MOMEX SR morphine sulfate as pentahydrate 60 mg tablet blister packs

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

morphine sulfate pentahydrate

Verfügbar ab:

Southern Cross Pharma Pty Ltd

INN (Internationale Bezeichnung):

morphine sulfate pentahydrate

Berechtigungsstatus:

Registered

Gebrauchsinformation

MOMEX SR tablets
1
MOMEX SR
MODIFIED RELEASE TABLETS
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.
MOMEX SR tablets contain the active ingredient morphine sulfate
pentahydrate. MOMEX SR 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 MOMEX SR tablets?
in the full CMI.
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
MOMEX SR tablets?
in the full CMI.
Some medicines may interfere with MOMEX SR 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.
•
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 MOMEX SR tablets by mouth.
More instructions can be found in Section 4. How do I use MOMEX SR
tablets?
in the full CMI.
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using MOMEX SR
tablets.
•
Tell your doctor or pharmacist if you are taking any other medicines
that you use to help you relax,
anything that contains alcohol (like cough syrup) or other medicines
that treat pain.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not take more than your doctor tells you to.
DRIVING
OR USING
MACHINES
•
MOMEX SR tablets may cause drowsiness. If affected, do not drive a
vehicle

Fachinformation

1
AUSTRALIAN PRODUCT INFORMATION
MOMEX SR (MORPHINE SULFATE
PENTAHYDRATE) MODIFIED RELEASE TABLETS
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Momex SR
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 _
Momex SR 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 Momex
SR. 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 Momex SR.
1
NAME OF THE MEDICINE
Morphine sulfate pentahydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The products Momex SR 10 mg, 30 mg, 60 mg and 100 mg contain morphine
sulfate
pentahydrate as the active ingredient.
2
Morphine sulfate pentahydrate 100 mg corresponds to 75 mg of morphine
free base.
List of excipients w