BETA-SYNTO Tablet Ref.[28144] Active ingredients: Betahistine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Codal Synto Ltd, 21 Constantinoupoleos, 3011 Limassol, Cyprus

Product name and form

Beta-Synto 8mg tablets.

Beta-Synto 16mg tablets.

Beta-Synto 24mg tablets.

Pharmaceutical Form

Tablet.

Beta-Synto 8mg tablets: white, round, flat tablets with bevelled edge, breakline on one side, diameter 6.5mm.

The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Beta-Synto 16mg tablets: white, round, flat tablets with bevelled edge, breakline on one side, diameter 9.0mm.

The tablet can be divided into equal halves.

Beta-Synto 24mg tablets: white, round, flat tablets with bevelled edge, breakline on one side, diamter 10.0mm.

The tablet can be divided into equal halves.

Qualitative and quantitative composition

Beta-Synto 8mg tablets: each tablet contains 8mg betahistine dihydrochloride.

Beta-Synto 16mg tablets: each tablet contains 16mg betahistine dihydrochloride.

Beta-Synto24mg tablets: each tablet contains 24mg betahistine dihydrochloride.

Excipients with known effect: lactose monohydrate.

Beta-Synto 8mg tablets: lactose monohydrate 50mg.

Beta-Synto 16mg tablets: lactose monohydrate 100mg.

Beta-Synto 24mg tablets: lactose monohydrate 150mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Betahistine

Betahistine dihydrochloride is a histamine-like drug in which pharmacological activity can be attributed to a specific effects and/or more direct influences on recovery mechanisms the vestibular nuclei. It has weak agonist activity at histamine H1 receptors and moderate antagonist activity at H3 receptors. Betahistine may increase blood flow to the cochlear region as well as to the whole brain.

List of Excipients

Lactose monohydrate
Maize starch
Microcrystalline cellulose Type 102
Citric acid anhydrous
Povidone (K value 22.5-26.7)
Crospovidone type A
Hydrogenated vegetable oil

Pack sizes and marketing

Blisters of PVC / PE / PVDC-aluminium.

Packs of 30 and 50 tablets are available.

Beta-Synto 16mg is also available in a pack of 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Codal Synto Ltd, 21 Constantinoupoleos, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Beta-Synto 8mg tablets: 021670
Beta-Synto 16mg tablets: 021671
Beta-Synto 24mg tablets: 021672

Beta-Synto 8mg tablets: 01 November 2012 / 20/11/2019
Beta-Synto 16mg tablets: 01 November 2012 / 20/11/2019
Beta-Synto 24mg tablets: 01 November 2012 / 20/11/2019

Drugs

Drug Countries
BETA-SYNTO Cyprus, Hong Kong

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