ACNOCIN 2000/35 TABLETS

Active substance: ETHINYLESTRADIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Acnocin® 2000/35 Tablets
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, familiy planning nurse 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 side effects not listed in this leaflet, please tell your doctor, familiy planning nurse or
pharmacist.

In this leaflet:
1. What Acnocin is and what it is used for
2. What you need to know before you take Acnocin
3. How to take Acnocin
4. Possible side effects
5. How to store Acnocin
6. Further information

1

What Acnocin is and what it is used for

Acnocin contains an oestrogen and an anti-androgen.
Acnocin is used to treat skin conditions - severe acne that has not
improved after the long term use of oral antibiotics and excessive hair
growth.
Acnocin also works as an oral contraceptive. However, do not use
Acnocin as a contraceptive unless you are also using it to treat your skin
condition. You and your doctor will have to consider all the things that would
normally apply to the safe use of an ordinary oral contraceptive.
If you are taking Acnocin for skin treatment, you must not take any other
oral contraceptive pill at the same time.
When your skin condition has cleared up and you stop taking Acnocin, 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. Acnocin stops the androgens affecting your skin and reduces the
amount of androgens produced.
Contraception
Acnocin will stop you getting pregnant by working in three ways: by
preventing an egg being released from your ovaries; by making the fluid
(mucus) in your cervix thicker, which makes it more difficult for sperm to
enter the womb; and by preventing the lining of your womb thickening
enough for an egg to grow in it.

Acnocin is a 21-day pill – you take one each day for 21 days, followed by 7
days when you take no pills.

The benefits of taking an oral contraceptive include:
• it is one of the most reliable reversible methods of contraception if used
correctly
• it doesnʼt interrupt sex
• it usually makes your periods regular, lighter and less painful
• it may help with pre-menstrual symptoms.

Acnocin will not protect you against sexually transmitted infections, such as
Chlamydia or HIV. Only condoms can help to do this.

Acnocin needs to be taken as directed to prevent pregnancy.

2

What you need to know before you take Acnocin

Before you take Acnocin
Itʼs important that you understand the benefits and risks of taking Acnocin
before you start taking it, or when deciding whether to carry on taking it.
Although Acnocin is suitable for most healthy women it isnʼt suitable for
everyone.

→ Tell your doctor if you have any of the illnesses or risk factors mentioned
in this leaflet.

Before you start taking Acnocin
• Your doctor will ask about you and your familyʼs medical problems and
check your blood pressure. You may also need other checks, such as a
breast examination.

While youʼre on Acnocin
• You will need regular check-ups with your doctor or family planning
nurse, usually when you need another prescription of Acnocin.
• 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 Acnocin,
because this type of medicine can affect the results of some tests.
• If youʼre going to have an operation, make sure your doctor knows
about it. You may need to stop taking Acnocin about 4–6 weeks before
the operation. This is to reduce the risk of a blood clot (see under section
2). Your doctor will tell you when you can start taking Acnocin again.

Acnocin and blood clots
Taking Acnocin may slightly increase your risk of having a blood clot
(called a thrombosis), especially in the first year of taking it.
A clot in a leg vein – a deep vein thrombosis (or DVT) – is not always
serious. However, if it moves up the veins and blocks an artery in the lungs,
it can cause chest pain, breathlessness, collapse or even death. This is
called a pulmonary embolism and is very rare.

Your chances of having a blood clot are only increased slightly by
taking Acnocin.
• Of 100,000 women who are not taking Acnocin, 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 Acnocin or the Pill, up to 40 will have a
blood clot in a year
• Of 100,000 women who are pregnant, around 60 will have a blood clot in
a year.

Very rarely, blood clots can also form in the blood vessels of the heart
(causing a heart attack) or the brain (causing a stroke). In healthy young
women the chance of having a heart attack or stroke is extremely small.

You are more at risk of having a blood clot:
• as you get older
• if you smoke
• if you or any of your close family have had blood clots
• if you are seriously overweight
• if you get migraines
• if you have cardiovascular disease (diseases of the heart or blood
vessels)
• if you have high blood pressure
• if you have diabetes
• if youʼre off your feet for a long time because of major surgery, injury or
illness.
→ Tell your doctor if any of these apply to you. Taking Acnocin may add
to this risk so may not be suitable for you.

Signs of a blood clot include:
• a migraine for the first time, a migraine that is worse than normal or
unusually frequent or severe headaches
• any sudden changes to your eyesight (such as loss of vision or blurred
vision)
• any sudden changes to your hearing, speech, sense of smell, taste or
touch
• pain or swelling in your leg
• stabbing pain when you breathe
• coughing for no apparent reason
• pain and tightness in the chest
• sudden weakness or numbness in one side or part of your body
• dizziness or fainting.
→ See a doctor as soon as possible. Do not take any more Acnocin
until your doctor says you can. Use another method of contraception,
such as condoms, in the meantime.

Acnocin and cancer
Acnocin reduces your risk of cancer of the ovary and womb if used in the
long term. However, it also seems to slightly increase your risk of cancer of
the cervix – although this may be due to having sex without a condom,
rather than Acnocin. All women should have regular smear tests.

If you have breast cancer, or have had it in the past, you should not take
Acnocin or other oral contraceptives, as they slightly increase your risk of
breast cancer. This risk goes up the longer youʼre on Acnocin, 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 Acnocin users is small. For example:
• Of 10,000 women who have never taken Acnocin or the Pill, about 16
will have breast cancer by the time they are 35 years old.
• Of 10,000 women who take Acnocin 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 Acnocin or the Pill, about 100
will have breast cancer by the time they are 45 years old.
• Of 10,000 women who take Acnocin 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 Acnocin has also been linked to liver diseases, such as jaundice
and non-cancer liver tumours, but this is rare. Very rarely, Acnocin 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 Acnocin.
Make sure Acnocin is OK for you

Acnocin should not be taken by some women
→ Tell your doctor or family planning nurse if you have any medical
problems or illnesses.

Do NOT take Acnocin if any apply to you. Taking Acnocin would put your
health at risk.
• If you are pregnant or might be pregnant
• If you are breast-feeding
• If you have cancer affected by sex hormones – such as some cancers of
the breast or womb lining or have ever had either of these conditions
• If you have vaginal bleeding that has not been explained by your doctor
• If you or your close family have ever had a problem with their blood
circulation. This includes a blood clot in the legs (deep vein thrombosis)
or the lungs (pulmonary embolism) or any other part of the body
• If you or your close family have ever had a heart attack or stroke.
• If you have any condition which makes you more at risk of a blood clot
(thrombosis – see under section 2 Acnocin and blood clots)
• If you have abnormal red blood cells (sickle-cell anaemia)
• If you have disorders of blood fat (lipid) metabolism
• If you have ever had a severe liver disease
• If you have certain types of jaundice (Dubin-Johnson or Rotor
syndromes)
• If you have ever had liver tumours
• If you have severe diabetes affecting your blood vessels
• If you have ever had a blister-like rash called herpes gestationis
• If you have had any of the following problems while pregnant:
• worsening of a hearing problem called otosclerosis
• persistent itching
• If you are allergic (hypersensitive) to any of the ingredients in Acnocin.

→ If you suffer from any of these, or get them for the first time while taking
Acnocin, contact your doctor as soon as possible. Do not take Acnocin.

Acnocin can make some illnesses worse
Some of the conditions listed below can be made worse by taking Acnocin.
Or they may mean it is less suitable for you. You may still be able to take
Acnocin 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,
circulation or blood clotting, such as high blood pressure or sickle cell
disease
• If you have varicose veins
• If you have had epilepsy or migraines
• If you have asthma
• If you are currently suffering from depression or have done so in the past
• If you are overweight (obese)
• If you have any gynaecological problems, such as fibroids
• If you have ever had inflamed veins (phlebitis)
• If you have an inherited form of deafness known as otosclerosis
• If you have the disease of the nervous system called multiple sclerosis
• If you have the inherited disease called porphyria
• If you have calcium deficiency with cramps (tetany)
• If you have the movement disorder called Sydenhamʼs chorea
• If you have ever had breast problems
• If you have diabetes
• If you have an intolerance to contact lenses
• If you have systemic lupus erythematosus
• If you have ever had kidney or liver problems, or have had gall stones
in the past
• If you have brown patches on your face or body (chloasma)
• If you have any disease that is prone to worsen during pregnancy
• If anyone in your family has had breast cancer.

→ Tell your doctor or family planning nurse if any apply to you. Also tell
them if you get any of these for the first time while taking Acnocin, 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
Acnocin, always tell your doctor, pharmacist or dentist that youʼre taking
Acnocin. Also check the leaflets that come with all your medicines to see if
they can be taken with hormonal contraceptives.

If you are taking Acnocin for skin treatment, you must not take any other oral
contraceptive at the same time.
Some medicines can stop Acnocin from working properly – for example:
• some medicines used to treat epilepsy
• griseofulvin (an anti-fungal medicine)
• phenylbutazone (an anti-inflammatory medicine)
• certain antibiotics
• certain sedatives (called barbiturates)
• St. Johnʼs Wort (a herbal remedy).

If you do need to take one of these medicines, Acnocin 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.

Acnocin can also affect how well other medicines work. For example, if
you have diabetes, you may need to take more insulin or other anti-diabetic
drugs while you take Acnocin. Your doctor will tell you if this is necessary.

Taking Acnocin with food and drink
There are no special instructions about food and drink while on Acnocin.

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Date prepared:
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Prepared by:
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RA Approved?
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Date approved:
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Approved by:
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Pregnancy and breast-feeding
Do not use Acnocin 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 Acnocin.
Driving and using machines
Acnocin has no known effect on the ability to drive or use machines.

Important information about some of the ingredients of Acnocin
Acnocin contains lactose and sucrose. If you have been told by your doctor
that you have intolerance to some sugars contact your doctor before taking
this medicine.

Acnocin 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 Acnocin. Their use
increases the chance of chloasma, a patchy discolouration of the skin (as it
does with ordinary oral contraceptives).

3

How to take Acnocin

If you are relying on this medicine to prevent pregnancy, always take
Acnocin as described here. Check with your doctor or family planning nurse
if you are not sure.
New users: see also ʻStarting Acnocinʼ below.

Take Acnocin every day for 21 days
Acnocin 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.
You donʼt need to use extra contraception during these seven pill-free days –
as long as you have taken your pills correctly and start the next strip of pills
on time.

Start your next strip on day eight
Start taking your next strip of Acnocin 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 Acnocin correctly, you will always start each new strip on
the same day of the week.
Starting Acnocin
New users or starting Acnocin after a break
It is best to take your first Acnocin 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 Acnocin from another contraceptive Pill
• If you are currently taking a 21-day Pill: start Acnocin 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
Acnocin
• If you are taking a 28-day Pill: start taking Acnocin 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 Acnocin
• If you are taking a progestogen-only Pill (POP or ʻmini Pillʼ): start
Acnocin 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 Acnocin 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 Acnocin 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 to start taking
Acnocin 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 Acnocin and for the first 7
days of pill taking.

Do not take Acnocin 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.
Donʼt 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
wonʼt have a bleed until after you finish the second strip of pills, but donʼt
worry. If you finish the second strip of pills and donʼt 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, family planning nurse 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 family planning clinic, or do a pregnancy test
yourself.

If you start a new strip of pills late, or make your ʻweek offʼ longer than seven
days, you may not be protected from pregnancy. If you had sex in the last
seven days, ask your doctor, family planning nurse 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 wonʼt 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 Acnocin, follow the instructions
under section 3 “A lost pill”, and take another pill.
If you are still sick or have diarrhoea more than 12 hours after taking
Acnocin, see under 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 family planning
clinic or doctors surgery. If you are pregnant, stop taking Acnocin and see
your doctor.

If you take more Acnocin than you should
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.

If you want to have a baby
If you are planning a baby, itʼs best to use another method of contraception
after stopping Acnocin 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, Acnocin can cause side effects, although not everybody
gets them.
→ Tell your doctor, pharmacist or family planning nurse if you are
worried about any side effects which you think may be due to Acnocin.

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

Signs of a blood clot:
• a migraine for the first time, a migraine that is worse than normal or
unusually frequent or severe headaches
• any sudden changes to your eyesight (such as loss of vision or blurred
vision)
• any sudden changes to your hearing, speech, sense of smell, taste or
touch
• pain or swelling in your leg
• stabbing pain when you breathe
• coughing for no apparent reason
• pain and tightness in the chest
• sudden weakness or numbness in one side or part of your body
• dizziness or fainting.
Signs of a severe allergic reaction to Acnocin:
• swelling of the face, lips, mouth, tongue or throat.
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 Acnocin.

Less serious side effects
• Bleeding and spotting between your periods can sometimes occur for
the first few months but this usually stops once your body has adjusted to
Acnocin. If it continues, becomes heavy or starts again, contact your
doctor
• headaches
• feeling sick, being sick and stomach upsets
• sore breasts
• depressive moods, loss of interest in sex
• putting on weight or losing weight
• chloasma (yellow brown patches on the skin). This may happen even if
you have been using Acnocin for a number of months. Chloasma may be
reduced by avoiding too much sunlight
• poor tolerance of contact lenses.
→ Tell your doctor, pharmacist or family planning nurse if you are
worried about any side effects which you think may be due to Acnocin.
Also tell them if any existing conditions get worse while you are taking
Acnocin.

Bleeding between periods should not last long
A few women have a little unexpected bleeding or spotting while they are
taking Acnocin, especially during the first few months. Normally, this bleeding
is nothing to worry about and will stop after a day or two. Keep taking
Acnocin 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 youʼve been taking Acnocin for a while
• carries on even after youʼve stopped taking Acnocin.

5

How to store Acnocin

Keep out of the reach and sight of children.
Do not use Acnocin after the expiry date which is stated on the carton. The
expiry date refers to the last day of that month.
Store in the original package.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Further information

What Acnocin 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, povidone, talc, magnesium
stearate (E572).

Tablet coating: sucrose, calcium carbonate, talc, titanium dioxide (E171),
povidone, macrogol, glycerol 85%, iron oxide yellow (E172), montan glycol
wax.
What Acnocin looks like and contents of the pack

Acnocin tablets are round, biconvex, yellow sugar-coated tablets.
The coated tablets are packed in plastic/aluminium blister each containing
coated tablets inserted into a carton. Each carton contains either 1, 3 or 6
blister strips. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Sandoz B.V.,
P.O. Box 10332, 1301 AH Almere,
The Netherlands.

This leaflet was last approved in 12/2011 (to be amended upon approval).

SZ00000LT000

Artwork Proof Box
A healthy decision

Ref: V009 - Update SPC & PIL to Brand

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

Proof no.
002.0

Date prepared:
16/12/2011

Prepared by:
TB

RA Approved?
Yes

Date approved:
16/12/2011

Approved by:
PR

T: 01276 698020
F: 01276 698324
W: www.uk.sandoz.com
E: sandoz.artwork@me.com

Colours:
Black
Black 20%

Fonts:
Helvetica

Dimensions: 180 x 470 mm

PROPOSED
MOCK UP

Artwork/RA Checklist:
Product name
Strength/dosage

Font size: 6.5pt
Pack size
PL number
Storage

Warnings
Excipients
Braille

Expand view ⇕

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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