Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
morphine sulfate pentahydrate, Quantity: 60 mg
Mundipharma Pty Ltd
Capsule, modified release
Excipient Ingredients: iron oxide red; sodium lauryl sulfate; indigo carmine; magnesium stearate; titanium dioxide; purified talc; macrogol 6000; iron oxide yellow; Gelatin; hydrogenated vegetable oil; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; industrial methylated spirit; iron oxide black; Shellac; sulfuric acid; ammonia
Oral
14 capsules
(S8) Controlled Drug
MS MONO capsules are 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 MONO capsules are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. MS MONO capsules are not indicated as an as-needed (PRN) analgesia.
Visual Identification: Hard gelatin capsules, containing white to off white multiparticulates 0.25 to 1.8mm in diameter, printed in black ink. Size 3, brown capsules marked MSOD 60.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2000-09-26
MS MONO ® MODIFIED RELEASE CAPSULES M S M o n o ® c a p s u l e 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 MONO CAPSULES? MS MONO capsules contain the active ingredient morphine sulfate pentahydrate. MS MONO capsules 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 MONO capsules? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE MS MONO CAPSULES? 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 MONO capsules? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with MS MONO capsules 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 MONO CAPSULES? • 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 MONO capsules by mouth. More instructions can be found in Section 4. How do I use MS MONO capsules? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING MS MONO CAPSULES? THINGS YOU SHOULD DO • Remind any doctor or dentist you visit that you are using MS MONO capsules. • Tell your doctor or pharmacist if you are taking any other medicines that you use to help you relax, anything that contains alcohol (like co Read the complete document
MS MONO® MODIFIED RELEASE CAPSULES Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION – MS MONO ® (MORPHINE SULFATE PENTAHYDRATE) MODIFIED RELEASE CAPSULES WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, MS MONO capsules 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 MONO capsules pose 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 MONO capsules. 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 MONO capsules. 1 NAME OF THE MEDICINE Morphine sulfate pentahydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION MS MONO capsules are a range of modified release capsules containing a multi-particulate formulation of morphine sulfate pentahydrate. Read the complete document