Herbion Zen Sen capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ginseng roots dry extract

Available from:

KRKA d.d.

ATC code:

առկա չէ (A13A)

INN (International Name):

ginseng roots dry extract

Dosage:

350mg

Pharmaceutical form:

capsules

Units in package:

(30/3x10/) in blister and (30) in plastic container

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2018-05-30

Summary of Product characteristics

1.3.1
Ginseng root dry extract
SPC, Labeling and Package Leaflet
SmPCPIL099534_2
19.12.2017 – Updated: 19.12.2017
Page 1 of 4
-
NAME OF THE MEDICINAL PRODUCT
Herbion
®
Ţen Šen capsules
-
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard, contains 350 mg extract (as dry extract) from
_Panax Ginseng _C. A. Meyer, radix
(Ginseng root) (2,5-5:1), with at least 21 mg (6%) of ginsenosides.
Extraction solvent: Ethanol 70% V/V.
The excipients are listed under item 6.1.
-
PHARMACEUTICAL FORM
Hard capsules:
Hard gelatin capsle (N1). The body and the cap of the capsule are
light brown colour. The content of
the capsules is yellowish brown powder or granulate.
-
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Herbion Ţen Šen capsules are used:
-
asthenic conditions of various origins,
-
protracted and/or excessive physical and mental stress,
-
during convalescence after infectious disease
-
to increase the body’s resistance to stress and adverse
environmental conditons.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended daily dose for adults is 1 capsule after breakfast.
The capsules should be taken with
some liquid. The capsules should be swallowed whole, without opening
them or chewing.
Patients are recommended to take Herbion Ţen Šen capsules for 4 to 8
weeks and then repeat the
course of therapy after consultation with the doctor. The break
between treatment repeated treatment
courses should be of at least 1 month.
4.3.
CONTRAINDICATIONS
Known hypersensitivity to the ginseng extract or to any other
ingredient of the drug.
Hypertension.
Excessive irritability or nervous excitability.
Sleep disturbances and insomnia.
Hemorrhage.
Fever syndrome as a consequence of acute infectious disease.
Epilepsy.
Children under 18 years of age.
4.4.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Ginseng may affect the process of blood coagulation. Therefore,
caution should be used during
concomitant use of medicines affecting blood coagulation.
1.3.1
Ginseng root dry extract
SPC, Labeling and Package Leaf