LOPERAMIDE HYDROCHLORIDE Capsules Ref.[7302] Active ingredients: Loperamide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Loperamide Hydrochloride 2 mg Hard Capsules.

Pharmaceutical Form

Capsule, hard.

Hard gelatin capsules size 4 with a mauve opaque body and a dark green opaque cap. Marked “LOPERA-MIDE 2” on the cap.

Qualitative and quantitative composition

Each capsule contains 2 mg loperamide hydrochloride.

Excipient with known effect: Each capsule contains 100 mg lactose monohydrate.

For the 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

Each capsule contains:

Lactose monohydrate
Maize starch
Magnesium stearate

The capsule cap contains:

Quinoline yellow (E104)
Indigo carmine (E132)
Titanium dioxide (E171)
Gelatin

The capsule body contains:

Erythrosin (E127)
Indigo carmine (E132)
Black iron oxide (E172)
Titanium dioxide (E171)
Gelatin

Printing ink contains:

Ammonium hydroxide
Povidone
Shellac
Simeticone
Sodium hydroxide
Titanium dioxide (E171)
Propylene glycol

Pack sizes and marketing

Blister packaging in packs of 4, 6, 8, 10, 12, 16, 18, 20, 24, 28 and 30 capsules.

Polypropylene pots with white polyethylene caps with optional polyethylene ullage fillers in packs of 4, 6, 8, 10, 12, 18, 20 and 28 capsules.

Marketing authorization holder

Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 04569/0201

Date of first authorisation: 17 November 1987

Date of latest renewal: 29 March 2000

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