MS Mono

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

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Hent Indlægsseddel (PIL)
19-06-2024
Hent Produktets egenskaber (SPC)
19-06-2024

Aktiv bestanddel:

Morphine sulfate

Tilgængelig fra:

Mundipharma Pty Ltd

Klasse:

Medicine Registered

Indlægsseddel

                                MS MONO
®
 CAPSULES
 
_Morphine sulfate (mor-fean sul-fate)_
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MS Mono controlled
release capsules ("capsules").
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MS MONO
CAPSULES ARE TAKEN FOR
MS Mono capsules contain morphine
sulfate. Morphine belongs to a group
of medicines called opioid
analgesics.
MS Mono capsules are used to treat
chronic severe pain.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
As with all strong painkillers, your
body may become used to you taking
MS Mono capsules. Taking it may
result in physical dependence.
Physical dependence means that you
may experience withdrawal
symptoms if you stop taking MS
Mono capsules suddenly, so it is
important to take it exactly as
directed by your doctor.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE MS MONO CAPSULES IF
YOU:
•
have any breathing problems such
as acute asthma, respiratory
depression (breathing slows or
weakens) or other obstructive
airways disease
•
are severely drowsy or have a
reduced level of consciousness
•
suffer from irregular heartbeats or
changes in the way the heart beats
•
have heart disease due to long-
term lung disease
•
have just consumed a large
amount of alcohol, regularly
consume large amounts of
alcohol or have confusion and
shaking due to alcohol
withdrawal
•
suffer from convulsions, fits or
seizures
•
have a head injury, brain tumour,
increased pressure in your head or
spine
•
have sudden, severe abdomina
                                
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Produktets egenskaber

                                 
 
MS Mono
®
 capsules PI (22 April 2013) 
SUPERSEDES PI (17 Feb 11) 
mfpmsmon10413 
PAGE: 1 of 14 
PRODUCT INFORMATION 
 
MS MONO

 CAPSULES  
30 MG, 60 MG, 90 MG AND 120 MG 
 
 
NAME OF THE MEDICINE 
Morphine sulfate BP 
The structural formula of morphine sulfate is: 
 
 
 
CAS Registry Number: 6211 - 15 - 0 
 
 
DESCRIPTION 
Morphine sulfate is  a  white, odourless crystalline powder or needle-like  crystals.   Morphine 
sulfate  has  solubility  of  1:21  in  water  and  1:1000  in  ethanol.    The  chemical  name  is  7,8-
didehydro-4,5

-epoxy-17-methylmorphinan-3,6α-diol  sulfate  salt  (2:1)  pentahydrate.    It  is 
practically insoluble in ether or chloroform.
  
 
 
MS  Mono  capsules  are  a  range  of  modified  release  capsules  containing  a  multi-particulate 
formulation  of  morphine  sulfate,  intended  for  once-daily  oral  administration.    The  inactive 
ingredients in MS Mono capsules are hydrogenated vegetable oil, macrogol 6000, magnesium 
stearate and purified talc.  The capsule shells contain gelatin and sodium lauryl sulfate.  They 
also contain the following colouring materials: 
 
 
STRENGTH 
COLOURING MATERIAL 
30 MG 
60 MG 
90 MG 
120 MG 
Erythrosine (E127) 
 
 
 
 
Indigo carmine (E132) 
 
 
 
 
Iron oxide black (E172) 
 
 
 
 
Iron oxide red (E172) 
 
 
 
 
Iron oxide yellow (E172) 
 
 
 
 
Titanium dioxide (E171) 
 
 
 
 
 
The capsules are all printed in black ink which contains shellac, iron oxide black (E172) and 
propylene glycol. 
 
 
 
MS Mono
®
 capsules PI (22 April 2013) 
SUPERSEDES PI (17 Feb 11) 
mfpmsmon10413 
PAGE: 2 of 14 
 
PHARMACOLOGY 
Pharmacodynamics 
Morphine and related compounds interact with specific receptors p
                                
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