YASMIN Film-coated tablet Ref.[51089] Active ingredients: 17 alpha-Ethinylestradiol Drospirenone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Bayer Limited, 1st Floor, The Grange Offices, The Grange, Brewery Road, Stillorgan, Co Dublin, A94 H2K7, Ireland

Product name and form

Yasmin 0.03 mg / 3 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

Light yellow, round tablets with convex faces, one side marked with the letters “DO” in a regular hexagon.

Qualitative and quantitative composition

Each film-coated tablet contains 0.030 mg ethinylestradiol and 3 mg drospirenone.

Excipient with known effect: lactose 46 mg (as lactose monohydrate 48.17 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

Tablet core:

Lactose monohydrate
Maize starch
Pregelatinised maize starch
Povidone K25
Magnesium stearate

Tablet coating:

Hypromellose
Macrogol 6000
Talc
Titanium dioxide (E171)
Iron oxide pigment, yellow (E172)

Pack sizes and marketing

PVC/Aluminium blister pack.

Pack sizes:

21 tablets
3x21 tablets
6x21 tablets
13x21 tablets

Not all pack sizes may be marketed.

Marketing authorization holder

Bayer Limited, 1st Floor, The Grange Offices, The Grange, Brewery Road, Stillorgan, Co Dublin, A94 H2K7, Ireland

Marketing authorization dates and numbers

PA1410/023/001

Date of first authorisation: 27 October 2000
Date of last renewal: 7 March 2015

Drugs

Drug Countries
YASMIN Austria, Brazil, Canada, Cyprus, Ecuador, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

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