GAMINE XR galantamine (as hydrobromide) 24mg modified release capsules blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

galantamine hydrobromide, Quantity: 30.756 mg (Equivalent: galantamine, Qty 24 mg)

MAH:

Arrotex Pharmaceuticals Pty Ltd

INN:

Galantamine hydrobromide

pharmaceutical_form:

Capsule, modified release

composition:

Excipient Ingredients: indigo carmine; iron oxide red; erythrosine; Gelatin; hypromellose; magnesium stearate; titanium dioxide; iron oxide yellow; microcrystalline cellulose; ethylcellulose

administration_route:

Oral

units_in_package:

28

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

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

leaflet_short:

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

authorization_status:

Registered

authorization_date:

2012-01-20

PIL

GAMINE XR – Consumer Medicine Information
Page 1 of 4
GAMINE XR CAPSULES
_galantamine hydrobromide _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Gamine XR 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 this medicine against the
benefits this medicine is expected to
have for you.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT TAKING
GAMINE XR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT GAMINE XR IS USED
FOR
Gamine XR 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 lack of
acetylcholine, a substance which
transmits messages between brain
cells. Gamine XR 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 this
medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE GAMINE XR IF YOU HAVE:
•
an allergy to Gamine XR 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 THIS MEDICINE IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
DO NOT USE IT BEYOND THE EXPIRY DATE
(MONTH AND YEAR) PRINTED ON THE
PACK.
_BEFORE YOU TAKE IT _
YOU MUST TELL YOUR DOCTOR IF YOU
ARE:
•
pregnant, or planning to become
pregnant
•
breastfeeding, or planning to
breastfeed
•
planning to underg

SPC

AUSTRALIAN PRODUCT INFORMATION – GAMINE XR (GALANTAMINE
(AS 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.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
GALANTAMINE 8 mg modified release capsules are opaque white-white,
size 2 hard gelatin capsules
containing one round biconvex tablet.
GALANTAMINE 16 mg modified release capsules are opaque flesh-flesh,
size 2 hard gelatin capsules
containing two round biconvex tablets.
GALANTAMINE 24 mg modified release capsules are opaque orange-orange,
size 2 hard gelatin
capsules containing three round biconvex tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Galantamine is indicated for the treatment of mild to moderately
severe dementia of the Alzheimer
type.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Galantamine modified release capsules should be administered once
daily in the morning, preferably
with food. Ensure adequate fluid intake during treatment. The capsule
must be swallowed whole.
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.
STARTING DOSE
The recommended starting dose is 8 mg a day for four weeks.
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 longer than several days, treatment
should be re-initiated with the
lowest daily dose and gradually increased to the maximum t