CLAIRETTE 2000/35 TABLETS

CLAIRETTE, Leaflet UK, 180 x 600mm, page 1

CYPROTERONE ACETATE / ETHINYLESTRADIOL

PACKAGE LEAFLET: INFORMATION FOR THE USER
Clairette® 2000/35 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.
• Keep this leaflet. You may need to read it again.
• If you have any questions or need more advice, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them.
• If any of the side effects gets severe, or if you notice any not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. WHAT CLAIRETTE® 2000/35 TABLETS IS AND
WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLAIRETTE®
2000/35 TABLETS
2.1 Before you take Clairette® 2000/35 Tablets
When should you contact your doctor
Clairette® 2000/35 Tablets and cancer
2.2 Make sure Clairette® 2000/35 Tablets is OK for you
Clairette® 2000/35 Tablets should not be taken by some women
Clairette® 2000/35 Tablets can make some illnesses worse
Taking other medicines
Taking Clairette® 2000/35 Tablets with food and drink
Pregnancy and breast-feeding
Driving and using machines
Clairette® 2000/35 Tablets contains lactose
Clairette® 2000/35 Tablets and sun-beds or sun-lamps
3. TAKING CLAIRETTE® 2000/35 TABLETS
Duration of use
How to take it
Starting Clairette® 2000/35 Tablets
A missed pill
A lost pill
If you are sick or have diarrhoea
Missed a period – could you be pregnant?
Taking more than one pill should not cause harm
When you want to get pregnant
4. POSSIBLE SIDE EFFECTS
4.1 Serious side effects – see a doctor straight away
4.2 Less serious side effects
4.3 Bleeding between periods should not last long
5. HOW TO STORE CLAIRETTE® 2000/35 TABLETS
6. WHAT IS IN CLAIRETTE® 2000/35 TABLETS AND WHO MAKES IT
1. WHAT CLAIRETTE® 2000/35 TABLETS IS AND
WHAT IT IS USED FOR
Clairette® 2000/35 Tablets contains an oestrogen and an anti-androgen.
Clairette® 2000/35 Tablets 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 Clairette® 2000/35 Tablets if your skin condition has
not improved after use of other anti-acne treatments, including topical
treatments and antibiotics.
If you are taking Clairette® 2000/35 Tablets 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 Clairette®
2000/35 Tablets, 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. Clairette® 2000/35 Tablets stops the
androgens affecting your skin and reduces the amount of androgens
produced.
Contraception
Clairette® 2000/35 Tablets is a 21-day Pill – you take one each day for 21
days, followed by 7 days when you take no pills.
Clairette® 2000/35 Tablets will not protect you against sexually transmitted
infections, such as Chlamydia or HIV. Only condoms can help to do this.
Clairette® 2000/35 Tablets needs to be taken as directed to prevent
pregnancy.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLAIRETTE®
2000/35 TABLETS
2.1 Before you take Clairette® 2000/35 Tablets
It’s important that you understand the benefits and risks of taking
Clairette® 2000/35 Tablets before you start taking it, or when deciding
whether to carry on taking it. Although Clairette® 2000/35 Tablets 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 Clairette® 2000/35 Tablets
• Your doctor will ask about you and your family’s medical problems and
check your blood 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 Clairette® 2000/35 Tablets
• You will need regular check-ups with your doctor, usually when you
need another prescription of Clairette® 2000/35 Tablets.
• You should go for 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.
• If you need a blood test tell your doctor that you are taking Clairette®
2000/35 Tablets, 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 Clairette® 2000/35 Tablets 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
Clairette® 2000/35 Tablets again.
• If you need to stop taking Clairette® 2000/35 Tablets, remember to
use another contraceptive (e.g. condoms) if you are relying on
Clairette® 2000/ 35 Tablets for contraception.
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
below in ‘Blood clots (Thrombosis)’ and in Section 4.
Clairette® 2000/35 Tablets 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 Clairette® 2000/35 Tablets 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 Clairette® 2000/35 Tablets compared
with women who do not take Clairette® 2000/35 Tablets 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 Clairette® 2000/35 Tablets.
• Of 100,000 women who are not taking Clairette® 2000/35 Tablets,
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 Clairette® 2000/35 Tablets 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
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 Clairette® 2000/35
Tablets you are strongly 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
Clairette® 2000/35 Tablets, as the treatment may have to be stopped. Your
doctor may tell you to stop using Clairette® 2000/35 Tablets several weeks
before surgery or while you are less mobile. Your doctor will also tell you
when you can start using Clairette® 2000/35 Tablets 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 Clairette® 2000/35
Tablets 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;
• 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 Clairette® 2000/35 Tablets.
See a doctor straight away if you also develop severe depression, a
severe allergic reaction, worsening of hereditary angioedema, signs of
breast cancer or cervical cancer or signs of severe liver problems
(symptoms and signs are described in section 4).
Clairette® 2000/35 Tablets and cancer
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 oestrogenprogestogen containing Pills like Clairette® 2000/35 Tablets also provide
the same protective effects. However, it also seems that taking Clairette®
2000/35 Tablets slightly increases your risk of cancer of the cervix –
although this may be due to having sex without a condom, rather than
Clairette® 2000/35 Tablets. All women should have regular smear tests.
If you have breast cancer, or have had it in the past, you should not take
Clairette® 2000/35 Tablets or other oral contraceptives, as they slightly
increase your risk of breast cancer. This risk goes up the longer you’re on
Clairette® 2000/35 Tablets, 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 Clairette® 2000/35
Tablets users is small. For example:
• Of 10,000 women who have never taken Clairette® 2000/35 Tablets
or the Pill, about 16 will have breast cancer by the time they are 35
years old.
• Of 10,000 women who take Clairette® 2000/35 Tablets 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.
• Of 10,000 women who have never taken Clairette® 2000/35 Tablets
or the Pill, about 100 will have breast cancer by the time they are 45
years old.
• Of 10,000 women who take Clairette® 2000/35 Tablets 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:
• if you have a close relative (mother, sister or grandmother) who has had
breast cancer
• if you are seriously overweight
> 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 Clairette® 2000/35 Tablets has also been linked to liver
diseases, such as jaundice and non- cancer liver tumours, but this is
rare. Very rarely, Clairette® 2000/35 Tablets 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 Clairette® 2000/35 Tablets.
2.2 Make sure Clairette® 2000/35 Tablets is OK for you
Clairette® 2000/35 Tablets should not be taken by some women
> Tell your doctor if you have any medical problems or illnesses.
Do not take Clairette® 2000/35 Tablets Tell your doctor if any of the
following conditions applies to you before starting to use Clairette®
2000/35 Tablets. 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 breast cancer
• 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:
- diabetes affecting your blood vessels
- very high blood pressure
- 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
• If you are allergic (hypersensitive) to any of the ingredients in Clairette®
2000/35 Tablets.
> If you suffer from any of these, or get them for the first time while
taking Clairette® 2000/35 Tablets, contact your doctor as soon as
possible.
Do not take Clairette® 2000/35 Tablets. If needed, use another form of
contraception.
Clairette® 2000/35 Tablets can make some illnesses worse
Some of the conditions listed below can be made worse by taking
Clairette® 2000/35 Tablets. Or they may mean it is less suitable for you.
You may still be able to take Clairette® 2000/35 Tablets 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 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 ‘Clairette® 2000/35 Tablets and sun-beds or sun-lamps’)
• If you have any illness that worsened during pregnancy or previous
use of the Pill or Clairette® 2000/35 Tablets (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 Clairette® 2000/35 Tablets, or if any
get worse or come back, because you may need to stop taking it.
Taking other medicines
If you ever need to take another medicine at the same time as taking
Clairette® 2000/35 Tablets, always tell your doctor, pharmacist or dentist
that you’re taking Clairette® 2000/35 Tablets. Also check the leaflets that
come with all your medicines to see if they can be taken with hormonal
contraceptives.
If you are taking Clairette® 2000/35 Tablets for skin treatment, you must
not take any other hormonal contraceptive at the same time.

CLAIRETTE, Leaflet UK, 180 x 600mm, page 2

Some medicines can stop Clairette® 2000/35 Tablets from working
properly – for example:
• some medicines used to treat epilepsy
• some medicines used to treat HIV
• griseofulvin (an anti-fungal medicine)
• certain antibiotics (oral tetracyclines)
• certain sedatives (called barbiturates)
• St. John’s Wort (a herbal remedy).
If you do need to take one of these medicines, Clairette® 2000/35 Tablets
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.
Clairette® 2000/35 Tablets can also affect how well other
medicines work.
Your doctor may need to adjust the dose of your other medicine.
In addition, Clairette® 2000/35 Tablets can also interfere with the results
of some blood tests, so always tell your doctor that you are taking
Clairette® 2000/35 Tablets if you have a blood test.
Taking Clairette® 2000/35 Tablets with food and drink
There are no special instructions about food and drink while on Clairette®
2000/35 Tablets.
Pregnancy and breast-feeding
Do not use Clairette® 2000/35 Tablets 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 Clairette® 2000/35 Tablets.
Driving and using machines
Clairette® 2000/35 Tablets has no known effect on the ability to drive or
use machines.
Clairette® 2000/35 Tablets contains lactose and sucrose
If you have been told by your doctor that you have intolerance to some
sugars, contact your doctor before using Clairette® 2000/35 Tablets.
Clairette® 2000/35 Tablets 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 Clairette®
2000/35 Tablets. Their use increases the chance of chloasma, a patchy
discolouration of the skin (as it does with ordinary oral contraceptives).
3. TAKING CLAIRETTE® 2000/35 TABLETS
Your doctor has chosen Clairette® 2000/35 Tablets as a treatment for your
acne or excessive hair growth on your face and body. However, Clairette®
2000/35 Tablets also has a contraceptive effect, so it is important to
follow the advice below if you are relying on Clairette® 2000/35 Tablets
for contraception.
If you are only using Clairette® 2000/35 Tablets 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 Clairette®
2000/35 Tablets.
How to take it
Take Clairette® 2000/35 Tablets every day for 21 days
Clairette® 2000/35 Tablets 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
Clairette® 2000/35 Tablets 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 Clairette® 2000/35 Tablets 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 Clairette® 2000/35 Tablets correctly, you will always
start each new strip on the same day of the week.
Starting Clairette® 2000/35 Tablets
New users or starting Clairette® 2000/35 Tablets after a break
It is best to take your first Clairette® 2000/35 Tablets 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 Clairette® 2000/35 Tablets from another contraceptive
Pill
• If you are currently taking a 21-day Pill: start Clairette® 2000/35
Tablets 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 Clairette® 2000/35 Tablets.
• If you are taking a 28-day Pill: start taking Clairette® 2000/35
Tablets 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 Clairette® 2000/35 Tablets.
• If you are taking a progestogen-only Pill (POP or ‘mini Pill’): start
Clairette® 2000/35 Tablets 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 Clairette® 2000/35 Tablets 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 Clairette®
2000/35 Tablets 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 Clairette®
2000/35 Tablets 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
Clairette® 2000/35 Tablets and for the first 7 days of pill taking.
Do not take Clairette® 2000/35 Tablets if you are breast-feeding
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 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 Clairette® 2000/35 Tablets, follow the instructions
in section 3.4 A lost pill, which describes how to take another pill.
If you are still sick or have diarrhoea more than 12 hours after taking
Clairette® 2000/35 Tablets, see section 3.3, 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 Clairette® 2000/35
Tablets and see your doctor.

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 Clairette® 2000/35 Tablets 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Clairette® 2000/35 Tablets 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 Clairette® 2000/35 Tablets.
4.1 Serious side effects – see a doctor straight away
Severe depression:
Although, it is not considered a direct side effect of Clairette® 2000/35
Tablets, you should stop Clairette® 2000/35 Tablets as a precaution, if you
develop severe depression, and see your doctor straight away.
Signs of a blood clot:
• 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.
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
• a red bumpy rash (hives) and itching.
Signs of breast cancer include:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel.
Signs of cancer of the cervix include:
• vaginal discharge that smells and/or contains blood
• unusual vaginal bleeding
• pelvic pain
• painful sex.
Signs of severe liver problems include:
• severe pain in your stomach
• yellow skin or eyes (jaundice)
• inflammation of the liver (hepatitis)
• your whole body starts itching.
> If you think you may have any of these, see a doctor straight
away.
You may need to stop taking Clairette® 2000/35 Tablets.
4.2 Less serious side effects
Common side effects
(between 100 and 1000 in every 10,000 users may be affected)
• feeling sick
• stomach ache
• putting on weight
• headaches
• depressive moods 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
• fluid retention
• migraine
• loss of interest in sex
• breast enlargement
• skin rash, which may be itchy
Rare side effects
(between 1 and 10 in every 10,000 users may be affected)
• poor tolerance of contact lenses
• losing weight
• increase of interest in sex
• vaginal or breast discharge
• venous blood clot
Other side effects reported
• bleeding and spotting between your periods can sometimes occur
for the first few months but this usually stops once your body has
adjusted to Clairette® 2000/35 Tablets. 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 Clairette® 2000/35 Tablets for a number of
months. Chloasma may be reduced by avoiding too much sunlight
and/or UV lamps
• occurence or deterioration of the movement disorder chorea
• Crohn’s disease or ulcerative colitis
• 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
> Tell your doctor or pharmacist if you are worried about any side
effects which you think may be due to Clairette® 2000/35 Tablets. Also
tell them if any existing conditions get worse while you are taking
Clairette® 2000/35 Tablets.
4.3 Bleeding between periods should not last long
A few women have a little unexpected bleeding or spotting while they are
taking Clairette® 2000/35 Tablets, especially during the first few months.
Normally, this bleeding is nothing to worry about and will stop after a day
or two. Keep taking Clairette® 2000/35 Tablets 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:
• carries on for more than the first few months
• starts after you’ve been taking Clairette® 2000/35 Tablets for a while
• carries on even after you’ve stopped taking Clairette® 2000/35 Tablets.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE CLAIRETTE® 2000/35 TABLETS
Keep all medicines out of the reach and sight of children.
No special storage precautions.
Do not use Clairette® 2000/35 Tablets after the expiry date shown on the
strip.
Do not throw away any medicines down a drain or into a bin. Ask your
pharmacist what to do with any medicines you do not want. This will help
to protect the environment.
6. WHAT IS IN CLAIRETTE® 2000/35 TABLETS AND
WHO MAKES IT
What is in Clairette® 2000/35 Tablets
The blister strips are supplied in a carton box. Each box contains 1 or 3
blister strips.
Not all pack sizes may be marketed.
Each tablet contains: 2 milligrams of the anti-androgen, cyproterone
acetate, and
35 micrograms of the oestrogen, ethinylestradiol.
Clairette® 2000/35 Tablets also contains the inactive ingredients:
Lactose, maize starch, povidone, talc, magnesium stearate, sucrose,
Macrogol 6000, calcium carbonate, glycerol 85%, montan glycol wax
and titanium dioxide (E171).
The company that holds the product licence for Clairette® 2000/35
Tablets is:
STRAGEN UK Ltd
Castle Court
41 London Road
Reigate
Surrey RH2 9RJ
UNITED KINGDOM
Clairette® 2000/35 Tablets is made by:
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
GERMANY
This leaflet was last updated
in December 2013.