APO-GALANTAMINE MR galantamine (as hydrobromide) 8 mg modified release capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

galantamine hydrobromide, Quantity: 10.252 mg (Equivalent: galantamine, Qty 8 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Galantamine hydrobromide

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: titanium dioxide; microcrystalline cellulose; hypromellose; ethylcellulose; Gelatin; magnesium stearate

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Galantamine is indicated for the treatment of mild to moderately severe dementia of the Alzheimer type

Product summary:

Visual Identification: opaque white-white size 2 hard gelatin capsule containing one round biconvex tablet; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-01-20

Patient Information leaflet

APO-GALANTAMINE MR CAPSULES
1
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
This leaflet answers some common
questions about this medicine. 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 this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need 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 (as
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.
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 increases
the amount of this substance, to help
improve or stabilise the symptoms
and therefore slow the progress of
Alzheimer’s disease.
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.
There is no evidence that this
medicine is addictive.
This medicine should not be used in
children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
galantamine
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
r

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-GALANTAMINE MR (GALANTAMINE
HYDROBROMIDE) MODIFIED RELEASE CAPSULES
1
NAME OF THE MEDICINE
Galantamine (as hydrobromide)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Galantamine
modified
release
capsules
contain
the
active
galantamine
hydrobromide,
equivalent to 8, 16, 24 mg galantamine base.
EXCIPIENTS WITH KNOWN EFFECT
Contains traces of galactose.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-GALANTAMINE 8 MG MODIFIED RELEASE CAPSULES
Opaque white-white, size 2 hard gelatin capsules containing one round
biconvex tablet.
APO-GALANTAMINE 16 MG MODIFIED RELEASE CAPSULES
Opaque flesh-flesh, size 2 hard gelatin capsules containing two round
biconvex tablets.
APO-GALANTAMINE 24 MG MODIFIED RELEASE CAPSULES
Opaque orange-orange, size 2 hard gelatin capsules containing three
round biconvex tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Galantamine is indicated for the treatment of mild to moderately
severe dementia of the
Alzheimer type.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Galantamine modified release capsules are intended for oral
administration.
Galantamine modified release capsules should be administered once
daily in the morning,
preferably with food. Ensure adequate fluid intake during treatment.
The contents should not
be crushed and sprinkled on food. The dose of galantamine should be
gradually increased to
the maintenance dose to minimise side effects.
DOSAGE
STARTING DOSE
The recommended starting dose is 8 mg a day for four weeks.
2
MAINTENANCE DOSE
•
The initial maintenance dose is 16 mg a day and patients should be
maintained on this dose
for at least 4 weeks.
•
An increase to the maximum recommended maintenance dose of 24 mg a day
should be
considered after appropriate assessment including evaluation of
clinical benefit and
tolerability.
•
There is no rebound effect after abrupt discontinuation of treatment,
for example, prior to
surgery.
RE-INITIATION OF THERAPY
If treatment is interrupted for longe