Diazepam Alkaloid tablets coated

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

diazepam

Доступна с:

Alkaloid AD Skopje

код АТС:

N05BA01

ИНН (Международная Имя):

diazepam

дозировка:

5mg

Фармацевтическая форма:

tablets coated

Штук в упаковке:

(30/2x15/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2021-06-29

Характеристики продукта

Diazepam Alkaloid 5 mg coated tablets
_ _
Summary of Product Characteristics
_ _
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Diazepam Alkaloid 5 mg coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One coated tablet contains 5 mg diazepam.
Excipients with known effect:
Each tablet contains 45.80 mg lactose monohydrate and 32.055 mg
sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
*
coated tablets
Green-yellow, glossy biconvex coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Anxiety
-
Insomnia
Benzodiazepines are only indicated when the disorder is severe,
disabling or subjecting the
individual to extreme distress.
-
In the control of muscle spasm including that associated with cerebral
spasticity.
-
In the management of epilepsy.
-
As pre-operative medication in minor surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_STANDARD DOSAGE_
For optimal effect, the dosage should be carefully individualised.
Treatment should begin at
the lowest effective dose appropriate to the particular condition.
_DURATION OF TREATMENT_
The duration of treatment should be as short as possible (see
_section 4.4_
) depending on the
indication, but should not exceed 4 weeks for insomnia and eight to
twelve weeks in cases of
anxiety, including tapering off process. Extension beyond these
periods should not take place
without re-evaluation of the situation.
Diazepam Alkaloid 5 mg coated tablets
_ _
Summary of Product Characteristics
_ _
2
It may be useful to inform the patient when treatment is started that
it will be of limited
duration and to explain precisely how the dosage will be progressively
decreased. Moreover it
is important that the patient should be aware of the possibility of
rebound phenomena, thereby
minimising anxiety over such symptoms should they occur while the
medicinal product is
being discontinued.
There are indications, that, in the case of benzodiazepines with a
short duration of action,
withdrawal phenomena can become