VACONTIL Capsule, hard

Active ingredients: Loperamide

Product name and form

Vacontil 2 mg capsules.

Pharmaceutical Form

Capsule, hard.

Dark green – Grey gelatine capsules size ‘4’.

Qualitative and quantitative composition

Each capsule contains loperamide hydrochloride 2 mg.

Excipient with known effect: lactose monohydrate.

For full list of excipients, see section 6.1.

Active Ingredient
Description

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

Capsule core:

Lactose monohydrate
Pregelatinized maize starch
Talc
Magnesium stearate

Capsule shell:

Gelatin
Sunset yellow (E110)
Brilliant blue (E133)
Erythrosine (E127)
Titanium dioxide (E171)

Pack sizes and marketing

Blister boxes with 10 or 20 capsules.

Blister boxes with 30 or 1000 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Authorization Dates

Medochemie Ltd, 1-10 Constantinoupoleos Street 3011, Cyprus

First authorisation date: 22.10.1982
Renewal date: 15.06.2011

Marketing authorization number:

8524

Drugs

Drug
Countries
Cyprus, Hong Kong, Singapore