Mercilon Tablets 150mcg/20mcg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DESOGESTREL, ETHINYLESTRADIOL

Available from:

Merck Sharp & Dohme B.V. Waarderweg 39, Haarlem Noord-Holland, 2031 BN, Netherlands

ATC code:

G03AA09

INN (International Name):

DESOGESTREL, ETHINYLESTRADIOL

Pharmaceutical form:

TABLET

Composition:

DESOGESTREL 150 microgram(s) ; ETHINYLESTRADIOL 20 microgram(s)

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Authorised

Authorization date:

2005-10-28

Patient Information leaflet

1
Package leaflet: Information for the user
MERCILON® TABLETS
150mcg/20 microgram Tablets
DESOGESTREL
ETHINYLESTRADIOL
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):
•
They are one of the most reliable reversible methods of contraception
if used correctly.
•
They slightly increase the risk of having a blood clot in the veins
and arteries, especially in the
first year or when restarting a combined hormonal contraceptive
following a break of 4 or more
weeks.
•
Please be alert and see your doctor if you think you may have symptoms
of a blood clot (see
section 2 “Blood clots”).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, or your
pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them even if
their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What is Mercilon and what is it used for?
1.1 Composition and type of Pill
1.2 Why use Mercilon
2. What you need to know before you use Mercilon
2.1 When you should not use Mercilon
2.2 When to take special care with Mercilon
2.3 When should you contact your doctor
3. How to use Mercilon
3.1 When and how to take the tablets
3.2 Starting your first pack of Mercilon
3.3 If too many Mercilon tablets are taken (overdose)
3.4 What to do if
3.5 If you want to stop taking Mercilon
4. Possible side effects
5. How to store Mercilon
6. Further information
6.1 What Mercilon contains
6.2 What Mercilon looks like and content of the pack
6.3 Marketing Authorisation Holder and Manufacturer
6.4 Last revision of this package leaflet.
1.
WHAT IS MERCILON AND WHAT IS IT USED FOR?
1.1
COMPOSITION AND TYPE OF PILL
2
MERCILON is a combined oral contraceptive (‘the combined Pill’).
Each tablet contains a small
amount of two d

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Mercilon 150/20 microgram Tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Desogestrel
150 micrograms
Ethinylestradiol
20 micrograms
Also contains approximately 68mg Lactose Monohydrate per tablet.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
The tablets are white, round, biconvex and 6mm in diameter. They are
coded on one side
‘Organon’ and an asterix ‘*’ and on the reverse side ‘TR’
above ‘4’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Contraception.
The decision to prescribe Mercilon should take into consideration the
individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE with
Mercilon compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
PAEDIATRIC POPULATION
The safety and efficacy of Mercilon in adolescents under the age of 18
years have not been
studied.
Method of administration: oral use.
Before starting Mercilon, a thorough general medical and
gynaecological examination (including
breasts and a cytological smear of the cervix) should be carried out
and the family medical history
carefully noted. Disturbances of the clotting mechanisms should be
ruled out if any members of
the family have suffered from thromboembolic diseases (e.g. deep vein
thrombosis, stroke,
myocardial infarction) at a young age.
Pregnancy must be excluded ideally by a pregnancy test.
As a precaution, thorough examinations should be conducted at
approximately six month intervals
during the use of the tablets.
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HOW TO TAKE MERCILON
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 for 21
consecutive days. Each subsequent
pack is started after a 7-day tablet-free interval, during which time
a withdrawal bleed usually
occurs. This usually starts on day 2-3 after the last tablet and may
not have finished befo