FLEXYESS 0.02/3 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
26-04-2024
Summary of Product characteristics
(SPC)
26-04-2024
Active ingredient:
DROSPIRENONE MICRONIZED ETHINYLESTRADIOL (AS BETADEX CLATHRATE MICRONIZED)
Available from:
Bayer Limited
INN (International Name):
DROSPIRENONE MICRONIZED ETHINYLESTRADIOL (AS BETADEX CLATHRATE MICRONIZED)
Dosage:
0.02/3 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
Page:
1 of
18
Flexyess PL
Flexyess PL, clean version, July 2014.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Flexyess 0.02 mg / 3 mg film-coated tablets
Ethinylestradiol / Drospirenone
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
or pharmacist. _
_ _
_This medicine has been prescribed for you, do not pass it on
to others. It may harm them. _
_ _
_If any of the 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”)._
IN THIS LEAFLET
1.
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WHAT FLEXYESS IS AND WHAT IT IS
USED FOR ....................................................................... 2
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2.
[/2143216.PA1410_065_001.b0815f22-a497-453e-a35d-1b1fe7cc395d.000001Flexyess_065.001.140902.html#2]
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE FLEXYESS ................................................. 2
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General notes ...........................
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flexyess 0.02 mg/3 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.020 mg ethinylestradiol (as betadex clathrate) and 3 mg drospirenone.
Excipient: lactose 46 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
The tablet is light pink, round with convex faces, one side embossed with the letters "DS" in a regular hexagon.
The tablet has a diameter of 6 mm and a thickness of 3 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Flexyess should take into consideration the individual woman’s current risk factors,
particularly those for venous thromboembolism (VTE), and how the risk of VTE with Flexyess compares with other
Combined Hormonal Contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral use
HOW TO TAKE FLEXYESS
Flexyess can only be used in combination with the Clyk tablet dispenser. The tablet dispenser will guide the user
through the regimen.
The Instructions for Use for the Clyk tablet dispenser should be read carefully before use and kept for future reference.
For instructions on how to prepare the Clyk tablet dispenser for use and how to dispense a tablet, see section 6.6.
One tablet must be taken every day at about the same time, if necessary with a little liquid. Tablets must always be
taken continuously for a minimum of 24 days.
Flexyess tablets can be taken continuously for up to 120 days, after which a 4-day tablet free interval must be taken.
The tablet taking consists of two phases:
1. A mandatory phase (Day 1 to Day 24):
When starting Flexyess, tablets must be taken conti
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