Sermion

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

nicergoline

Tilgængelig fra:

Pfizer Italia S.r.l. Localita Marino del Tronto

INN (International Name):

nicergoline

Dosering:

30mg

Lægemiddelform:

tablets film-coated

Recept type:

Prescription

Produktets egenskaber

ST 18_0
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sermion
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Film-coated Tablet 5 mg
_Active ingredient: _nicergoline 5 mg
_ _
Film-coated Tablet 30 mg
_Active ingredient: _nicergoline 30 mg_ _
_ _
For a full list of excipients please_ _see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated Tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of cognitive disorders, including dementia, due
to chronic cerebrovascular
and organic brain damage, accompanied by a decrease in memory,
concentration, thinking,
activity, increased fatigability and emotional disorders.
_ _
_NOTE:_ Before starting treatment with nicergoline, it is necessary to
ascertain that these symptoms
are not a manifestation of another disease (such as internal,
psychiatric or neurological diseases)
and do not require specific treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral route.
The tablets should be taken with food and swallowed with a small
amount of liquid without
chewing.
The recommended daily dose is 30–60 mg, depending on the severity of
the symptoms and the
patient’s individual response to treatment.
It is recommended to take the 30 mg daily dose at breakfast.
Patients with impaired renal function (serum creatinine ≥2 mg/dL)
are recommended to take
Sermion

at lower therapeutic doses.
4.3
CONTRAINDICATIONS
A recent myocardial infarction, acute bleeding, pronounced
bradycardia, impairment of orthostatic
regulation, hypersensitivity to nicergoline, other ergotamine
derivatives or other ingredients of the
drug, sucrase/isomaltase deficiency, fructose intolerance,
glucose-galactose malabsorption, age
under 18, pregnancy and breastfeeding.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Clinical trials have shown that single or multiple use of nicergoline
could cause a decrease in
systolic and, to a greater extent, diastolic blood pressure in
patients with normal and increased
blood pressure. These results may vary, since other studies h