Nimvastid

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

rivastigmine

Διαθέσιμο από:

Krka, d.d., Novo mesto

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: 10

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2009-05-11

Φύλλο οδηγιών χρήσης

68
B. PACKAGE LEAFLET
69
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NIMVASTID 1.5 MG HARD CAPSULES
NIMVASTID 3 MG HARD CAPSULES
NIMVASTID 4.5 MG HARD CAPSULES
NIMVASTID 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 or pharmacist.
-
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 Nimvastid is and what it is used for
2.
What you need to know before you take Nimvastid
3.
How to take Nimvastid
4.
Possible side effects
5.
How to store Nimvastid
6.
Contents of the pack and other information
1.
WHAT NIMVASTID IS AND WHAT IT IS USED FOR
The active substance of Nimvastid 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, Nimvastid
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.
Nimvastid 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 and orodispersible tablets can also be used
for the treatment of dementia in
a

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nimvastid 1.5 mg hard capsules
Nimvastid 3 mg hard capsules
Nimvastid 4.5 mg hard capsules
Nimvastid 6 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nimvastid 1.5 mg hard capsules
Each hard capsule contains rivastigmine hydrogen tartrate equivalent
to 1.5 mg rivastigmine.
Nimvastid 3 mg hard capsules
Each hard capsule contains rivastigmine hydrogen tartrate equivalent
to 3 mg rivastigmine.
Nimvastid 4.5 mg hard capsules
Each hard capsule contains rivastigmine hydrogen tartrate equivalent
to 4.5 mg rivastigmine.
Nimvastid 6 mg hard capsules
Each hard capsule contains rivastigmine hydrogen tartrate equivalent
to 6 mg rivastigmine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Nimvastid 1.5 mg hard capsules
White to almost white powder in a capsule with yellow cap and yellow
body.
Nimvastid 3 mg hard capsules
White to almost white powder in a capsule with orange cap and orange
body.
Nimvastid 4.5 mg hard capsules
White to almost white powder in a capsule with brownish red cap and
brownish red body.
Nimvastid 6 mg hard capsules
White to almost white powder in a capsule with a brownish red cap and
orange 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.
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 by the
patient.
3
Posology
Rivastigmine should be administered twice a day, with morning and
evening meals. The capsules
should be swall