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DIANETTE TABLETS

Active substance(s): CYPROTERONE ACETATE / ETHINYLESTRADIOL

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Dianette®
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.
R Keep this leaflet. You may need to read it again.
R If you have any questions or need more advice, ask your doctor or
pharmacist.
R This medicine has been prescribed for you. Do not pass it on to
others. It may harm them.
R 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 Dianette is and what it is used
for
2. What you need to know before you
take Dianette
2.1 Before you take Dianette
When should you contact your
doctor
Dianette and cancer
2.2 Make sure Dianette is OK for you
Dianette should not be taken by some
women
Dianette can make some illnesses
worse
Taking other medicines
Taking Dianette with food and drink

Pregnancy and breast-feeding
Driving and using machines
Dianette contains lactose
Dianette and sun-beds or sun-lamps

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

3. Taking Dianette
Duration of use
How to take it
Starting Dianette
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

5. How to store Dianette
6. What is in Dianette and who makes
it

1. WHAT DIANETTE IS AND WHAT IT IS USED FOR
Dianette contains an oestrogen and an anti-androgen.
Dianette 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 Dianette if your skin condition has not
improved after use of other anti-acne treatments, including topical
treatments and antibiotics.
If you are taking Dianette 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
Dianette, 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. Dianette stops
the androgens affecting your skin and reduces the amount of
androgens produced.

Contraception
Dianette is a 21-day Pill – you take one each day for 21 days,
followed by 7 days when you take no pills.
Dianette will not protect you against sexually transmitted
infections, such as Chlamydia or HIV. Only condoms can help to
do this.
Dianette needs to be taken as directed to prevent pregnancy.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIANETTE
2.1 Before you take Dianette
It’s important that you understand the benefits and risks of taking
Dianette before you start taking it, or when deciding whether to
carry on taking it. Although Dianette is suitable for most healthy
women it isn’t suitable for everyone.
MTell your doctor if you have any of the illnesses or risk factors
mentioned in this leaflet.
Before you start taking Dianette
R 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 Dianette
R You will need regular check-ups with your doctor, usually when
you need another prescription of Dianette.
R You should go for regular cervical smear tests.
R 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.
R If you need a blood test tell your doctor that you are taking
Dianette, because this type of medicine can affect the results of
some tests.
R If you’re going to have an operation, make sure your doctor
knows about it. You may need to stop taking Dianette 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 Dianette again.
R If you need to stop taking Dianette, remember to use another
contraceptive (e.g. condoms) if you are relying on Dianette 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.
Dianette 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 Dianette 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 Dianette compared with women
who do not take Dianette 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

When using a hormonal contraceptive like Dianette you are
strongly advised to stop smoking, especially if you are older
than 35 years;
R if one of your close relatives has had a blood clot in the leg, lung
or other organ at a young age;
R if you are overweight;
R 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;
R if you have polycystic ovary syndrome;
R if you have recently had a baby;
R if you have certain rare medical conditions such as systemic
lupus erythematosus, Crohn’s disease or ulcerative colitis;
R if you have sickle cell disease.
If this applies to you, it is important to tell your doctor that you are
using Dianette, as the treatment may have to be stopped. Your
doctor may tell you to stop using Dianette several weeks before
surgery or while you are less mobile. Your doctor will also tell you
when you can start using Dianette 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:
R with increasing age;
R if you smoke.
When using a hormonal contraceptive like Dianette you are
strongly advised to stop smoking, especially if you are older
than 35 years;
R if you are overweight;
R if you have high blood pressure;
R if a close relative has had a heart attack or stroke at a young age;
R if you have a high level of fat in your blood (cholesterol or
triglycerides);
R if you get migraines;
R if you have a problem with your heart (valve disorder, disturbance
of the rhythm);
R if you have polycystic ovary syndrome;
R if you have diabetes;
R if you have certain rare medical conditions such as systemic
lupus erythematosus;
R if you have sickle cell disease.

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 Dianette.
R Of 100,000 women who are not taking Dianette, not on the Pill
and not pregnant, about 5 to 10 will have a blood clot in a year.
R Of 100,000 women who take Dianette or the Pill, up to 40 will
have a blood clot in a year.
R 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:
R with increasing age;
R if you smoke.

2.2 Make sure Dianette is OK for you
Dianette should not be taken by some women
If you have the inherited disease called porphyria
MTell your doctor if you have any medical problems or
R

illnesses.
Do not take Dianette Tell your doctor if any of the following
conditions applies to you before starting to use Dianette. Your
doctor may then advise you to use a different treatment:
R If you are using another hormonal contraceptive
R If you are pregnant or might be pregnant
R If you are breast-feeding
R If you have or have ever had breast cancer
R If you have (or have ever had) a blood clot in your leg
(thrombosis), lung (pulmonary embolism) or other part of your
body.
R 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)
R If you have (or have ever had) a heart attack or stroke.
R If you have a condition that may increase the risk of a blood
clot in your arteries. This applies to the following conditions:
P diabetes affecting your blood vessels
P very high blood pressure
P a very high level of fat in your blood (cholesterol or
triglycerides)
R If you have problems with blood clotting (e.g. protein C
deficiency)
R If you have (or have ever had) a migraine, with visual
disturbances
R 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
R If you have ever had liver tumours
R If you are allergic (hypersensitive) to any of the ingredients in
Dianette.
MIf you suffer from any of these, or get them for the first time
while taking Dianette, contact your doctor as soon as
possible. Do not take Dianette. If needed, use another form of
contraception.

Dianette can make some illnesses worse
Some of the conditions listed below can be made worse by taking
Dianette. Or they may mean it is less suitable for you. You may
still be able to take Dianette but you need to take special care
and have check-ups more often.
R If you or your close family have ever had problems with your
heart or circulation, such as high blood pressure
R If you or your close family have ever had problems with blood
clotting
R If you have had migraines
R If you are currently suffering from depression or have done so
in the past
R If you are overweight (obese)

84830054_02.indd 1

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
R If you have brown patches on your face or body (chloasma) (see
below ‘Dianette and sun-beds or sun-lamps’)
R If you have any illness that worsened during pregnancy or
previous use of the Pill or Dianette (see section 4)
MTell your doctor if any apply to you. Also tell them if you get
any of these for the first time while taking Dianette, or if any get
worse or come back, because you may need to stop taking it.
R
R

Taking other medicines
If you ever need to take another medicine at the same time as
taking Dianette, always tell your doctor, pharmacist or dentist that
you’re taking Dianette. Also check the leaflets that come with all
your medicines to see if they can be taken with hormonal
contraceptives.

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

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).

Dianette 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
oestrogen-progestogen containing Pills like Dianette also provide
the same protective effects. However, it also seems that taking
Dianette slightly increases your risk of cancer of the cervix –
although this may be due to having sex without a condom, rather
than Dianette. All women should have regular smear tests.
If you have breast cancer, or have had it in the past, you should not
take Dianette or other oral contraceptives, as they slightly increase
your risk of breast cancer. This risk goes up the longer you’re on
Dianette, 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 Dianette users is
small. For example:
R Of 10,000 women who have never taken Dianette or the Pill,
about 16 will have breast cancer by the time they are 35 years
old.
R Of 10,000 women who take Dianette 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.
R Of 10,000 women who have never taken Dianette or the Pill,
about 100 will have breast cancer by the time they are 45 years
old.
R Of 10,000 women who take Dianette 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:
R if you have a close relative (mother, sister or grandmother) who
has had breast cancer
R if you are seriously overweight
MSee 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.
R Taking Dianette has also been linked to liver diseases, such as
jaundice and non-cancer liver tumours, but this is rare. Very
rarely, Dianette has also been linked with some forms of liver
cancer in women who have taken it for a long time.
MSee 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 Dianette.

If you are taking Dianette for skin treatment, you must not take any
other hormonal contraceptive at the same time.
Some medicines can have an influence on the blood levels of
Dianette and can stop it from working properly – for example:
R some medicines used to treat epilepsy
R some medicines used to treat HIV and Hepatitis C Virus
infections (so-called protease inhibitors and non-nucleoside
reverse transcriptase inhibitors)
R griseofulvin (an anti-fungal medicine)
R certain antibiotics (oral tetracyclines)
R certain sedatives (called barbiturates)
R St. John’s Wort (a herbal remedy).
If you do need to take one of these medicines, Dianette 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.
Dianette can also affect how well other medicines work. Your
doctor may need to adjust the dose of your other medicine.
In addition, Dianette can also interfere with the results of some
blood tests, so always tell your doctor that you are taking Dianette
if you have a blood test.

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

Pregnancy and breast-feeding
Do not use Dianette 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 Dianette.

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

Dianette contains lactose and sucrose
If you have been told by your doctor that you have intolerance to
some sugars, contact your doctor before using Dianette.

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

16.07.2015 08:55:04

Packaging Technology Berlin gbkop
page 1
Bayer Pharma AG
client: 0021
material-no.: 84830054
PZ: 2589A-3A
code-no.: 311
name: LF-INS-Dianette SCT 21
country: GB/-/BPH
colors: Black
version: 16.07.2015/02
approval:
dimension: 297 x 594 mm

Package leaflet: Information for the user

Duration of use
Your doctor will tell you how long you need to keep taking Dianette.

How to take it
Take Dianette every day for 21 days
Dianette comes in strips of 21 pills, each marked with a day of the
week.
R Take your pill at the same time every day.
R Start by taking a pill marked with the correct day of the week.
R Follow the direction of the arrows on the strip. Take one pill each
day, until you have finished all 21 pills.
R 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 Dianette 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
Dianette 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 Dianette correctly, you will always start each
new strip on the same day of the week.

Starting Dianette
New users or starting Dianette after a break
It is best to take your first Dianette 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 Dianette from another contraceptive Pill
R

If you are currently taking a 21-day Pill: start Dianette 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 Dianette.

R

R

If you are taking a 28-day Pill: start taking Dianette 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 Dianette.
If you are taking a progestogen-only Pill (POP or ‘mini Pill’):
start Dianette 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 Dianette 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
Dianette 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
Dianette 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 Dianette and for the first 7 days of pill taking.
Do not take Dianette 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.
R 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.
R Continue to take a pill every day for the next seven days at
your usual time.
R 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.
R Use extra contraception for seven days after missing a pill,
such as condoms.
R 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 Dianette, 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 Dianette, see section 3.3, A missed pill.
MTalk 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 Dianette 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 Dianette 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, Dianette can cause side effects, although not
everybody gets them.
MTell your doctor or pharmacist if you are worried about any
side effects which you think may be due to Dianette.

4.1 Serious side effects – see a doctor
straight away
Severe depression:
Although, it is not considered a direct side effect of Dianette, some
women have reported feeling depressed whilst taking Dianette. In
very rare cases this has been associated with thoughts of ending
their lives. If you develop severe depression, you should stop
Dianette as a precaution, 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;
R any unusual, severe, or long-lasting headache or worsening of
migraine;
R partial or complete loss of vision, or double vision;
R slurring or speech disability;
R sudden changes to your hearing, sense of smell, or taste;
R dizziness or fainting;
R weakness or numbness in any part of your body;
R severe pain in your abdomen;
R severe pain or swelling in either of your legs.
Signs of a severe allergic reaction or worsening of hereditary
angioedema:
R swelling of the hands, face, lips, mouth, tongue or throat. A
swollen tongue/throat may lead to difficulty swallowing and
breathing
R a red bumpy rash (hives) and itching.
Signs of breast cancer include:
R dimpling of the skin
R changes in the nipple
R any lumps you can see or feel.
Signs of cancer of the cervix include:
R vaginal discharge that smells and/or contains blood
R unusual vaginal bleeding
R pelvic pain
R painful sex.
R
R
R

Signs of severe liver problems include:
R severe pain in your stomach
R yellow skin or eyes (jaundice)
R inflammation of the liver (hepatitis)
R your whole body starts itching.
MIf you think you may have any of these, see a doctor straight
away. You may need to stop taking Dianette.

4.2 Less serious side effects
Common side effects (between 100 and 1000 in every 10,000 users
may be affected)
feeling sick
R stomach ache
R putting on weight
R headaches
R depressive moods or mood swings
R sore or painful breasts
Uncommon side effects (between 10 and 100 in every 10,000 users
may be affected)
R being sick and stomach upsets
R fluid retention
R migraine
R loss of interest in sex
R breast enlargement
R skin rash, which may be itchy
Rare side effects (between 1 and 10 in every 10,000 users may be
affected)
R poor tolerance of contact lenses
R losing weight
R increase of interest in sex
R vaginal or breast discharge
R venous blood clot
Other side effects reported
R bleeding and spotting between your periods can sometimes
occur for the first few months but this usually stops once your
body has adjusted to Dianette. If it continues, becomes heavy or
starts again, contact your doctor
R chloasma (yellow brown patches on the skin). This may happen
even if you have been using Dianette for a number of months.
Chloasma may be reduced by avoiding too much sunlight and/or
UV lamps
R occurence or deterioration of the movement disorder chorea
R Crohn’s disease or ulcerative colitis
R

increase in blood pressure
conditions that may worsen during pregnancy or previous use
of the Pill:
P yellowing of the skin (jaundice)
P persistent itching (pruritus)
P kidney or liver problems
P gall stones
P certain rare medical conditions such as systemic lupus
erythematosus
P blister-like rash (herpes gestationis) whilst pregnant
P an inherited form of deafness (otosclerosis)
P a personal or family history or a form of sickle cell disease
P swelling of body parts (hereditary angioedema)
P an inherited disease called porphyria
P cancer of the cervix
MTell your doctor or pharmacist if you are worried about any
side effects which you think may be due to Dianette. Also tell
them if any existing conditions get worse while you are taking
Dianette.

R
R

4.3 Bleeding between periods should not
last long
A few women have a little unexpected bleeding or spotting while
they are taking Dianette, especially during the first few months.
Normally, this bleeding is nothing to worry about and will stop after
a day or two. Keep taking Dianette 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.
MMake an appointment to see your doctor if you get
breakthrough bleeding or spotting that:
R carries on for more than the first few months
R starts after you’ve been taking Dianette for a while
R carries on even after you’ve stopped taking Dianette.
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 DIANETTE
Keep all medicines out of the reach and sight of children.
Do not store above 25°C.
Do not use Dianette 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 DIANETTE AND WHO MAKES IT
What is in Dianette
Each box of Dianette contains three strips of 21 beige tablets.
Each tablet contains: 2 milligrams of the anti-androgen,
cyproterone acetate, and 35 micrograms of the oestrogen,
ethinylestradiol.
Dianette also contains the inactive ingredients:
lactose, maize starch, povidone, talc, magnesium stearate (E572),
sucrose, polyethylene glycol 6000, calcium carbonate (E170),
titanium dioxide (E171), glycerol (E422), montan glycol wax, yellow
ferric oxide pigment (E172).
The company that holds the product licence for Dianette is:
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire,
RG14 1JA

Dianette is made by:
Bayer Pharma AG, Berlin, Germany
or
Bayer Weimar GmbH & Co KG, Weimar, Germany
or
Delpharm Lille SAS, Lys-Lez-Lannoy, France
Dianette is a registered trademark of Bayer Pharma AG.
This leaflet was last updated in June 2015.

84830054

Dianette®
84830054

84830054_02.indd 2

16.07.2015 08:55:45

Packaging Technology Berlin gbkop
page 2
Bayer Pharma AG
client: 0021
material-no.: 84830054
PZ: 2589A-3A
code-no.: 311
name: LF-INS-Dianette SCT 21
country: GB/-/BPH
colors: Black
version: 16.07.2015/02
approval:
dimension: 297 x 594 mm

3. TAKING DIANETTE
Your doctor has chosen Dianette as a treatment for your acne or
excessive hair growth on your face and body. However, Dianette also
has a contraceptive effect, so it is important to follow the advice
below if you are relying on Dianette for contraception.
If you are only using Dianette for your acne or excessive hair growth,
you can still follow this advice, but ask your doctor if you are
unsure.

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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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