APO-Galantamine
Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
Lietošanas instrukcija
(PIL)
23-05-2024
Produkta apraksts
(SPC)
23-05-2024
Aktīvā sastāvdaļa:
Galantamine hydrobromide
Pieejams no:
Apotex Pty Ltd
Klase:
Medicine Registered
Lietošanas instrukcija
APO-GALANTAMINE MR
CAPSULES
_Contains the active ingredient galantamine (as galantamine
hydrobromide)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about galantamine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Galantamine MR. It contains the
active ingredient galantamine
hydrobromide.
It is used to treat:
•
mild to moderately severe
dementia of the Alzheimer's type.
The symptoms of Alzheimer's
disease include confusion, memory
loss or other changes in behaviour.
As the disease progresses, patients
find it more and more difficult to
carry out their normal daily activities.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
The symptoms of Alzheimer's
disease are thought to be due to a
lack of acetylcholine, a substance
which transmits messages between
brain cells. APO-Galantamine MR
increases the a
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Produkta apraksts
Product Information
APO-Galantamine MR modified release capsules
Page 1 of 18
APO-GALANTAMINE MR CAPSULES
NAME OF THE MEDICINE
PROPRIETARY NAME: APO-Galantamine MR galantamine (as hydrobromide) modified release
capsules
NON PROPRIETARY NAME: Galantamine (as hydrobromide)
COMPOSITION
Galantamine modified release capsules contain the
active galantamine hydrobromide,
equivalent to 8, 16, 24 mg galantamine base. Inactive
ingredients include microcrystalline
cellulose, hypromellose, ethylcellulose and magnesium stearate. The capsules contain
gelatin and titanium dioxide (8, 16 and 24 mg), iron oxide red (16
and 24 mg) indigo carmine,
erythrosine and iron oxide yellow (24 mg).
The chemical structure of galantamine is:
C
17
H
21
NO
3.
HBr
CAS number: 1953-04-4
MW: 368.27
DESCRIPTION
Chemical name: Galantamine hydrobromide, (4a_S_,
6_R_, 8a_S_)-4a,5,9,10,11,12-hexahydro-3-
methoxy-11-methyl-6_H_benzofuro[3a,3,2-_ef_][2]benzazepin-6-ol hydrobromide, is a white to
almost white powder with a solubility in water at 25
o
C of 3.69 g/100 mL. It is slightly soluble in
methanol and very slightly soluble in ethanol and
acetonitrile. The pK
a
is 8.2 with a pH of 5.2.
Galantamine hydrobromide
contains three chiral centres and is presented as a single
enantiomer.
PHARMACOLOGY
Galantamine is a cholinomimetic with a
dual mechanism of action. Galantamine is a
reversible inhibitor of the enzyme acetylcholinesterase, and
enhances the intrinsic action of
acetylcholine on nicotinic receptors.
PHARMACODYNAMICS
The cognitive dysfunction (memory, attention, learning) in dementia of the Alzheimer type is
related to the profound dysfunction of the cholinergic neurotrans
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