Thioctacid 600 HR

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

alfa-lipoic acid

Saatavilla:

MEDA Pharma GmbH & Co. KG

INN (Kansainvälinen yleisnimi):

alfa-lipoic acid

Annos:

600mg

Lääkemuoto:

tablets film-coated

Prescription tyyppi:

Prescription

Valmisteyhteenveto

EXPERT INFORMATION
(SUMMARY OF PRODUCT CHARACTERISTICS/SPC)
MEDA Pharma GmbH & Co. KG
THIOCTACID
® 600 HR
LAST REVISED: FEBRUARY 2010
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Thioctacid
®
600 HR
Film-coated tablet contains 600 mg alpha-lipoic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Alpha-lipoic acid
1 film-coated tablet contains 600 mg of alpha-lipoic acid.
For a 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 alpha-
lipoic 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 alpha-lipoic 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 the
resorption of alpha-lipoic acid. 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.
Thioctacid 600 HR is contraindicated in children (refer to section
4.3).
EXPERT INFORMATION
(SUMMARY OF PRODUCT CHARACTERISTICS/SPC)
MEDA Pharma GmbH & Co. KG
THIOCTACID
® 600 HR
LAST REVISED: FEBRUARY 2010
2
4.3
CONTRAINDICATIONS
Thioctacid 600 HR is absolutely contraindicated in patients with known
hypersensitivity to
alpha-lipoic acid or any of the other ingredients.
Caution:
Children and adolescents must not be treated with Thioctacid 600 HR as
there is insu