ERDOTIN Capsules, hard Ref.[8577] Active ingredients: Erdosteine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK

Product name and form

Erdotin 300 mg capsules.

Pharmaceutical Form

Capsules, hard.

The product appears as a capsule with a green cap and a yellow body.

Qualitative and quantitative composition

Each capsule contains 300 mg of erdosteine.

For full list of excipients, see section 6.1.

Active Ingredient Description
Erdosteine

Erdosteine is a mucolytic agent reducing the viscosity of mucus and purulent sputum. Erdosteine is a prodrug, becoming active after metabolism whereby free thiol groups are formed.

List of Excipients

Capsule content:

Microcrystalline cellulose
Povidone
Magnesium stearate

Capsule shell:

Gelatin
Titanium dioxide (E171)
Iron oxide, yellow (E172)
Indigotine (E132)

Pack sizes and marketing

Each PVC/PVdC/Aluminium blister pack contains 10 capsules. Pack-sizes of 20 or 60 capsules per carton.

Not all pack sizes may be marketed.

Marketing authorization holder

Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK

Marketing authorization dates and numbers

PL 27827/0039

27/09/2011

Drugs

Drug Countries
ERDOTIN Ireland, Israel, United Kingdom

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