Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Bayer (Pty) Ltd, Reg. No.: 1968/011192/07, 27 Wrench Road, Isando, 1609
FEMODENE ED 0,03 mg/0,075 mg coated tablets.
| Pharmaceutical Form |
|---|
|
Coated tablets. The hormone-containing tablets are small, white, round with convex faces. The hormone-free tablets are larger, white, round with convex faces. |
The 28-day pack (Every-Day pack) contains:
21 hormone-containing small white tablets:
Each coated tablet contains ethinylestradiol 0,03 mg and gestodene 0,075 mg.
Contains sugar (lactose – 36 mg and sucrose – 20 mg).
7 hormone-free large white coated tablets.
Contains sugar (lactose – 46 mg and sucrose – 34 mg).
For full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 17 alpha-Ethinylestradiol |
Ethinylestradiol is chemically and biologically identical to endogenous human oestradiol. It substitutes for the loss of estrogen production in menopausal women, and alleviates menopausal symptoms. Estrogens prevent bone loss following menopause or ovariectomy. |
|
| Gestodene |
|
| List of Excipients |
|---|
|
Calcium carbonate |
FEMODENE ED is packed in colourless transparent PVC/aluminium blisters containing 21 small, white hormonal tablets plus 7 large white non-hormonal tablets per blister strip.
The blister strip is sealed in a hermetic foil pouch.
The foil pouch is packed into an outer cardboard carton.
Pack sizes: 28 tablets, 84 tablets and 280 tablets.
Not all pack sizes are marketed.
Bayer (Pty) Ltd, Reg. No.: 1968/011192/07, 27 Wrench Road, Isando, 1609
W/21.8.2/98
15 September 1989
| Drug | Countries | |
|---|---|---|
| FEMODENE | Lithuania, United Kingdom, South Africa |
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