SEVREDOL morphine sulfate pentahydrate 20mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
morphine sulfate pentahydrate, Quantity: 20 mg
Available from:
Mundipharma Pty Ltd
INN (International Name):
morphine sulfate pentahydrate
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: povidone; lactose; magnesium stearate; purified talc; pregelatinised maize starch; titanium dioxide; sunset yellow FCF aluminium lake; polyvinyl alcohol; macrogol 3350; erythrosine aluminium lake
Administration route:
Oral
Units in package:
20 tablets
Prescription type:
(S8) Controlled Drug
Therapeutic indications:
Treatment of chronic severe pain of cancer.
Product summary:
Visual Identification: Pink, film coated, biconvex capsule-shaped tablets with a scoreline and "IR" to the left and "20" to the right; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2013-10-08
Patient Information leaflet
SEVREDOL
® TABLETS
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
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.
1.
WHY AM I USING SEVREDOL?
SEVREDOL contains the active ingredient morphine sulfate pentahydrate.
SEVREDOL is used for the treatment of chronic severe
pain of cancer.
For more information, see Section 1. Why am I using SEVREDOL? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SEVREDOL?
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
SEVREDOL? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SEVREDOL 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.
4.
HOW DO I USE SEVREDOL?
•
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 SEVREDOL by mouth.
More instructions can be found in Section 4. How do I use SEVREDOL? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SEVREDOL?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using SEVREDOL.
•
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
•
SEVREDOL may cause drowsiness. If affected, do not drive a vehicle or
Read the complete document
Summary of Product characteristics
SEVREDOL
®
TABLETS
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION – SEVREDOL
® (MORPHINE
SULFATE PENTAHYDRATE) TABLETS
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, SEVREDOL
tablets 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 _
SEVREDOL tablets 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 SEVREDOL
tablets. 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 SEVREDOL tablets.
1
NAME OF THE MEDICINE
Morphine sulfate pentahydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SEVREDOL 10 mg tablets contain 10 mg morphine sulfate pentahydrate.
SEVREDOL 20 mg tablets contain 20 mg morphine sulfate pentahydrate.
SEVREDOL tablets contain the fo
Read the complete document
