Mercilon 21

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

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Active ingredient:

Desogestrel 150ug;  ; Ethinylestradiol 20ug;  

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Desogestrel 150 µg

Pharmaceutical form:

Tablet

Composition:

Active: Desogestrel 150ug   Ethinylestradiol 20ug   Excipient: Colloidal silicon dioxide dl-Alpha tocopherol Lactose monohydrate Magnesium stearate Potato starch Povidone Stearic acid

Units in package:

Calendar pack, 3x21, 63 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aspen Oss B.V

Product summary:

Package - Contents - Shelf Life: Calendar pack, 3x21 - 63 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1987-07-09

Summary of Product characteristics

                                Mercilon 21 A110120 Version 2.0 
 
Page 1 
RA 0111 OS S7 (Ref 6.0) August 2008 
 
NEW ZEALAND DATA SHEET 
MERCILON
®
 21 
Desogestrel plus ethinyloestradiol 
 
NAME OF MEDICINE 
Mercilon 21 
Tablets 
Desogestrel 0.15 mg; ethinyloestradiol 0.02 mg 
 
PRESENTATION 
Each pack Mercilon 21 consists of: 
21 white, round (6 mm diameter) biconvex tablets coded TR/4 on one
side and ORGANON 
and a star on the other side, and containing desogestrel (a
progestogen) 0.15 mg, 
ethinyloestradiol (an oestrogen) 0.02 mg. 
 
USES 
ACTIONS 
 
ATC classification G03A A09.  
 
Mercilon 21 is a combined oral contraceptive preparation for
continuous administration 
containing as active substances the oestrogen, ethinyloestradiol, and
the progestogen, 
desogestrel.  Clinical studies have revealed that the oral
contraceptive preparations 
containing ethinyloestradiol and desogestrel lack undesirable
metabolic effects.  These 
effects are thought to result from the androgenic activity of some
progestogens in oral 
contraceptives.  Because of this, Mercilon 21 may have a favourable
effect on androgen-
related skin disorders such as acne and hirsutism. When taken
according to the 
recommended dosage scheme, Mercilon 21 suppresses the hypophyseal
gonadal function 
and thereby ovulation. 
The contraceptive effect of COCs is based on the interaction of
various factors, the most 
important of which are seen as the inhibition of ovulation and
the changes in the cervical 
secretion.  As well as protection against pregnancy, COCs have
several positive properties 
which, next to the negative properties (see WARNINGS AND
PRECAUTIONS and ADVERSE 
EFFECTS), can be useful in deciding on the method of birth control.
 The cycle is more regular 
and the menstruation is often less painful and bleeding is lighter.
 The latter may result in a 
decrease in the occurrence of iron deficiency.  Apart from this,
there is evidence of a 
reduced risk of endometrial cancer and ovarian cancer.  Fu
                                
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