Thiogamma tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

thioctic acid

Available from:

Dragenopharm Apotheker Puschl GmbH

ATC code:

A16AX01

INN (International Name):

thioctic acid

Dosage:

600mg

Pharmaceutical form:

tablets film-coated

Units in package:

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

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-05-11

Summary of Product characteristics

1
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_THIOGAMMA 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
_THIOGAMMA 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 _THIOGAMMA 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 _THIOGAMMA
FILM-COATED TABLET_, as
there is no clinical experience for this age group.
_Hepatic impairment _
Experience is limited in patients with hepatic impairment. Therefore _
THIOGAMMA FILM-_
_COATED TABLET_ should be used with caution in these patients.
Method of administration
For oral use.
_THIOGAMMA 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.
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As diabetic polyneuropathy is a chronic disease, long-term therapy
with _THIOGAM