MINESSE Film-coated tablet Ref.[50575] Active ingredients: 17 alpha-Ethinylestradiol Gestodene

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton 2196, South Africa Tel: +27(0)11 320 6000 / 0860 734 937 (Toll-free South Africa)

Product name and form

MINESSE, 60/15 micrograms film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

24 pale yellow round film-coated hormonal tablets with convex faces, approximately 5,7 mm in diameter.

4 white round film-coated non-hormonal tablets with convex faces, approximately 6 mm in diameter.

Qualitative and quantitative composition

Each yellow active tablet contains 60 μg gestodene and 15 μg ethinylestradiol (24 tablets). The 4 white tablets are placebo and do not contain any active ingredients.

Contains sugar (lactose monohydrate).

Excipients with known effect:

Each MINESSE 60 μg/15 μg active tablet contains 39,84 mg lactose monohydrate.

Each inactive (placebo) tablet contains 39,900 mg lactose monohydrate.

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.

Gestodene
List of Excipients

Pale yellow active tablets:

Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Polacrilin potassium

Active tablet coating:

Montanglycol wax
Opadry yellow
Polyethylene glycol 1450

White inactive (placebo) tablets:

Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Polacrilin potassium

Inactive tablet coating:

Montanglycol wax
Opadry white
Polyethylene glycol 1500

Pack sizes and marketing

A carton containing a calendar pack consisting of a PVC and aluminium blister strip with 24 pale yellow hormonal tablets and 4 white non-hormonal tablets.

Marketing authorization holder

Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton 2196, South Africa
Tel: +27(0)11 320 6000 / 0860 734 937 (Toll-free South Africa)

Marketing authorization dates and numbers

33/18.8/0341

11 December 2000

Drugs

Drug Countries
MINESSE Austria, Brazil, Spain, France, Ireland, Israel, Tunisia, South Africa

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