Sermion tablets coated

Land: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

nicergoline

Fáanlegur frá:

Pfizer Italia S.r.L.

ATC númer:

C04AE02

INN (Alþjóðlegt nafn):

nicergoline

Skammtar:

5mg

Lyfjaform:

tablets coated

Einingar í pakka:

(30/2x15/) in blister

Gerð lyfseðils:

Prescription

Leyfisstaða:

Registered

Leyfisdagur:

2023-10-06

Vara einkenni

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sermion
®
30 mg - Film-coated Tablets
Sermion
®
10 mg - Film-coated Tablets
Sermion
®
5 mg - Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 5mg, 10mg or 30 mg Nicergoline.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
5 mg tablets: round, convex, film-coated, orange tablets.
10 mg tablets: round, convex, film-coated, white tablets.
30 mg tablets: round, biconvex, film-coated, yellow tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As assisting measure for the symptomatic treatment of chronic,
cerebro-organic performance disorders
within a therapeutical concept in demential syndromes with the
following symptoms: impaired memory,
concentration disturbances, thinking disorders, early fatigue, lack of
drive and motivation and affective
disturbances. The primary target group are demential syndromes in
primary degenerative dementia, vascular
dementia and mixed forms of these.
_ _
_PLEASE NOTE:_ Before initiating treatment with nicergoline, it should
be ensured that symptoms do not result
from another underlying and specifically treatable disease (such of
internal and psychiatric neurological
nature).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology_ _
The recommended daily dose is 1 – 2 tablets (corresponding to 30 –
60 mg Nicergoline), depending on the
severity of symptoms and the individual patients´ response.
_Elderly (over 65 years) _
According to results of pharmacokinetic and tolerability studies, a
dosage adjustment is not required for this
population.
_Children and adolescents under 18 years _
Sermion 30 mg film coated tablets are not indicated for the treatment
of children and adolescents aged
below 18. The safety and efficacy of Sermion in this population has
not been established, therefore no
recommendation on a posology can be made.
2
_Patients with impaired renal function _
As renal excretion is the main route of elimination of Nicergoline and