Juliana 0.02mg/3mg film-coated tablets

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

ETHINYLESTRADIOL, DROSPIRENONE

Tersedia dari:

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

Kode ATC:

G03AA12

INN (Nama Internasional):

ETHINYLESTRADIOL 0.02 mg DROSPIRENONE 3 mg

Bentuk farmasi:

FILM-COATED TABLET

Komposisi:

ETHINYLESTRADIOL 0.02 mg DROSPIRENONE 3 mg

Jenis Resep:

POM

Area terapi:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Status otorisasi:

Withdrawn

Tanggal Otorisasi:

2017-06-20

Selebaran informasi

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PACKAGE LEAFLET: INFORMATION FOR THE USER
JULIANA 0.02 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 Juliana is and what it is used for
2.
What you need to know before you use Juliana
3.
How to take Juliana
4.
Possible side effects
5.
How to store Juliana
6.
Contents of the pack and other information
1.
WHAT JULIANA IS AND WHAT IT IS USED FOR
-
Juliana 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 JULIANA
GENERAL NOTES
Before you start using Juliana 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 Juliana , your doctor will ask you some
questions abou

Karakteristik produk

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1.
NAME OF THE MEDICINAL PRODUCT
Juliana 0.02 mg/3 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.02 mg ethinylestradiol and 3 mg
drospirenone.
Excipients with known effect:
Each film-coated tablet contains 47.38 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round, biconvex film-coated tablet with “20” on one side.
The other side is without
engraving.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Juliana should take into consideration the
individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the risk
of VTE with Juliana 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 JULIANA
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 must 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 JULIANA
•
No preceding hormonal contraceptive use (in the past month)
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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 a combined hormonal contraceptive (combined oral
contraceptive(COC), vaginal ring, or transdermal patch)
The woman should start with Juliana 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 tablet-free or placebo tablet interval of her
previous COC. In case a
vaginal ring or transdermal patch has b