IMODIUM Capsule Ref.[50854] Active ingredients: Loperamide

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland

Product name and form

Imodium 2 mg Capsules.

Pharmaceutical Form

Capsule, hard. (capsule).

Gelatin capsules with an opaque green cap and an opaque dark grey body, containing white powder.

Qualitative and quantitative composition

Each capsule contains 2 mg of loperamide hydrochloride.

Excipient with known effect: Each capsule contains 127 mg lactose.

For a 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

Capsule content:

Lactose
Maize starch
Talc
Magnesium stearate

Capsule cap:

Titanium dioxide (E171)
Yellow ferric oxide (E172)
Indigotindisulphonate sodium (E132)
Gelatin

Capsule body:

Titanium dioxide (E171)
Black ferrous oxide (E172)
Indigotindisulphonate sodium (E132)
Erythrosin (E127)
Gelatin

Pack sizes and marketing

Imodium Capsules are packaged in blister packs consisting of polyvinylchloride, glass clear 250 micrometre and aluminium foil (thickness 20 micrometre) coating on the inner side with a colourless heat seal lacquer: PVC mixed polymers with acrylates 6 g/m², in an outer cardboard carton.

The packs contain 60 capsules.

Marketing authorization holder

Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0330/045/002

Date of first authorisation: 14 April 1977
Date of last renewal: 30 January 2009

Drugs

Drug Countries
IMODIUM Austria, Canada, Cyprus, Germany, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, South Africa

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