WILZIN Hard capsule Ref.[7402] Active ingredients: Zinc

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Recordati Rare Diseases, Immeuble Le Wilson, 70, avenue du Général de Gaulle, F-92800 Puteaux, France

Product name and form

Wilzin 50 mg hard capsules.

Pharmaceutical Form

Hard capsule.

Capsule with orange opaque cap and body, imprinted “93-377”.

Qualitative and quantitative composition

Each hard capsule contains 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate).

Excipients: Each capsule contains 1.75 mg of sunset yellow FCF (E110)

For a full list of excipients, see section 6.1.

Active Ingredient Description
Zinc

Zinc blocks the intestinal absorption of copper from the diet and the reabsorption of endogenously secreted copper. Zinc induces the production of metallothionein in the enterocyte, a protein that binds copper thereby preventing its transfer into the blood. The bound copper is then eliminated in the stool following desquamation of the intestinal cells.

List of Excipients

Capsule content:

Maize starch
Magnesium stearate

Capsule shell:

Gelatin
Titanium dioxide (E171)
Sunset yellow FCF (E110)

Printing ink:

Black iron oxide (E172)
Shellac

Pack sizes and marketing

White HDPE bottle with a polypropylene and HDPE closure and contains a filler (cotton coil). Each bottle contains 250 capsules.

Marketing authorization holder

Recordati Rare Diseases, Immeuble “Le Wilson”, 70, avenue du Général de Gaulle, F-92800 Puteaux, France

Marketing authorization dates and numbers

EU/1/04/286/002

Date of first authorisation: 13 October 2004
Date of latest renewal: 13 October 2009

Drugs

Drug Countries
WILZIN Austria, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom

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