Exelon

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

rivastigmine

Διαθέσιμο από:

Novartis Europharm Limited

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: 46

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

1998-05-11

Φύλλο οδηγιών χρήσης

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Exelon 1.5 mg hard capsules
Exelon 3.0 mg hard capsules
Exelon 4.5 mg hard capsules
Exelon 6.0 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Exelon 1.5 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
1.5 mg rivastigmine.
Exelon 3.0 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
3.0 mg rivastigmine.
Exelon 4.5 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
4.5 mg rivastigmine.
Exelon 6.0 mg hard capsules
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 capsules
Exelon 1.5 mg hard capsules
Off-white to slightly yellow powder in a capsule with yellow cap and
yellow body, with red imprint
“EXELON 1,5 mg” on body.
Exelon 3.0 mg hard capsules
Off-white to slightly yellow powder in a capsule with orange cap and
orange body, with red imprint
“EXELON 3 mg” on body.
Exelon 4.5 mg hard capsules
Off-white to slightly yellow powder in a capsule with red cap and red
body, with white imprint
“EXELON 4,5 mg” on body.
Exelon 6.0 mg hard capsules
Off-white to slightly yellow powder in a capsule with red cap and
orange body, with red imprint
“EXELON 6 mg” on body.
3
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 th

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Exelon 1.5 mg hard capsules
Exelon 3.0 mg hard capsules
Exelon 4.5 mg hard capsules
Exelon 6.0 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Exelon 1.5 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
1.5 mg rivastigmine.
Exelon 3.0 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
3.0 mg rivastigmine.
Exelon 4.5 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
4.5 mg rivastigmine.
Exelon 6.0 mg hard capsules
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 capsules
Exelon 1.5 mg hard capsules
Off-white to slightly yellow powder in a capsule with yellow cap and
yellow body, with red imprint
“EXELON 1,5 mg” on body.
Exelon 3.0 mg hard capsules
Off-white to slightly yellow powder in a capsule with orange cap and
orange body, with red imprint
“EXELON 3 mg” on body.
Exelon 4.5 mg hard capsules
Off-white to slightly yellow powder in a capsule with red cap and red
body, with white imprint
“EXELON 4,5 mg” on body.
Exelon 6.0 mg hard capsules
Off-white to slightly yellow powder in a capsule with red cap and
orange body, with red imprint
“EXELON 6 mg” on body.
3
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 th