Valused capsules soft

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

valerian root dry extract, hop strobiles dry extract, passion flower dry extract

متاح من:

P.P.F. "Hasco-Lek" S.A.

ATC رمز:

առկա չէ (N05CM)

INN (الاسم الدولي):

valerian root dry extract, hop strobiles dry extract, passion flower dry extract

جرعة:

60mg+ 40mg+ 40mg

الشكل الصيدلاني:

capsules soft

الوحدات في الحزمة:

(30/2x15/) in blister

نوع الوصفة الطبية :

OTC

الوضع إذن:

Registered

تاريخ الترخيص:

2023-03-10

خصائص المنتج

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
VALUSED, 60 mg + 40 mg + 40 mg, soft capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Oval shape, olive-green colour capsule, with smooth and shiny surface.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 capsule contains:
_ _
60 mg of dry extract from _Valeriana officinalis_ L. sl., radix
(valerian root), (DER 3–4:1), extraction
solvent: ethanol 60 % V/V;
40 mg of dry extract from _Humulus lupulus_ L., flos (hop strobile),
(DER 4-6:1), extraction solvent:
methanol 30 % V/V;
40 mg of dry extract from _ Passiflora incarnata_ L., herba (passion
flower), (DER native 4-6:1),
extraction solvent: ethanol 90 % V/V;
Excipients which shall be taken into account the medicinal product
composition: sorbitol, purified
soybean oil.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Soft capsule.
4
CLINICAL PARTICULARS
The efficacy of the product is based exclusively on its long-standing
use and experience.
4.1
THERAPEUTIC INDICATIONS
The product is traditionally used to relieve symptoms of nervous
tension as a sedative agent, and in
temporary difficulty falling asleep due to nervous conditions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 12 years of age: 2 capsules 2 to 3 times
daily.
In difficulty falling asleep: 2 to 3 capsules once daily, half an hour
before bedtime.
If the symptoms persist or worsen after 2 weeks of use, a doctor
should be consulted.
_Children _
The safety and efficacy of this product in children aged under 12
years have not been established. This
product should not be used in children under 12 years.
Page 2 of 4
Method of administration
The product is administered orally.
4.3
CONTRAINDICATIONS
The product should not be used:
-
in case of hypersensitivity to the active substances or to any of the
excipients listed in section
6.1,
-
in case of intolerance to valerian,
-
in patients with rarely occurring hereditary fructose intolerance, due
to sorbito