ZUMENON Film-coated tablet Ref.[7703] Active ingredients: Estradiol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Product name and form

Zumenon 2mg Film-coated Tablets.

Pharmaceutical Form

Brick-red, round, biconvex, film-coated tablets imprinted with ‘379’ on one side.

Qualitative and quantitative composition

Each tablet contains 2 mg estradiol (as hemihydrate).

Excipient with known effect: each tablet contains 118.2 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Estradiol

Estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms. Oestrogens prevent bone loss following menopause or ovariectomy.

List of Excipients

Tablets core:

Lactose
Hypromellose
Maize Starch
Colloidal andydrous silica
Magnesium stearate

Film-coat:

Hypromellose
Talc
Macrogol 400
Titanium dioxide E171
Iron oxide red E172
Iron oxide black E172
Iron oxide yellow E172

Pack sizes and marketing

The tablets are packed in blister strips of 28. The blister strips are made of PVC film with covering Aluminium foil. Each carton contains 84 tablets.

Marketing authorization holder

Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0053

14 May 1997 / 23 Mar 2006

Drugs

Drug Countries
ZUMENON Australia, Netherlands, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.