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APLEEK 60 MICROGRAMS/24 HOURS + 13 MICROGRAMS/24 HOURS TRANSDERMAL PATCH

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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 
BLOOD CLOTS ....................................................................................................................... 5 
Combined hormonal contraceptives and cancer ....................................................................... 9 
Bleeding between periods ....................................................................................................... 10 
What to do if no bleeding occurs ............................................................................................ 10 
Children and adolescents ............................................................................................................ 10 
Other medicines and apleek........................................................................................................ 10 
Laboratory tests ....................................................................................................................... 11 
apleek with food, drink and alcohol ........................................................................................... 11 
Pregnancy and breast-feeding..................................................................................................... 11 
Driving and using machines ....................................................................................................... 11 
3.  How to use apleek ...................................................................................................................... 11 
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When to start apleek for the first time ........................................................................................ 12 
After a miscarriage ..................................................................................................................... 13 
After having a baby .................................................................................................................... 13 
Where to apply the patch ............................................................................................................ 13 
What did you receive in the pharmacy ....................................................................................... 14 
How to prepare the patch for application ................................................................................... 15 
Instructions on further use .......................................................................................................... 18 
Patch Change Day ...................................................................................................................... 19 
Patch-free days ........................................................................................................................... 19 
Reminder card and reminder stickers ......................................................................................... 20 
If you use more apleek than you should ..................................................................................... 21 
If you forget to use apleek .......................................................................................................... 22 
What to do in case of skin irritation ........................................................................................... 24 
How to shift your ‘Patch Change Day’ to another day .............................................................. 25 
What to do if you vomit or have severe diarrhoea ..................................................................... 25 
If you stop using apleek .............................................................................................................. 25 
4.  Possible side effects .................................................................................................................... 25 
Serious side effects ..................................................................................................................... 25 
The following side effects were reported in apleek users: ......................................................... 25 
Description of selected side effects ............................................................................................ 26 
5.  How to store apleek .................................................................................................................... 28 
Disposal of patches and other handling ...................................................................................... 28 
6.  Contents of the pack and other information ............................................................................... 29 
What apleek contains .................................................................................................................. 29 
What apleek looks like and contents of the pack ....................................................................... 29 
Marketing Authorisation Holder and Manufacturer ................................................................... 29 

1. What apleek is and what it is used for
apleek is a patch used to prevent pregnancy.
Each patch contains two different female hormones, namely gestodene and ethinylestradiol which
are delivered continuously in small amounts over a period of 7 days.
Because apleek contains a combination of two hormones it belongs to the group of ‘combined
hormonal contraceptives’.
2. What you need to know before you use apleek
General notes
Before you start using apleek you should read the information on blood clots in section 2. It is
particularly important to read the symptoms of a blood clot – see Section 2 “Blood clots”).
Before you can begin using apleek, your doctor will ask you some questions about your personal
health history and that of your close relatives. The doctor will also measure your blood pressure
and, depending upon your personal situation, may also carry out some other tests.
In this leaflet, several situations are described where you should stop using apleek, or where the
reliability of apleek may be decreased. In such situations you should either not have sex or you
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should take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier
method. Do not use rhythm or temperature methods. These methods can be unreliable because
apleek alters the monthly changes of body temperature and cervical mucus.
apleek, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or
any other sexually transmitted disease.
Do not use apleek
You should not use apleek if you have any of the conditions listed below. If you do have any of the
conditions listed below, you must tell your doctor. Your doctor will discuss with you what other
form of birth control would be more appropriate.


if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis,
DVT), your lungs (pulmonary embolus, PE) or other organs



if you know you have a disorder affecting your blood clotting – for instance, protein C
deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or
antiphospholipid antibodies



if you need an operation or if you are off your feet for a long time (see section "Blood clots")



if you have ever had a heart attack or stroke



if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and
may be a first sign of a heart attack) or transient ischaemic attack (TIA – temporary stroke
symptoms)



if you have any of the following diseases that may increase your risk of a clot in the arteries:
 severe diabetes with blood vessel damage
 very high blood pressure
 a very high level of fat in the blood (cholesterol or triglycerides)
 a condition known as hyperhomocysteinaemia



if you have (or have ever had) a type of migraine called ‘migraine with aura’



if you have (or have ever had) liver disease (symptoms of which may be yellowing of the skin
or itching over the whole body) and your liver is still not working normally



if you have (or have ever had) a cancer that may grow under the influence of sex hormones (e.g.
of the breast or the genital organs)



if you have (or have ever had) a benign or malignant tumour of the liver



if you have any unexplained bleeding from the vagina



if you are allergic to ethinylestradiol, gestodene or any of the other ingredients of this medicine
(listed in section 6). This may cause, for example, itching, rash or swelling.

If any of these conditions appear for the first time while using apleek, remove the patch
immediately, stop using it and consult your doctor. In the meantime, use non-hormonal
contraceptive measures. See also section 2 ‘General notes’ above.

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Warnings and precautions
When should you contact your doctor?
Seek urgent medical attention
-

if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in
the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart
attack or a stroke (see ‘Blood clot’ (thrombosis) section below.)

For a description of the symptoms of these serious side effects please go to “How to recognise a
blood clot”.
Talk to your doctor, pharmacist or nurse before using apleek.
In some situations you need to take special care while using apleek or any other combined
hormonal contraceptive, and your doctor may need to examine you regularly.
Tell your doctor if any of the following conditions apply to you. If the condition develops, or
gets worse while you are using apleek, you should also tell your doctor.
 if you smoke
 if you have diabetes
 if you are overweight
 if you have high blood pressure
 if you have a problem with your heart (valve disorder, disturbance of the heart rhythm)
 if anyone of your close relatives has ever had a blood clot (thrombosis in the leg, lung
‘pulmonary embolism’, or elsewhere), a heart attack or a stroke at a young age
 if you suffer from migraine
 if you have epilepsy (see section 2 ‘Other medicines and apleek’)
 if a close relative has (or has ever had) breast cancer
 if you have a disease of the liver or gall bladder
 if you have depression
 if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
 if you have systemic lupus erythematosus (SLE - a disease affecting your natural defence
system)
 if you have a haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing
failure of the kidneys)
 if you have sickle cell anaemia (an inherited disease of the red blood cells)
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 if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family
history for this condition. Hypertriglyceridaemia has been associated with an increased risk
of developing pancreatitis (inflammation of the pancreas)
 if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood
clot’)
 if you have just given birth you are at an increased risk of blood clots. You should ask your
doctor how soon after delivery you can start using apleek
 if you have an inflammation in the veins under the skin (superficial thrombophlebitis)
 If you have varicose veins
 if you have a condition that occurred for the first time or worsened during pregnancy or
previous use of sex hormones (e.g. hearing loss, a metabolic disease called porphyria, a skin
disease called herpes gestationis, or Sydenham's chorea, a nerve disease causing sudden
movements of the body)


if you have (or have ever had) golden brown pigment patches (so-called ‘pregnancy
patches’) especially on the face (chloasma). If this is the case, avoid direct exposure to
sunlight or ultraviolet light.

 if you have hereditary angioedema. Consult your doctor immediately if you experience
symptoms of angioedema such as swollen face, tongue or throat, and/or difficulty
swallowing, or hives, together with difficulty breathing. Products containing oestrogens
may induce or worsen symptoms of angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as apleek increases your risk of developing a blood
clot compared with not using one. In rare cases a blood clot can block blood vessels and cause
serious problems.
Blood clots can develop


in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE)



in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’ or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or,
very rarely, they may be fatal.
It is important to remember that the overall risk of a harmful blood clot due to apleek is
small.

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HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms.
Are you experiencing any of these signs?

What are you possibly suffering from?



Deep vein thrombosis

swelling of one leg or along a vein in the leg or
foot especially when accompanied by:


pain or tenderness in the leg which may be
felt only when standing or walking



increased warmth in the affected leg



change in colour of the skin on the leg e.g.
turning pale, red or blue



sudden unexplained breathlessness or rapid
breathing;



sudden cough without an obvious cause, which
may bring up blood;



sharp chest pain which may increase with deep
breathing;



severe light headedness or dizziness;



rapid or irregular heartbeat



severe pain in your stomach;

Pulmonary embolism

If you are unsure, talk to a doctor as some of these
symptoms such as coughing or being short of breath
may be mistaken for a milder condition such as a
respiratory tract infection (e.g. a ‘common cold’).
Symptoms most commonly occur in one eye:


immediate loss of vision or



painless blurring of vision which can progress to
loss of vision



chest pain, discomfort, pressure, heaviness



sensation of squeezing or fullness in the chest,
arm or below the breastbone;



fullness, indigestion or choking feeling;



upper body discomfort radiating to the back, jaw,
throat, arm and stomach;



sweating, nausea, vomiting or dizziness;



extreme weakness, anxiety, or shortness of
breath;



rapid or irregular heartbeats

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Retinal vein thrombosis (blood clot in the
eye)

Heart attack

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sudden weakness or numbness of the face, arm or Stroke
leg, especially on one side of the body;



sudden confusion, trouble speaking or
understanding;



sudden trouble seeing in one or both eyes;



sudden trouble walking, dizziness, loss of
balance or coordination;



sudden, severe or prolonged headache with no
known cause;



loss of consciousness or fainting with or without
seizure.

Sometimes the symptoms of stroke can be brief with
an almost immediate and full recovery, but you
should still seek urgent medical attention as you may
be at risk of another stroke.


swelling and slight blue discolouration of an
extremity;



severe pain in your stomach (acute abdomen)

Blood clots blocking other blood vessels

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?


The use of combined hormonal contraceptives has been connected with an increase in the risk of
blood clots in the vein (venous thrombosis). However, these side effects are rare. Most
frequently, they occur in the first year of use of a combined hormonal contraceptive.



If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT).



If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.



Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of using a combined
hormonal contraceptive for the first time. The risk may also be higher if you restart using a
combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks
or more
After the first year, the risk gets smaller but is always slightly higher than if you were not using a
combined hormonal contraceptive.
When you stop apleek your risk of a blood clot returns to normal within a few weeks.
What is the risk of developing a blood clot?
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The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you
are using.
The overall risk of a blood clot in the leg or lung (DVT or PE) with apleek is small.
-

Out of 10,000 women who are not using any combined hormonal contraceptive and are not
pregnant, about 2 will develop a blood clot in a year.

-

Out of 10,000 women who are using a combined hormonal contraceptive that contains
levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a blood clot in a year.

-

Out of 10,000 women who are using a combined oral contraceptive that contains gestodene
between about 9 and 12 women will develop a blood clot in a year.

-

It is not yet known how the risk of a blood clot with apleek compares to the risk with a
combined hormonal contraceptive that contains levonorgestrel and a combined oral
contraceptive that contains gestodene.

-

The risk of having a blood clot will vary according to your personal medical history (see
"Factors that increase your risk of a blood clot" below).
Risk of developing a blood clot in a
year

Women who are not using a combined hormonal
pill/patch/ring and are not pregnant

About 2 out of 10,000 women

Women using a combined hormonal contraceptive pill
containing levonorgestrel, norethisterone or
norgestimate

About 5-7 out of 10,000 women

Women using a combined oral contraceptive (pill)
containing gestodene

About 9-12 out of 10,000 women

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with apleek is small but some conditions will increase the risk. Your risk is
higher:


if you are very overweight (body mass index or BMI over 30kg/m2);



if one of your immediate family has had a blood clot in the leg, lung or other organ at a young
age (e.g. below the age of about 50). In this case you could have a hereditary blood clotting
disorder;



if you need to have an operation, or if you are off your feet for a long time because of an injury
or illness, or you have your leg in a cast. The use of apleek may need to be stopped several
weeks before surgery or while you are less mobile. If you need to stop apleek ask your doctor
when you can start using it again.



as you get older (particularly above about 35 years);



if you gave birth less than a few weeks ago.

The risk of developing a blood clot increases the more conditions you have.
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Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have
some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you, even if you are unsure.
Your doctor may decide that apleek needs to be stopped.
If any of the above conditions change while you are using apleek, for example a close family
member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your
doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause
a heart attack or a stroke.
Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke from using apleek is very small but can
increase:


with increasing age (beyond about 35 years);



if you smoke. When using a combined hormonal contraceptive like apleek you are advised
to stop smoking. If you are unable to stop smoking and are older than 35 your doctor may
advise you to use a different type of contraceptive;



if you are overweight;



if you have high blood pressure;



if a member of your immediate family has had a heart attack or stroke at a young age (less
than about 50). In this case you could also have a higher risk of having a heart attack or
stroke;



if you, or someone in your immediate family, have a high level of fat in the blood
(cholesterol or triglycerides);



if you get migraines, especially migraines with aura;



if you have a problem with your heart (valve disorder, disturbance of the rhythm called
atrial fibrillation)



if you have diabetes.

If you have more than one of these conditions or if any of them are particularly severe the risk of
developing a blood clot may be increased even more.
If any of the above conditions change while you are using apleek, for example you start smoking, a
close family member experiences a thrombosis for no known reason; or you gain a lot of weight,
tell your doctor.
Combined hormonal contraceptives and cancer
Breast cancer has been observed slightly more often in women using combined hormonal
contraceptives, but it is not known whether this is caused by the treatment itself. For example, it
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may be that more tumours are detected in women on combined hormonal contraceptives because
they are examined by their doctor more often. The risk of breast tumours becomes gradually less
after stopping the combined hormonal contraceptive. It is important to regularly check your breasts
and you should contact your doctor if you feel any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been
reported in combined hormonal contraceptive users. In isolated cases, these tumours have led to
life-threatening internal bleeding. Contact your doctor if you have unusually severe abdominal pain.
The most important risk factor for cervical cancer is persistent Human Papilloma Virus (HPV)
infection. Some studies suggest that long-term use of combined hormonal contraceptives increases a
woman's risk of developing cervical cancer. However, it is not clear to what extent sexual
behaviour or other factors such as Human Papilloma Virus increases this risk.
Bleeding between periods
With all combined hormonal contraceptives, for the first few months, you can have irregular
vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use
sanitary protection, but continue to use apleek as normal.
Irregular vaginal bleeding usually stops once your body has adjusted to apleek (usually after about
3 cycles). If it continues, becomes heavy or starts again, tell your doctor.
What to do if no bleeding occurs
If you have used apleek correctly and have not taken any other medicines, it is highly unlikely that
you are pregnant. Continue to use apleek as usual.
If you have used apleek incorrectly, or, if you have used apleek correctly but the expected bleeding
does not happen twice in a row, you may be pregnant. Contact your doctor immediately. Do not
continue with the next patch until you are sure that you are not pregnant. In the meantime, use nonhormonal contraceptive measures. See also section 2 ‘General notes’ above.
Children and adolescents
Safety and efficacy of apleek have not been demonstrated in adolescents under 18 years of age.
Other medicines and apleek
Please tell your doctor or pharmacist if you are using, have recently used or might use any other
medicines or herbal products, including medicines obtained without a prescription. Also tell any
other doctor or dentist who prescribes another medicine (or the pharmacist from whom you got the
medicine) that you use apleek. They can tell you if you need to take additional contraceptive
precautions (for example condoms) and if so, for how long, or, whether the use of another medicine
you need must be changed.
Some medicines can have an influence on the blood levels of apleek and can make it less effective
in preventing pregnancy, or can cause unexpected bleeding. These include:
o medicines used for the treatment of:
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 epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine,
eslicarbazepine, topiramate, felbamate)
 tuberculosis (e.g. rifampicin, rifabutin)
 sleep disorder narcolepsy (modafinil)
 high blood pressure in the blood vessels in the lungs (bosentan)
 HIV and Hepatitis C Virus infections (so-called protease inhibitors and nonnucleoside reverse transcriptase inhibitors), other infections (griseofulvin).
o the herbal remedy St. John's wort
Combined hormonal contraceptives may influence the effect of other medicines such as the antiepileptic lamotrigine.
Laboratory tests
If you need a blood test or other laboratory tests tell your doctor or the laboratory staff that you are
using apleek because hormonal contraceptives can affect the results of some tests.
apleek with food, drink and alcohol
It is not expected that food, drink or alcohol will affect the way apleek works.
Pregnancy and breast-feeding
Do not use apleek if you are pregnant, or, if you think you may be pregnant. If you become
pregnant while using apleek, remove it immediately and contact your doctor.
If you want to become pregnant, you can stop using apleek at any time (see also section 3 ‘If you
stop using apleek’).
apleek is generally not recommended for use during breast-feeding. If you want to use apleek while
you are breast-feeding you should contact your doctor.
Driving and using machines
You can drive or operate machinery while using apleek.
3. How to use apleek
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
apleek prevents you from becoming pregnant by transferring hormones to your body through your
skin. The patch must stick securely to your skin in order for it to work properly.
The efficacy of apleek depends on how well you follow the instructions for using the patch. The
more closely you follow these instructions, the less chance you have of getting pregnant.
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Therefore, always use apleek exactly as described in this booklet. If you do not follow these
instructions, you may increase your risk of getting pregnant.
When to start apleek for the first time
Make a note of which day of the week you apply your first patch. This weekday will become your
weekly 'Patch Change Day' (see the section on ‘Patch Change Day’ below in this section 3).
Follow the rules for starting or switching to apleek by selecting the contraceptive method used in
the previous month in the left column of the following table:
Rules for starting or switching to apleek
Contraceptive method
used in previous month

Rules for starting or switching to apleek

No hormonal
contraceptive

Start using apleek on the first day of your cycle (Day 1 of your
period). apleek will work immediately and it is not necessary to
use an additional contraceptive method.
You may also start wearing a patch on Days 2-5 of your cycle, but
you must make sure you also use an additional contraceptive
method (e.g. condom) during the 7 days of wearing the first patch.

Combined hormonal
contraceptive pill

We recommend you to start using apleek the day AFTER you
take the last hormone-containing tablet from your pill pack.
This means no tablet-free break. If your pill pack also contains
hormone-free tablets you can start apleek on the day AFTER
taking the last tablet containing hormones. If you are not sure
which this is, ask your doctor or pharmacist.
You can also start later, but never start later than the first day after
the end of the break of your pill (or the first day after the last
hormone-free tablet of your pill).

Combined
contraceptive vaginal
ring

Start using apleek on the day of removal of the last ring of a
cycle pack, but at the latest when the next application would have
been due.

Combined
contraceptive patch

Start using apleek on the day of removal of the last patch of a
cycle pack, but at the latest when the next application would have
been due.

Progestogen-only pill
(“Minipill”)

You can switch to apleek on any day without a break.
You must use extra protective measures (e.g. condom) during
the 7 days of wearing the first patch.

Progestogen-only
implant

Start using apleek on the day of removal.
You must use extra protective measures (e.g. condom) during
the 7 days of wearing the first patch.

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Contraceptive method
used in previous month

Rules for starting or switching to apleek

Progestogen-releasing
intrauterine system

Start using apleek on the day of removal.
You must use extra protective measures (e.g. condom) during
the 7 days of wearing the first patch.

Progestogen-only
injection

Start using apleek on the day when the next injection would
have been due.
You must use extra protective measures (e.g. condom) during
the 7 days of wearing the first patch.

After a miscarriage
Follow the advice of your doctor.
After having a baby
If you have just had a baby, your doctor may tell you to wait until after your first normal period
before you start using apleek. Sometimes it is possible to start sooner. Your doctor will advise you.
If, after having a baby, you have had sex before starting apleek, be sure that you are not pregnant or
wait until your next menstrual period before applying the patch.
If you want to start apleek after having a baby and are breast-feeding, discuss this first with your
doctor.
Ask your doctor what to do if you are not sure when to start using apleek.
Where to apply the patch
Use apleek only on the following sites: abdomen, buttocks or outer upper arm, in a place where it
will not be rubbed by tight clothing (see figure below). For example, do NOT place the patch at
the waistband of your clothing.

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Make sure your skin at the application site is unbroken, healthy, clean, dry, and preferably
hairless. Do NOT put the patch on your breasts, on cut, red or irritated skin, or in the same place
you put your last patch.
Do NOT use lotions, creams, oils, powders, make-up or other products on the skin area where
the patch is or will be placed. It may stop the patch sticking properly or cause it to become
loose.
Vary where you place the patch by using different areas at the same application site. For example,
you can change from left to right side of the abdomen or from left to right buttock or upper arm.
You can also use a different application site each week (e.g. one week the outer upper arm, next
week the abdomen).
Check your patch daily to ensure that it is sticking securely to your skin.
Please note





Only wear ONE patch at a time.
If your patch is applied correctly, you can bathe or shower as usual.
There are no restrictions such as swimming, using a sauna and exercising as long as the patch
remains applied correctly.
The transparent patch is UV/sunlight protected so it can be exposed to sunlight and does not
need to remain covered by clothing.

What did you receive in the pharmacy
At the pharmacy you received an apleek box which includes this booklet plus either 3 or 9 or 18
sealed sachets, each containing one apleek patch.
The number of sachets depends on the prescription your doctor has given you.

Each sealed sachet contains one patch, for application onto your skin. The patch is round and
transparent:


On its sticky side the patch is covered by a two-part square-shaped shiny clear protective
liner



On the opposite side the patch is covered by a milky white square-shaped cover sheet
which prevents the patch from being stuck in the sachet

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Round transparent patch
plus two-part square-shaped,
shiny, clear protective liner
Milky white
square-shaped
cover sheet

How to prepare the patch for application
1. Tear along the top side of the sachet with your fingers. The notches will help guide the tear.
Do not use scissors. Do not cut, damage or alter the patch in any way because this may reduce
the contraceptive effect.

2. The round contraceptive patch is enclosed between a two-part square-shaped clear protective
liner and a milky-white square shaped cover sheet. It is important you remove the patch together
with both the clear protective liner and the milky-white cover sheet from the sachet. Do not
discard the sachet. The sachet should be kept for disposal of the patch after use (see
‘Disposal of patches’ in section 5).

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3. Apply the patch immediately after opening the sachet, as follows:


First remove the one-piece milky white square-shaped cover sheet from the top side of the
patch.

After removal from the patch, the milky white square-shaped cover sheet that prevents the patch
from getting stuck in the sachet should be discarded.
The two-part square-shaped shiny clear protective liner covers the bottom (sticky) side of the round
transparent patch. The sticky side contains the active drugs. You should avoid touching the sticky
surface of the patch so that the stickiness is maintained.


Next remove half of the clear protective liner.

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While holding the patch by the edge which is still covered by the second half of the protective
liner, position the patch on the skin where it will be worn.



With half of the patch gently sticking to the application site, remove the second half of the
protective liner.



Press down firmly on the patch with the palm of your hand for 30 seconds. Make sure that the
edges stick well.

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Remember not to discard the sachet as you will need it to dispose of the patch after use (see
‘Disposal of patches’ in section 5).
Instructions on further use
Each patch should be used as follows: Three patches, each used for 1 week, and the 7-day patchfree interval make up a 4-week cycle.

CALENDAR
WEEK MON TUE WED THU FRI SAT SUN
1ST PATCH

1

2ND PATCH

2

3RD PATCH

3
4

NO PATCH



Apply a new patch on the same day each week (your ‘Patch Change Day’ – see ‘Patch Change
Day’ below in this section 3) for 3 weeks in a row.



Make sure you have removed your old patch before applying the new patch because only one
patch should be worn at a time.



Be sure to use a different application area for each new patch.



During week 4, DO NOT wear a patch. Make sure you removed your old patch. Your period
should begin during this week. If your period does not occur, see section 2 ‘What to do if no
bleeding occurs’. For the precise scheme when to apply/remove a patch, see section ‘Patch
Change Day’ below in this section 3.



On the day after week 4 ends, start a new 4-week cycle on the same weekday by applying a
new patch ('Patch Change Day'), regardless of whether your period is continuing or has
stopped.

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1ST PATCH

1

2ND PATCH

2

3RD PATCH

3
4



NO PATCH

Repeat the same steps every 4 weeks.

Patch Change Day
Apply every new patch on the same day of the week. This day will be your ‘Patch Change Day’.
For example, if the first patch is applied on a Sunday, all subsequent patches will also be applied on
a Sunday. Wear only one patch at a time.

1st patch

Week 1 (cycle Day 1): application of the 1st patch

2nd patch

Week 2 (cycle Day 8): removal of the 1st patch and immediate application of the
2nd patch

3rd patch

Week 3 (cycle Day 15): removal of the 2nd patch and immediate application of the
3rd patch

No patch

Week 4 (cycle Day 22): removal of the 3rd patch, no patch from cycle Days 2228!

You may change your patch at any time on the ‘Patch Change Day’.
Start your next cycle on the same ‘Patch Change Day’, at the end of the 7-day patch-free interval
(Days 22-28).
Patch-free days
Do not wear a patch during week 4 (from cycle Days 22 – 28).

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CALENDAR
WEEK

1ST PATCH

1

2ND PATCH

2

3RD PATCH

3
4

NO PATCH

You must never have your patch off for more than 7 consecutive days.
If you have more than 7 patch-free days, YOU MAY NOT BE PROTECTED FROM
PREGNANCY.
If you have had sex during such an extended patch-free interval, you already may have become
pregnant. Use back-up contraception, for example condoms (see also ‘What you should do in case
of detached, missed, or not replaced patches’ later on in this section 3).
Reminder card and reminder stickers
To help you remember the ‘Patch Change Day’, you may find the detachable reminder card and
reminder stickers at the end of this booklet useful.
On the reminder card, you can highlight your ‘Patch Change Day’ for the 4-week cycle. You can
also use the reminder stickers provided to mark your personal calendar or diary.

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REMINDER CARD
Mark your `Patch Change Day´ on the calendar below.
Check daily if your patch sticks securely on your skin.

CALENDAR
WEEK MON TUE WED THU FRI SAT SUN
1ST PATCH

1

2ND PATCH

2

3RD PATCH

3
4

After completing week 4, you should start a new
cycle on your `Patch Change Day´

The reminder sticker with the tick symbol should be placed on the day
you apply your 1st patch in week 1 – this is your ‘Patch Change Day’.

The two reminder stickers with the arrow symbols should be placed
on your ‘Patch Change Days’ in weeks 2 and 3.

The sticker with the cross symbol should be placed on your
‘Patch Change Day’ in week 4. During week 4, DO NOT wear a patch.

After you have completed the 4-week cycle, you should repeat the steps above.
If you use more apleek than you should
apleek is unlikely to cause an overdose because the patch releases a steady amount of the hormones.
Do not use more than one patch at a time. Serious side effects have not been reported when large
doses of hormonal contraceptives were accidentally taken.
Overdose by applying several patches at a time may cause nausea or vomiting.
Young girls may have bleeding from the vagina. In case of overdose, contact your doctor or
pharmacist.

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If you forget to use apleek
What you should do in case of detached, missed, or not replaced patches:
If a patch is partially or completely detached


for less than one day (up to 24 hours)
You should try to reapply the patch to the same place or replace it with a new patch
immediately. No back-up contraception is needed. Your ‘Patch Change Day’ will remain the
same.



for more than one day (24 hours or more), or if you are not sure how long the patch has been
detached
YOU MAY NOT BE PROTECTED FROM PREGNANCY. Stop the current contraceptive
cycle and start a new cycle immediately by applying a new patch. You now have a new ‘Day
1’ and a new ‘Patch Change Day’. You must use back-up contraception, such as condoms,
spermicide, or diaphragm, for the first week of the new cycle.
Do not reapply a patch if it is no longer sticky, if it has become stuck to itself or another
surface, if it has other material stuck to it or if it has previously become loose or fallen off. If
you cannot reapply a patch, apply a new patch immediately. Do not use other adhesives or
wraps to hold apleek in place.

If you forget to change your patch


at the start of any patch cycle
(Week One /Day 1):
YOU MAY NOT BE PROTECTED FROM PREGNANCY. Apply the first patch of your new
cycle as soon as you remember. You now have a new ‘Patch Change Day’ and a new ‘Day 1’.
You must use back-up contraception, such as condoms, spermicide, or diaphragm, for the first
week of the new cycle.



in the middle of the patch cycle
(Week Two/Day 8 or Week Three/Day 15):
 If you are late for one or two days (up to 48 hours),
apply a new patch immediately. Apply the next patch on your usual ‘Patch Change
Day’. No back-up contraception is needed.
 If you are late for more than two days (48 hours or more),
YOU MAY NOT BE PROTECTED FROM PREGNANCY. Stop the current
contraceptive cycle and start a new 4-week cycle immediately by putting on a new
patch. You now have a new ‘Patch Change Day’ and a new ‘Day 1’. Use back-up
contraception for one week.

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at the end of the patch cycle
(Week Four/Day 22):
If you forget to remove your patch, take it off as soon as you remember (at the latest by Day
28). Start the next cycle on your usual ‘Patch Change Day’, which is the day after Day 28. No
back-up contraception is needed.

The consequences of detached, missed, or not replaced patches and what you should do is presented
in the following table:

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Consequences of detached, missed, or not replaced patches and required action
Detached patches a Time
frame
Patch detached

< 24 hours
> 24 hours

Patches not
replaced on time a

Time
frame

1st patch
(Week 1, Day 1)
not applied on time

1st patch
not applied
on ‘Patch
Change
Day’

1st or 2nd patch
< 48 hours
(Week 1/2 or 2/3)
not replaced on time
> 48 hours

Consequences on Required action a
contraceptive
reliability a
Contraceptive
- Apply new patch immediately
efficacy ensured - No back-up contraception needed
- ‘Patch Change Day’ unchanged
Contraceptive
- Start new 4-week cycle
efficacy
immediately by applying a new
compromised
patch
- Use back-up contraception for the
next 7 daysb
- Note new ‘Patch Change Day’
Consequences on Required action a
contraceptive
reliability a
Contraceptive
- Start new 4-week cycle
efficacy
immediately by applying a new
compromised
patch
- Use back-up contraception for the
next 7 days b
- Note new ‘Patch Change Day’
Contraceptive
efficacy ensured
Contraceptive
efficacy
compromised

-

Apply new patch immediately
No back-up contraception needed
‘Patch Change Day’ unchanged
Start new 4-week cycle
immediately by applying a new
patch
Use back-up contraception for the
next 7 days b
Note new ‘Patch Change Day’
Remove patch
Start next 4-week cycle on your
normal ‘Patch Change Day’

3rd patch
Contraceptive
c
(Week 3/4)
efficacy ensured not removed on time
a
Applies to each cycle.
b
Back-up contraception is any additional non-hormonal method of contraception with the
exception of the ‘calendar’ method and the ‘temperature’ method.
c
Provided that the 3rd patch has been replaced by a new one at the latest on the regular Day 1
of the new patch cycle.

Order the prescription of the next pack in time i.e. prior to the use of the last patch in the
pack to ensure that you do not run out of patches.
What to do in case of skin irritation
If patch use results in uncomfortable irritation at the site of the patch, remove the patch and place a
new patch on a different location. Use the new patch until the next scheduled ‘Patch Change Day’.

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How to shift your ‘Patch Change Day’ to another day
If you wish to shift your ‘Patch Change Day’, complete your current cycle and remove the third
patch on the correct day. During the patch-free week, you may select an earlier (never a later)
‘Patch Change Day’ by applying a new patch on your desired day. You must never have your patch
off for more than seven days.
What to do if you vomit or have severe diarrhoea
The amount of drug you get from apleek should not be affected by vomiting or diarrhoea.
If you stop using apleek
You can stop using apleek at any time. If you do not want to become pregnant, ask your doctor for
advice about other reliable methods of birth control. If you want to become pregnant, stop using
apleek and wait for a menstrual period before starting to try to become pregnant. You will be able
to calculate the expected delivery date more easily.
You may get irregular, little or no menstruation if you stop using apleek, especially if your periods
were not regular before you started to use apleek.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, apleek can cause side effects, although not everybody gets them. If you get any
side effect, particularly if severe and persistent, or have any change to your health that you think
may be due to apleek, please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in
your arteries (arterial thromboembolism (ATE)) is present for all women taking combined
hormonal contraceptives. For more detailed information on the different risks from taking combined
hormonal contraceptives please see section 2 ‘What you need to know before you use apleek’.
Serious side effects
See section 2 ‘Warnings and precautions, Blood clots and Combined hormonal contraceptives and
cancer’ for side effects, including serious reactions, associated with the use of combined hormonal
contraceptives and section 2 ‘Do not use apleek’. Please read these sections carefully and consult
your doctor at once where appropriate.
The following side effects were reported in apleek users:
Very common: may affect more than 1 in 10 women


application site reaction

Common: may affect up to 1 in 10 women

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emotional lability
Page 25 of 35



migraine



nausea



genital tract bleeding



breast pain

Uncommon: may affect up to 1 in 100 women


depression/depressive mood



decrease and loss of libido

Rare: may affect up to 1 in 1,000 women


harmful blood clots in a vein or artery

Description of selected side effects
Side effects with very low frequency or with delayed onset of symptoms which are considered to be
related to the group of combined hormonal contraceptives are listed below (see also section 2 ‘Do
not use apleek’ and ‘Warnings and precautions’):
Blood clots
 harmful blood clots in a vein or artery for example:
o

in a leg or foot (i.e. DVT)

o

in a lung (i.e. PE)

o

heart attack

o

stroke

o

mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack
(TIA)

o

blood clots in the liver, stomach/intestine, kidneys or eye.

The chance of having a blood clot may be higher if you have any other conditions that increase this
risk (See section 2 for more information on the conditions that increase risk for blood clots and the
symptoms of a blood clot).
Tumours
 The frequency of diagnosis of breast cancer is very slightly increased among users of combined
hormonal contraceptives. As breast cancer is rare in women under 40 years of age the excess
number is small in relation to the overall risk of breast cancer. It is not known whether there is a
direct link to users of combined hormonal contraceptives.
 liver tumours (benign and malignant)

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Other conditions
 a skin condition characterised by itchy red blotches or swollen patches of skin (erythema
multiforme)
 a skin condition characterised by tender red nodules (erythema nodosum)
 increased blood fats (hypertriglyceridemia, resulting in an increased risk of pancreatitis when
using combined hormonal contraceptives)
 high blood pressure
 occurrence or worsening of conditions for which a link to combined hormonal contraceptives is
not definite: jaundice and/or itching related to blocked bile flow (cholestasis); gallstone
formation; a metabolic condition called porphyria; systemic lupus erythematosus (disease of the
immune system); haemolytic uraemic syndrome (a blood clotting disorder causing failure of the
kidneys); a nerve disease causing sudden movements of the body called Sydenham’s chorea;
herpes gestationis (a type of skin condition that occurs during pregnancy); hearing loss
 in women with hereditary angioedema (characterised by sudden swelling of e.g. the face, tongue
or throat) external oestrogens may induce or worsen symptoms of angioedema
 disturbed liver function
 changes in glucose tolerance or effect on peripheral insulin resistance
 worsening of inflammatory bowel disease (Crohn’s disease, ulcerative colitis)
 worsening of epilepsy
 golden brown pigment patches (so-called ‘pregnancy patches especially on the face)
 hypersensitivity (including symptoms such as rash, hives)
Interactions
Unexpected bleeding and/or contraceptive failure may result from interactions of other medicines
with combined hormonal contraceptives (e.g. the herbal remedy St. John’s wort, or medicines for
epilepsy, tuberculosis, HIV and Hepatitis C Virus infections). See section 2 ‘Other medicines and
apleek’.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
You can also report side effects directly (see details below). By reporting side effects, you can help
provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

5. How to store apleek
Keep this medicine out of the sight and reach of children.
Store in the original sachet in order to protect from light and moisture. Do not freeze.
Do not use apleek after the expiry date, which is stated on the folding box and sachet label after
EXP. The expiry date refers to the last day of that month.
Disposal of patches and other handling
The patch should be applied immediately upon removal from the protective sachet.
No make-up, creams, lotions, powders or other topical products should be applied to the skin area
where apleek is or will be placed.
The active substances gestodene and ethinylestradiol pose a risk to the environment, especially to
fish. Moreover, gestodene and ethinylestradiol are persistent in the environment. Used patches
should not be flushed down the toilet nor placed in liquid waste disposal systems.
The used patch should be discarded carefully according to the following instructions:
 Keep the original sachet after use for disposal of the patch.
 Fold the used patch in half, adhesive/sticky side inwards.
 Place it in the original sachet.
 Close by folding the open edge.
 There is a two page label on the sachet.
 Lift the first page of the label and use it to seal the folded edge of the sachet.
 Below the first page, disposal instructions can be found on the second page.
Discard safely out of the reach of children or pets. Any used or unused patches should be discarded
according to local requirements. In case of doubt consult your pharmacist. These measures will help
to protect the environment.

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6. Contents of the pack and other information
What apleek contains
The active substances are gestodene and ethinylestradiol. Each 11 cm2 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 dose of 20 micrograms) per 24 hours.
The other excipients in the patch are:
Backing layer: low density polyethylene (PE) outer layer
Adhesive layer: adhesive containing: ester of hydrogenated rosin, polybutene, polyisobutylene,
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate), bemotrizinol
Separation foil: polyethylene terephthalate (PET) film
Adhesive matrix: adhesive containing: ester of hydrogenated rosin, polybutene, polyisobutylene,
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)
Release liner: siliconized polyethylene terephthalate (PET) film.
What apleek looks like and contents of the pack
An apleek folding box contains: this booklet (including reminder card and reminder stickers) plus
either 3, 9 or 18 sealed sachets; each sachet contains one transdermal patch.
Not all pack sizes may be marketed.
The thin transdermal patch is round, transparent, and has a size of 11 cm²:


On its sticky side the patch is covered by a two-part square-shaped shiny clear protective liner.



On the opposite side the patch is covered by a milky white square-shaped cover sheet which
prevents the patch from being stuck in the sachet.

Marketing Authorisation Holder and Manufacturer
Marketing Authorization Holder
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Manufacturer
Bayer Weimar GmbH und Co. KG
99427 Weimar
Germany

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This medicinal product is authorised in the Member States of the EEA under the following
names:
Country
Austria (AT)

Proposed (invented) name,
strength, and pharmaceutical
form
apleek 60 Microgramm/24 h + 13 Microgramm/24 h transdermales
Pflaster

Belgium (BE)

apleek 60 microgram/24 uur + 13 microgram/24 uur pleister voor
transdermaal gebruik

Bulgaria (BG)

аплийк 60 микрограма/24 часа + 13 микрограма/24 часа

Cyprus (CY)

apleek 60 μικρογραμμάρια/24 ώρες + 13 μικρογραμμάρια/24 ώρες
διαδερμικό έμπλαστρο

Czech Republic (CZ)

apleek 60 mikrogramů/24 hodin + 13 mikrogramů/24 hodin
transdermální náplast

Denmark (DK)

apleek 60 mikrogram/24 timers + 13 mikrogram/24 timers
depotplaster

Estonia (EE)

apleek 60 mikrogrammi/24 tunnis + 13 mikrogrammi/24 tunnis
transdermaalne plaaster

Finland (FI)

apleek 60 mikrog/24 tuntia + 13 mikrog/24 tuntia depotlaastari

France (FR)

apleek 60 microgrammes/24 heures + 13 microgrammes/24 heures
dispositif transdermique

Germany (DE)

apleek, 60 Mikrogramm/24 Stunden + 13 Mikrogramm/24
Stunden, Transdermales Pflaster

Greece (EL)

apleek 60 μικρογραμμάρια/24 ώρες + 13 μικρογραμμάρια/24 ώρες
διαδερμικό έμπλαστρο

Hungary (HU)

apleek 60 mikrogramm/24 óra + 13 mikrogramm/24 óra
transzdermális tapasz

Iceland (IS)

apleek 60 míkrógrömm/24 klst + 13 míkrógrömm/24 klst
forðaplástur

Ireland (IE)

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

Italy (IT)

apleek 60 microgrammi/24 ore + 13 microgrammi/24 ore cerotto
transdermico

Latvia (LV)

apleek 60 mikrogrami/24 stundās + 13 mikrogrami/24 stundās

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transdermāls plāksteris
Lithuania (LT)

apleek 60 mikrogramų/24 val. + 13 mikrogramų/24 val.
transderminis pleistras

Luxembourg (LU)

apleek 60 microgrammes/24 heures + 13 microgrammes/24 heures
dispositif transdermique

Malta (MT)

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

The Netherlands (NL)

apleek 60 microgram/24 uur + 13 microgram/24 uur pleister voor
transdermaal gebruik

Poland (PL)

apleek 60 mikrogramów/24 godziny + 13 mikrogramów/24
godziny system transdermalny plaster

Portugal (PT)

apleek 60 microgramas/24 horas + 13 microgramas/24 horas
Sistema transdérmico

Romania (RO)

apleek 60 micrograme/24 ore + 13 micrograme/24 ore plasture
transdermic

Slovak Republic (SK)

apleek 60 mikrogramov/24 hodín + 13 mikrogramov/24 hodín
transdermálna náplasť

Slovenia (SI)

apleek 60 mikrogramov/24 ur + 13 mikrogramov/24 ur
transdermalni obliž

Spain (ES)

apleek 60 microgramos cada 24 horas + 13 microgramos cada 24
horas parche transdérmico

United Kingdom (UK)

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

This leaflet was last revised in 02/2014

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Place these reminder stickers on your calendar or
diary and read section ’reminder card and reminder
stickers’.



<3 transdermal patches>

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Place these reminder stickers on your calendar or diary and
read section ’reminder card and reminder stickers’.

<9 transdermal patches>

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Place these reminder stickers on your calendar or diary and
read section ’reminder card and reminder stickers’.

Place these reminder stickers on your calendar or diary and
read section ’reminder card and reminder stickers’.

<18 transdermal patches>

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REMINDER CARD
Mark your `Patch Change Day´ on the calendar below.
Check daily if your patch sticks securely on your skin.

CALENDAR
WEEK MON TUE WED THU
1ST PATCH

1

2ND PATCH

2

3RD PATCH

3

FRI

SAT SUN

4
After completing week 4, you should start a new
cycle on your `Patch Change Day´.

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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