MILLINETTE 30/75 MICROGRAM COATED TABLETS

Active substance: GESTODENE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MILLINETTE® 30/75
microgram coated tablets
ethinylestradiol / gestodene

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 further questions, ask your doctor.
• 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Millinette is and what it is used for
2. Before you take Millinette
3. How to take Millinette
4. Possible side effects
5. How to store Millinette
6. Further information
1. WHAT MILLINETTE IS AND WHAT IT IS
USED FOR
Millinette is a combined oral contraceptive,
one of a group of drugs often referred to as
the Pill. It contains two types of hormone:
an oestrogen, ethinylestradiol, and a
progestogen, gestodene. These hormones
stop the ovary from releasing an egg each
month (ovulation). They also thicken the
fluid (mucus) at the neck of the womb
(cervix) making it more difficult for the
sperm to reach the egg, and alter the lining
of the womb to make it less likely to accept
a fertilised egg.
Medical research and vast experience have
shown that, if taken correctly, the Pill is an
effective reversible form of contraception.
Remember, combined oral contraceptive
pills like Millinette will not protect you
against sexually-transmitted diseases (such
as AIDS). Only condoms can help to do this.
How your body gets ready for pregnancy
(the menstrual cycle).
You can usually become pregnant
(conceive) from the time you start to
have periods (usually in your teens), until
your periods stop (the menopause). Every
menstrual cycle takes about 28 days.
About halfway through this cycle, an egg
is released from one of your ovaries into a
Fallopian tube. This is called ovulation.
The egg travels down the Fallopian tube
towards your womb. When you have sex,
your partner’s penis releases millions of
sperm into your vagina. Some of these
sperm travel up through your womb into
your Fallopian tubes. If there is an egg in
one of these tubes and a sperm reaches it,
you can become pregnant. This is called
‘conception’.
A fertilised egg settles in the lining of your
womb and takes nine months to grow into
a baby. As an egg can live for up to two
days, and sperm for up to five days, you can
become pregnant if you have had sex up
to five days before ovulation and for some
time afterwards. If a sperm does not fertilise
an egg, you will lose the egg at the end of
your menstrual cycle along with the lining
of your womb. This is called a ‘period’.
How do natural hormones work?
Your menstrual cycle is controlled by
two sex hormones made by your ovaries:
oestrogen and progesterone (which is a
progestogen). Your oestrogen levels increase
during the first half of your menstrual cycle,
and make your womb develop a thick
lining, ready to receive the egg if conception
happens. Progesterone comes later in your
menstrual cycle and changes the lining of
the womb to prepare it for pregnancy.
If you don’t become pregnant, you will
then make less of these hormones and this
causes the lining of your womb to break
down. As mentioned above, this womb
lining leaves your body as a period. If you
do become pregnant, your ovaries and
placenta (this attaches the growing baby
to the womb and gives it food) carry on
making progesterone and oestrogen to stop
any more eggs being released. This means
that while you are pregnant you will not
ovulate or have periods.
How does the pill work?
A combined contraceptive pill such as
Millinette contains hormones which are like
those that your body produces (oestrogen
and progestogen). These hormones help
to stop you from getting pregnant, just as
your natural hormones would stop you
conceiving again when you are already
pregnant.
The combined contraceptive pill protects
you against getting pregnant in three ways.
1. You won’t release an egg to be fertilised
by sperm.
2. The fluid in the neck of your womb
thickens so it is more difficult for sperm
to enter it.
3. The lining of your womb does not
thicken enough for an egg to grow in it.
2. BEFORE YOU TAKE MILLINETTE
Do not take Millinette:
You should not use Millinette if you have
any of the conditions listed below. If you
do have any of the conditions listed below,
you must tell your doctor. Your doctor may
then decide that Millinette is not suitable
for you and advise you to use another
method of contraception.
Tell your doctor if:
• you have ever had a disorder affecting
your blood circulation known as
thrombosis (for example, blood clots in
your legs, lungs, heart, brain, eyes or in
any other part of your body);
• you have ever had a heart attack or
angina (severe chest pain) or a stroke
(such as sudden weakness or tingling in
one side of your body);
• you or any member of your close family
have any medical condition which makes
you more at risk of developing blood
clots (see also the section ‘The pill and
thrombosis’);
• you have diabetes with changes to the
blood vessels;
• you have or have ever had an eye
disorder due to circulatory disease;
• you have high blood pressure
(hypertension);
• you have liver disease or if you have ever
had this;
• you have liver tumours or if you have
ever had these;
• you have breast cancer or other cancer,
for example ovarian cancer, cervical
cancer, or cancer of the uterus (womb);
• you have unusual bleeding from your
vagina;
• you have or have ever had migraine;
• you are allergic (hypersensitive) to
gestodene, ethinylestradiol or any of
the other ingredients of Millinette;
• you are pregnant or think you might be.
If you get any of these conditions while you

are taking Millinette, do not take any more
pills and contact your doctor immediately.
In the meantime, use another method of
contraception such as a condom or cap
plus spermicide.
Take special care with Millinette:
Regular check-ups
Before you start taking Millinette, your
doctor should take your medical history by
asking you some questions about yourself
and other members of your family. Your
doctor will take your blood pressure and
make sure you are not pregnant. Your
doctor may also examine you. Once you
have started taking Millinette, your doctor
will see you again for regular check-ups.
This will happen when you go back to your
doctor for more pills.
Tell your doctor immediately if...
you have any of the following conditions
while you are taking Millinette. Also, do not
take any more pills until you have spoken to
your doctor. In the meantime, use another
method of contraception such as a condom
or cap plus spermicide.
• If you get a migraine for the first time, or
if you already have migraines but they get
worse or happen more often than before.
• Symptoms of a blood-clot formation.
(See also the section - ‘The pill and
thrombosis.’) These symptoms include:
• unusual pain or swelling in your legs;
• sudden sharp pains in your chest
which may reach your left arm;
• sudden shortness of breath or
difficulty in breathing;
• sudden coughing for no apparent
reason;
• any unusual, severe or long-lasting
headache;
• any sudden changes to your eyesight
(such as loss of vision or blurred
vision);
• slurred speech or any other difficulties
affecting your speech;
• vertigo (spinning sensation);
• dizziness, fainting or fits;
• sudden weakness or numbness in one
side or part of your body;
• difficulties in moving around (known as
motor disturbances); or
• severe pain in your abdomen (known
as acute abdomen).
• Surgery or immobilisation (not being
able to move around as normal). You
must stop taking Millinette at least four
weeks before a planned major operation
(for example, stomach surgery), or if you
are having any surgery to your legs. Also,
if you are immobilised for a long time
(for example, you are in bed after an
accident or operation, or you have a
plaster cast on a broken leg). The pill
should not be resumed until 2 weeks
after complete remobilisation. Your
doctor will tell you when you can start
taking Millinette again.
• If you think you may be pregnant.
Tell your doctor before starting to take
Millinette if...
you know you suffer from any of the
following conditions. You need to tell your
doctor if this is the case as these conditions
may get worse while you are taking the pill.
If any of these conditions do get worse or
you have them for the first time, tell your
doctor as soon as you can. Your doctor
may tell you to stop using Millinette and
advise you to use another method of
contraception.
• If you, or any member of your family,
have a blood-fat (lipid) disorder called
hypertriglyceridaemia, as this disorder
can increase your risk of getting a disease
of your pancreas, called pancreatitis.
• If you suffer from:
• high blood pressure (hypertension);
• yellowing of the skin (jaundice);
• itching of your whole body (pruritus);
• gallstones;
• the inherited disease called porphyria;
• systemic lupus erythematosus - SLE
(an inflammatory disease which can
affect many parts of the body,
including the skin, joints and internal
organs);
• a blood disorder called haemolytic
uraemic syndrome - HUS (a disorder
where blood clots cause the kidneys
to fail);
• the movement disorder called
Sydenham’s chorea;
• the rash known as herpes gestationis;
• the inherited form of deafness known
as otosclerosis;
• disturbed liver function;
• diabetes;
• depression;
• Crohn’s disease or ulcerative colitis
(chronic inflammatory bowel diseases);
• brown patches on your face and body
(chloasma), which you can reduce
by staying out of the sun and not
using sunbeds or sunlamps.
The pill and thrombosis
Some studies have suggested that the risk
of developing various blood-circulation
disorders is slightly greater in women who
take the combined pill than in those who
do not. This can lead to a thrombosis. A
thrombosis is when you have a blood clot
which may block a blood vessel. The clot
may form in the veins (venous thrombosis)
or in the arteries (arterial thrombosis).
Most blood clots can be treated, with no
long-term danger. However, a thrombosis
can cause serious permanent disabilities or
could even kill you, though this is very rare.
Blood clots sometimes form in the deep
veins of the legs (deep venous thrombosis).
If this blood clot breaks away from the
veins where it is formed, it may reach and
block the arteries of the lungs, causing a
‘pulmonary embolism’.
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 extremely rare cases, blood clots can
form in other places such as the liver, gut,
kidney or eye.
A blood clot can develop whether or not
you are taking the pill. It can also happen
if you become pregnant. The risk is higher
in people who take the pill than in people
who don’t take the pill, but it isn’t as high

as the risk during pregnancy. A thrombosis
is most likely in the first year of taking any
combined pill.
· For Millinette there are about 30 to
40 cases of thrombosis for every 100,000
women each year.
· In pregnant women, there are about
60 cases of thrombosis for every 100,000
pregnancies each year.
Symptoms of a blood-clot formation are
listed under ‘Tell your doctor immediately if’.
If you notice possible signs of a thrombosis,
stop taking the pill and contact your doctor
immediately. In the meantime, use another
method of contraception such as a condom
or cap plus spermicide.
You should also remember that certain
conditions can increase your risk of
thrombosis. They include:
• age (the risk of having a heart attack or
stroke increases as you get older);
• smoking (with heavier smoking and
increasing age, your risk of thrombosis
increases). When using the pill stop
smoking, especially if you are over 35;
• if any member of your close family has
ever had any illness caused by blood
clots, or a heart attack, or a stroke;
• being very overweight (obese);
• having a disorder of blood-fat (lipid)
metabolism, or other very rare blood
disorders;
• having high blood pressure (hypertension);
• having a heart-valve disorder or a certain
heart-rhythm disorder;
• having given birth recently (you will have
an increased risk of thrombosis after
giving birth);
• having diabetes mellitus;
• having systemic lupus erythematosus SLE (an inflammatory disease which can
affect many parts of the body, including
the skin, joints and internal organs);
• having a blood disorder called
haemolytic uraemic syndrome - HUS
(a disorder where blood clots cause the
kidneys to fail);
• having Crohn’s disease or ulcerative colitis
(chronic inflammatory bowel diseases);
• having sickle cell disease;
• getting a migraine for the first time, or if
you already have migraines but they get
worse or happen more often than before;
• having a major operation, any surgery to
your legs or not being able to move
around as normal.
Your risk of having a deep venous thrombosis
temporarily increases after an operation or
any time when you can’t move around as
normal (for example, when you have your
leg or legs in plaster or splints). If you are on
the pill, this risk could be higher. Tell your
doctor you are using the pill well before
you expect to go into hospital or have an
operation. Your doctor may tell you to stop
taking the pill several weeks before or after
an operation. If there is no time for this,
your doctor may give you a medicine to
reduce your risk of thrombosis. Your doctor
will also tell you when you can start taking
the pill again, once you are back on your feet.
The pill and cancer
Some studies have found that you may have
an increased risk of cervical cancer if you
use the pill in the long term. This increased
risk may not be caused by the pill, because
it could be due to the effects of sexual
behaviour and other circumstances.
Every woman is at risk of breast cancer
whether or not she takes the pill. Breast
cancer is rare in women under 40. Breast
cancer has been found slightly more often
in women who take the pill than in women
of the same age who don’t take the pill. If
you stop taking the pill, this reduces your
risk, so that 10 years after stopping the pill
the risk of finding breast cancer is the same
as for women who have never taken the pill.
Since breast cancer is a rare condition in
women below 40 years of age, the increase
in number of diagnosed cases of breast
cancer in current and previous users of the
pill is small compared to the risk of breast
cancer during their entire life time.
For example:
• Of 10,000 women who have never taken
the Pill, about 16 will have breast cancer
by the time they are 35 years old.
• Of 10,000 women who take 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
the Pill, about 100 will have breast cancer
by the time they are 45 years old.
• Of 10,000 women who take 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
• 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.
Rarely, using the pill has led to liver diseases
such as jaundice and benign liver tumours.
Very rarely, the pill has been associated
with some forms of malignant liver
tumours (cancer) in long-term users.
Liver tumours may lead to life-threatening
intra-abdominal haemorrhage (bleeding
in the abdomen). So, if you have pain in
your upper abdomen that does not get
better, tell your doctor. Also, if your skin
becomes yellow (jaundiced), you must
tell your doctor.
Taking other medicines
Please tell your doctor or pharmacist if
you are taking and have recently taken
any other medicines, including medicines
obtained without a prescription.
Some medicines may stop Millinette from
working properly.
If you are taking any other medicine
while you are taking Millinette, be sure to
tell your doctor (or dentist, if they have
prescribed antibiotics). Your doctor (or
dentist) can tell you whether you should
use extra contraceptive precautions and
for how long.

Medicines which can sometimes stop
Millinette from working properly are:
• antibiotics (such as ampicillin,
tetracycline and rifampicin);
• medicines used to treat epilepsy or
other illnesses of nervous system, such
as primidone, carbamazepine,
oxcarbazepine, topiramate, hydantoins
or barbiturates (such as phenobarbitone);
• ritonavir (a medicine used to treat HIV
infections);
• griseofulvin (a medicine used to treat
fungal infections);
• the herbal remedy commonly known as
St John’s Wort (hypericum perforatum).
You may have to use another method of
contraception as well, such as the condom,
while you are taking these medicines - and
for a further seven days afterwards. Your
doctor may advise you to use these extra
precautions for even longer.
If you are taking antibiotics, always ask your
doctor’s advice about extra precautions.
Always mention you are on the combined
pill if you are prescribed any medicines.
The herbal remedy St John’s Wort
(Hypericum perforatum) may prevent oral
contraceptives from working properly and
should not be taken at the same time as
this medicine. If you are already taking a
St John’s Wort preparation, stop taking
St John’s Wort and tell your doctor at
your next visit.
Millinette may influence the effect of
other medicines, such as cyclosporine,
lamotrigine, therefore in such case you
should consult your doctor.
Pregnancy and breast-feeding
Pregnancy
If you think you might be pregnant, stop
taking Millinette and talk to your doctor
immediately. Until you have spoken to
your doctor, use another method of
contraception such as a condom or a
cap plus spermicide. Ask your doctor
or pharmacist for advice before taking
any medicine.
Breast-feeding
Ask your doctor or pharmacist for advice
before taking Millinette. Millinette should
not be taken during breast-feeding.
Driving and using machines
Millinette has no or only minor influence
on the ability to drive and use machines.
Important information about some of the
ingredients of Millinette
If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product. Millinette contains
sucrose.
Before you have any blood tests
Tell your doctor or the laboratory staff
that you are taking the pill, because oral
contraceptives can affect the results of
some tests.
3. HOW TO TAKE MILLINETTE
Always take Millinette exactly as your
doctor has told you. You should check
with your doctor if you are not sure.
This pack is designed to help you remember
to take your pills.
Starting the first pack
Take the first pill on the first day of your
period. This is day one of your cycle - the
day when bleeding starts.
If you start on day 2-5 of your period,
you should use another method of
contraception as well, such as the condom,
for the first seven pill-taking days, but this
is only for the first pack.
You can take your pill at any time, but you
should take it about the same time each
day. You may find it easiest to take it either
last thing at night or first thing in the
morning. Take a pill every day in the order
shown until you finish all 21 pills in the pack.
Once you have taken all 21 pills, stop for
seven days. You will probably bleed during
some of these seven days.
You do not need to use any other form of
contraception during the seven-day break
provided you have taken the 21 pills properly
and you start the next pack on time.
The next pack
After seven pill-free days, start your next
pack. Do this whether or not you are still
bleeding. You will always start a new pack
on the same day of the week.
Changing to Millinette from another
combined hormonal contraceptive
You should start with Millinette on the day
after you take the last pill of your present
strip (or the day after the last active pill, if
your present pill strip also contains dummy
pills), but no later than on the day after
the usual tablet-free or dummy pill interval
with your previous pill.
Changing to Millinette from progestogenonly preparations (progestogen-only pills,
injection, implant)
You may change from progestogen-only
pills (POPs) on any day. Stop taking the POP
and start taking Millinette the next day at
the same time point. When changing from
injections, Millinette should be started
when the next injection is due to be given.
When changing from an implant, Millinette
should be started on the day the implant is
removed. In all these cases you should also
use a barrier method for the first 7 days of
taking the pills.
Starting after childbirth or miscarriage
or abortion
After a birth, abortion or miscarriage,
your doctor should advise you about
taking the pill.
You can start using Millinette immediately
after a miscarriage or abortion which
occurs during the first three months of
pregnancy. In this case it is not necessary
to take further contraceptive measures.
If you have had a delivery or abortion which
occurs during the second three months of
pregnancy, you can start taking Millinette
21-28 days after giving birth or having an
abortion. If you are breast-feeding, the
combined pill is not recommended because
it can reduce your flow of milk. Alternative
contraception (such as the condom) must
be used for the first 7 days of pill-taking. If
you have had unprotected sex you should
not start Millinette until your period starts
or you are sure you are not pregnant. If you
have any questions about starting Millinette
after childbirth or abortion, ask your doctor
or pharmacist.
If you take more Millinette than you should
If you take more Millinette than you should,
it is not likely that it will do you any harm,
but you may feel sick, actually be sick or
have some vaginal bleeding. If you have any
of these symptoms, you should talk to your

doctor who can tell you what, if anything,
you need to do.
If you forget to take Millinette
If you forget to take a pill please follow
these instructions.
If one pill is 12 hours late or less
Your contraceptive protection should not
be affected if you take the late pill at once,
and keep taking your next pills at the usual
time. This may mean taking two pills in
one day.
If you are more than 12 hours late in taking
a pill, or have missed more than one pill
If you are more than 12 hours late in taking
a pill, or you have missed more than one
pill, your contraceptive protection may be
lower so you must use extra protection.
The more pills you have missed, the
more risk there is that your contraceptive
protection is reduced. In this case follow
the instructions for daily practice:
What to do if you miss the pill during the
first week?
You must take the last missed tablet as
soon as you remember, even if this means
that you have to take 2 tablets at the same
time. Thereafter, you should continue
taking the tablets at the usual time of the
day. You must also use a barrier method
of contraception, e.g. a condom, for the
next 7 days. If intercourse has taken place
during the preceding 7 days the possibility
of pregnancy must be considered. The more
missed tablets and the closer to the tabletfree interval this happens, the greater the
risk of pregnancy.
What to do if you miss the pill during the
second week?
You must take the last missed tablet as
soon as you remember even if this means
that you have to take 2 tablets at the same
time. Thereafter, you should continue
taking the tablets at the usual time of the
day. Provided that the tablets have been
taken in a correct manner during the 7
days preceding the missed tablet, it is not
necessary to take further contraceptive
measures. However, if this is not the case, or
if more than 1 tablet has been missed, you
should use another contraceptive method
for 7 days.
What to do if you miss the pill during the
third week?
The risk of contraceptive failure is higher
because of the approaching tablet-free
interval. Reduced contraceptive protection
may, however, be prevented by following
one of the following two alternatives. It is
not necessary to take further contraceptive
precautions, provided that all tablets have
been taken correctly during the 7 days
preceding the first missed tablet.
However, if you have not taken Millinette
correctly during the 7 days preceding the
first missed tablet, you should follow the
first of the two alternatives and additionally
use a barrier method (such as a condom)
for the next 7 days.
1. Take the last missed tablet as soon as you
remember, even if it means that you have
to take 2 tablets at the same time. You
should continue taking the tablets at
the usual time of the day. Start your next
pack immediately after taking the last
tablet in the current pack, i.e. without a
tablet-free interval between the packs.
Withdrawal bleeding is unlikely until the
end of the second pack, but there may be
some spotting, or breakthrough bleeding,
on the days you are taking tablets.
2. Stop taking tablets from the current
pack. You should then have 7 pill-free
days, including those when you forgot
to take you tablets, before starting your
next pack.
If you have missed tablets and then do
not get a withdrawal bleeding in the first
normal tablet-free interval, the possibility
of pregnancy must be considered.
If you have missed taking one (or more)
pills, and have had unprotected sexual
intercourse; you may be pregnant. Ask your
doctor or pharmacist about emergency
contraception.
If you stop taking Millinette
If you stop taking Millinette, you can
become pregnant. You should discuss other
methods of contraception with your doctor
to avoid pregnancy.
What to do if you have a stomach upset?
If you have been sick or had diarrhoea
within 3-4 hours after taking the pill, the
active substances in the pill may not be
fully absorbed into your body. In this
case the advice concerning missed pills,
described above should be followed. In
case of vomiting or diarrhoea, use extra
contraceptive precautions, such as a
condom, for any intercourse during the
stomach upset and for the next seven days.
What to do if you want to delay or to shift
your period?
If you want to delay or to shift your period,
you should contact your doctor for advice.
If you want to delay your period, you
should continue the next pack of Millinette
after taking the last tablet in the current
pack, without a pill-free interval. You can
take as many pills from this next pack
as you want, until the end of the second
blister pack. When you use the second
pack, you may have breakthrough bleeding
or spotting. Regular intake of Millinette is
resumed after the usual 7 days tablet-free
interval.
If you want to shift your period to another
day of the week
If you take Millinette correctly, you will
always have your monthly period on the
same day of the month. If you want to shift
your period to another day of the week,
rather than the one you are used to with
the present pill intake, you may shorten
(but never lengthen) the forthcoming
pill-free interval by as many days as you like.
For example, if your monthly period usually
starts on Friday and you want it to start on
Tuesday (i.e. three days earlier), you should
start the next pack of Millinette three days
earlier. The shorter the pill-free interval, the
greater the possibility that you will not have
a withdrawal bleeding, and that you may
have breakthrough bleeding or spotting
during the second pack.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Millinette can cause side
effects, although not everybody gets them.
The following serious adverse events have
been reported in women using combined
oral contraceptives, see section 2 under “The
pill and thrombosis” and “The pill and cancer”.
• Venous thromboembolism (a blood clot
in vessels);

• Arterial thrombotic disorders
(obstruction of an artery);
• Cervical cancer (cancer of the neck of
the womb).
Reasons for stopping Millinette immediately
If you experience any of the following
conditions whilst taking Millinette, take no
further tablets and tell your doctor straight
away. In the meantime use another nonhormonal method of contraception such
as a condom.
• Migraine for the first time, or if existing
migraine occurs more often or worse
than before;
• Unusually bad headache or if you have
headaches more often than before;
• Sudden changes to your eyesight or
difficulties in seeing or speaking;
• Unusual pains or swelling in your leg,
sharp pains in your chest or sudden
shortness of breath, crushing pains or
feelings of heaviness in your chest,
persistent coughing or coughing blood;
• Numbness in an arm or leg;
• Your skin becomes yellow (jaundice);
• A large increase in your blood pressure;
• The levels of lipids (fats) in your blood
change;
• Pregnancy;
• Definite worsening of conditions
which had got worse during a previous
pregnancy or while taking the pill in
the past;
• Severe abdominal pain.
These side effects have been reported in
women using the pill, which can occur
in the first few months after starting
Millinette, but they usually stop once
your body has adjusted to the pill.
The most commonly reported undesirable
effects (more than 1 in 10 women) are:
irregular bleeding; nausea; weight gain;
tender breast; headache.
Common (equal or more than 1 in 100
women, but less than 10 in 100):
Mood changes, including depression
and irritability; acne; none, reduced or
painful bleeding; breast enlargement and
secretion; changes in vaginal secretions;
abdominal pain; fluid retention; changes
in sexual desire (increased or decreased);
nervousness; eye irritation; dizziness; visual
disturbances; migraine; increase or decrease
in body weight.
Uncommon (equal or more than 1 in 1,000
women, but less than 1 in 100) and rare
(equal or more than 1 in 10,000 women,
but less than 1 in 1,000):
Allergic reactions; vomiting; brown
patches on your face and body (chloasma
or melasma); loss of hair; excessive hair
growth; rash; rash with tender red lumps
on the leg and arms (erythema nodosum);
high blood pressure; breast cancer; cervical
cancer; blood clot; enhanced levels of
blood fat; decrease in blood folate level;
impaired hearing (otosclerosis); abdominal
cramps or bloating; abnormal vaginal
smears; inflammation of the pancreas; liver
tumours; chorea (a movement disease);
systemic lupus erythematosus (SLE, a
disease of the connective tissue); changes in
appetite (increase or decrease); irritation of
the eye due to contact lenses.
Very rare (less than 1 in 10,000 women):
Worsening of systemic lupus erythematosus
(SLE, a disease of the connective tissue);
worsening of an inherited disease called
porphyria; worsening of chorea (a
movement disease); urticaria; angioedema;
inflammation of the optic nerve (may
lead to partial or complete loss of vision);
blood clot in the blood-vessels of the eye;
aggravation of varicose veins; inflammation
of the walls of the bowel (ischemic colitis);
gallbladder disease (including gallstones);
fever; rash of the face, arms and legs
(erythema multiforme); a blood disorder
called haemolytic uraemic syndrome (a
disorder where blood clots cause the
kidneys to fail).
Unknown frequency: Liver disorders.
If you notice any side effects not mentioned
in this leaflet, please inform your doctor or
pharmacist.
If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor
or pharmacist.
5. HOW TO STORE MILLINETTE
Keep out of the reach and sight of children.
Store below 25°C. Store in the original
package in order to protect from light
and moisture.
Do not use after the expiry date stated on
the package after Exp. The expiry date refers
to the last date of that month.
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 Millinette contains
The active substances are: 30 micrograms
ethinylestradiol and 75 micrograms
gestodene in one coated tablet.
The other ingredients are:
Tablet core: Sodium calcium edetate,
Magnesium stearate, Silica colloidal
anhydrous, Povidone K-30, Maize starch,
Lactose monohydrate.
Tablet coat: Quinoline yellow (E 104),
Povidone K-90, Titanium dioxide (E 171),
Macrogol 6000, Talc, Calcium carbonate
(E170), Sucrose.
What Millinette looks like and contents of
the pack
Yellow, round, biconvex sugar-coated
tablets, both sides are without imprinting.
Packaging:
Blister: PVC/PVDC/aluminium.
Blister: PVC/PVDC/aluminium in PETP/
aluminium/PE bag.
Pack sizes: 1 x 21 tablets; 3 x 21 tablets,
6 x 21 tablets, 13 x 21 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Medimpex France SA, 1-3 rue Caumartin,
75009 Paris, France
Distributed by:
Consilient Health (UK) Ltd., 500 Chiswick
High Road, London W4 5RG
Manufacturer:
Gedeon Richter Plc., 1103 Budapest,
Gyömroi út 19-21, Hungary
˝
This leaflet was last revised in February 2011

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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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