MS MONO morphine sulfate pentahydrate 90mg modified release capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

morphine sulfate pentahydrate, Quantity: 90 mg

Available from:

Mundipharma Pty Ltd

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: purified talc; iron oxide red; titanium dioxide; magnesium stearate; sodium lauryl sulfate; iron oxide black; macrogol 6000; erythrosine; hydrogenated vegetable oil; Gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; industrial methylated spirit; Shellac; sulfuric acid; ammonia

Administration route:

Oral

Units in package:

14 capsules

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

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.

Product summary:

Visual Identification: Hard gelatin capsule, containing white to off white multiparticulates 0.25 to 1.8mm in diameter, printed in black ink. Size 2, pink capsules marked MSOD 90.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2000-09-26

Patient Information leaflet

MS MONO
® MODIFIED RELEASE CAPSULES
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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 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

Summary of Product characteristics

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.