VACONTIL Tablet Ref.[28044] Active ingredients: Loperamide

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Medochemie Ltd, 1-10 Constantinoupoleos Street 3011, Cyprus

Product name and form

Vacontil 2 mg tablets.

Pharmaceutical Form

Tablets.

White, round, flat, scored tablets, embossed “V” with a diameter of 7mm.

Qualitative and quantitative composition

Each tablet contains loperamide hydrochloride 2 mg.

Excipient with known effect: lactose monohydrate and sodium.

For full list of excipients, see section 6.1.

Active Ingredient Description
Loperamide

By binding to opiate receptors in the gut wall, loperamide hydrochloride reduces propulsive peristalsis, increases intestinal transit time and enhances resorption of water and electrolytes. Loperamide increases the tone of the anal sphincter, which helps reduce faecal incontinence and urgency.

List of Excipients

Lactose monohydrate
Microcrystalline cellulose
Croscarmellose sodium
Magnesium stearate

Pack sizes and marketing

Combination blisters of polyvinylchloride film and aluminium foil. Blisters with a patient information leaflet are inserted in a carton.

Cartons containing 10 or 20 tablets are available.

Cartons containing 40, 100, 500 or 1000 tablets are available.

Not all pack sizes may be marketed.

Marketing authorization holder

Medochemie Ltd, 1-10 Constantinoupoleos Street 3011, Cyprus

Marketing authorization dates and numbers

21022

First authorisation date: 22.08.2011
Renewal date: 09/08/2016

Drugs

Drug Countries
VACONTIL Cyprus, Hong Kong, Malta, Singapore

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