Orlyelle 0,02 mg/3 mg filmomhulde tabletten

Country: Belanda

Bahasa: Belanda

Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Bahan aktif:

DROSPIRENON ; ETHINYLESTRADIOL

Boleh didapati daripada:

Laboratorios Liconsa S.A.

Kod ATC:

G03AA12

INN (Nama Antarabangsa):

DROSPIRENON ; ETHINYLESTRADIOL

Borang farmaseutikal:

Filmomhulde tablet

Komposisi:

CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYSORBAAT 80 (E 433) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Laluan pentadbiran:

Oraal gebruik

Kawasan terapeutik:

Drospirenone And Ethinylestradiol

Ringkasan produk:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYSORBAAT 80 (E 433); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);

Tarikh kebenaran:

2014-03-26

Risalah maklumat

LF-DRSP EE-NL-NL.H.2890.001.IA.015-D0
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ORLYELLE 0,02 MG / 3 MG FILMOMHULDE TABLETTEN
ETHINYLESTRADIOL/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.

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. Do no pass it on to others.
It may harm them even
if their signs of illness are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor, pharmacist or nurse.
IN THIS LEAFLET:
1.
WHAT ORLYELLE IS AND WHAT IT IS USED FOR
2.
BEFORE YOU TAKE ORLYELLE
3.
HOW TO TAKE ORLYELLE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ORLYELLE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT ORLYELLE IS AND WHAT IT IS USED FOR
Orlyelle 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.
BEFORE YOU TAKE ORLYELLE
GENERAL NOTES
Before you start using Orlyelle 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”
LF-DRSP EE-NL-NL.H.2890.001.IA.015-D0
2
Before you can begin taking Orlyelle, your doctor will ask you some
questions about your personal
he

Ciri produk

NL/H/2890/001/IA/015
1/21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Orlyelle 0,02 mg/3 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg
of drospirenone
Excipient with known effect:
Lactose monohydrate 44 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round film-coated tablets of 5.7 mm diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Orlyelle should take into consideration the
individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE with
Orlyelle compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral use.
HOW TO TAKE ORLYELLE
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 ORLYELLE

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 combined hormonal contraceptive (combined oral
contraceptive (COC),
vaginal ring, or transdermal patch)
NL/H/2890/001/IA/015
2/21
The woman should start with Orlyelle 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 been used the woman should start using Orlyelle
_ _preferably