ARX MORPHINE MR morphine sulfate pentahydrate 100 mg modified release tablet blister packs

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

morphine sulfate pentahydrate, Quantity: 100 mg

Verfügbar ab:

Southern Cross Pharma Pty Ltd

INN (Internationale Bezeichnung):

morphine sulfate pentahydrate

Darreichungsform:

Tablet, modified release

Zusammensetzung:

Excipient Ingredients: hyetellose; hypromellose; magnesium stearate; povidone; purified talc; titanium dioxide; iron oxide black; macrogol 400

Verabreichungsweg:

Oral

Einheiten im Paket:

20 tablets, 28 tablets, 60 tablets

Verschreibungstyp:

(S8) Controlled Drug

Anwendungsgebiete:

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.

Produktbesonderheiten:

Visual Identification: smooth, round, biconvex grey, film coated tablets embossed with 100 on one face.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2009-04-22

Gebrauchsinformation

MORPHINE MR APOTEX tablets
1
MORPHINE MR APOTEX
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.
MORPHINE MR APOTEX tablets contain the active ingredient morphine
sulfate pentahydrate. MORPHINE MR APOTEX 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 MORPHINE MR APOTEX
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
MORPHINE MR APOTEX tablets?
in the full CMI.
Some medicines may interfere with MORPHINE MR APOTEX 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 MORPHINE MR APOTEX tablets by mouth.
More instructions can be found in Section 4. How do I use MORPHINE MR
APOTEX tablets?
in the full CMI.
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using MORPHINE MR
APOTEX 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.
DRIV

Fachinformation

1
AUSTRALIAN PRODUCT INFORMATION
MORPHINE MR APOTEX (MORPHINE SULFATE
PENTAHYDRATE) MODIFIED RELEASE TABLETS
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, MORPHINE MR
APOTEX 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 MR APOTEX 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 MR APOTEX. 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 MR APOTEX.
1
NAME OF THE MEDICINE
Morphine sulfate pentahydrate
2
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 active ingredient.
Morphine sulfate pentahydrate 100 mg corr