FEMOSTON Film-coated tablet Ref.[28076] Active ingredients: Dehydroprogesterone Estradiol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Product name and form

Femoston 1/10mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

Oestradiol only tablets: Round, biconvex, white film-coated tablets with inscription ‘379’.

Oestradiol/dydrogesterone combination tablets: Round, biconvex, grey film-coated tablets with inscription ‘379’.

Qualitative and quantitative composition

Each tablet contains 1mg oestradiol (as hemihydrate) or a combination of 1mg oestradiol (as hemihydrate) and 10mg dydrogesterone.

Excipient with known effect: lactose monohydrate.

For the full list of excipients see 6.1.

Active Ingredient Description
Dehydroprogesterone

Dydrogesterone is an orally-active progestogen having an activity comparable to parenterally administered progesterone.

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

Oestradiol only tablets:
Lactose,
Hypromellose
Maize starch
Colloidal anhydrous silica
Magnesium stearate

Opadry Y-l-7000 white:

Hypromellose
Polyethylene glycol 400
Titanium dioxide (E171)

Oestradiol/dydrogesterone tablets:

Lactose
Hypromellose
Maize starch
Colloidal anhydrous silica
Magnesium stearate

Opadry II grey 85F27664:

Polyvinyl alcohol
Macrogol 3350
Talc
Titanium dioxide (E171)
Iron oxide black (E172)

Pack sizes and marketing

PVC film with a covering aluminium foil.

Blister packs:

  • 28 film-coated tablets
  • 84 film-coated tablets

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 46302/0035

27/09/1995

Drugs

Drug Countries
FEMOSTON Austria, Australia, Brazil, Cyprus, Germany, Estonia, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Netherlands, Poland, Romania, Singapore, United Kingdom, South Africa

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