Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
ELOINE 0.02 mg / 3 mg film coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. The active tablets are light pink, round with convex faces; one side marked with the letters “DS” in a regular hexagon. The placebo tablets are white, round with convex faces, one side marked with the letters “DP” in a regular hexagon. |
24 light pink film-coated tablets: Each film-coated tablet contains 0.020 mg ethinylestradiol (as betadex clathrate) and 3 mg drospirenone.
Excipient with known effect: lactose 46 mg (as lactose monohydrate 48.18 mg)
4 white placebo (inactive) film-coated tablets: The tablet does not contain active substances.
Excipient with known effect: lactose 22 mg (as lactose monohydrate 23.21 mg)
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. |
|
| Drospirenone |
Drospirenone is a progestogen. In a therapeutic dosage, drospirenone also possesses antiandrogenic and mild antimineralocorticoid properties. It has no estrogenic, glucocorticoid and antiglucocorticoid activity. This gives drospirenone a pharmacological profile closely resembling the natural hormone progesterone. |
| List of Excipients | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
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Transparent PVC/Aluminium blister in a folding box.
Pack sizes:
28 tablets
3 × 28 tablets
6 × 28 tablets
Each blister contains 24 light pink active film-coated tablets and 4 white placebo film-coated tablets.
Not all pack sizes may be marketed.
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
PL 00010/0575
26 June 2008 / 13 June 2012
| Drug | Countries | |
|---|---|---|
| ELOINE | Austria, United Kingdom, South Africa |
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