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Read all of this leaflet carefully before you start taking 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 or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
Cyproterone Acetate / Ethinylestradiol is used to treat skin conditions such as acne, very oily skin and
excessive hair growth in women of reproductive age. Due to its contraceptive properties it should only
be prescribed for you if your doctor considers that treatment with a hormonal contraceptive is
appropriate.
You should only take Cyproterone Acetate / Ethinylestradiol if your skin condition has not improved
after use of other anti-acne treatments, including topical treatments and antibiotics.
2. What you need to know before you take Cyproterone Acetate / Ethinylestradiol
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When should you contact your doctor?
Stop taking the tablets and contact your doctor immediately if you notice possible signs of a
blood clot. These symptoms are described in section 2 ‘Cyproterone Acetate / Ethinylestradiol
and blood clots’
Taking Cyproterone Acetate / Ethinylestradiol may slightly increase your risk of having a blood
clot (called a thrombosis), especially in the first year of taking it.
A clot in a leg vein – a deep vein thrombosis (or DVT) – is not always serious. However, if it moves
up the veins and blocks an artery in the lungs, it can cause chest pain, breathlessness or collapse. A
full recovery is not always made and in 1-2% of cases, can be fatal. This is called a pulmonary
embolism and is very rare.
Your chances of having a blood clot are only increased slightly by taking Cyproterone Acetate /
Ethinylestradiol compared with women who do not take Cyproterone Acetate / Ethinylestradiol or
any contraceptive pill.
Of 100,000 women who are not taking Cyproterone Acetate / Ethinylestradiol, not on the
Pill and not pregnant, about 5 to 10 will have a blood clot in a year.
Of 100,000 women who take Cyproterone Acetate / Ethinylestradiol or the Pill, up to 40
will have a blood clot in a year.
Of 100,000 women who are pregnant, around 60 will have a blood clot in a year.
Very rarely, blood clots can also form in the blood vessels of the heart (causing a heart attack) or the
brain (causing a stroke). In healthy young women the chance of having a heart attack or stroke is
extremely small.
Using a combined pill increases a woman’s risk of developing such clots compared with a woman not
taking any combined pill. The risk of developing a blood clot in a vein is highest during the first year
a woman uses the pill. The risk is not as high as the risk of developing a blood clot during pregnancy.
The risk of blood clots in a vein in users of a combined pill increases further:
If you have polycystic ovary syndrome
as you get older
if you smoke
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o When using a hormonal contraceptive like Cyproterone Acetate / Ethinylestradiol
you are strongly advised to stop smoking, especially if you are older than 35 years
if you or any of your close family have had blood clots in the leg, lung or other organ at a
young age
if you are overweight
if you have very rare blood disorders
if you have recently had a baby
if you have diabetes
if you have certain rare medical conditions such as systemic lupus erythematosus, Crohn’s
disease or ulcerative colitis
if you have sickle cell disease
if you must have an operation, or if you’re off your feet for a long time because of an injury
or illness, or have your leg in a plaster cast.
→ If this applies to you, it is important to tell your doctor that you are using Cyproterone Acetate /
Ethinylestradiol, as the treatment may have to be stopped. Your doctor may tell you to stop using
Cyproterone Acetate / Ethinylestradiol several weeks before surgery or while you are less mobile.
Your doctor will also tell you when you can start using Cyproterone Acetate / Ethinylestradiol again
after you are back on your feet.
The use of a combined pill has been connected with an increased risk of clots in the arteries. This risk
increases further:
If you have polycystic ovary syndrome
as you get older
if you smoke
o When using a hormonal contraceptive like Cyproterone Acetate / Ethinylestradiol
you are strongly advised to stop smoking, especially if you are older than 35 years
if you are overweight
if you have high blood pressure
if a close relative has had a heart attack or stroke at a young age
if you have high levels or a disorder of blood fat (cholesterol or triglycerides) metabolism,
or some other very rare blood disorders
if you get migraines
if you have a heart valve disorder, disturbance of heart rhythm, or a particular type of
irregular heartbeat (atrial fibrillation)
if you have recently had a baby
if you have diabetes
if you have certain rare medical conditions such as systemic lupus erythematosus, Crohn’s
disease or ulcerative colitis
if you have sickle cell disease
Stop taking the tablets and see your doctor immediately if you notice possible signs of a blood
clot such as:
a migraine for the first time, a migraine that is worse than normal, unusual, or are frequent, or
severe or long-lasting headaches
any sudden changes to your eyesight (such as partial or complete loss of vision, double
vision, or blurred vision)
any sudden changes to your hearing, speech (such as slurring or speech disability), sense of
smell, taste or touch
severe pain in your abdomen
severe pain or swelling in either of your legs
breathlessness or stabbing pain when you breathe
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unusual sudden coughing for no apparent reason
severe pain and tightness in the chest which may reach the left arm
sudden weakness or numbness in one side or any part of your body
dizziness or fainting.
→ See a doctor as soon as possible. Do not take any more Cyproterone Acetate /
Ethinylestradiol until your doctor says you can. If needed, use another method of contraception, such
as condoms, in the meantime.
Following a blood clot, recovery is not always complete. Rarely serious permanent disabilities may
occur or the blood clot may even be fatal.
Directly after giving birth, women are at an increased risk of blood clots so you should ask your
doctor how soon after delivery you can start taking Cyproterone Acetate / Ethinylestradiol.
If you have breast cancer, or have had it in the past, you should not take Cyproterone Acetate /
Ethinylestradiol or other oral contraceptives, as they slightly increase your risk of breast cancer. This
risk goes up the longer you’re on Cyproterone Acetate / Ethinylestradiol, but returns to normal within
about 10 years of stopping it. Because breast cancer is rare in women under the age of 40, the extra
cases of breast cancer in current and recent Cyproterone Acetate / Ethinylestradiol users is small. For
example:
Of 10,000 women who have never taken Cyproterone Acetate / Ethinylestradiol or the
Pill, about 16 may have breast cancer by the time they are 35 years old.
Of 10,000 women who take Cyproterone Acetate / Ethinylestradiol or the Pill for 5 years
in their early twenties, about 17–18 may have breast cancer by the time they are 35 years
old.
Of 10,000 women who have never taken Cyproterone Acetate / Ethinylestradiol or the
Pill, about 100 may have breast cancer by the time they are 45 years old.
Of 10,000 women who take Cyproterone Acetate / Ethinylestradiol or the Pill for 5 years
in their early thirties, about 110 may have breast cancer by the time they are 45 years old.
→ See a doctor as soon as possible if you notice any changes in your breasts, such as dimpling of
the skin, changes in the nipple or any lumps you can see or feel.
Taking Cyproterone Acetate / Ethinylestradiol has also been linked to liver diseases, such as
jaundice and noncancer liver tumours, but this is rare. Very rarely, Cyproterone Acetate /
Ethinylestradiol has also been linked with some forms of liver cancer in women who have
taken it for a long time.
→ See a doctor as soon as possible if you get severe pain in your stomach, or yellow skin or eyes
(jaundice). You may need to stop taking Cyproterone Acetate / Ethinylestradiol.
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→ Tell your doctor if you have any medical problems or illnesses.
→ If you suffer from any of these, or get them for the first time while taking Cyproterone
Acetate / Ethinylestradiol, contact your doctor as soon as possible. Do not take Cyproterone
Acetate / Ethinylestradiol. If needed, use another form of contraception.
→ Tell your doctor if any apply to you. Also tell them if you get any of these for the first time
while taking Cyproterone Acetate / Ethinylestradiol, or if any get worse or come back, because you
may
need to stop taking it.
Cyproterone Acetate / Ethinylestradiol will not protect you against sexually transmitted
infections, such as Chlamydia or HIV. Only condoms can help to do this.
If you are taking Cyproterone Acetate / Ethinylestradiol for skin treatment, you must not take
any other hormonal contraceptive at the same time.
Some medicines can stop Cyproterone Acetate / Ethinylestradiol from working properly –
for example:
some medicines used to treat epilepsy (such as primidone, phenytoin,
carbamazepine, oxcarbazepine, topiramate, felbamate)
some medicines used to treat HIV and Hepatitis C Virus infection (so-called protease
inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nelfinavir
and nevirapine)
griseofulvin and rifampicin (anti-fungal medicines)
certain sedatives (called barbiturates)
St. John’s wort (a herbal remedy).
If you do need to take one of these medicines, Cyproterone Acetate / Ethinylestradiol may not
be suitable for you or you may need to use extra contraception for a while. Your doctor,
pharmacist or dentist can tell you if this is necessary and for how long.
Do not use Cyproterone Acetate/Ethinylestradiol if you have Hepatitis C and are taking the
medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this may cause
increases in liver function blood test results (increase in ALT liver enzyme).
Your doctor will prescribe another type of contraceptive prior to start of the treatment with these
medicinal products.
Cyproterome Acetate/Ethinylestradiol can be restarted approximately 2 weeks after completion of
this treatment. See section “Do not take Cyproterone Acetate/Ethinylestradiol”.
Cyproterone Acetate / Ethinylestradiol can also affect how well other medicines work.
Cyproterone Acetate / Ethinylestradiol may increase or decrease the amount of certain medicines
(such as ciclosporin and lamotrigine) in your blood. Your doctor may need to adjust the dose of
your other medicine.
In addition, Cyproterone Acetate / Ethinylestradiol can also interfere with the results of some blood
tests, so always tell your doctor that you are taking Cyproterone Acetate / Ethinylestradiol if you
have a blood test.
Do not use Cyproterone Acetate / Ethinylestradiol if you are pregnant or are breast-feeding.
If you think you might be pregnant, do a pregnancy test to confirm that you are before you stop
taking Cyproterone Acetate / Ethinylestradiol.
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If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Your doctor has chosen Cyproterone Acetate / Ethinylestradiol as a treatment for your severe acne
or excessive hair growth on your face and body. However, Cyproterone Acetate / Ethinylestradiol
also has a contraceptive effect, so it is important to follow the advice below if you are relying on
Cyproterone Acetate / Ethinylestradiol for contraception.
If you are only using Cyproterone Acetate / Ethinylestradiol for your acne or excessive hair
growth, you can still follow this advice, but ask your doctor if you are unsure.
Duration of use
Your doctor will tell you how long you need to keep taking Cyproterone Acetate / Ethinylestradiol.
How to take it
A missed pill
If you are less than 12 hours late with a pill, take it straight away. Keep taking your pills at the
usual time. This may mean taking two pills in one day. Don’t worry – your contraceptive
protection should not be reduced.
If you are more than 12 hours late with a pill, or you have missed more than one pill,
your contraceptive protection may be reduced.
Take the most recently missed pill as soon as you remember, even if it means taking two
at once. Leave any earlier missed pills in the pack.
Continue to take a pill every day for the next seven days at your usual time.
If you come to the end of a strip of pills during these seven days, start the next strip
without taking the usual seven day break. You probably won’t have a bleed until after you
finish the second strip of pills, but don’t worry. If you finish the second strip of pills and
don’t have a bleed, do a pregnancy test before starting another strip.
Use extra contraception for seven days after missing a pill, such as condoms.
If you have missed one or more pills from the first week of your strip (days 1 to 7) and
you
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had sex in that week, you could become pregnant. Contact your doctor or pharmacist
for advice as soon as possible. They may recommend you use emergency
contraception.
If you have missed any of the pills in a strip, and you do not bleed in the first pill free break,
you may be pregnant. Contact your doctor or do a pregnancy test yourself.
If you start a new strip of pills late, or make your ‘week off’ longer than seven days, you may not
be
protected from pregnancy. If you had sex in the last seven days, ask your doctor or pharmacist
for advice. You may need to consider emergency contraception.
You should also use extra contraception, such as a condom, for seven days.
A lost pill
If you lose a pill,
Either take the last pill of the strip in place of the lost pill. Then take all the other pills on their
proper days. Your cycle will be one day shorter than normal, but your contraceptive protection
won’t be affected. After your seven pill-free days you will have a new starting day, one day earlier
than before.
Or if you do not want to change the starting day of your cycle, take a pill from a spare strip if you
have one. Then take all the other pills from your current strip as usual. You can then keep the
opened spare strip in case you lose any more pills.
If you are still sick or have diarrhoea more than 12 hours after taking Cyproterone
Acetate / Ethinylestradiol, see section above, A missed pill.
→ Talk to your doctor if your stomach upset carries on or gets worse. He or she may
recommend another form of contraception.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following side effects happen, you may need urgent medical attention. Stop
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taking Cyproterone Acetate / Ethinylestradiol and contact a doctor or go to the nearest
hospital immediately.
Other conditions that may happen or worsen during pregnancy or use of the Pill such as:
- yellowing of the skin (jaundice)
- persistent itching (pruritus)
- kidney or liver problems
- gall stones
- certain rare medical conditions such as systemic lupus erythematosus
- blister-like rash (herpes gestationis) whilst pregnant
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- an inherited form of deafness (otosclerosis)
- a personal or family history or a form of sickle cell disease
- an inherited disease called porphyria
- cancer of the cervix
- movement disorder chorea
If you have hereditary angioedema medicines containing certain female sex hormones
(oestrogens) may induce or worsen the symptoms of angioedema (see section 2 “Cyproterone
Acetate / Ethinylestradiol can make some illnesses worse”).
You may also have unexpected bleeding if you are not taking your pills regularly, so try to take
your pill at the same time every day. Also, unexpected bleeding can sometimes be caused by
other medicines.
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→ Make an appointment to see your doctor if you get breakthrough bleeding or spotting that:
carries on for more than the first few months
starts after you’ve been taking Cyproterone Acetate / Ethinylestradiol for a while
carries on even after you’ve stopped taking Cyproterone Acetate / Ethinylestradiol.
Do not use this medicine after the expiry date which is stated on the carton/strip after EXP. The
expiry date refers to the last day of that month.
Keep the blister strips in the outer carton in order to protect from light. Do not store above 25oC.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
The active substances are cyproterone acetate and ethinylestradiol. Each coated tablet contains
cyproterone acetate 2 mg and ethinylestradiol 35 micrograms.
The tablet also contains: Lactose monohydrate, Maize starch, Povidone, Talc, Magnesium stearate,
Sucrose, Macrogol, Calcium carbonate, Glycerol 85%, Titanium dioxide, Iron oxide yellow,
Montanglycol wax.
What Cyproterone Acetate and Ethinylestradiol looks like and contents of the pack
Cyproterone Acetate / Ethinylestradiol tablets are round, beige, coated tablets with no markings.
These tablets are available in blister packs of 21, 42, 63, 84, 105, 126, 147, 168, 189, 210, 231, 252
tablets*. Your pharmacist will dispense the number of tablets prescribed by your doctor.
*Not all pack sizes may be marketed.
Manufacturer:
Bayer Weimar GmbH und Co. KG, Dobereinerstrasse 20, 99427 Weimar, Germany
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