Juliana 28 0.02mg/3mg film-coated tablets

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

ETHINYLESTRADIOL, DROSPIRENONE

제공처:

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

ATC 코드:

G03AA12

INN (국제 이름):

ETHINYLESTRADIOL 0.2 mg DROSPIRENONE 3 mg

약제 형태:

FILM-COATED TABLET

구성:

ETHINYLESTRADIOL 0.2 mg DROSPIRENONE 3 mg

처방전 유형:

POM

치료 영역:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

승인 상태:

Withdrawn

승인 날짜:

2017-06-20

환자 정보 전단

Page
1
of
17
PACKAGE LEAFLET: INFORMATION FOR THE USER
JULIANA 28 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 28 is and what it is used for
2.
What you need to know before you use Juliana 28
3.
How to take Juliana 28
4.
Possible side effects
5.
How to store Juliana 28
6.
Contents of the pack and other information
1.
WHAT JULIANA 28 IS AND WHAT IT IS USED FOR
-
Juliana 28 is a contraceptive pill and is used to prevent pregnancy.
-
Each of the 21 pink 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 JULIANA 28
GENERAL NOTES
Before you start using Juliana 28 you should read the information on
blood clots in section 2.
It is particularly important to read the symptoms of a

제품 특성 요약

Page
1
of
20
1.
NAME OF THE MEDICINAL PRODUCT
Juliana 28 0.02 mg/3 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
21 PINK FILM-COATED TABLETS (ACTIVE TABLETS):
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.
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: Pink, round, biconvex film-coated tablet with “20”
on one side. The other side
is without engraving.
Placebo tablets: White, round, film-coated tablets with “PL” on
one side. The other side is
without engraving.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Juliana 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 Juliana 28 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 28
Page
2
of
20
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 JULIANA 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 a com