Minesse

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

GESTODENE, ETHINYLESTRADIOL

Inapatikana kutoka:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC kanuni:

G03AA10

INN (Jina la Kimataifa):

GESTODENE ETHINYLESTRADIOL

Dawa fomu:

FILM-COATED TABLET

Tungo:

GESTODENE ETHINYLESTRADIOL

Dawa ya aina:

POM

Eneo la matibabu:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2006-09-22

Taarifa za kipeperushi

Page 1 of 12
Pfleet No.: 2014-0004784
PACKAGE LEAFLET: INFORMATION FOR THE USER
MINESSE 60 MICROGRAMS/15 MICROGRAMS, FILM-COATED TABLETS
Gestodene/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 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, ask your doctor 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 or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What MINESSE is and what it is used for
2.
What you need to know before you take MINESSE
3.
How to take MINESSE
4.
Possible side effects
5.
How to store MINESSE
6.
Contents of the pack and other information
1.
What MINESSE is and what it is used for

MINESSE is an oral contraceptive pill and is used to prevent
pregnancy.

Each of the 24 pale yellow tablets contains a small amount of two
different female hormones, namely
gestodene and ethinylestradiol.

The 4 white tablets contain no active substances and are called
placebo tablets.

Contraceptive pills that contain two hormones are called
“combination” pills.
2.
What you need to know before you take MINESSE
_ _
GENERAL NOTES
Before you can begin taking MINESSE, your doctor will ask you some
questions about your personal health
hist

Tabia za bidhaa

Ref.: MS 6_0
Page 1 of 16
Pfleet number: 2014-0007971
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MINESSE
60 micrograms / 15 micrograms
film-coated tablet
2.
QUANTITATIVE AND QUALITATIVE COMPOSITION
Gestodene : ..... ............ ………60 micrograms
Ethinylestradiol: ........... ………15 micrograms
For one pale-yellow, film-coated tablet (active tablet)
Excipient with known effect: lactose
The white, film-coated tablets do not contain any active ingredients
(placebo).
Excipient with known effect: lactose
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
The active tablet is a pale-yellow round tablet with convex faces
embossed with “60”on one
side and “15”on the other.
The placebo tablet is a white round tablet with convex faces.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral hormonal contraception.
The decision to prescribe Minesse should take into consideration the
individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the risk
of VTE with Minesse compares with other combined hormonal
contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Take regularly and without omission, one tablet daily at the same time
of the day, for 28
consecutive days (one pale-yellow, active tablet during the first 24
days, one white, inactive
tablet during the 4 following days) with no free interval between each
blister pack. A
withdrawal bleed 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 Minesse
-
No preceding hormonal contraceptive use in the past month:
-
Take the first tablet on the first day of menstrual bleeding.
Ref.: MS 6_0
Page 2 of 16
Pfleet number: 2014-0007971

Changing from another combined oral contraceptive (COC):
The woman should start Minesse_ _on the day after the last active
tablet of her previous COC.
_-_
_ _
Changing from a progestin-only method (m