REMINYL Prolonged Release Capsules 24mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

GALANTAMINE HYDROBROMIDE

Boleh didapati daripada:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

GALANTAMINE HYDROBROMIDE

Unit dalam pakej:

28Capsule Capsules

Dikeluarkan oleh:

JANSSEN CILAG SPA

Risalah maklumat

REMINYL
® PROLONGED RELEASE CAPSULES
Galantamine hydrobromide (8mg, 16mg, 24mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What REMINYL
®
is used for
2.
How REMINYL
®
works
3.
Before you use REMINYL
®
4.
How to use REMINYL
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of REMINYL
®
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
WHAT REMINYL
®
IS USED FOR
REMINYL
®
contains the active substance
‘galantamine’. It is used to treat mild to
moderately severe Alzheimer’s disease, a
type of dementia that alters brain function.
Alzheimer’s disease causes increasing
memory loss, confusion and behavioral
changes, which make it increasingly
difficult to carry out normal daily
activities.
HOW REMINYL
® WORKS
Alzheimer’s disease symptoms are
believed to be due to lack of acetylcholine,
a substance responsible for sending
messages between brain cells.
REMINYL
®
increases the amount of
acetylcholine in the brain and so could
improve the symptoms of the disease.
The capsules are made in a ‘prolonged
release’ form. This means that they release
the medicine more slowly.
BEFORE YOU USE REMINYL
®
-
_When you must not use it _
Do not take REMINYL
®
:
•
If you are allergic to galantamine or to
any of the other ingredients of this
medicine.
_ _
_Pregnancy _
If you are pregnant, think you may be
pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice
before taking this medicine.
_Breastfeeding _
It is not known whether galantamine
passes into human milk. You should not
breastfeed while you are taking
REMINYL
®
.
_Children _
REMINYL
®
is not recommended for
children.
_ _
-
_Before you start use it _
Before you take REMINYL
®
, your
doctor needs to know if you have, or
had, any of the following:
•
Liver or kidney problem.
•
A heart condition.
•
An ulcer or a history of ulcers in the
stomach or gut.
•
A blockage of the stomach or in the gut.
•
Seizures [
_or fits_
] such as

Ciri produk

1
PRODUCT NAME
REMINYL
®
(galantamine hydrobromide)
DOSAGE FORMS AND STRENGTHS
Prolonged-released capsules
PROLONGED RELEASE CAPSULES
8 mg capsules:
White opaque, size 4 hard gelatin capsules with the inscription “G
8”, containing white to off-
white
pellets.
Each
capsule
contains
galantamine
hydrobromide,
equivalent
to
8
mg
galantamine base.
16 mg capsules:
Pink opaque, size 2 hard gelatin capsules with the inscription “G
16”, containing white to off-
white
pellets.
Each
capsule
contains
galantamine
hydrobromide,
equivalent
to
16
mg
galantamine base.
24 mg capsules:
Caramel opaque, size 1 hard gelatin capsules with the inscription “G
24”, containing white to
off-white pellets. Each capsule contains galantamine hydrobromide,
equivalent to 24 mg
galantamine base.
CLINICAL INFORMATION
INDICATIONS
REMINYL is indicated for the treatment of mild to moderately severe
dementia of the
Alzheimer type.
DOSAGE AND ADMINISTRATION
_DOSAGE-ADULTS _
Ensure adequate fluid intake during treatment.
_ _
_ _
_STARTING DOSE _
The recommended starting dose of REMINYL prolonged release capsules is
8 mg/day for 4
weeks.
_ _
_CONVERSION FROM IMMEDIATE-RELEASE FORMULATIONS TO PROLONGED RELEASE
CAPSULES_
Patients currently being treated with REMINYL immediate-release
formulations (tablets or
oral solution) can convert to REMINYL prolonged-release capsules by
taking their last dose
of REMINYL immediate-release tablets or oral solution in the evening
and starting REMINYL
prolonged-release capsules once daily treatment the next morning. When
converting from
REMINYL
twice
daily
immediate-release
formulations
to
REMINYL
once
daily
prolonged-release capsules, the same total daily dose should be
administered.
_MAINTENANCE DOSE _
The initial maintenance dose is 16 mg/day (16mg once a day with
capsules) and patients should
be maintained on 16 mg/day for at least 4 weeks.
An increase to the maximum recommended maintenance dose of 24 mg/day
(24mg once a day
with capsules) should be considered after appropriate assessment
including evalua