Julia 0.03mg/3mg film-coated tablets

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

ETHINYLESTRADIOL, DROSPIRENONE

Disponible depuis:

Mithra Pharmaceuticals S.A Rue Saint-Georges 5, 4000, Liege, Belgium

Code ATC:

G03AA12

DCI (Dénomination commune internationale):

ETHINYLESTRADIOL 0.03 mg DROSPIRENONE 3 mg

forme pharmaceutique:

FILM-COATED TABLET

Composition:

ETHINYLESTRADIOL 0.03 mg DROSPIRENONE 3 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2017-06-20

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
JULIA 0.03 MG/3 MG FILM-COATED TABLETS
Ethinylestradiol and drospirenone
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 effect, 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 Julia is and what it is used for
2.
What you need to know before you use Julia
3.
How to take Julia
4.
Possible side effects
5.
How to store Julia
6.
Contents of the pack and other information
1.
WHAT JULIA IS AND WHAT IT IS USED FOR
-
Julia is a contraceptive pill and is used to prevent pregnancy.
-
Each tablet contains a small amount of two different female hormones,
namely drospirenone
and ethinylestradiol.
-
Contraceptive pills that contain two hormones are called
“combination” pills.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE JULIA
GENERAL NOTES
Before you start using Julia you should read the information on blood
clots in section 2. It is
particularly important to read the symptoms of a blood clot – see
Section 2 “Blood clots”.
Before you can begin taking Julia , your doctor will ask you some
questions about your personal
health history

Résumé des caractéristiques du produit

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1.
NAME OF THE MEDICINAL PRODUCT
Julia 0.03 mg /3 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.03 mg ethinylestradiol and drospirenone 3 mg.
Excipients with known effect:
Each film-coated tablet contains 49.77 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round, biconvex film-coated tablet with “30” on one side.
The other side is without engraving.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Julia should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Julia
compares with other combined hormonal contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Route of administration: oral use
HOW TO TAKE JULIA
The tablets must be taken every day at about the same time, if
necessary with a little liquid, in the
order shown on the blister pack. 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.
HOW TO START JULIA
-
No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman's natural cycle (i.e.
the first day of her menstrual
bleeding).
-
Changing from another combined hormonal contraceptive (combined oral
contraceptive (COC),
vaginal ring or transdermal patch)
The woman should start with Julia preferably on the day after the last
active tablet (the last tablet
containing the active substances) of her previous COC, but at the
latest on the day following the usual
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tablet-free or placebo tablet interval of her previous COC. In case a
vaginal ring or transdermal patch
has been used, the wom