Julia 28 0.03mg/3mg film-coated tablets

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

ETHINYLESTRADIOL, DROSPIRENONE

Disponibbli minn:

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

Kodiċi ATC:

G03AA12

INN (Isem Internazzjonali):

ETHINYLESTRADIOL 0.03 mg DROSPIRENONE 3 mg

Għamla farmaċewtika:

FILM-COATED TABLET

Kompożizzjoni:

ETHINYLESTRADIOL 0.03 mg DROSPIRENONE 3 mg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

L-istatus ta 'awtorizzazzjoni:

Withdrawn

Data ta 'l-awtorizzazzjoni:

2017-06-20

Fuljett ta 'informazzjoni

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PACKAGE LEAFLET: INFORMATION FOR THE USER
JULIA 28 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 28 is and what it is used for
2.
What you need to know before you use Julia 28
3.
How to take Julia 28
4.
Possible side effects
5.
How to store Julia 28
6.
Contents of the pack and other information
1.
WHAT JULIA 28 IS AND WHAT IT IS USED FOR
-
Julia 28 is a contraceptive pill and is used to prevent pregnancy.
-
Each of the 21 yellow tablets contains a small amount of two different
female
hormones, namely drospirenone and ethinylestradiol.
-
The 7 white tablets contain no active substances and are also called
placebo tablets.
-
Contraceptive pills that contain two hormones are called
“combination” pills.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE JULIA 28
GENERAL NOTES
Before you start using Julia 28 you should read the information on
blood clots in section 2. It
is particularly important to read the symptoms of a blood clot –

Karatteristiċi tal-prodott

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1.
NAME OF THE MEDICINAL PRODUCT
Julia 28 0.03 mg /3 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
21 YELLOW FILM-COATED TABLETS (ACTIVE TABLETS):
Each film-coated tablet contains 0.03 mg ethinylestradiol and 3 mg
drospirenone.
Excipients with known effect: each film-coated tablet contains 49.77
mg of lactose
monohydrate.
7 WHITE PLACEBO (INACTIVE) FILM-COATED TABLETS:
The tablets do not contain any active substances.
Excipients with known effect: each film-coated tablet contains 39.80
mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Active tablet:
Yellow, round, biconvex film-coated tablet with “30” on one side.
The other side is without
engraving.
Placebo tablets:
White, round, biconvex film-coated tablet with (PL” on one side. The
other side is without
engraving.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Julia 28 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 28 compares with other combined hormonal
contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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Posology
Route of administration: oral use
HOW TO TAKE JULIA 28
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.
Tablet taking is continuous. One tablet is to be taken daily for 28
consecutive days.
Each subsequent pack is started the day after the last tablet of the
previous pack.
Withdrawal bleeding usually starts on day 2-3 after starting the
placebo tablets (last
row) and may not have finished before the next pack is started.
HOW TO START JULIA 28
-
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