Flexyess 0.02mg/3mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DROSPIRENONE, ETHINYLESTRADIOL

Available from:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

ATC code:

G03AA12

INN (International Name):

DROSPIRENONE 3 mg ETHINYLESTRADIOL 0.02 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DROSPIRENONE 3 mg ETHINYLESTRADIOL 0.02 mg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Withdrawn

Authorization date:

2013-01-29

Patient Information leaflet

Flexyess PIL 
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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 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 not pass it on to others. It may harm them. _
_ _
_If you get any side effects, talk 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 
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1. [/PIL_MA513_04401.html#2]
  [/PIL_MA513_04401.html#2]
What Flexyess is and what it
is used for ................................................................................... 2
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  [/PIL_MA513_04401.html#2]
2. [/PIL_MA513_04401.html#2]
  [/PIL_MA513_04401.html#2]
What you  need to know before you
take Flexyess ................................................................... 2
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  [/PIL_MA513_04401.html#2]
General notes ..............................................................

Summary of Product characteristics

Page 1 of 1

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

0T
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 with known effect: lactose 46 mg 
For the full list of excipients, see section 6.1. 

3 
PHARMACEUTICAL FORM 

Film-coated tablets 

The tablets are light pink, round with convex faces,
one side embossed with the letters 
"DS" in a regular hexagon. 

The tablets have 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). 
Page 2 of 2

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

_METHOD OF ADMINISTRATION_: oral use 

_POSOLOGY_ 

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�