MELODENE Coated tablet Ref.[50569] Active ingredients: 17 alpha-Ethinylestradiol Gestodene

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Bayer (Pty) Ltd, Reg. No.: 1968/011192/07, 27 Wrench Road, ISANDO, 1609

Product name and form

MELODENE 0,02 mg/0,075 mg coated tablets.

Pharmaceutical Form

Coated tablets.

The hormone-containing tablet is small, white round with convex faces.

The hormone-free tablet is large, pink round with convex faces.

Qualitative and quantitative composition

21 hormone-containing white coated tablets

Each coated tablet contains ethinylestradiol 0,02 mg and gestodene 0,075 mg.

Excipient: lactose 35 mg and sucrose 20 mg.

7 hormone-free pink coated tablets

Excipient: lactose 45 mg and sucrose 34 mg.

For a 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.

Gestodene
List of Excipients

Calcium carbonate
Ferric oxide pigment, red
Ferric oxide, yellow
Glycerol 85% (w/w)
Lactose monohydrate
Macrogol 6 000
Magnesium stearate
Maize starch
Montanglycol wax (wax E)
Povidone 25 000
Povidone 700 000
Sucrose
Talc
Titanium dioxide

Pack sizes and marketing

MELODENE is packed in colourless transparent PVC/aluminium blisters containing 21 white hormone-containing tablets plus 7 pink hormone-free tablets per blister strip. The blister strip is packed into an outer cardboard carton.

Pack sizes: 28 tablets and 84 tablets.

Not all pack sizes are marketed.

Marketing authorization holder

Bayer (Pty) Ltd, Reg. No.: 1968/011192/07, 27 Wrench Road, ISANDO, 1609

Marketing authorization dates and numbers

31/18.8/0462

6 April 1998

Drugs

Drug Countries
MELODENE Spain, South Africa

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