Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Bayer (Pty) Ltd, Reg. No.: 1968/011192/07, 27 Wrench Road, ISANDO, 1609
DIANE-35 0,035 mg/2,0 mg coated tablet.
| Pharmaceutical Form |
|---|
|
Coated tablets. The hormone-containing tablet is small beige, round with convex faces. The hormone-free tablet is large white, round with convex faces. |
21 hormone-containing beige coated tablets: Each coated tablet contains ethinylestradiol 0,035 mg and cyproterone acetate 2 mg
Contains sugar (19 mg sucrose and 31 mg lactose monohydrate).
7 hormone-free larger white coated tablets.
Contains sugar (34 mg sucrose and 48 mg lactose monohydrate)
For the 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. |
|
| Cyproterone |
Cyproterone acetate acts as an antiandrogen by blocking androgen receptors. It also has progestogenic activity, which exerts a negative feedback effect on hypothalamic receptors, so leading to a reduction in gonadotrophin release, and hence to diminished production of testicular androgens. Sexual drive and potency are reduced and gonadal function is inhibited. |
| List of Excipients |
|---|
|
Calcium carbonate precipitate |
PVC/PE.EVOH.PE/PCTFE/aluminium blisters of 28 tablets.
Bayer (Pty) Ltd, Reg. No.: 1968/011192/07, 27 Wrench Road, ISANDO, 1609
V/21.8.2/300
22 September 1988
| Drug | Countries | |
|---|---|---|
| DIANE-35 | Brazil, Canada, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Lithuania, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, South Africa |
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