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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GESTODENE, ETHINYLESTRADIOL

Available from:

Gedeon Richter Plc Gyomroi ut 19-21 1103 Budapest, Hungary

ATC code:

G03AA10

INN (International Name):

GESTODENE 2.1 mg ETHINYLESTRADIOL 0.55 mg

Pharmaceutical form:

TRANSDERMAL PATCH

Composition:

GESTODENE 2.1 mg ETHINYLESTRADIOL 0.55 mg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Withdrawn

Authorization date:

2014-02-18

Patient Information leaflet

Page 1 of 35
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
1.
What Lisvy is and what it is used for
...........................................................................................
2
2.
What you need to know before you use Lisvy
..............................................................................
2
Do not use Lisvy
...........................................................................................................................
3
Warnings and precautions
............................................................................................................
4
BLOOD CLOTS
....................................................................................

Summary of Product characteristics

Page 1 of 29
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.
SUMMARY OF PRODUCT CHARACTERISTICS
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 550 micrograms
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:
Page 2 of 29
For three consecutive weeks (21 days), one new patch is applied per
week and the used patch
removed. Week Four is patch-free. Withdrawal bleeding is expected to
begin during this time. One
week after the last patch is removed, a new 4-week cycle is started by
applying a new patch (on the
same weekday as before, the ‘Patch Change Day’), regardless of
whether usual withdrawal bleeding
is continuing or has stopped. See ‘Reduced cycle con