REMINYL galantamine 16mg (as hydrobromide) modified release capsule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

galantamine hydrobromide, Quantity: 20.51 mg (Equivalent: galantamine, Qty 16 mg); galantamine, Quantity: 16 mg (Equivalent: galantamine hydrobromide, Qty 20.51 mg)

Available from:

Janssen-Cilag Pty Ltd

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: diethyl phthalate; ethylcellulose; hypromellose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; maize starch; sucrose; macrogol 400; titanium dioxide; sorbitan monolaurate; iron oxide red; Gelatin; sodium lauryl sulfate; ethanol absolute; sulfuric acid

Administration route:

Oral

Units in package:

56 capsules, 28 capsules, 84 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for the treatment of mild to moderately severe dementia of the Alzheimer type.

Product summary:

Visual Identification: Opaque, pink, size 2 capsule imprinted with 'G16' containing white to off-white pellets; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2004-05-19

Patient Information leaflet

REMINYL
®
(210422) ACMI
1
REMINYL
®
_MODIFIED RELEASE CAPSULES _
_Galantamine hydrobromide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about REMINYL 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 REMINYL
against the benefits this medicine is
expected to have for you.
If you have any concerns about
taking REMINYL, ask your doctor or
pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT REMINYL IS
USED FOR
REMINYL 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. REMINYL 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
REMINYL for another reason. Ask
your doctor if you have any questions
about why this medicine has been
prescribed for you.
BEFORE YOU TAKE
REMINYL
_WHEN YOU MUST NOT TAKE IT _
Do not take REMINYL if you have:
•
an allergy to REMINYL 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 REMINYL if the
packaging is torn or shows signs of
tampering. Do not use REMINYL
beyond the expiry date (month and
year) printed on the pack.
_BEFORE YOU START TO TAKE IT _
You must tell your doctor if you are:
•
pregnant, or planning to become
pregnant
•
breastfeeding, or planning to
breastfeed
•
planning to undergo surgery
which will require anaes

Summary of Product characteristics

CCDS201023
Page 1 of 18
REMINYL(220315) API
AUSTRALIAN PRODUCT INFORMATION
REMINYL
® (GALANTAMINE)
MODIFIED RELEASE CAPSULE
1
NAME OF THE MEDICINE
Galantamine (as hydrobromide)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
REMINYL modified release capsules contain the active galantamine
hydrobromide, equivalent
to 8, 16, 24 mg galantamine base.
Excipients with known effect: sugars
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
REMINYL 8 mg modified release capsules are white opaque, size 4 hard
gelatin capsules
with the inscription “G8”, containing white to off-white pellets.
REMINYL 16 mg modified release capsules are pink opaque, size 2 hard
gelatin capsules with
the inscription “G16”, containing white to off-white pellets.
REMINYL 24 mg modified release capsules are caramel opaque, size 1
hard gelatin capsules
with the inscription “G24”, containing white to off-white pellets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
REMINYL is indicated for the treatment of mild to moderately severe
dementia of the
Alzheimer type.
4.2
DOSE
AND
METHOD
OF
ADMINSTRATION
REMINYL modified release capsules should be administered once daily in
the morning,
preferably with food. Ensure adequate fluid intake during treatment.
The dose of REMINYL
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.
Product Information - Australia
CCDS201023 Page 2 of 19
REMINYL(220315)API
•
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
shou