Ristidic 6,0 mg, capsule, hard

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

RIVASTIGMINEWATERSTOFTARTRAAT 9,6 mg/stuk SAMENSTELLING overeenkomend met ; RIVASTIGMINE 6 mg/stuk

Beschikbaar vanaf:

Bausch Health Ireland Limited 3013 Lake Drive, Citywest Business Campus D24 PPT3 DUBLIN 24 (IERLAND)

ATC-code:

N06DA03

INN (Algemene Internationale Benaming):

RIVASTIGMINEWATERSTOFTARTRAAT 9,6 mg/stuk SAMENSTELLING overeenkomend met ; RIVASTIGMINE 6 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; 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, 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:

2009-11-04

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISTIDIC 1,5 MG, CAPSULE, HARD
RISTIDIC 3,0 MG, CAPSULE, HARD
RISTIDIC 4,5 MG, CAPSULE, HARD
RISTIDIC 6,0 MG, CAPSULE, HARD
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. Do not pass it on to
others. It may harm
them, even if their
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 LEAFLET:
1.
What Ristidic is and what it is used for
2.
What you need to know before you take Ristidic
3.
How to take Ristidic
4.
Possible side effects
5.
How to store Ristidic
6.
Content of the pack and other information
1.
WHAT RISTIDIC IS AND WHAT IT IS USED FOR
The active substance of Ristidic 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, Ristidic 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.
Ristidic 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
behaviour. The capsules can also be used for the treatment of dementia
in adult patients with
Parkinson’s disease.
2. WHAT YO

Productkenmerken

1
1. NAME OF THE MEDICINAL PRODUCT
Ristidic 1.5 mg hard capsules
Ristidic 3.0 mg hard capsules
Ristidic 4.5 mg hard capsules
Ristidic 6.0 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains rivastigmine hydrogen tartrate corresponding to
rivastigmine 1.5 mg.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
rivastigmine 3.0 mg.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
rivastigmine 4.5 mg.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
rivastigmine 6.0 mg.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsules
Ristidic
1.5 mg hard capsules, are yellow/yellow hard gelatine capsule
imprinted with “RIVA
1.5mg” on body with black ink containing white to off-white granular
powder of 1.5 mg of
rivastigmine.
Ristidic
3.0 mg hard capsules, are light orange/ light orange hard gelatine
capsule imprinted
with “RIVA 3mg” on body with black ink containing white to
off-white granular powder of
3.0 mg of rivastigmine
Ristidic
4.5 mg hard capsules, are caramel/caramel hard gelatine capsule
imprinted with
“RIVA 4.5mg” on body with black ink containing white to off-white
granular powder of 4.5
mg of rivastigmine.
Ristidic
6.0 mg hard capsules, are light orange/caramel hard gelatine capsule
imprinted with
“RIVA 6mg” on body with black ink containing white to off-white
granular powder of 6.0 mg
of rivastigmine.
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
2
only be started if a caregiver is