Rivastigmine DEMO 3 mg, capsules, hard

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

RIVASTIGMINEWATERSTOFTARTRAAT 4,8 mg/stuk SAMENSTELLING overeenkomend met ; RIVASTIGMINE 3 mg/stuk

Beschikbaar vanaf:

Demo SA Pharmaceutical Industry 21st Km Nat. Rd. Athens-Lamia 14568 KRIONERI, ATTICA (GRIEKENLAND)

ATC-code:

N06DA03

INN (Algemene Internationale Benaming):

RIVASTIGMINEWATERSTOFTARTRAAT 4,8 mg/stuk SAMENSTELLING overeenkomend met ; RIVASTIGMINE 3 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; GELATINE (E 441) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Rivastigmine

Product samenvatting:

Hulpstoffen: AMMONIA (E 527); CELLULOSE, MICROKRISTALLIJN (E 460); GELATINE (E 441); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); KALIUMHYDROXIDE (E 525); MAGNESIUMSTEARAAT (E 470b); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); ZWARTE INKT;

Autorisatie datum:

2010-04-20

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVASTIGMINE DEMO 1.5 MG HARD CAPSULES
RIVASTIGMINE DEMO 3.0 MG HARD CAPSULES,
RIVASTIGMINE DEMO 4.5 MG HARD CAPSULES
RIVASTIGMINE DEMO 6.0 MG HARD CAPSULES
Rivastigmine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Rivastigmine DEMO is and what it is used for
2. What you need to know before you take Rivastigmine DEMO
3. How to take Rivastigmine DEMO
4. Possible side effects
5. How to store Rivastigmine DEMO
6. Contents of the pack and other information
1. WHAT RIVASTIGMINE DEMO IS AND WHAT IT IS USED FOR
The active substance of Rivastigmine DEMO is rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase
inhibitors. In
patients with Alzheimer’s dementia or dementia due to Parkinson’s
disease, certain
nerve
cells
die
in
the
brain,
resulting
in
low
levels
of
the
neurotransmitter
acetylcholine (a substance that allows nerve cells to communicate with
each other).
Rivastigmine
works
by
blocking
the
enzymes
that
break
down
acetylcholine:
acetylcholinesterase
and
butyrylcholinesterase.
By
blocking
these
enzymes,
Rivastigmine allows levels of acetylcholine to be increased in the
brain, helping to
reduce
the
symptoms
of
Alzheimer’s
disease
and
dementia
associated
with
Parkinson’s disease.
Rivastigmine
DEMO
is
used
for
the
treatment
of
adult
patients
with
mild
to
moderately severe Alzheimer’s dementia, a progressive brain disorder
that gradually
affects memory, intellectual ability and behavior. The capsules and

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rivastigmine DEMO 1.5 mg hard capsules
Rivastigmine DEMO 3.0 mg hard capsules
Rivastigmine DEMO 4.5 mg hard capsules
Rivastigmine DEMO 6.0 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains rivastigmine hydrogen tartrate corresponding to
1.5 mg
rivastigmine.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
3.0 mg
rivastigmine.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
4.5 mg
rivastigmine.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
6.0 mg
rivastigmine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
1.5 mg hard capsules
Hard gelatin capsule, with a yellow coloured body and a yellow
coloured cap. The cap
is imprinted radially with “R9VS” above “1.5” in black ink.
3.0 mg hard capsules
Hard gelatin capsule, with a yellow coloured body and a orange
coloured cap. The cap
is imprinted radially with “R9VS” above “3” in black ink.
4.5 mg hard capsules
Hard gelatin capsule, with a red coloured body and a red coloured cap.
The cap is
imprinted radially with “R9VS” above “4.5” in black ink.
6.0 mg hard capsules
Hard gelatin capsule, with a yellow coloured body and a red coloured
cap. The cap is
imprinted radially with “R9VS" above "6" in black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic
treatment
of
mild
to
moderately
severe
Alzheimer’s
dementia.
Symptomatic treatment of mild to moderately severe dementia in
patients with
idiopathic Parkinson’s disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a physician
experienced in the
diagnosis
and
treatment
of
Alzheimer’s
dementia
or
dementia
associated
with
Parkinson’s disease. Diagnosis should be made according to current
guidelines.
Therapy with rivastigmine should only be started if a caregiver is
available who will
regularly monitor intake of the medicinal product