Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
tramadol hydrochloride, Quantity: 150 mg
Southern Cross Pharma Pty Ltd
Tramadol hydrochloride
Tablet, modified release
Excipient Ingredients: hyprolose; magnesium stearate; colloidal anhydrous silica; calcium hydrogen phosphate dihydrate
Oral
20 tablets
(S4) Prescription Only Medicine
Indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. Not indicated for use in chronic non-cancer pain other than in exceptional circumstances. Not indicated as an as-needed (PRN) analgesia.
Visual Identification: off-white, capsule shaped tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2009-03-10
APO-TRAMADOL SR 1 APO-TRAMADOL SR MODIFIED RELEASE TABLETS The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. APO-TRAMADOL SR contains the active ingredient tramadol hydrochloride. APO-TRAMADOL SR is used to relieve severe pain. For more information, see Section 1. Why am I taking APO-TRAMADOL SR? in the full CMI. Do not take if you have ever had an allergic reaction to tramadol hydrochloride, other opioids or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. FOR MORE INFORMATION, SEE SECTION 2. WHAT SHOULD I KNOW BEFORE I TAKE APO-TRAMADOL SR? IN THE FULL CMI. Some medicines may interfere with APO-TRAMADOL SR and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. Swallow the tablets whole with a glass of water. Discuss with your doctor the correct dose for you. Do not take more than four of the 100 mg tablets per day or two of the 150 mg or of the 200 mg tablets per day. More instructions can be found in Section 4. How do I take APO-TRAMADOL SR? in the full CMI. THINGS YOU SHOULD DO Remind any doctor, dentist or pharmacist you visit that you are taking APO-TRAMADOL SR. Remind your doctor if you are allergic to tramadol, opioids or any of the ingredients in this medicine or if you have had any problems with drug or alcohol dependence. If you become pregnant or plan to breast-feed while taking this medicine, tell your doctor immediately. If you are about started any new medicine, tell your doctor or pharmacist that you are taking this medicine. If your pain is not as severe or if your pain is not helped or gets worse, talk to your doctor. If you are going to have surger Read the complete document
APO-Tramadol SR – AUSTRALIAN PRODUCT INFORMATION AUSTRALIAN PRODUCT INFORMATION APO-TRAMADOL SR, 100MG, 150MG AND 200MG MODIFIED RELEASE TABLETS WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, APO-Tramadol SR 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 _ APO-Tramadol SR 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 APO-Tramadol SR. 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 APO-Tramadol SR. APO-Tramadol SR – AUSTRALIAN PRODUCT INFORMATION 1. NAME OF THE MEDICINE Tramadol hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION APO-Tramadol SR tablets contain the active ingredient tramadol hydrochloride Each modified release Read the complete document