Reminyl

Pajjiż: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Galantamine hydrobromide 20.51mg equivalent to 16 mg galatamine base; Galantamine hydrobromide 20.51mg equivalent to 16 mg galatamine base

Disponibbli minn:

Janssen-Cilag (New Zealand) Ltd

INN (Isem Internazzjonali):

Galantamine hydrobromide 20.51 mg (= 16 mg galatamine base)

Dożaġġ:

16 mg

Għamla farmaċewtika:

Modified release capsule

Kompożizzjoni:

Active: Galantamine hydrobromide 20.51mg equivalent to 16 mg galatamine base Excipient: Diethyl phthalate Ethylcellulose Gelatin Hypromellose Iron oxide red Opacode black S-1-27794 Opadry clear OY-7240 Sugar spheres Titanium dioxide Active: Galantamine hydrobromide 20.51mg equivalent to 16 mg galatamine base Excipient: Diethyl phthalate Ethylcellulose Gelatin Hypromellose Opacode black S-1-277002 Opadry clear OY-7240 Sugar spheres

Unitajiet fil-pakkett:

Blister pack, PVC-PE-PVDC/Al, 28 capsules

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Janssen Pharmaceutica NV

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Package - Contents - Shelf Life: Blister pack, PVC-PE-PVDC/Al - 28 capsules - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC-PE-PVDC/Al - 56 capsules - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC-PE-PVDC/Al - 84 capsules - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 30 capsules - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 300 capsules - 24 months from date of manufacture stored at or below 30°C

Data ta 'l-awtorizzazzjoni:

2003-03-28

Fuljett ta 'informazzjoni

REMINYL(210803)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 contains a
medicine called galantamine
hydrobromide, which increases the
amount of acetylcholine 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 galantamine
hydrobromide 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

Karatteristiċi tal-prodott

CCDS201023
1
REMINYL(210803)ADS
REMINYL

CAPSULES
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
REMINYL
®
8 mg, 16 mg, 24 mg modified release capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release capsule contains galantamine hydrobromide
equivalent to 8, 16 or
24 mg of galantamine base as the active ingredient.
Excipient(s) with known effect
Sucrose (
contained in sugar spheres)
For the full list of excipients, see section 6.1.
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 ADMINISTRATION
DOSE
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.
CCDS201023
2
REMINYL(210804)ADS
•
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
tolerated dose to
achieve the desired clinical effect. The incidence and se