Dianette Tablets - Three Months Supply 63 UK

Dianette tablets are a combined oral contraceptive pill containing ethinylestradiol 35mcg and cyproterone 2mg (co-cyprindiol 2mg/35mcg). Dianette tablets are prescribed for the treatment of acne in women.

Dianette Patient Information Leaflet.
Package leaflet: Information for the user Dianette® 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.
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
Dianette and blood clots
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
3. Taking Dianette
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
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 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 - severe acne that has not improved after the long term use of oral antibiotics and excessive hair growth.
Dianette also works as an oral contraceptive. However, do not use Dianette 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 (‘the Pill').
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.
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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.
→ Tell your doctor if you have any of the illnesses or risk factors mentioned in this
leaflet.
Before you start taking Dianette
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
You will need regular check-ups with your doctor, usually when you need
another prescription of Dianette.
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 Dianette, 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 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.
(v20_0) 4 If you need to stop taking Dianette, remember to use another contraceptive (e.g.
condoms) if you are relying on Dianette for contraception.
Dianette and blood clots
Taking Dianette 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 Dianette.
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.
Of 100,000 women who take Dianette 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:
If you have polycystic ovary syndrome
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 have a disorder of blood fat (lipid) metabolism, or some other very rare
blood disorders
if you get migraines
if you have a heart valve disorder or a particular type of irregular heartbeat
(atrial fibrillation)
if you have recently had a baby
if you have high blood pressure
if you have diabetes
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 you're 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 Dianette may add to this risk
so may not be suitable for you.
Signs of a blood clot include:
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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 Dianette until your doctor
says you can. If needed, use another method of contraception, such as condoms, in the
meantime.
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:
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.
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.
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.
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:
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.
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Taking Dianette has also been linked to liver diseases, such as jaundice and noncancer
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.
→ 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 Dianette.
2.2 Make sure Dianette is OK for you
Dianette should not be taken by some women
→ Tell your doctor if you have any medical problems or illnesses.
Do not take Dianette if any of the following apply to you. Taking Dianette would put
your health at risk.
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 ever had a problem with your 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 section 2.1, Dianette and blood clots)
 If you have any symptoms of a blood clot, such as chest pain (angina pectoris)
or ‘mini-stroke' (transient ischaemic attack)
 If you have very high or uncontrolled blood pressure
 If you have ever suffered from 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 have severe diabetes affecting your blood vessels
 If you are allergic (hypersensitive) to any of the ingredients in Dianette.
→ If 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.
 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)
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 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
˜Dianette and sun-beds or sun-lamps')
 If you have any illness that worsened during pregnancy or previous use of the
Pill or Dianette (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 Dianette, 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 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.
If you are taking Dianette for skin treatment, you must not take any other hormonal
contraceptive at the same time.
Some medicines can stop Dianette 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, 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.
(v20_0) 8
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).
3. TAKING Dianette
Your doctor has chosen Dianette as a treatment for your severe 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.
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.
 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 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
 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.
 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
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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 pillfree
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.

→ 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 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.
→ Tell 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, you should stop Dianette 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
(v20_0) 12
 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 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 Dianette.
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
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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
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 Dianette. 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 Dianette 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 Dianette. Also tell them if any existing conditions get worse while
you are taking Dianette.
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.
→ 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 Dianette for a while
carries on even after you've stopped taking Dianette.
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 March 2012.

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom
Telephone: +44 (0)1635 563 000
Facsimile: +44 (0)1635 563 393
Company Web Site: http://www.bayer.co.uk
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.

 

 

1 pack

www.medicines.org.uk/emc/files/pil.1122.pdf

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