Mercilon 28

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Desogestrel 150ug;  ; Ethinylestradiol 20ug;  

Available from:

Organon (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 Lactose monohydrate Magnesium stearate Potato starch

Units in package:

Calendar pack, 1 x (21+7), Sample pack, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aspen Oss B.V

Therapeutic indications:

Oral contraception.

Product summary:

Package - Contents - Shelf Life: Calendar pack, 1 x (21+7), Sample pack - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Calendar pack, 3x(21+7) - 84 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1987-07-09

Patient Information leaflet

New Zealand Consumer Medicine Information
MERCILON
® 28
Desogestrel and
ethinylestradiol
Tablets for oral use
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING MERCILON
28.
This leaflet answers some common questions about Mercilon 28. It does
not contain all
the available information. It does not take the place of talking to
your doctor, pharmacist,
or professional health care provider.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
Mercilon 28 against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR,
PHARMACIST OR
HEALTH CARE PROVIDER.
Keep this leaflet with the medicine. You may need to read it again.
WHAT MERCILON 28 IS TAKEN FOR
Mercilon 28 is a combined oral hormonal contraceptive, commonly known
as a ‘Birth
Control Pill’ or ‘the Combined Pill’ that has been prescribed to
prevent you from getting
pregnant.
Oral contraceptives are a very effective method of birth control. When
taken correctly
(without missing tablets) the chance of becoming pregnant is very low.
Mercilon 28 consists of 21 large white tablets, each containing 2
active ingredients:
20 micrograms of
ethinylestradiol
(an estrogen) and 150 micrograms of desogestrel (a
progestogen) and 7 small white inactive tablets (first row of the
strip).
Because of the small amounts of different female hormones in the
active tablets,
Mercilon 28 is considered a low-dose combined oral contraceptive.
Mercilon 28 prevents pregnancy in several ways:
•
It inhibits the egg release by stopping it maturing;
2
•
Changing the cervical mucus consistency making it difficult for sperm
to reach the
egg; and
•
Changing the lining of the uterus making it less suitable for
implantation.
The following non-contraceptive health benefits have been associated
with the
Combined Pill:
•
Your periods may be lighter and shorter. As a result, the risk of
anaemia may be
lower. Your period pains may become less severe or may completely
d

Summary of Product characteristics

NEW ZEALAND DATA SHEET
S-CCDS-MK8276A--TB-112018
Page 1 of 15
1 MERCILON
®
28 0.15 MG/0.02 MG TABLETS
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Desogestrel 0.15 mg; ethinylestradiol 0.02 mg.
Excipient with known effect:
-
lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Tablets.
Each pack of Mercilon 28 consists of:
• 21 large (6 mm diameter), white, round 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,
ethinylestradiol (an oestrogen) 0.02 mg; and
• 7 small (4.5 mm diameter), white, round, flat tablets with
bevelled edges, coded KH/2 on one
side and a square on the other side, and containing no active
ingredients.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
4.2 DOSE AND METHOD OF ADMINISTRATION
HOW TO TAKE MERCILON 28
Tablets must be taken in the order directed on the package every day
at about the same time
with some liquid as needed. One tablet is to be taken daily, starting
with the large (active)
tablets for 21 consecutive days followed by the small (placebo)
tablets for 7 days. Each
subsequent pack is started immediately following the last placebo
tablet. During the placebo
days a withdrawal bleed usually occurs. This usually starts on day 2-3
after the last active
tablet and may not have finished before the next pack is started.
HOW TO START TAKING MERCILON 28
The tablets are taken starting with the tablet marked with the
corresponding day from the green
section of the pack (active tablets).
_No preceding hormonal contraceptive use (in the past month) _
Tablet-taking has to start on day 1 of the woman’s natural cycle
(i.e. the first day of her
menstrual bleeding). Starting on days 2-5 is allowed, but during the
first cycle a barrier method
is recommended in addition for the first 7 days of tablet-taking.
_Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC), _
_vaginal ring, or transdermal patch)_