Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ginkgo biloba (folium) standardized extract
A. MENARINI SINGAPORE PTE. LTD.
Ginkgo biloba (folium) standardized extract
30Tablet Tablets; 60Tablet Tablets; 90Tablet Tablets
Dr.Willmar Schwabe GmbH & Co. KG
Tebonin® intens 120 mg Date: 24.02.2014 Version: 020 INFORMATION FOR THE USER PLEASE READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. Nevertheless you still need to use Tebonin® intens 120 mg carefully to get the best result from it. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if your need more information or advice. - You must contact a doctor if your symptoms worsen or if you do not achieve any improvement. This _leaflet_ contains the following information: 1. WHAT _TEBONIN® INTENS 120 MG _IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE _TEBONIN® INTENS 120 MG _ 3. HOW TO TAKE _TEBONIN® INTENS 120 MG _ 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE _TEBONIN® INTENS 120 MG _ 6. COMPOSITION AND PACK SIZES OF _TEBONIN® INTENS 120 MG _ 7. MANUFACTURER/DISTRIBUTOR OF _TEBONIN® INTENS 120 MG _ TEBONIN® INTENS 120 MG® 120 mg / film-coated tablet For adults from 18 years on ACTIVE SUBSTANCE: DRY EXTRACT FROM GINKGO BILOBA LEAVES 1. WHAT TEBONIN® INTENS 120 MG IS AND WHAT IT IS USED FOR 1.1 TEBONIN® INTENS 120 MG CONTAINS AN EXTRACT FROM GINKGO LEAVES 1.2 TEBONIN® INTENS 120 MG IS USED - For the symptomatic treatment of mental losses due to organic brain syndrome within the framework of a general therapeutic concept in case of progressive impairment or loss of mental capacities (dementia syndrome) having as major symptoms: Deficient memory, disturbances of concentration, depressive mood, dizziness, tinnitus and headache. Individual response to the treatment cannot be predicted. Prior to starting treatment with this preparation, clarification should be obtained as to whether the pathological symptoms encountered are not based on an underlying disease requiring a specific treatment. - 1 - Tebonin® intens 120 mg Date: 24.02.2014 Version: 020 - Improvement of the pain-free walking distance in peripheral arterial occlusive disease in FONTAINE stage II (intermittent claudication) within the framework of ph Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS TEBONIN® INTENS 120 MG 1. NAME OF THE MEDICINAL PRODUCT TEBONIN® INTENS 120 MG 120 mg / film-coated tablet For adults from 18 years on 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet contains: Pharmaceutically active constituent: Dry extract from Ginkgo biloba leaves (35-67:1) 120 mg; extraction agent: acetone 60% (w/w). The extract is quantified to 26.4 – 32.4 mg flavonoids, calculated as flavone glycosides, and 6.0 – 8.4 mg terpene lactones of which 3.36 – 4.08 mg ginkgolides A, B, C as well as 3.12 – 3.84 mg bilobalide, and contains less than 0.6 µg ginkgolic acids per film- coated tablet. Contains lactose. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS - For the symptomatic treatment of mental losses due to organic brain syndrome within the framework of a general therapeutic concept for dementia syndromes having as major symptoms: Deficient memory, disturbances of concentration, depressive mood, dizziness, tinnitus and headache. The primary target group includes patients with demential syndrome in primary degenerative dementia, vascular dementia and mixed forms of both. Individual response to the treatment cannot be predicted. Note: Prior to starting treatment with Ginkgo extract, clarification should be obtained as to whether the pathological symptoms encountered are not based on an underlying disease requiring a specific treatment. - Improvement of the pain-free walking distance in peripheral arterial occlusive disease in FONTAINE stage II (intermittent claudication) within the framework of physical therapeutic measures, in particular walking training. Tebonin intens 120 mg - version: 020 / 24.02.2014 - 1 - SUMMARY OF PRODUCT CHARACTERISTICS TEBONIN® INTENS 120 MG - Vertigo of vascular and involutional origin. Adjuvant treatment in the case of tinnitus of vascular and involutional origin. _The following note for the patient is included in the instruct Lire le document complet