Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
morphine sulfate pentahydrate, Quantity: 20 mg
Mundipharma Pty Ltd
morphine sulfate pentahydrate
Tablet, film coated
Excipient Ingredients: povidone; lactose; magnesium stearate; purified talc; pregelatinised maize starch; titanium dioxide; sunset yellow FCF aluminium lake; polyvinyl alcohol; macrogol 3350; erythrosine aluminium lake
Oral
20 tablets
(S8) Controlled Drug
Treatment of chronic severe pain of cancer.
Visual Identification: Pink, film coated, biconvex capsule-shaped tablets with a scoreline and "IR" to the left and "20" to the right; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2013-10-08
SEVREDOL ® TABLETS S E V R E D O L ® 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 SEVREDOL? SEVREDOL contains the active ingredient morphine sulfate pentahydrate. SEVREDOL is used for the treatment of chronic severe pain of cancer. For more information, see Section 1. Why am I using SEVREDOL? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SEVREDOL? 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 SEVREDOL? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with SEVREDOL 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 SEVREDOL? • 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 SEVREDOL by mouth. More instructions can be found in Section 4. How do I use SEVREDOL? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SEVREDOL? THINGS YOU SHOULD DO • Remind any doctor or dentist you visit that you are using SEVREDOL. • Tell your doctor or pharmacist if you are taking any other medicines that you use to help you relax, anything that contains alcohol (like cough syrup) or other medicines that treat pain. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. • Do not take more than your doctor tells you to. DRIVING OR USING MACHINES • SEVREDOL may cause drowsiness. If affected, do not drive a vehicle or Lue koko asiakirja
SEVREDOL ® TABLETS Page 1 of 18 AUSTRALIAN PRODUCT INFORMATION – SEVREDOL ® (MORPHINE SULFATE PENTAHYDRATE) TABLETS WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, SEVREDOL tablets 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 _ SEVREDOL tablets 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 SEVREDOL tablets. 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 SEVREDOL tablets. 1 NAME OF THE MEDICINE Morphine sulfate pentahydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SEVREDOL 10 mg tablets contain 10 mg morphine sulfate pentahydrate. SEVREDOL 20 mg tablets contain 20 mg morphine sulfate pentahydrate. SEVREDOL tablets contain the fo Lue koko asiakirja