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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Drospirenone; Ethinylestradiol

Available from:

Laboratorios Leon Farma, S.A.

ATC code:

G03AA; G03AA12

INN (International Name):

Drospirenone; Ethinylestradiol

Dosage:

0.03 / 3 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

Authorization status:

Not marketed

Authorization date:

2009-10-09

Patient Information leaflet

LF-DRSP-EE-CC-IE.H.0763.001.IA.011-D0
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PACKAGE LEAFLET: INFORMATION FOR THE USER
0.02 MG/3 MG 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, pharmacist or
nurse.
•
This medicine has been prescribed for you only, do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
LF-DRSP-EE-CC-IE.H.0763.001.IA.011-D0
2
1.
WHAT IS AND WHAT IT IS USED FOR
•
is a contraceptive pill and is used to prevent
pregnancy.
•
Each film-coated 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 TO TAKE
GENERAL NOTES
Before you start using you should read the information
on blood clots in section
2. It is particul

Summary of Product characteristics

Health Products Regulatory Authority
09 November 2022
CRN00D6FY
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ethinylestradiol / Drospirenone Leon Farma 0.03mg/3 mg Film-coated
Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.03 mg of ethinylestradiol and 3 mg
of drospirenone
Excipient with known effect: each tablet contains 62 mg lactose
monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
Yellow, round film-coated tablets with a diameter of 5.7mm approx.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Ethinylestradiol/Drospirenone Leon Farma
should take into consideration the individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the risk of VTE with
Ethinylestradiol/Drospirenone Leon Farma compares with other combined
hormonal contraceptives (CHCs) (see sections 4.3
and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION_
Oral use.
Posology
HOW TO TAKE ETHINYLESTRADIOL/DROSPIRENONE LEON FARMA 0.03MG/3 MG
FILM-COATED TABLETS
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 ETHINYLESTRADIOL/DROSPIRENONE LEON FARMA 0.02 MG/ 3 MG
FILM COATEDTABLETS

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)
Health Products Regulatory Authority
09 November 2022