APLEEK Transdermal Patch
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:
ETHINYLESTRADIOL GESTODENE
Available from:
Bayer Limited
INN (International Name):
ETHINYLESTRADIOL GESTODENE
Pharmaceutical form:
Transdermal Patch
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
apleek 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 apleek is and what it is used
for ..........................................................................................
2
2.
What you need to know before you use
apleek ............................................................................ 2
Do not use
apleek .........................................................................................................................
3
Warnings and
precautions ............................................................................................................
4
BLO
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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
apleek 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.
apleek is intended for women of fertile age. Safety and efficacy have been established in women aged 18 to 45 years.
The decision to prescribe apleek should take into consideration the individual woman’s current risk factors, particularly
those for venous thromboembolism (VTE), and how the risk of VTE with apleek compares with other combined
hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
apleek 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 removed. Week Four is
patch-free. Withdrawal bleeding is expected to begin during this time. One week after the last patch is r
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