Rivastigmine Actavis

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

rivastigmine hydrogen tartrate

Διαθέσιμο από:

Actavis Group PTC ehf

Φαρμακολογική κατηγορία (ATC):

N06DA03

INN (Διεθνής Όνομα):

rivastigmine

Θεραπευτική ομάδα:

Psychoanaleptics,

Θεραπευτική περιοχή:

Dementia; Alzheimer Disease; Parkinson Disease

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

Revision: 17

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2011-06-16

Φύλλο οδηγιών χρήσης

49
B. PACKAGE LEAFLET
50
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVASTIGMINE ACTAVIS 1.5 MG HARD CAPSULES
RIVASTIGMINE ACTAVIS 3 MG HARD CAPSULES
RIVASTIGMINE ACTAVIS 4.5 MG HARD CAPSULES
RIVASTIGMINE ACTAVIS 6 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 Actavis is and what it is used for
2.
What you need to know before you take Rivastigmine Actavis
3.
How to take Rivastigmine Actavis
4.
Possible side effects
5.
How to store Rivastigmine Actavis
6.
Contents of the pack and other information
1.
WHAT RIVASTIGMINE ACTAVIS IS AND WHAT IT IS USED FOR
The active substance of Rivastigmine Actavis 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 Actavis 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 Actavis is used for the treatment of adult patients with
mild to moderately severe
Alzheimer’s dementia, a progressive brain disorder that gradually
affec

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Rivastigmine Actavis 1.5 mg hard capsules
Rivastigmine Actavis 3 mg hard capsules
Rivastigmine Actavis 4.5 mg hard capsules
Rivastigmine Actavis 6 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rivastigmine Actavis 1.5 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
1.5 mg rivastigmine.
Rivastigmine Actavis 3 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
3 mg rivastigmine.
Rivastigmine Actavis 4.5 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
4.5 mg rivastigmine.
Rivastigmine Actavis 6 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
6 mg rivastigmine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (Capsule).
Rivastigmine Actavis 1.5 mg hard capsules
Off-white to slightly yellow powder in a hard capsule with yellow cap
and yellow body, with red
imprint “RIV 1.5mg” on body.
Rivastigmine Actavis 3 mg hard capsules
Off-white to slightly yellow powder in a hard capsule with orange cap
and orange body, with red
imprint “RIV 3mg” on body.
Rivastigmine Actavis 4.5 mg hard capsules
Off-white to slightly yellow powder in a hard capsule with red cap and
red body, with white imprint
“RIV 4.5mg” on body.
Rivastigmine Actavis 6 mg hard capsules
Off-white to slightly yellow powder in a hard capsule with red cap and
orange body, with red imprint
“RIV 6mg” on body.
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.
3
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. Diagnosi