REMINYL CR 8 mg CAPSULES

Riik: Lõuna-Aafrika Vabariik

keel: inglise

Allikas: South African Health Products Regulatory Authority (SAHPRA)

Saadav alates:

Janssen Pharmaceutica (Pty) Ltd

Annus:

See ingredients

Ravimvorm:

CAPSULES

Koostis:

EACH CAPSULE CONTAINS GALANTAMINE HYDROBROMIDE EQUIVALENT TO GALANTAMINE 8,0 mg

Volitamisolek:

Registered

Loa andmise kuupäev:

2009-04-12

Infovoldik

APPLICANT: JANSSEN PHARMACEUTICA (PTY) LTD.
PRODUCT PROPRIETARY NAME: REMINYL
®
CR (PROLONGED RELEASE CAPSULES)
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_PAGE 1 OF 9 _
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
Schedule 4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
REMINYL
® CR
_(galantamine hydrobromide) _
_8-MG; 16-MG AND 24-MG PROLONGED RELEASE CAPSULES _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING REMINYL
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your
pharmacist.
REMINYL has been prescribed for you personally and you should not
share your medicine with other
people. It may harm them, even if their symptoms are the same as
yours.
1.
WHAT REMINYL CONTAINS_ _

The active substance is galantamine hydrobromide._ _

REMINYL comes in the form of tablets and as prolonged release
capsules._ _
The capsules come in three different strengths: 8 mg; 16 mg and 24 mg
galantamine.
The capsules contain as inactive ingredients gelatin, diethyl
phthalate, ethyl cellulose, hypromellose,
polyethylene glycol, sugar (59 mg, 117 mg and 176 mg respectively),
maize starch and titanium
dioxide (E171).
The 16 mg capsules also contain red ferric oxide (E172).
The 24 mg capsules also contain red ferric oxide (E172) and yellow
ferric oxide (E172).
APPLICANT: JANSSEN PHARMACEUTICA (PTY) LTD.
PRODUCT PROPRIETARY NAME: REMINYL
®
CR (PROLONGED RELEASE CAPSULES)
________________________________________________________________________________________
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_PAGE 2 OF 9 _
2. WHAT REMINYL IS USED FOR
REMINYL is used to treat mild to moderately severe dementia of the
Alzheimer type.
3.
BEFORE YOU TAKE REMINYL
OTHER MEDICAL PROBLEMS:
REMINYL may adversely affect the following:
-
some heart disorders;
-
stomach ulcer or a history of ulcers;
-
acute abdominal pain;
-
some disorders of the nervous system (like epilepsy);
-
respiratory diseases that interfere with breathing (like asthma);
-
a re

Toote omadused

APPLICANT: JANSSEN PHARMACEUTICA (PTY) LTD.
PRODUCT PROPRIETARY NAME: REMINYL
®
CR (PROLONGED RELEASE CAPSULES)
______________________________________________________________________________
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_PAGE 1 OF 16 _
PACKAGE INSERT
SCHEDULING STATUS
Schedule 4
PROPRIETARY NAME (AND DOSAGE FORM)
S4 REMINYL
®
CR 8 mg (Prolonged Release Capsules)
S4REMINYL
®
CR 16 mg (Prolonged Release Capsules)
S4REMINYL
®
CR 24 mg (Prolonged Release Capsules)
COMPOSITION
REMINYL prolonged release capsules contain galantamine hydrobromide,
equivalent to respectively
8 mg, 16 mg and 24 mg galantamine base.
PHARMACOLOGICAL CLASSIFICATION
A. 5.3 - Cholinomimetics
PHARMACOLOGICAL ACTION
PHARMACODYNAMICS
Galantamine, a tertiary alkaloid is a selective, competitive and
reversible inhibitor of
acetylcholinesterase. In addition, galantamine enhances the intrinsic
action of acetylcholine on
nicotinic receptors, probably through binding to an allosteric site of
the receptor.
PHARMACOKINETICS
Absorption
After oral intake of a single dose 8 mg galantamine, a peak plasma
concentration of 43 ± 13 ng/ml, is
reached after 1,2 hours, with a mean AUC

of 427 ± 102 ng.h/ml. The absolute oral bioavailability of
galantamine is 88,5 %. Oral intake of galantamine with food slows down
its rate of absorption (C
max
reduced by about 25 %), but does not affect the extent to which it is
absorbed (AUC).
APPLICANT: JANSSEN PHARMACEUTICA (PTY) LTD.
PRODUCT PROPRIETARY NAME: REMINYL
®
CR (PROLONGED RELEASE CAPSULES)
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_PAGE 2 OF 16 _
The prolonged release capsules are bioequivalent to the b.i.d.
immediate release tablets with
respect to AUC
24h
and C
min
. The C
max
value is reached after 4.4 hours, was about 24 % lower than
that of tablet. Food has no effect on AUC and C
max
of the prolonged release capsules and slightly
increases t
max
by about 12 %.
Distribution
The plasma protein binding of galantamine is low: 17,7 ± 0,8 %. In
whole blood, galantamine is
mainly distr