Pajjiż: Armenja
Lingwa: Ingliż
Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
alfa-lipoic acid
MEDA Pharma GmbH & Co. KG
A16AX01
alfa-lipoic acid
600mg
tablets film-coated
(30) in glass container, (100) in glass container
Prescription
Registered
2019-12-17
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 Aqra d-dokument sħiħ