Minulet 75 micrograms/30 micrograms coated tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Ethinyloestradiol; Gestodene

Dostupné s:

Pfizer Healthcare Ireland

ATC kód:

G03AA; G03AA10

INN (Mezinárodní Name):

Ethinyloestradiol; Gestodene

Dávkování:

75 mcg/30 microgram(s)

Léková forma:

Coated tablet

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Progestogens and estrogens, fixed combinations; gestodene and ethinylestradiol

Stav Autorizace:

Marketed

Datum autorizace:

1988-03-25

Informace pro uživatele

Page 1 of 15
2022-0081366
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MINULET
® 75 MICROGRAMS/30 MICROGRAMS COATED TABLETS
gestodene and ethinylestradiol
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, 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 MINULET IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MINULET
3.
HOW TO TAKE MINULET
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MINULET
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT MINULET IS AND WHAT IT IS USED FOR
Minulet is an oral contraceptive.
The name of your medicine is Minulet 75 micrograms/30 micrograms
coated tablets.
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”).
HOW THE FEMALE REPRODUCTIVE SYSTEM WORKS:
Once a month, an egg (or ovum) is released from
one of the ovaries and passes along the Fallopian
tube to the womb. Fertilisation (the joining together
of the male's sperm with the female's egg) usually
takes place while the egg is still in the Fallopian
tube. The fertilised egg embeds itself in the wall of
the womb, which has been specially prepared to
receive it, and it grows into a baby.
If fertil

Charakteristika produktu

Health Products Regulatory Authority
12 January 2023
CRN00D7R6
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minulet 75 micrograms/30 micrograms coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 micrograms gestodene and 30 micrograms
ethinylestradiol.
Excipients with known effect
Also includes lactose monohydrate 37.43 mg and sucrose 19.66 mg per
tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablets.
White, round, biconvex, sugar-coated tablets with a shiny surface.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Minulet should take into consideration the
individual woman’s current risk factors, particularly those
for venous thromboembolism (VTE), and how the risk of VTE with Minulet
compares with other CHCs (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO TAKE MINULET
Regular daily intake of tablets for 21 consecutive days is important
for the preservation of contraceptive efficacy.
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 occurs. This usually starts on day 2-3
after the last tablet and may not have finished before the
next pack is started.
HOW TO START MINULET
_No hormonal contraceptive use within the preceding month_
The user should begin taking Minulet on Day 1 of her natural menstrual
cycle (i.e. the first day of menstrual bleeding).
Beginning Minulet use on days 2-7 of the menstrual cycle is allowed;
however a non-hormonal back-up method of birth
control [e.g. condoms and spermicide] is recommended during the first
7 days of Minulet use.
_Switching from another combined hormonal contraceptive (CHC)_
Minulet use should begin preferably on the day after the last active
tablet of the