Ethinylestradiol/Drospirenone Leon Farma & Placebo 0.03 mg/3 mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
07-12-2019
Summary of Product characteristics
(SPC)
02-05-2019
Active ingredient:
Ethinylestradiol; Drospirenone
Available from:
Laboratorios Leon Farma, S.A.
ATC code:
G03AA; G03AA12
INN (International Name):
Ethinylestradiol; Drospirenone
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-DRSPEE-IE-NO.H.0147.002.IB025-d0
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ETHINYLESTRADIOL / DROSPIRENONE LEON FARMA & PLACEBO 0.03 MG/3 MG0.03
MG/3 MG 28 FILM-
COATED TABLETS
(ETHINYLESTRADIOL/DROSPIRENONE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPOTANT 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,
even if their signs of illness are the same as yours.
•
If you get any side effects, tal to your doctor or pharmacist. 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 Ethinylestradiol / Drospirenone Leon Farma & Placebo 0.03 mg/3
mgis and what it is used
for
2.
What you need to know before you take Ethinylestradiol / Drospirenone
Leon Farma & Placebo
0.03 mg/3 mg
3.
How to take Ethinylestradiol / Drospirenone Leon Farma & Placebo 0.03
mg/3 mg
4.
Possible side effects
5.
How to store Ethinylestradiol / Drospirenone Leon Farma & Placebo 0.03
mg/3 mg
6.
Contents of the pack and other information
LF-DRSPEE-IE-NO.H.0147.002.IB025-d0
2
1.
WHAT ETHINYLESTRADIOL / DROSPIRENONE LEON FARMA & PLACEBO 0.03 MG/3
MGIS AND WHAT IT
IS USED FOR
Ethinylestradiol / Drospirenone Leon Farma & Placebo 0.03 mg/3 mgis a
contraceptive pill and
is used to prevent pregnancy.
Each of the 21yellow tablet contains a small amount of two diff
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
01 May 2019
CRN008V14
Page 1 of 15
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 of
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
of 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.
Placebo tablets: White, round film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Ethinylestradiol/Drospirenone Leon Farma &
Placebo 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 & Placebo compares with other
combined hormonal contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
HOW TO TAKE ETHINYLESTRADIOL/DROSPIRENONE LEON FARMA & PLACEBO
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 FARMA & PLACEBO
_No preceding hormonal contraceptive use (in the past month)_
Tablet-taking has to start on day 1 of the woman’s natural cycle
Read the complete document
