MICROGYNON Sugar-coated tablets Ref.[28081] Active ingredients: 17 alpha-Ethinylestradiol Levonorgestrel

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Product name and form

Microgynon 30.

Pharmaceutical Form

Sugar-coated tablets.

Each tablet is beige.

Qualitative and quantitative composition

Each tablet contains:

Actives:

Levonorgestrel: 150 mcg
Ethinylestradiol: 30 mcg

Excipients:

Lactose: 32.820 mg
Sucrose: 19.371 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.

Levonorgestrel

The precise mode of action of levonorgestrel as an emergency contraceptive is not known. At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest.

List of Excipients

Each tablet contains:

Core:

Lactose monohydrate
Maize starch
Povidone 25
Talc
Magnesium stearate (E 572)

Coating:

Sucrose
Povidone 90
Macrogol 6000 (polyethylene glycol 6000)
Calcium carbonate (E 170)
Glycerol 85%
Titanium dioxide (E 171)
Yellow ferric oxide pigment (E 172)
Glycol montanate
Talc
Purified water

Pack sizes and marketing

Deep drawn strips made of polyvinyl chloride film with counter-sealing foil made of aluminium with heat sealable coating.

Presentation: Each carton contains either 1, 3 or 50 blister memo-packs. Each blister memo-pack contains 21 tablets.

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Marketing authorization dates and numbers

PL 00010/0545

Date of First Authorisation: 28 November 1973
Date of Renewal: 5 December 2008

Drugs

Drug Countries
MICROGYNON Austria, Australia, Ecuador, Spain, Hong Kong, Israel, Malta, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom

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