MS CONTIN 10mg
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
26-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
morphine sulfate pentahydrate, Quantity: 10 mg
Available from:
Mundipharma Pty Ltd
INN (International Name):
morphine sulfate pentahydrate
Pharmaceutical form:
Tablet, modified release
Composition:
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
Administration route:
Oral
Units in package:
60 tablets (hospital only), 20 tablets, 28
Prescription type:
(S8) Controlled Drug
Therapeutic indications:
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.
Product summary:
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
Authorization status:
Registered
Authorization date:
2013-06-24
Patient Information leaflet
MS CONTIN
® MODIFIED RELEASE TABLETS
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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
Summary of Product characteristics
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
