GALANTAMINE AN SR galantamine (as hydrobromide) 24mg modified release capsules blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
galantamine hydrobromide
Available from:
Southern Cross Pharma Pty Ltd
INN (International Name):
Galantamine hydrobromide
Authorization status:
Registered
Patient Information leaflet
________________________________________________________________________________
C: Products/Galant/CMI AN 27february2015
Page
1 of 4
GALANTAMINE AN SR CAPSULES
_Galantamine hydrobromide _
_ _
CONSUMER MEDICINE INFORMATION
_ _
What is in this leaflet
This leaflet answers some common
questions about Galantamine AN SR
modified release capsules. It does not
contain all the available information. 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 Galantamine AN SR against
the benefits this medicine is expected
to have for you.
If you have any concerns about taking
Galantamine AN SR, ask your doctor
or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What Galantamine AN
SR is used for
Galantamine AN SR 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.
The symptoms of Alzheimer’s disease
are thought to be due to a lack of
acetylcholine, a substance which
transmits messages between brain
cells. Galantamine AN SR increases
the amount of this substance to help
improve or stabilise the symptoms and
therefore slow the progress of
Alzheimer’s disease.
Your doctor may have prescribed
Galantamine AN SR for another
reason. Ask your doctor if you have
any questions about why this medicine
has been prescribed for you.
Before you take
Galantamine AN SR
_When you must not take it _
Do not take Galantamine AN SR if you
have:
an allergy to Galantamine AN SR
or any of the ingredients. See
PRODUCT DESCRIPTION at the end of
this leaflet for a list of ingredients.
severe liver and/or kidney disease.
Do not take Galantamine AN SR if the
packaging is torn or shows signs of
tampering. Do not use Galantamine
AN SR beyond the expiry date (month
and year) printed
Read the complete document
Summary of Product characteristics
C:Products/Galantamine/PI AN
Page 1 of 19
PRODUCT INFORMATION
GALANTAMINE AN SR MODIFIED RELEASE CAPSULES
NAME OF THE MEDICINE
PROPRIETARY NAME: Galantamine AN SR galantamine (as hydrobromide)
modified
release capsules
NON PROPRIETARY NAME: Galantamine (as hydrobromide)
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.
C:Products/Galantamine/PI AN
Page 2 of 19
PHARMACODYNAMICS
The cognitive dysfunction (memory, attention, learning) in dementia of
the Alzheimer
type is related to the profound dysfunction of the cholinergic
neurotransmission system
in
the
brain.
Galantamine,
a
tertiary
alkaloid,
enhances
the
efficacy
of
the
physiologically
available
acetylcholine
through
a
dual
mechanism
of
action:
acetylcholinesterase inhibition and nicotinic receptor modulation.
Galantamine is a selective, competitive and reversible inhibitor of
acetylcholinesterase,
the enzyme responsible for t
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