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CYPROTERONE ACETATE 2.0MG ETHINYLESTRADIOL 0.035MG TABLETS

Active substance(s): CYPROTERONE ACETATE / ETHINYLESTRADIOL / CYPROTERONE ACETATE / ETHINYLESTRADIOL / CYPROTERONE ACETATE / ETHINYLESTRADIOL

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Sandoz Ltd
PL 04416/1040
Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets

Patient Information Leaflet
08/12/2016

Package leaflet: Information for the patient

Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets
Cyproterone acetate/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.

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 pharmacist or nurse.
− 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, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet See section 4.
What is in this leaflet:
1. What Cyproterone/Ethinylestradiol tabletsis and what it is used for
2. What you need to know before you take Cyproterone/Ethinylestradiol tablets
3. How to take Cyproterone/Ethinylestradiol tablets
4. Possible side effects
5. How to store Cyproterone/Ethinylestradiol tablets
6. Contents of the pack and other information
1. What Cyproterone/Ethinylestradiol tablets is and what it is used for 1. What

Cyproterone/Ethinylestradiol tablets are and what they are used for
Cyproterone/Ethinylestradiol contains an oestrogen and an anti-androgen.
Cyproterone/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/Ethinylestradiol if your skin condition has not
improved after use of other anti-acne treatments, including topical treatments and
antibiotics.

PIL.1040.004.2d

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Sandoz Ltd
PL 04416/1040
Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets

Patient Information Leaflet
08/12/2016

If you are taking Cyproterone/Ethinylestradiol for skin treatment, you must not take any
other hormonal contraceptive at the same time.
When your skin condition has cleared up and you stop taking Cyproterone/Ethinylestradiol,
you will need to go back to your original/preferred method of contraception.
Treating skin conditions
Androgens are hormones that stimulate hair growth and the grease glands in your skin. If you
produce too much androgen, or if you are sensitive to the effect, the grease glands may
produce too much sebum. This can block the grease glands, which can become infected and
inflamed causing acne spots. Cyproterone/Ethinylestradiol stops the androgens affecting your
skin and reduces the amount of androgens produced.
Contraception
Cyproterone/Ethinylestradiol is a 21-day Pill – you take one each day for 21 days, followed by
7 days when you take no pills.
Cyproterone/Ethinylestradiol will not protect you against sexually transmitted infections, such
as Chlamydia or HIV. Only condoms can help to do this.
Cyproterone/Ethinylestradiol needs to be taken as directed to prevent pregnancy.
2. What you need to know before you take Cyproterone/Ethinylestradiol tablets

2.

Before you take Cyproterone/Ethinylestradiol tablets

It’s important that you understand the benefits and risks of taking Cyproterone/Ethinylestradiol
before you start taking it, or when deciding whether to carry on taking it. Although
Cyproterone/Ethinylestradiol is suitable for most healthy women it isn’t suitable for everyone.
→ Tell your doctor if you have any of the illnesses or risk factors mentioned in this leaflet.
Before you start taking Cyproterone/Ethinylestradiol
ood
pressure and exclude the likelihood of you being pregnant. You may also need other checks,
such as a breast examination, but only if these examinations are necessary for you or if you have
any special concerns.
While you’re on Cyproterone/Ethinylestradiol
regular check-ups with your doctor, usually when you need another
prescription of Cyproterone/Ethinylestradiol.
regular cervical smear tests.
Check your breasts and nipples every month for changes – tell your doctor if you can see or
feel anything odd, such as lumps or dimpling of the skin.
PIL.1040.004.2d

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Sandoz Ltd
PL 04416/1040
Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets

Patient Information Leaflet
08/12/2016

If you need a blood test tell your doctor that you are taking Cyproterone/Ethinylestradiol,
because this type of medicine can affect the results of some tests.
If you’re going to have an operation, make sure your doctor knows about it. You may need
to stop taking Cyproterone/Ethinylestradiol about 4–6 weeks before the operation. This is to
reduce the risk of a blood clot (see section 2.1). Your doctor will tell you when you can start
taking Cyproterone/Ethinylestradiol again.
If you need to stop taking Cyproterone/Ethinylestradiol, remember to use another
contraceptive (e.g. condoms) if you are relying on Cyproterone/Ethinylestradiol for
contraception.
Do not take Cyproterone/Ethinylestradiol
Tell your doctor if any of the following conditions applies to you before starting to use
Cyproterone/Ethinylestradiol. Your doctor may then advise you to use a different treatment:


















If you are using another hormonal contraceptive
If you are pregnant or might be pregnant
If you are breast-feeding
If you have (or have ever had) or if you are suspected of having breast cancer or cancer of
the genital organs
If you have (or have ever had) a blood clot in your leg (thrombosis), lung (pulmonary
embolism) or other part of your body.
If you have (or have ever had) a disease that may be an indicator of a heart attack in the future
(e.g. angina pectoris which causes severe pain in the chest) or ‘mini-stroke’ (transient
ischaemic attack)
If you have (or have ever had) a heart attack or stroke.
If you have a condition that may increase the risk of a blood clot in your arteries. This applies
to the following conditions:
o diabetes affecting your blood vessels
o very high blood pressure
o a very high level of fat in your blood (cholesterol or triglycerides)
If you have problems with blood clotting (e.g. protein C deficiency)
If you have (or have ever had) a migraine, with visual disturbances
If you have ever had a severe liver disease, and you have been told by your doctor that your
liver test results are not yet back to normal
If you have ever had liver tumours
Undiagnosed vaginal bleeding
If you are allergic to cyproterone, ethinylestradiol or any of the other ingredients of this
medicine (listed in section 6).
if you have blood disease called porphyria

→ If you suffer from any of these, or get them for the first time while taking
Cyproterone/Ethinylestradiol, contact your doctor as soon as possible. Do not take
Cyproterone/Ethinylestradiol. If needed, use another form of contraception.
Cyproterone/Ethinylestradiol is not for use in men.
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Sandoz Ltd
PL 04416/1040
Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets

Patient Information Leaflet
08/12/2016

Warnings and precautions
When should you contact your doctor
Stop taking tablets and contact your doctor immediately if you notice possible signs of a
blood clot. The symptoms are described in section 2 ‘Blood clots (Thrombosis)’.
Cyproterone/Ethinylestradiol also works as an oral contraceptive. You and your doctor will have
to consider all the things that would normally apply to the safe use of oral hormonal
contraceptives
Blood clots (thrombosis)
Taking Cyproterone/Ethinylestradiol may slightly increase your risk of having a blood clot
(called a thrombosis). Your chances of having a blood clot are only increased slightly by taking
Cyproterone/Ethinylestradiol compared with women who do not take
Cyproterone/Ethinylestradiol or any contraceptive pill. A full recovery is not always made and
in 1-2% of cases, can be fatal.
Blood clots in a vein
A blood clot in a vein (known as a ‘venous thrombosis’) can block the vein. This can happen in
veins of the leg, the lung (a lung embolus), or any other organ.
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.
Your chances of having a blood clot are only increased slightly by taking
Cyproterone/Ethinylestradiol.
not taking Cyproterone/Ethinylestradiol, not on the Pill and
not pregnant, about 5 to 10 will have a blood clot in a year.
take Cyproterone/Ethinylestradiol or the Pill, up to 40 will have
a blood clot in a year.
pregnant, around 60 will have a blood clot in a year
The risk of blood clots in a vein in users of a combined pill increases further:
• with increasing age;
• if you smoke.
When using a hormonal contraceptive like Cyproterone/Ethinylestradiol you are strongly
PIL.1040.004.2d

V020G: SPC and PIL CMDH PAR +
PSUR safety update + RFI + Post
approval RFI

IS

Sandoz Ltd
PL 04416/1040
Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets

Patient Information Leaflet
08/12/2016

advised to stop smoking, especially if you are older than 35 years;
• if one of your close relatives has had a blood clot in the leg, lung or other organ at a young
age;
• if you are overweight;
• if you must 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 plaster cast;
• if you have polycystic ovary syndrome;
• if you have recently had a baby;
• 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 this applies to you, it is important to tell your doctor that you are using Cyproterone/Ethinylestradiol,
as the treatment may have to be stopped. Your doctor may tell you to stop using
Cyproterone/Ethinylestradiol several weeks before surgery or while you are less mobile. Your doctor
will also tell you when you can start using Cyproterone/Ethinylestradiol again after you are back on
your feet.

Blood clots in an artery
A blood clot in an artery can cause serious problems. For example, a blood clot in an artery in the
heart may cause a heart attack, or in the brain may cause a stroke.
The use of a combined pill has been connected with an increased risk of clots in the arteries. This
risk increases further:
• with increasing age;
• if you smoke. When using a hormonal contraceptive like Cyproterone/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 a high level of fat in your blood (cholesterol or triglycerides);
• if you get migraines;
• if you have a problem with your heart (valve disorder, disturbance of the rhythm).
• if you have polycystic ovary syndrome;
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Sandoz Ltd
PL 04416/1040
Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets

Patient Information Leaflet
08/12/2016

• if you have diabetes;
• if you have certain rare medical conditions such as systemic lupus erythematosus;
• if you have sickle cell disease.
Symptoms of blood clots
Stop taking tablets and see your doctor immediately if you notice possible signs of a blood
clot, such as:

• an unusual sudden cough;
• severe pain in the chest which may reach the left arm;
• breathlessness;
• any unusual, severe, or long-lasting headache or worsening of migraine;
• partial or complete loss of vision, or double vision;
• slurring or speech disability;
• sudden changes to your hearing, sense of smell, or taste;
• dizziness or fainting;
• weakness or numbness in any part of your body;
• severe pain in your abdomen;
• severe pain or swelling in either of your legs.

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/Ethinylestradiol
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 estrogens may induce or worsen symptoms of angioedema.

Cyproterone/Ethinylestradiol and cancer
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Sandoz Ltd
PL 04416/1040
Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets

Patient Information Leaflet
08/12/2016

While high dose COCs reduce your risk of cancer of the ovary and womb if used in the long term, it is
not clear whether lower dose oestrogen-progestogen containing Pills like Cyproterone/Ethinylestradiol
also provide the same protective effects. However, it also seems that taking
Cyproterone/Ethinylestradiol slightly increases your risk of cancer of the cervix – although this may be
due to having sex without a condom, rather than Cyproterone/Ethinylestradiol. All women should have
regular smear tests.
If you have breast cancer, or have had it in the past, you should not take Cyproterone/Ethinylestradiol
or other oral contraceptives, as they slightly increase your risk of breast cancer. This risk goes up the
longer you’re on Cyproterone/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/Ethinylestradiol users is small. For example:
never taken Cyproterone/Ethinylestradiol or the Pill, about 16 will
have breast cancer by the time they are 35 years old.
take Cyproterone/Ethinylestradiol or the Pill for 5 years in their early
twenties, about 17–18 will have breast cancer by the time they are 35 years old.
never taken Cyproterone/Ethinylestradiol or the Pill, about 100 will
have breast cancer by the time they are 45 years old.
take Cyproterone/Ethinylestradiol or the Pill for 5 years in their early
thirties, about 110 will have breast cancer by the time they are 45 years old.
Your risk of breast cancer is higher:

→ 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.
cancer liver tumours, but this is rare. Very rarely, Cyproterone/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/Ethinylestradiol.
Make sure Cyproterone/Ethinylestradiol is OK for you
Cyproterone/Ethinylestradiol should not be taken by some women
→ Tell your doctor if you have any medical problems or illnesses.

Cyproterone/Ethinylestradiol can make some illnesses worse
Some of the conditions listed below can be made worse by taking Cyproterone/Ethinylestradiol. Or they
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approval RFI

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Sandoz Ltd
PL 04416/1040
Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets

Patient Information Leaflet
08/12/2016

may mean it is less suitable for you. You may still be able to take Cyproterone/Ethinylestradiol but you
need to take special care and have check-ups more often.













If you or your close family have ever had problems with your heart or circulation, such as high
blood pressure
If you or your close family have ever had problems with blood clotting
If you have had migraines
If you are currently suffering from depression or have done so in the past
If you are overweight (obese)
If you have the inherited disease called porphyria
If you have a blood disease called HUS (haemolytic uraemic syndrome) which causes kidney
damage
If you have diabetes
If you have inflammation of the pancreas (pancreatitis), or a history or family history of high
levels of fat in your blood (hypertriglyceridemia), as you may be at risk of developing
pancreatitis
If you have brown patches on your face or body (chloasma) (see below
‘Cyproterone/Ethinylestradiol and sun-beds or sun-lamps’)
If you have any illness that worsened during pregnancy or previous use of the Pill or
Cyproterone/Ethinylestradiol (see section 4)

→ Tell your doctor if any apply to you. Also tell them if you get any of these for the first time while
taking Cyproterone/Ethinylestradiol, or if any get worse or come back, because you may need to stop
taking it.

Children
This medicine is not recommended for children.
Other medicines and Cyproterone/Ethinylestradiol
If you ever need to take another medicine at the same time as taking
Cyproterone/Ethinylestradiol, always tell your doctor, pharmacist or dentist that you’re taking
Cyproterone/Ethinylestradiol. Also check the leaflets that come with all your medicines to see
if they can be taken with hormonal contraceptives.
If you are taking
Cyproterone/Ethinylestradiol for skin treatment, you must not take any other hormonal
contraceptive at the same time.
Some medicines can stop Cyproterone/Ethinylestradiol from working properly – for example:




some medicines used to treat epilepsy
some medicines used to treat HIV
griseofulvin (an anti-fungal medicine), rifampicin



certain sedatives (called barbiturates)

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Sandoz Ltd
PL 04416/1040
Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets



Patient Information Leaflet
08/12/2016

St. John’s Wort (a herbal remedy).

If you do need to take one of these medicines, Cyproterone/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.
Cyproterone/Ethinylestradiol can also affect how well other medicines work. Your doctor
may need to adjust the dose of your other medicine.
In addition, Cyproterone/Ethinylestradiol can also interfere with the results of some blood tests,
so always tell your doctor that you are taking Cyproterone/Ethinylestradiol if you have a blood
test.
Cyproterone/Ethinylestradiol with food and drink
There are no special instructions about food and drink while on Cyproterone/Ethinylestradiol.

Pregnancy and breast-feeding
Do not use Cyproterone/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/Ethinylestradiol.

PIL.1040.004.2d

V020G: SPC and PIL CMDH PAR +
PSUR safety update + RFI + Post
approval RFI

IS

Sandoz Ltd
PL 04416/1040
Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets

Patient Information Leaflet
08/12/2016

Driving and using machines
Cyproterone/Ethinylestradiol has no known effect on the ability to drive or use machines.

Cyproterone/Ethinylestradiol contains sucrose and lactose
If you have been told by your doctor that you have intolerance to some sugars contact your
doctor before taking this medicine.
Cyproterone/Ethinylestradiol and sun-beds or sun-lamps
Sun-lamps are used by some women for acne as well as to tan the skin. This is not a very
useful treatment for acne. Do not use sun-beds or sun-lamps and avoid prolonged sunbathing if
you are taking Cyproterone/Ethinylestradiol. Their use increases the chance of chloasma, a
patchy discolouration of the skin (as it does with ordinary oral contraceptives).
3. How to take Cyproterone/Ethinylestradiol

3.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

How to take Cyproterone/Ethinylestradiol tablets

Your doctor has chosen Cyproterone/Ethinylestradiol as a treatment for your acne or excessive hair
growth on your face and body. However, Cyproterone/Ethinylestradiol also has a contraceptive effect,
so it is important to follow the advice below if you are relying on Cyproterone/Ethinylestradiol for
contraception.
If you are only using Cyproterone/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/Ethinylestradiol.
In general, treatment with Cyproterone/Ethinylestradiol is necessary for several months. When
your skin is completely clear, or the amount of body and facial hair growth has decreased,
treatment should be continued for at least a further 3–4 cycles. Afterwards, you should not
continue to take Cyproterone/Ethinylestradiol solely for contraception. You will be able to have
further courses of treatment, if the problem keeps returning. If the effect in severe acne is
insufficient after at least 6 months of treatment, or in excessive hair growth after at least 12
months of treatment, your doctor will reconsider therapy.

How to take it

Take Cyproterone/Ethinylestradiol every day for 21 days
PIL.1040.004.2d

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Sandoz Ltd
PL 04416/1040
Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets

Patient Information Leaflet
08/12/2016

Cyproterone/Ethinylestradiol comes in strips of 21 pills, each marked with a day of the week.
 Take your pill at the same time every day.
 Start by taking a pill marked with the correct day of the week.
 Follow the direction of the arrows on the strip. Take one pill each day, until you have finished all
21 pills.
 Swallow each pill whole, with water if necessary. Do not chew the pill.

Then have seven pill-free days
After you have taken all 21 pills in the strip, you have seven days when you take no pills.
Within a few days of taking the last pill from the strip, you should have a withdrawal bleed like a period.
This bleed may not have finished when it is time to start your next strip of pills.

If you are relying on this medicine to prevent pregnancy, always take Cyproterone/Ethinylestradiol as
described here. You don’t need to use extra contraception during the seven pill-free days – as long as you
have taken your pills correctly and start the next strip of pills on time. Check with your doctor if you are
not sure.

Start your next strip on day eight Start taking your next strip of Cyproterone/Ethinylestradiol after the
seven pill-free days (on day eight) – even if you are still bleeding. So if you take the last pill of one pack
on a Friday, you will take the first pill of your next pack on the Saturday of the following week. Always
start the new strip on time.
As long as you take Cyproterone/Ethinylestradiol correctly, you will always start each new strip on the
same day of the week.

Starting Cyproterone/Ethinylestradiol

New users or starting Cyproterone/Ethinylestradiol after a break
It is best to take your first Cyproterone/Ethinylestradiol pill on the first day of your next period. By
starting in this way, you will have contraceptive protection with your first pill.

Changing to Cyproterone/Ethinylestradiol from another contraceptive Pill
 If you are currently taking a 21-day Pill: start Cyproterone/Ethinylestradiol the next day after
the end of the previous strip. You will have contraceptive protection with your first pill. You will
not have a bleed until after your first strip of Cyproterone/Ethinylestradiol.
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PL 04416/1040
Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets

Patient Information Leaflet
08/12/2016

 If you are taking a 28-day Pill: start taking Cyproterone/Ethinylestradiol the day after your last
active pill. You will have contraceptive protection with your first pill. You will not have a bleed
until after your first strip of Cyproterone/Ethinylestradiol.
 If you are taking a progestogen-only Pill (POP or ‘mini Pill’): start
Cyproterone/Ethinylestradiol on the first day of bleeding, even if you have already taken the
progestogen-only Pill for that day. You will have contraceptive cover straight away.

Starting Cyproterone/Ethinylestradiol after a miscarriage or abortion
If you have had a miscarriage or an abortion during the first three months of pregnancy, your doctor
may tell you to start taking Cyproterone/Ethinylestradiol straight away. This means that you will have
contraceptive protection with your first pill.
If you have had a miscarriage or an abortion after the third month of pregnancy, ask your doctor for
advice. You may need to use extra contraception, such as condoms, for a short time.

Contraception after having a baby
If you have just had a baby, your doctor may advise you that Cyproterone/Ethinylestradiol should be
started 21 days after delivery provided that you are fully mobile. You do not have to wait for a period.
You will need to use another method of contraception, such as a condom, until you start
Cyproterone/Ethinylestradiol and for the first 7 days of pill taking.

Do not take Cyproterone/Ethinylestradiol if you are breast-feeding

PIL.1040.004.2d

V020G: SPC and PIL CMDH PAR +
PSUR safety update + RFI + Post
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Sandoz Ltd
PL 04416/1040
Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets

Patient Information Leaflet
08/12/2016

If you forget to take Cyproterone/Ethinylestradiol

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 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
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Sandoz Ltd
PL 04416/1040
Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets

Patient Information Leaflet
08/12/2016

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 sick or have diarrhoea
If you are sick (vomit) or have very bad diarrhoea, your body may not get its usual dose of hormones
from that pill. If you are better within 12 hours of taking Cyproterone/Ethinylestradiol, follow the
instructions in section 3‘A lost pill’, which describes how to take another pill.
If you are still sick or have diarrhoea more than 12 hours after taking Cyproterone/Ethinylestradiol, see
section 3‘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.

Missed a period – could you be pregnant?
Occasionally, you may miss a withdrawal bleed. This could mean that you are pregnant, but that is very
unlikely if you have taken your pills correctly. Start your next strip at the normal time. If you think that
you might have put yourself at risk of pregnancy (for example, by missing pills or taking other
medicines), or if you miss a second bleed, you should do a pregnancy test. You can buy these from the
chemist or get a free test at your doctors surgery. If you are pregnant, stop taking
Cyproterone/Ethinylestradiol and see your doctor.

If you take more Cyproterone/Ethinylestradiol than you should
Taking more than one pill should not cause harm
It is unlikely that taking more than one pill will do you any harm, but you may feel sick, vomit or have
some vaginal bleeding. Talk to your doctor if you have any of these symptoms.

When you want to get pregnant
If you are planning a baby, it’s best to use another method of contraception after stopping
Cyproterone/Ethinylestradiol until you have had a proper period. Your doctor or midwife relies on the
date of your last natural period to tell you when your baby is due. However, it will not cause you or the
baby any harm if you get pregnant straight away.
If you stop taking Cyproterone/Ethinylestradiol
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You can stop taking [nationally completed name] whenever you want.
Ask your doctor for advice about other reliable methods of birth control if you do not want to
become pregnant.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
→ Tell your doctor or pharmacist if you are worried about any side effects which you think may be
due to Cyproterone/Ethinylestradiol.

Serious side effects – see a doctor straight away
Severe depression:
Although, it is not considered a direct side effect of Cyproterone/Ethinylestradiol, you should stop
Cyproterone/Ethinylestradiol as a precaution, if you develop severe depression, and see your doctor
straight away.

Signs of a blood clot:

he left arm;

-lasting headache or worsening of migraine;

dizziness or fainting;

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Signs of a severe allergic reaction or worsening of hereditary angioedema:
swelling of the hands, face, lips, mouth, tongue or throat. A swollen tongue/throat may lead to
difficulty swallowing and breathing

Signs of breast cancer include:
dimpling of the skin
changes in the nipple
lumps you can see or feel.

Signs of cancer of the cervix include:
vaginal discharge that smells and/or contains blood
vaginal bleeding
pelvic pain
painful sex.

Signs of severe liver problems include:
pain in your stomach
yellow skin or eyes (jaundice)
inflammation of the liver (hepatitis)
itching.

→ If you think you may have any of these, see a doctor straight away. You may need to stop taking
Cyproterone/Ethinylestradiol.

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Less serious side effects
Common side effects (between 100 and 1000 in every 10,000 users may be affected)
feeling sick

or mood swings
sore or painful breasts

Uncommon side effects (between 10 and 100 in every 10,000 users may be affected)
being sick and stomach upsets

Rare side effects (between 1 and 10 in every 10,000 users may be affected)
poor tolerance of contact lenses

hypersensitivity (rash, itching, hives, difficulty breathing or swallowing, dizziness)
erythema nodosum (rash with painful red lumps, pain in joints and muscles)
erythema multiforme (rash, skin reddening, blistering of lips, eyes or mouth, skin peeling)

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Frequency not known (cannot be estimated from the available data)
bleeding and spotting between your periods can sometimes occur for the first few months but
this usually stops once your body has adjusted to Cyproterone/Ethinylestradiol. If it continues,
becomes heavy or starts again, contact your doctor
chloasma (yellow brown patches on the skin). This may happen even if you have been using
Cyproterone/Ethinylestradiol for a number of months. Chloasma may be reduced by avoiding too
much sunlight and/or UV lamps
ccurence or deterioration of the movement disorder chorea
Crohn’s disease or ulcerative colitis.

Hypertriglyceridemia (high level of triglycerides in the blood)

Conditions that may worsen during pregnancy or previous use of the Pill:
- 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
- an inherited form of deafness (otosclerosis)
- a personal or family history or a form of sickle cell disease
- swelling of body parts (hereditary angioedema)
- an inherited disease called porphyria
- cancer of the cervix
If you have hereditary angioedema medicines containing certain female sex hormones (estrogens)
may induce or worsen the symptoms of angioedema (see section Warnings and precautions).)

→ Tell your doctor or pharmacist if you are worried about any side effects which you think may
be due to Cyproterone/Ethinylestradiol. Also tell them if any existing conditions get worse while
you are taking Cyproterone/Ethinylestradiol.
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Bleeding between periods should not last long
A few women have a little unexpected bleeding or spotting while they are taking
Cyproterone/Ethinylestradiol, especially during the first few months. Normally, this bleeding is nothing
to worry about and will stop after a day or two. Keep taking Cyproterone/Ethinylestradiol as usual. The
problem should disappear after the first few strips.
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.
→ Make an appointment to see your doctor if you get breakthrough bleeding or spotting that:

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 via Yellow Card Scheme:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.

55. How to store Cyproterone/Ethinylestradiol

How to store Cyproterone/Ethinylestradiol tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or on each blister
strip after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
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.
6. Contents of the pack and other information

and other information
What Cyproterone/Ethinylestradiol contains
• The active substances are: cyproterone acetate and ethinylestradiol.
Each coated tablet contains 2.00 mg cyproterone acetate and 0.035 mg ethinylestradiol.
• The other ingredients are:
Tablet core:
Lactose monohydrate
Maize starch
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Povidone K25
Talcum
Magnesium stearate
Tablet coating:
Sucrose
Calcium carbonate
Talcum
Polyethylene glycol 6000
Povidone K90
Titanium dioxide (E171)
Glycerol 85%
Montan glycol wax
Iron oxide-yellow (E172)
What Cyproterone/Ethinylestradiol looks like and contents of the pack

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Cyproterone/Ethinylestradiol are round, biconvex, yellow sugar-coated tablets with a 5. 6–
5.8 mm nominal diameter.
The coated tablets are packed in plastic/aluminium blister each containing 21 coated tablets
inserted into a carton. Each carton contains either 1, 3 6 or 13 blister strips.
Not all pack sizes may be marketed.
Marketing Authorisation Holder

Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR.
United Kingdom

Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
Salutas Pharma GmbH
Otto-von Guericke-Allee 1
39179 Barleben
Germany

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Cyproterone acetate 2.00 mg Ethinylestradiol 0.035 mg coated tablets

Patient Information Leaflet
08/12/2016

This leaflet was last revised in 12/2016

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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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