Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
morphine sulfate pentahydrate, Quantity: 10 mg
Mundipharma Pty Ltd
morphine sulfate pentahydrate
Tablet, modified release
Excipient Ingredients: purified talc; lactose; hyetellose; magnesium stearate; cetostearyl alcohol; titanium dioxide; iron oxide yellow; iron oxide red; polyvinyl alcohol; iron oxide black; macrogol 3350
Oral
60 tablets (hospital only), 20 tablets, 28
(S8) Controlled Drug
MS CONTIN is 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. MS CONTIN is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. MS CONTIN is not indicated as an as-needed (PRN) analgesia.
Visual Identification: light tan film-coated, biconvex tablet, plain on one side and imprinted with the dosage on the other; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2013-06-24
MS CONTIN ® MODIFIED RELEASE TABLETS M S C O N T I N ® t a b l e t s CONSUMER MEDICINE INFORMATION (CMI) SUMMARY 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. 1. WHY AM I USING MS CONTIN TABLETS? MS CONTIN tablets contain the active ingredient morphine sulfate pentahydrate. MS CONTIN tablets are used for the management of pain severe enough to require daily, long-term opioid treatment and for which other forms of treatment have failed or are otherwise inappropriate to provide sufficient management of pain. For more information, see Section 1. Why am I using MS CONTIN tablets? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE MS CONTIN TABLETS? Do not use if you have ever had an allergic reaction to morphine 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 use MS CONTIN tablets? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with MS CONTIN tablets 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. 4. HOW DO I USE MS CONTIN TABLETS? • Your doctor will tell you exactly how much to take. • Follow the instructions given to you by your doctor or your pharmacist. • You must only take MS CONTIN tablets by mouth. More instructions can be found in Section 4. How do I use MS CONTIN tablets? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING MS CONTIN TABLETS? THINGS YOU SHOULD DO • Remind any doctor or dentist you visit that you are using MS CONTIN tablets. • Tell your doctor or pharmacist if you are taking any other medicines that you use to help you relax, anything that contains a Read the complete document
MS CONTIN® TABLETS MS CONTIN® SUSPENSION MODIFIED RELEASE GRANULES Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION MS CONTIN ® (MORPHINE SULFATE PENTAHYDRATE) TABLETS MS CONTIN ® SUSPENSION (MORPHINE SULFATE PENTAHYDRATE) MODIFIED RELASE GRANULES WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, MS CONTIN tablets or suspension 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 _ MS CONTIN tablets or suspension 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 MS CONTIN tablets or suspension. 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 MS CONTIN tablets or suspension. 1 NAME OF THE MEDICINE Morphine sulfate pentahydrate MS CONTIN® TABLETS MS Read the complete document