LISVY Transdermal Patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ETHINYLESTRADIOL, GESTODENE

Available from:

Gedeon Richter Plc

ATC code:

G03AA10

INN (International Name):

ETHINYLESTRADIOL, GESTODENE

Pharmaceutical form:

Transdermal Patch

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens and estrogens, fixed combinations

Authorization status:

Authorised

Authorization date:

2015-06-05

Patient Information leaflet

1 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

Lisvy 60 micrograms/24 hours + 13 micrograms/24 hours transdermal
patch 
gestodene/ethinylestradiol 

This medicine is subject to additional monitoring. This
will allow quick identification of new safety 
information. You can help by reporting any side effects you
may get. See the end of section 4 for how to 
report side effects. 

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”) 
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. 


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. 

WHAT IS IN THIS LEAFLET 
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What Lisvy is and what it is used
for ........................................................................................... 2
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What you need to know before you
use Lisvy ...................................................................

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety
information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to
report adverse reactions.
1 NAME OF THE MEDICINAL PRODUCT
Lisvy 60 micrograms/24 hours + 13 micrograms/24 hours transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 11 cm
2
transdermal patch contains 2.10 mg gestodene and 0.55 mg ethinylestradiol.
Each transdermal patch releases 60 micrograms gestodene per 24 hours and 13 micrograms ethinylestradiol (equal to
oral doses of 20 micrograms) per 24 hours.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch.
Thin matrix-type transdermal patch consisting of five layers.
The patch is round, transparent, and has a size of 11 cm
2
. On its sticky side the patch is covered by a two-part square-
shaped shiny clear protective liner.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Female hormonal contraception.
Lisvy is intended for women of fertile age. Safety and efficacy have been established in women aged 18 to 45 years.
The decision to prescribe Lisvy should take into consideration the individual woman’s current risk factors, particularly
those for venous thromboembolism (VTE), and how the risk of VTE with Lisvy compares with other combined
hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Lisvy is used in a 28-day (4-week) cycle:
For three consecutive weeks (21 days), one new patch is applied per week and the used patch is removed. Week Four is
patch-free. Withdrawal bleeding is expected to begin during this time. One week after the last patch is removed,�