MORPHINE MR AN morphine sulfate pentahydrate 30 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

morphine sulfate pentahydrate

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

morphine sulfate pentahydrate

Authorization status:

Registered

Patient Information leaflet

MORPHINE MR AN Modified Release tablets
1
MORPHINE MR AN
MODIFIED RELEASE
TABLETS
_Contains the active ingredient morphine sulfate pentahydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about MORPHINE MR
AN. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:

if there is anything you do not
understand in this leaflet,

if you are worried about taking
your medicine, or

to obtain the most up-to-date
information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
MORPHINE MR AN. It contains the
active ingredient morphine sulfate
pentahydrate
It is used to treat:

chronic severe pain.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS _
Opioid analgesics such as morphine
sulphate have been used to treat
chronic cancer pain for many years.
In most cases addiction does not
occur. However, over time your body
becomes used to taking morphine, so
if you suddenly stop taking your
MORPHINE MR AN tablets you
may experience some symptoms of
withdrawal.
It is important that you discuss this
issue with your doctor.
_USE IN CHILDREN _
This medicine must not be used in
children under one year of age or
weighing less than 25 kg. Safety and
effectiveness has not been
establi

Summary of Product characteristics

Product Information – Australia
Morphine MR AN modified release tablets
Page 1
MORPHINE MR AN MODIFIED RELEASE TABLETS
NAME OF THE MEDICINE
Morphine sulfate pentahydrate
Chemical Name:
Di(7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol)
sulfate
pentahydrate.
Structural Formula:
Molecular formula:
C
34
H
40
N
2
O
10
S.5H
2
O
Molecular Weight:
759
CAS Number:
6211-15-0
DESCRIPTION
Morphine sulfate pentahydrate is a white, odourless, crystalline
powder or needle-like crystals. It
is soluble in water and ethanol. It is practically insoluble in ether
or chloroform.
Each modified release tablet contains 10 mg, 30 mg, 60 mg or 100 mg
morphine sulfate
pentahydrate as the active ingredient. In addition, each modified
release tablet contains the
following inactive ingredients: lactose (except the 100 mg),
hyetellose, hypromellose, povidone,
purified talc and magnesium stearate. The tablet coatings contain a
different colourant for each
strength, as follows:

10 mg – Opadry buff OY-3607

30 mg – Opadry violet OY-6708

60 mg – Opadry orange OY-3533

100 mg - Opadry grey OY-8238
Morphine sulfate pentahydrate 100 mg corresponds to 75 mg of morphine
free base.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Morphine sulfate pentahydrate is a narcotic analgesic.
PHARMACODYNAMICS
Morphine is a phenanthrene alkaloid obtained from opium. Morphine and
related compounds
interact with specific receptors primarily found in the brain, spinal
cord and the myenteric plexus
of the gut wall. In humans, the principal pharmacological actions of
morphine are in the central
nervous system (analgesia, drowsiness, mood changes (including
euphoria and dysphoria),
mental clouding, respiratory depression, nausea or emesis, miosis) and
on smooth muscle
(increased gastrointestinal tone with a reduction in propulsive
motion, increased biliary pressure
and increased tone of the ureter and vesical sphincter).
Product Information – Australia
Morphine MR AN modified release tablets
Page 2
Morphine induced analgesia is a result of increas