin capsules size 4 with Snap fit closure. The contents cons Прочитать полный документ