CO-CYPRINDIOL 2000/35 TABLETS

Active substance: ETHINYLESTRADIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

CAMILETTE

CO-CYPRINDIOL 2000 / 35 TABLETS
(Cyproterone acetate / Ethinylestradiol)
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, even if their symptoms are
the same as yours.
- If any of the side effects become severe, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

THIS LEAFLET CONTAINS
1. What Camilette is for
2. Before you take Camilette
3. How to take Camilette
4. Possible side effects
5. How to store Camilette
6. Further information

1. WHAT CAMILETTE IS FOR
Camilette is used in women to treat severe acne that has not improved
after the long term use of oral antibiotics, and excessive hair growth.
Camilette contains a combination of two active substances, an oestrogen
called ethinylestradiol and an anti-androgen called cyproterone acetate.
Together this combination of substances is known as co-cyprindiol.
Androgens are hormones that stimulate both the growth of hair and the
grease glands on your skin. The active substances in Camilette stop
these androgens affecting your skin and reduce the amount of
androgens you produce.
Camilette also works as an oral contraceptive. You do not therefore
need to use another contraceptive method whilst taking this medicine,
provided you follow the instructions on how to take it properly.
Although taking Camilette correctly will prevent pregnancy, Camilette
will not protect you against sexually transmitted infections, such as
Chlamydia or HIV. Only condoms can help to do this.
When your condition has cleared up, you should stop taking Camilette
and go back to your original/preferred method of contraception.
Do not use Camilette solely for contraceptive purposes.

2. BEFORE YOU TAKE CAMILETTE
It’s important that you understand the benefits and risks of taking
Camilette before you start taking it, or when deciding whether to carry
on taking it. Although Camilette is suitable for most women, it is not
suitable for everyone.
Regular medical check-ups
Before you start taking Camilette your doctor will give you a check-up to
ensure that it is suitable for you to take. You will also need to return for
regular check-ups with your doctor whilst you are taking Camilette.
Do not take Camilette and tell your doctor if you:
 are allergic (hypersensitive) to ethinylestradiol, cyproterone acetate
or any of the other ingredients in Camilette, (listed in section 6 of this
leaflet)
 or a close family member, (parent or sibling), have ever had a blood
clot form in the veins of the legs (deep vein thrombosis) or the lungs
(pulmonary embolism) or any other part of the body
 or a close family member, (parent or sibling), have ever had a heart
attack or stroke
 or a close family member, (parent or sibling), have any condition
which makes you more at risk of a blood clot (see ‘Camilette and
blood clots’ below)
 suffer from abnormal red blood cells(sickle cell anaemia)
 suffer from vaginal bleeding of unknown cause
 are pregnant or think you might be pregnant
 are breast-feeding
 have had any of the following conditions whilst pregnant:
- persistent itching (pruritus)
- a skin rash that develops into blisters (herpes gestationis)
- yellowing of the skin and whites of the eyes (jaundice)
- an inherited form of deafness (otosclerosis)
 have, or have ever had, cancer of the breast or of the lining of the
womb (endometrium)
 have, or have ever had, liver tumours
 suffer from a type of jaundice known as Dubin-Johnson syndrome or
Rotor syndrome
 have severely altered liver function (your doctor can know this by
performing a blood test)
 have severe diabetes affecting your blood vessels
 have lipid metabolism disorders (high blood cholesterol or
triglycerides)
If any of these occur whilst taking Camilette, stop taking Camilette and
contact your doctor as soon as possible.
Camilette can make some conditions worse
Some of the conditions listed below can be made worse by taking
Camilette; others may mean Camilette is less suitable for you. While
you may still be able to take Camilette, you will need to take special
care and have check-ups more often.
Tell your doctor if you suffer or have previously suffered from:
 problems with your heart or circulation, including high blood pressure
(hypertension)
 problems with blood clotting
 varicose veins or inflamed veins (phlebitis)
 inflammation of the pancreas (pancreatitis)
 diabetes
 high levels of fat in your blood (hypertriglyceridemia)
 obesity (being severely overweight)
 muscle cramps or spasms caused by calcium deficiency (tetany)
 a disease of the nervous system such as multiple sclerosis or
Sydenham’s chorea
 fits (epilepsy)
 breast problems
 benign tumours of the womb (uterine fibroids)
 an intolerance to contact lenses
 asthma
 migraines
 depression
 brown patches on your face or body (chloasma), (see ‘Camilette and
sun-beds or sun-lamps’ below)
 any illness that is likely to worsened during pregnancy:
- kidney or liver problems
- gallstones
- a disease causing inflammation of connective tissue (systemic
lupus erythematosus)
- sickle cell disease
- swelling of body parts (hereditary angioedema)
- an inherited metabolic disease called porphyria
Tell your doctor if any of these apply to you. Also tell them if you get any
for the first time, if any get worse or come back while taking Camilette,
as you may need to stop taking it.
Camilette and Sun-Beds or Sun-Lamps
Sun-lamps are used by some women for acne as well as to tan the skin.
The use of sun-beds or sun-lamps and prolonged sunbathing should be
avoided when you are taking Camilette, as they increase the chance of
chloasma, a patchy discolouration of the skin.

Camilette and Blood Clots
The use of Camilette increases your risk of developing a blood clot,
especially in the first year of taking it.
A clot formed in the deep veins of the legs (deep vein thrombosis or
DVT) is not always serious. However, if this clot breaks off, moves up
the veins and blocks an artery in the lungs, it can cause chest pain,
breathlessness, collapse or even death. This is very rare and is called a
pulmonary embolism.
Also very rarely, blood clots can 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.
In extremely rare cases blood clots can develop in other places such as
the liver, gut, kidney or eye.
Your chances of developing a blood clot are only slightly increased by
taking Camilette;
 In healthy women who are not taking Camilette, not on the Pill and
are not pregnant, about 5 - 10 in 100,000 will have a blood clot each
year.
 Of those women who are taking Camilette or the Pill, up to 40 in
100,000 will have a blood clot each year.
 Of those women who are pregnant, around 60 in 100,000 will have a
blood clot each year.
You are more at risk of having a blood clot with certain factors, including:
 increasing age
 being severely overweight (obesity)
 a personal or family history of having had blood clots
 smoking
 sickle cell disease
 have a disorder of blood fat (lipid) metabolism, or some other very
rare blood disorders
 high blood pressure (hypertension)
 a heart valve disorder or a particular type of irregular heartbeat (atrial
fibrillation)
 polycystic ovary syndrome
 migraines
 diabetes
 the auto-immune disease systemic lupus erythematosus
 a chronic inflammatory bowel disease (Crohn’s disease or ulcerative
colitis)
 being immobile or unable to move around as much as usual, for
example because of surgery, injury or illness
 having recently given birth
Tell your doctor if any of these apply to you. Camilette may add to that
risk and so may not be suitable for you.
The symptoms of a blood clot are described in section 4 of this leaflet. If
you experience any of them, see a doctor as soon as possible. Do not
take any more Camilette until your doctor says you can and use another
method of contraception, such as condoms, in the meantime.
Camilette and Cancer
Whilst Camilette offers protection against cancers of the ovary and
lining of the womb (endometrium), there is a slightly increased risk of
cancer of the neck of the womb (cervix) with long-term use. It is
uncertain as to whether this increased risk is caused by the Camilette or
due to other factors such as sexual behaviour.
You should go for regular cervical smear tests.
There is also a slightly increased risk of finding breast cancer in women
using Camilette and other oral contraceptives when compared with
women of the same age who have never taken them. It is uncertain
whether oral contraceptives cause the increased risk of breast cancer
or whether women taking them are examined more often and so the
breast cancer is detected earlier.
However, it has been shown that breast cancers diagnosed in women
who take oral contraceptives are less likely to have spread to other
parts of their bodies, than those in women who do not take them.
While breast cancer is rare in women under 40 years of age, the risk
significantly increases with increasing age. Therefore, the risk of finding
breast cancer in women who have taken oral contraceptives is affected
by the age at which a woman stops taking them.
Once women stop taking oral contraceptives the additional risk of
breast cancer reduces and within about 10 years is the same as for
women who have never taken them.
Your chances of developing breast cancer are only slightly increased by
taking Camilette;
 In those women who have never taken Camilette or the Pill, about 16
in 10,000 will have breast cancer by the time they are 35 years old.
 In those women who take Camilette or the Pill for 5 years in their
early twenties, about 17 to 18 in 10,000 will have breast cancer by
the time they are 35 years old.
 In those women who have never taken Camilette or the Pill, about
100 in 10,000 will have breast cancer by the time they are 45 years
old.
 In those women who take Camilette or the Pill for 5 years in their
early thirties, about 110 in 10,000 will have breast cancer by the time
they are 45 years old.
You should regularly check your breasts for any changes.
In rare cases benign liver tumours, and even more rarely malignant liver
tumours have been reported in women who have taken Camilette for a
long time.
The symptoms of these cancers are described in section 4 of this
leaflet. If you experience any of them, see a doctor as soon as possible.
Do not take any more Camilette until your doctor says you can and use
another method of contraception, such as condoms, in the meantime.
Taking other medicines
Always tell your doctor or pharmacist if you are intending to take or
have recently taken any other medicine at the same time as taking
Camilette, even those medicines that are bought without a prescription.
In particular, tell your doctor, pharmacist or dentist if you are given any
of the following medicines as they may stop Camilette from working
properly as a contraceptive:
 medicines used to treat epilepsy such as carbamazepine,
eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin and
topiramate
 medicines used to treat HIV such as nelfinavir, nevirapine and
ritonavir
 medicines for treating fungal infections such as griseofulvin,
clotrimazole, ketoconazole and tioconazole
 antibiotic medicines, used to treat bacterial infections, such as
tetracyclines, rifabutin and rifampicin
 the herbal remedy, St. John’s Wort
If you are relying on Camilette for contraception and need to take one of
these medicines, you may need to use an alternative non-hormonal
method of contraception for a while. Your doctor, pharmacist or dentist
can tell you if this is necessary and for how long.
Camilette can also affect how well other medicines work. Your doctor
may need to adjust the dose of your other medication. Always follow
your doctor’s advice.
Operations and tests
If you are going to have an operation, tell your doctor you are taking
Camilette. You may need to stop taking it 4-6 weeks before the surgery.
After the operation you should not start taking Camilette again until your
doctor advises you to, especially if you are not able to move around as
usual.
Taking Camilette may also affect the results of some clinical tests. If you
are going to have any tests, it is important to tell your doctor or nurse
that you are taking Camilette.
Pregnancy and breast-feeding
Do not take Camilette whilst you are pregnant or breast-feeding.
If you think you might be pregnant, stop taking Camilette and consult
your doctor. Use another form of contraception, such as a condom, in
the meanwhile.

Driving and using machines
Camilette has no known effect on the ability to drive or use machines.
Camilette contains lactose and sucrose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before using Camilette.

3. HOW TO TAKE CAMILETTE
Your doctor has chosen Camilette as a treatment for your acne and/or
excessive hair growth. However, Camilette also has a contraceptive
effect and so you must not take any other hormonal contraceptive at the
same time.
It is important to follow the advice below if you are relying on Camilette
for contraception. Check with your doctor if there is anything you are not
sure of.
Taking Camilette
Camilette comes in strips of 21 pills, each marked with a day of the
week.
 Start by taking a pill marked with the correct day of the week.
 Take one pill each day, moving along the strip in a clock-wise
direction, until you have finished all 21 pills on the strip.
 Try to take your pill at the same time every day.
 Swallow each pill whole, with water.
After you have taken all 21 pills in the strip, you have a seven day
break when you take no pills.
Within a few days of taking the last pill from the strip, you will have a
withdrawal bleed like a period. These bleeds should be regular, and will
probably be lighter than your periods before. You don’t need to use
extra contraception during the seven day break as you are very unlikely
to become pregnant, as long as you have taken your pills correctly and
start the next strip of pills on time.
Start taking your next strip of Camilette after the seven pill-free days
(i.e. on the eighth day) – even if your bleed has not yet finished. As long
as you take Camilette correctly, you will find each new strip of tablets
begins on the same day of the week as the one before. Always start the
new strip on time if you are relying on this medicine as contraception.
Check with your doctor or pharmacist if you are not sure.
Your doctor should stop treating you with this medicine when your skin
has completely cleared, or the amount of hair growth has decreased.
However, you will be able to have further courses of treatment if your
problem returns.
Starting Camilette
New users or starting Camilette after a break
It is best to take your first Camilette 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 Camilette from another contraceptive Pill
- If you are currently taking a 21-day Pill: finish your current pack of
21 day contraceptive pills and then start taking Camilette the next day.
Do not leave a gap between packs. By starting in this way you will not
have a period until after your first strip of Camilette but you will have
contraceptive protection with your first pill.
- If you are taking a 28-day Pill: start taking Camilette the day after
your last active pill. Do not leave a gap between packs. By starting in
this way you will not have a period until after your first strip of
Camilette but you will have contraceptive protection with your first pill.
- If you are taking a progestogen-only Pill (POP or ‘mini Pill’): start
Camilette on the first day of your period, even if you have already
taken a progestogen-only Pill on that day. You will have contraceptive
cover straight away.
Starting Camilette 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 Camilette
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.
Starting Camilette after having a baby
If you have just had a baby, your doctor may advise you that Camilette
should be started 21 days after delivery, providing you are fully mobile.
You do not have to wait for a period; however you will need to use
another method of contraception, such as a condom, until you start
Camilette and for the first 7 days of pill taking.
Do not take Camilette if you are breast-feeding
A missed pill
If you are less than 12 hours late with a pill:
Don’t worry. Your contraceptive protection should not be affected if you
take the late pill straight away. Keep taking your remaining pills at the
usual time. This may mean taking two pills in one day.
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. You should:
- take the most recently missed pill as soon as you remember. 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 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, such as condoms, for seven days after
missing a pill.
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 have become
pregnant. Contact your doctor or pharmacist for advice as soon as
possible. You may need to consider emergency contraception.
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.
If you lose a pill:
You should take the last pill of the strip in place of the lost pill. Then take
all the remaining 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.
If you are sick or have diarrhoea
If you are sick (vomit) or have diarrhoea, your body may not get its
usual dose of hormones from that pill. You should continue to take a pill
every day for the next seven days as usual, but you should also use
another method of contraception. If you come to the end of a strip
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.
If your stomach upset carries on or gets worse, talk to your doctor. They
may recommend another form of contraception.
Missed a period – could you be pregnant?
Occasionally, you may miss a period. This could mean that you are
pregnant. You should do a pregnancy test before starting another strip.
If you are pregnant, stop taking Camilette and see your doctor as soon
as possible.
If you take more Camilette than you should
It is unlikely that taking more than one pill will do you any harm, but if
you feel sick, vomit or have any vaginal bleeding contact your doctor
straight away.

If you want to get pregnant
If you are planning a baby, it’s best to stop using Camilette and use
another method of contraception until you have had a natural period.
Your doctor or midwife relies on the date of your last natural period to
tell you when the baby is due. You should be aware that when you stop
taking Camilette, your periods may not return right away. However, it
will not cause any harm if you get pregnant straight away.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Camilette can cause side effects, although not
everybody gets them.
If you get any of the following side effects, stop taking Camilette
and tell your doctor immediately:
 Allergic reaction, the symptoms of which may include:
- swelling of the face, tongue or throat which may cause difficulty
swallowing and breathing
- red, raised lumps (hives) and itching
 Severe depression, although this is not considered a direct side
effect of Camilette, you should stop Camilette as a precaution and
see your doctor straight away
 Blood clot, the signs of which include:
- a migraine for the first time or migraines that are unusually frequent
or more severe than normal
- any sudden changes to your eyesight, hearing, speech, sense of
smell, taste or touch
- pain or swelling in your leg
- pain and tightness in the chest
- shortness of breath
- coughing for no apparent reason or coughing up blood
- weakness or numbness in any part of your body
- dizziness or fainting
 Breast cancer, you should check your breasts and nipples every
month for changes, and tell your doctor if you can see or feel
anything odd, such as:
- dimpling of the skin
- changes in the nipple
- any lumps you can see or feel
 Cervical cancer, the symptoms of which include:
- an unpleasant smelling vaginal discharge
- unusual vaginal bleeding
- pelvic pain
- pain in and around the vagina during sex
 Liver problems, the signs of which include:
- pain in your stomach area
- yellowing of the skin or whites of the eyes (jaundice)
- inflammation of the liver (hepatitis) which may cause light pressure
or pain below the right ribs
If you think you may have any of these, see a doctor straight away. You
may need to stop taking Camilette. If you do need to stop taking
Camilette, remember to use another method of contraceptive (e.g.
condoms).
Common side effects (affects more than 1 in every 100 users)
 feeling sick (nausea), stomach ache
 putting on weight
 headaches
 depressive moods or mood swings
 sore or painful breasts
Uncommon side effects (affects more than 1 in every 1,000 users, but
less than 1 in every 100 users)
 being sick (vomiting), diarrhoea
 fluid retention
 migraine
 loss of interest in sex
 breast enlargement
 skin rash, itching
Rare side effects (affects less than 1 in every 1,000 users)
 poor tolerance of contact lenses
 losing weight
 increase of interest in sex
 vaginal or breast discharge
Other reported side effects
 high levels of fat in your blood (hypertriglyceridemia)
 worsening of the movement disorder chorea
 chronic inflammatory bowel disease (Crohn’s disease or ulcerative
colitis), symptoms of which may include abdominal pain and blood
and/or mucus in your stools
 chloasma (yellow-brown patches on the skin). This may happen even
if you have been using Camilette for a number of months. Chloasma
may be reduced by avoiding too much sunlight and UV lamps
 bleeding and spotting between your periods can sometimes occur for
the first few months, but this usually stops once your body has
adjusted to Camilette. If it continues, becomes heavy or starts again,
contact your doctor
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.
If any of these side effects become serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
Also tell your doctor if any of your existing conditions get worse whilst
you are taking Camilette.

5. HOW TO STORE CAMILETTE
Keep all medicines out of the sight and reach of children.
Do not use Camilette after the expiry date which is stated on the carton
and blister strips. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to dispose of any medicines you no longer
require. These measures will help protect the environment.

6. FURTHER INFORMATION
What Camilette contains:
The active ingredients, (the ingredients which make the medicine work),
in Camilette are cyproterone acetate and ethinylestradiol. Each tablet
contains 2 milligrams of cyproterone acetate and 35 micrograms of
ethinylestradiol.
The other ingredients are; lactose, maize starch, povidone, talc,
magnesium stearate (E 572), sucrose, macrogol 6000, calcium
carbonate (E 170), titanium dioxide (E 171), glycerol, montan glycol
wax, yellow ferric oxide pigment (E 172).
What Camilette looks like and contents of the pack
Camilette tablets are beige/pale yellow, round, sugar-coated tablets.
Each box of Camilette contains three blister strips, each comprising of
21 tablets.
Marketing Authorisation Holder:
Chatfield Pharmaceuticals Limited,
Kramer Mews, London SW5 9JL
Manufacturer:
Haupt Pharma GmbH,
Schleebruggenkamp 15, D-48159 Munster, Germany
For more information about this product, please contact the Marketing
Authorisation Holder.
This leaflet was last revised in 05/2013

CF0045/O/PIL/CF1

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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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