Mercilon

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

DESOGESTREL; ETHINYLESTRADIOL

Verfügbar ab:

Merck Sharp & Dohme Limited

ATC-Code:

G03AA09

INN (Internationale Bezeichnung):

DESOGESTREL; ETHINYLESTRADIOL

Darreichungsform:

TABLET

Zusammensetzung:

DESOGESTREL 150 µg; ETHINYLESTRADIOL 20 µg

Verschreibungstyp:

POM

Therapiebereich:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2005-10-28

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MERCILON®
Desogestrel (150 micrograms)
Ethinyl estradiol (20 micrograms)
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”).

Some women should not take the Pill because of current medical
problems or illnesses.
Please read this leaflet to make sure Mercilon is right for you.

To prevent pregnancy it is important to take Mercilon as instructed
and to start each pack
on time. Please make sure that you understand what to do if you miss a
pill or if you think
you are pregnant.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions or need more advice, ask your
doctor, family planning
nurse or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, family planning
nurse or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT MERCILON IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MERCILON
3.
HOW TO TAKE MERCILON
3.3 A MISSED PILL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MERCILON
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT MERCILON IS AND WHAT IT IS USED FOR
Mercilon is a combined oral contraceptive pill (‘the Pill’). YOU
TAKE IT TO PREVENT PREGNANCY.
This low-dose contraceptive contains two types of female

Fachinformation

Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mercilon
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Desogestrel B.P.
150 micrograms
Ethinylestradiol Ph.Eur
20 micrograms
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
Tablets are round, biconvex and 6 mm in diameter. They are coded on
one side TR4 and on the
reverse side Organon*.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral 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
4.2.1
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 before the next pack is started.
4.2.2
HOW TO START MERCILON
_No preceding hormonal contraceptive use [in the past month]: _
It is preferable that tablet intake from the first pack is started on
the first day of
Page 2 of 19
menstruation in which case no extra contraceptive precautions are
necessary.
If menstruation has already begun, (that is 2, 3, or 4 days
previously), tablet taking should
commence on day 5 of the menstrual period. In this case additional
contraceptive
precautions must be taken for the first 7 days of tablet taking.
If menstruation began more than 5 days previously then the patient
should be advised to wait
until her next menstrual period before starting to take Mercilon.
_Changing from a 21 day pill or another 22 day pill to Mercilon: _
All tablets in the old pack should be finished. The first Mercilon
tab