Thiogamma tablets film-coated

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

thioctic acid

Доступна с:

Dragenopharm Apotheker Puschl GmbH

код АТС:

A16AX01

ИНН (Международная Имя):

thioctic acid

дозировка:

600mg

Фармацевтическая форма:

tablets film-coated

Штук в упаковке:

(30/3x10/) in blister, (60/6x10/) in blister, (100/10x10/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2022-01-13

Характеристики продукта

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_THIOCTIC ACID FILM-COATED TABLET_
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of alpha-lipoic acid.
Excipient with known effect:
each film-coated tablet contains 49,0 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
yellow, oblong, film-coated tablet with smooth cover and one breaking
notch on both
sides. The score line is only to facilitate breaking for ease of
swallowing and not to divide
into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_THIOCTIC ACID FILM-COATED TABLET_ is indicated in Adults with
“Sensory disturbances in
cases of diabetic polyneuropathy”.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Individual and Daily Doses
In the case of sensory disturbances associated with diabetic
polyneuropathy, the following
daily dose is recommended for adults:
The daily dose is 1 _ THIOCTIC ACID FILM-COATED TABLET_ (equivalent to
600 mg of alpha-
Lipoic acid), which is taken approximately 30 minutes before the first
meal.
In cases of severe sensory disturbances, infusion therapy with
alpha-lipoic acid can be
carried out initially.
_Paediatric population _
Children and adolescents should not be treated with _THIOCTIC ACID
FILM-COATED TABLET_, as
there is no clinical experience for this age group.
_Hepatic impairment _
Experience is limited in patients with hepatic impairment. Therefore _
THIOCTIC ACID FILM-_
_COATED TABLET_ should be used with caution in these patients.
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Method of administration
For oral use.
_THIOCTIC ACID FILM-COATED TABLET_ should be taken whole and with
plenty of water on an
empty stomach. The tablets should not be chewed. The simultaneous
consumption of
food may
hinder
resorption.
It
is
therefore particularly
important
in patients
with a
prolonged stomach emptying time that the tablets are taken half an
hour before breakfast.
As diabetic polyneuropathy is a chronic disease, long-