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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

gestodene 2.1 mg, ethinylestradiol 0.55 mg

Available from:

Bayer PLC

ATC code:

G03AA10

INN (International Name):

gestodene, ethinylestradiol

Pharmaceutical form:

transdermal patch

Authorization status:

Authorised

Authorization date:

2014-02-18

Patient Information leaflet

Page 1 of 35 

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 
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What apleek is and what it is used
for .......................................................................................... 2
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What you need to know before you
use apleek ............................................................................ 2
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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 
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: 
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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 cy