Thioctacid 600 HR tablets film-coated

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

alfa-lipoic acid

Verfügbar ab:

Rottapharm Ltd.

ATC-Code:

A16AX01

INN (Internationale Bezeichnung):

alfa-lipoic acid

Dosierung:

600mg

Darreichungsform:

tablets film-coated

Einheiten im Paket:

(30) in glass container, (100) in glass container

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2022-03-01

Fachinformation

EXPERT INFORMATION
(SUMMARY OF PRODUCT CHARACTERISTICS/SPC)
MEDA Pharma GmbH & Co. KG
THIOCTACID
® 600 HR
LAST REVISED: DECEMBER 2016
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
THIOCTACID
® 600 HR
Film-coated tablets, containing 600 mg thioctic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Thioctic acid
Each film-coated tablet contains 600 mg of thioctic acid.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of symptoms of peripheral (sensomotor) diabetic
polyneuropathy
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The daily dose is 1 film-coated tablet of Thioctacid 600 HR
(equivalent to 600 mg of thioctic
acid), to be taken in form of a single dose about 30 minutes prior to
the first meal.
In case of severe symptoms of peripheral (sensomotor) diabetic
polyneuropathy, treatment can
be started by means of an infusion therapy with thioctic acid.
Thioctacid 600 HR Film-coated tablets shall be taken unchewed and with
an appropriate
quantity of liquid on an empty stomach. The uptake of food at the same
time may impair
absorption. Therefore, it is very important – in particular in
patients with prolonged gastric
emptying time – that the tablet will be taken half an hour before
breakfast.
Due to the fact that diabetic polyneuropathy is a chronic disease,
long-term treatment may be
required.
The basis for treatment of diabetic polyneuropathy is an optimum
diabetic control.
_Paediatric population _
Thioctacid 600 HR is contraindicated in children and adolescents
(refer to section 4.3).
EXPERT INFORMATION
(SUMMARY OF PRODUCT CHARACTERISTICS/SPC)
MEDA Pharma GmbH & Co. KG
THIOCTACID
® 600 HR
LAST REVISED: DECEMBER 2016
2
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the excipients
listed in section 6.1.
Caution:
Children and adolescents must not be treated with Thioctacid 600 HR as
there is no clinical
experience with this age group.
4.4
SPECI