RIGEVIDON Coated tablet Ref.[49643] Active ingredients: 17 alpha-Ethinylestradiol Levonorgestrel

Source: Web Search  Revision Year: 2020  Publisher: Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary

Product name and form

Rigevidon coated tablets.

Pharmaceutical Form

Coated tablet.

White, biconvex, circular tablets.

Qualitative and quantitative composition

Each tablet contains 150 micrograms levonorgestrel and 30 micrograms ethinylestradiol.

Excipients with known effect: Each tablet contains 33 mg of lactose monohydrate and 22.46 mg of sucrose.

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.

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

Core:

Silica, colloidal anhydrous
Magnesium stearate
Talc
Maize starch
Lactose monohydrate

Coating:

Sucrose
Talc
Calcium carbonate
Titanium dioxide (E171)
Copovidone K90
Macrogol 6000
Silica, colloidal anhydrous
Povidone K30
Carmellose sodium

Pack sizes and marketing

Aluminium-PVC/PVDC blister.

Pack sizes: 1×21, 3×21, 6×21 and 13×21 coated tablets.

Not all pack size may be marketed.

Marketing authorization holder

Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary

Marketing authorization dates and numbers

PL 04854/0120

11/09/2007

Drugs

Drug Countries
RIGEVIDON Austria, Ecuador, Spain, Finland, Hong Kong, Lithuania, Poland, Romania, United Kingdom

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