ANAMORPH 30mg Tablet Blister

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

morphine sulfate pentahydrate, Quantity: 30 mg

متاح من:

Arrotex Pharmaceuticals Pty Ltd

الشكل الصيدلاني:

Tablet, uncoated

تركيب:

Excipient Ingredients: magnesium stearate; lactose; croscarmellose sodium

طريقة التعاطي:

Oral

الوحدات في الحزمة:

20 tablets, 10 tablets, 6 tablets, 8 tablets

نوع الوصفة الطبية :

(S8) Controlled Drug

الخصائص العلاجية:

Anamorph is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

ملخص المنتج:

Visual Identification: Round white flat bevelled edge tablet 5/16" diameter, scored on one side and marked with letter M above breakline and the numeral 30 below; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

الوضع إذن:

Registered

تاريخ الترخيص:

1991-12-11

نشرة المعلومات

ANAMORPH- Consumer Medicine Information
Page 1 of 5
ANAMORPH TABLETS
morphine sulfate pentahydrate
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ANAMORPH tablets.
It does not contain all the available
information about this medicine.
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 ANAMORPH
against the benefits they expect it
will have for you.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT IS ANAMORPH
USED FOR
The name of your medicine is
ANAMORPH. It is available as a 30
mg tablet.
The active ingredient is called
morphine sulfate
.
Morphine sulfate
belongs to a group
of medicines called analgesics. It is
an opioid analgesic, and it acts in
the central nervous system by
blocking pain and your emotional
response to pain.
ANAMORPH is used to treat
moderate to severe pain.
Your doctor however may have
prescribed ANAMORPH for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
ANAMORPH HAS BEEN PRESCRIBED
FOR YOU.
This medicine only available with a
doctor’s prescription.
ANAMORPH may be habit-forming,
so it is important to take it exactly
as directed by your doctor.
AS WITH ALL OTHER OPIOID
CONTAINING PRODUCTS, YOUR BODY
MAY BECOME USED TO YOU TAKING
ANAMORPH. TAKING IT MAY
RESULT IN PHYSICAL DEPENDENCE.
PHYSICAL DEPENDENCE MEANS
THAT YOU MAY EXPERIENCE
WITHDRAWAL SYMPTOMS IF YOU
STOP TAKING ANAMORPH
SUDDENLY, SO IT IS IMPORTANT TO
TAKE IT EXACTLY AS DIRECTED BY
YOUR DOCTOR.
WARNING
LIMITATIONS OF USE
should only be used when your doctor decides that other treatment
options are not able to
effectively manage your pain or you cannot tolerate them.
HAZARDOUS AND HARMFUL USE
ANAMORPH poses risks of abuse, misuse and addiction which can lead to
overdose and death. Your
doctor will monitor you regularly during treatment.
LIFE TH

خصائص المنتج

1
AUSTRALIAN PRODUCT INFORMATION
ANAMORPH (MORPHINE SULFATE PENTAHYDRATE) TABLET
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Anamorph
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 _
Anamorph 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
Anamorph. 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 Anamorph.
1
NAME OF THE MEDICINE
Morphine sulfate pentahydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Morphine is a phenanthrene-derivative opiate agonist. Morphine is the
chief opium alkaloid which is
dried or partially dried latex from the capsules of _Papaver
sonniferum_.
Anamorph tablets: Each tablet contains 30 mg morphine