Tri-Minulet Coated* Tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Ethinyloestradiol; Gestodene; Ethinylestradiol; Gestodene; Ethinylestradiol; Gestodene

Disponível em:

Pfizer Healthcare Ireland

Código ATC:

G03AA; G03AA10

DCI (Denominação Comum Internacional):

Ethinyloestradiol; Gestodene; Ethinylestradiol; Gestodene; Ethinylestradiol; Gestodene

Dosagem:

percent volume/volume

Forma farmacêutica:

Coated tablet

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

Progestogens and estrogens, fixed combinations; gestodene and ethinylestradiol

Status de autorização:

Not marketed

Data de autorização:

1988-05-18

Folheto informativo - Bula

Page 1 of 16
2022-0081366
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRI-MINULET 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 TRI-MINULET IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRI-MINULET
3.
HOW TO TAKE TRI-MINULET
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TRI-MINULET
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT TRI-MINULET IS AND WHAT IT IS USED FOR
The name of your medicine is Tri-Minulet Tablets.
Tri-Minulet is an oral contraceptive.
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 fertilisation does not take place, then the egg

Características técnicas

Health Products Regulatory Authority
21 November 2022
CRN00D7RP
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tri-Minulet Coated* Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each beige tablet contains 30 micrograms ethinylestradiol and 50
micrograms gestodene.
Each dark brown tablet contains 40 micrograms ethinylestradiol and 70
micrograms gestodene.
Each white tablet contains 30 micrograms ethinylestradiol and 100
micrograms gestodene.
Excipients with known effect:
Each beige tablet contains 37.455mg lactose monohydrate and 19.371mg
sucrose.
Each dark brown tablet contains 37.425mg lactose monohydrate and
19.180mg sucrose.
Each white tablet contains 37.405mg lactose monohydrate and 19.660mg
sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablets.
Beige round sugar-coated tablets, dark brown round sugar-coated
tablets and white round sugar-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Tri-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
Tri-Minulet compares with other CHCs (see sections 4.3
and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
PAEDIATRIC POPULATION
Paediatric data are not available. Safety and efficacy of CHCs have
been established in adult women of reproductive age.
GERIATRIC POPULATION
CHCs are not indicated for use in postmenopausal women.
HOW TO TAKE TRI-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 fin