Ethinylestradiol / Drospirenone Leon Farma & Placebo 0.03 mg/ 3 mg Film-coated Tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Drospirenone; Ethinylestradiol

Tersedia dari:

Laboratorios Leon Farma, S.A.

Kode ATC:

G03AA; G03AA12

INN (Nama Internasional):

Drospirenone; Ethinylestradiol

Dosis:

0.03 mg/3 milligram(s)

Bentuk farmasi:

Film-coated tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2009-10-09

Selebaran informasi

LF-DRSPEE-IE-IE.H.0764.002.IA.013_Day 0
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ETHINYLESTRADIOL/DROSPIRENONE LEON FARMA 0.03 MG/3 MG 28 FILM-COATED
TABLETS
ETHINYLESTRADIOL/DROSPIRENONE)
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 no pass it on to
others. It may harm them.
•
If you get any side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
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”)
WHAT IS IN THIS LEAFLET
:
1.
What Ethinylestradiol/Drospirenone Leon Farma is and what it is used
for
2.
What you need to know before you take Ethinylestradiol/Drospirenone
Leon Farma
3.
How to take Ethinylestradiol/Drospirenone Leon Farma
4.
Possible side effects
5.
How to store Ethinylestradiol/Drospirenone Leon Farma
6.
Contents of the pack and other information
1.
WHAT ETHINYLESTRADIOL/DROSPIRENONE LEON FARMA IS AND WHAT IT IS USED
FOR
•
Ethinylestradiol/Drospirenone Leon Farma is a contraceptive pill and
is used to prevent
pregnancy.
•
Each of the 21yellow tablet 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 NEE

Karakteristik produk

Health Products Regulatory Authority
27 October 2022
CRN00D6Z2
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ethinylestradiol / Drospirenone Leon Farma & Placebo 0.03 mg/ 3 mg
Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
YELLOW TABLETS (ACTIVE TABLETS):
Each film-coated tablet contains 0.03 mg of ethinylestradiol and 3 mg
of drospirenone
Excipient with known effect: Each film-coated tablet contains 62 mg
lactose monohydrate
WHITE TABLETS (PLACEBO TABLETS):
The tablet does not contain active substances
Excipient with known effect: Each film-coated tablet contains 89.5 mg
lactose anhydrous
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Active tablets: Yellow, round film-coated tablets with a diameter of
5.7 mm approx.
Placebo tablets: White, round film-coated tablets with a diameter of
5.7 mm approx.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION_
Oral use.
Posology
HOW TO TAKE ETHINYLESTRADIOL/DROSPIRENONE LEON
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 ETHINYLESTRADIOL/DROSPIRENONE LEON

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) The woman should start with
Ethinylestradiol/Drospirenone Leonpreferably on the day after the
last active tablet (the last tablet con