MINESSE 60 micrograms/15 micrograms film-coated tablet

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Gestodene; Ethinylestradiol

Commercializzato da:

Pfizer Healthcare Ireland

Codice ATC:

G03AA; G03AA10

INN (Nome Internazionale):

Gestodene; Ethinylestradiol

Dosaggio:

60 mcg/15 microgram(s)

Forma farmaceutica:

Film-coated tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Progestogens and estrogens, fixed combinations; gestodene and ethinylestradiol

Stato dell'autorizzazione:

Not marketed

Data dell'autorizzazione:

2000-06-23

Foglio illustrativo

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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 or
nurse.
•
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, pharmacist or nurse.
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
hi

Scheda tecnica

Health Products Regulatory Authority
23 February 2023
CRN00D7L0
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MINESSE 60 micrograms/15 micrograms film-coated tablet
2 QUALITATIVE AND QUANTITATIVE 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.

Changing from another combined oral contraceptive (COC):The woman
should start Minesseon the day after the
last active tablet of her previous COC.
Health Products Regulatory Authority
23 February 2023
CRN00D7L0
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
Changing from