MORPHINE LUPIN MR morphine sulfate pentahydrate 10 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

morphine sulfate pentahydrate, Quantity: 10 mg

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

morphine sulfate pentahydrate

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: povidone; hypromellose; magnesium stearate; hyetellose; purified talc; lactose monohydrate; titanium dioxide; iron oxide yellow; iron oxide red; macrogol 400

Administration route:

Oral

Units in package:

28 tablets, 60 tablets, 20 tablets

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

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. Is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. Is not indicated as an as-needed (PRN) analgesia.

Product summary:

Visual Identification: smooth, round, biconvex buff, film coated tablets embossed with 10 on one face.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-07-03

Summary of Product characteristics

MORPHINE LUPIN MR v2
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
MORPHINE LUPIN MR (MORPHINE SULFATE
PENTAHYDRATE) MODIFIED RELEASE TABLETS
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, MORPHINE
LUPIN MR 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 _
MORPHINE LUPIN MR 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 MORPHINE
LUPIN MR. 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 MORPHINE LUPIN MR.
MORPHINE LUPIN MR v2
Page 2 of 20
1
NAME OF THE MEDICINE
Morphine sulfate pentahydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release tablet contains 10 mg, 30 mg, 60 mg or 100 mg of
morphine sulfate
pentahydrate as the a