MEDOVENT Tablet Ref.[28247] Active ingredients: Ambroxol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2017  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Medovent 30 mg tablets.

Pharmaceutical Form

Tablet.

Tablets are white, flat, round, scored with 8 mm diameter.

The score line is not intended for breaking the tablet.

Qualitative and quantitative composition

Each tablet contains 30mg ambroxol hydrochloride.

Excipient with known effect: lactose. Each Medovent 30 mg tablet contains 134 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ambroxol

Ambroxol induces activation of the surfactant system by acting directly on the type II pneumocytes of the alveoles and the Clara cells in the region of the small airways. It promotes the formation and outward transfer of surface-active material in the alveolar and bronchial region of the foetal and adult lungs.

List of Excipients

Lactose
Microcrystalline cellulose
Sodium carboxymethylcellulose
Silicon dioxide
Magnesium stearate

Pack sizes and marketing

Polyvinylchloride film-aluminium foil blisters, with a patient information leaflet in a card carton. Packs containing 20, 30, 50 and 60 tablets are available.

Polyvinylchloride securitainers with a tamper evident closure containing 250, 500, or 1000 tablets are also available.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

11437

First authorization: 23/10/1987
Renewal authorization: 07/04/2010

Drugs

Drug Countries
MEDOVENT Cyprus, Hong Kong, Malta

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