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MILLINETTE 30/75 MICROGRAM COATED TABLETS

Active substance(s): ETHINYLESTRADIOL / GESTODENE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MILLINETTE® 30/75
microgram coated tablets
Ethinylestradiol and Gestodene

Important things to know about combined hormonal contraceptives (CHCs):
• They are one of the most reliable reversible methods of contraception if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a
combined hormonal contraceptive following a break of 4 or more weeks.
• Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

In this leaflet:
1. What Millinette is and what it is used for
2. What you need to know before you use 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 hormonal 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 hormonal
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. What you need to know before you use Millinette
General notes
Before you start using Millinette you should read the information on blood clots
(thrombosis) in section 2. It is particularly important to read the symptoms of a
blood clot – see Section 2 “Blood clots”.
When you should not use 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
will discuss with you what other form of birth control would be more appropriate.
• if you are allergic to ethinylestradiol or gestodene or any of the other ingredients
of this medicine (listed in section 6)
• if you have (or have ever had) a blood clot in a blood vessel of your legs (deep
vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs
• if you know you have a disorder affecting your blood clotting – for instance,
protein C deficiency, protein S deficiency, antithrombin-III-deficiency, Factor V
Leiden or antiphospholipid-antibodies
• if you need an operation or if you are off your feet for a long time (see section
‘Blood clots’ (thrombosis and embolus)
• if you have ever had a heart attack or a stroke
• if you have (or have ever had) angina pectoris (a condition that causes severe
chest pain and may be a first sign of a heart attack) or transient ischaemic
attack [TIA – temporary stroke symptoms])
• if you have any of the following diseases that may increase your risk of a clot in
the arteries:
• severe diabetes with blood vessel damage
• very high blood pressure
• a very high level of fat in the blood (cholesterol or triglycerides)
• a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called ‘migraine with aura’
• if 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
‘Blood clots’)
• if you have or have ever had an eye disorder due to circulatory disease
• if you have liver disease or if you have ever had this
• if you have liver tumours or if you have ever had these
• if you have breast cancer or other cancer, for example ovarian cancer, cervical
cancer, or cancer of the uterus (womb)
• if you have unusual bleeding from your vagina
• if 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.

When to take special care with Millinette:
When should you contact your doctor?
Seek urgent medical attention
• if you notice possible signs of a blood clot that may mean you are suffering
from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the
lung (i.e. pulmonary embolism), a heart attack or a stroke (see ‘Blood clots’
section below).
For a description of the symptoms of these serious side effects please go to
“How to recognise a blood clot”.
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 if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Millinette, you should
also tell your doctor.

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.
• ­ is medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the
Th
same as yours.
• I
­ ­ f any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Your doctor may tell you to stop using Millinette and advise you to use another
method of contraception.
If you have:

­ elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family
history for this condition. Hypertriglyceridaemia has been associated with an
increased risk of developing pancreatitis (inflammation of the pancreas);
• systemic lupus erythematosus (SLE -;a disease affecting your natural defence
­
system);
• haemolytic uraemic syndrome (HUS – a disorder of blood clotting causing failure
­
of the kidneys).
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;

­ 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);
• sickle cell anaemia (an inherited disease of the red blood cells);
­
• if you need an operation, or you are off your feet for a long time (see in section 2
­
‘Blood clots’);
• just given birth you are at an increased risk of blood clots. You should ask your
­
doctor how soon after delivery you can start taking Millinette;
• an inflammation in the veins under the skin (superficial thrombophlebitis).
­

­ varicose veins.

­ brown patches on your face and body (chloasma), which you can reduce by
staying out of the sun and not using sunbeds or sunlamps.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Millinette increases your risk of
developing a blood clot compared with not using one. In rare cases a blood clot
can block blood vessels and cause serious problems.
Blood clots can develop
• in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE)
• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’
or ATE).
Recovery from blood clots is not always complete. Rarely, there may be serious
lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of having a harmful blood clot
due to any Millinette is small.

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.

What can happen if a blood clot forms in a vein?
• The use of combined hormonal contraceptives has been connected with an
increase in the risk of blood clots in the vein (venous thrombosis). However, these
side effects are rare. Most frequently, they occur in the first year of use of a
combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot it can cause a deep vein
thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung it can cause a
pulmonary embolism.
• Very rarely a clot may form in a vein in another organ such as the eye (retinal vein
thrombosis).
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking
a combined hormonal contraceptive for the first time. The risk may also be higher if
you restart taking a combined hormonal contraceptive (the same product or a
different product) after a break of 4 weeks or more
After the first year, the risk gets smaller but is always slightly higher than if you were
not using a combined hormonal contraceptive.
When you stop Millinette your risk of a blood clot returns to normal within a few
weeks.
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal
contraceptive you are taking.
The overall risk of a blood clot in the leg or lung (DVT or PE) with Millinette is
small.
• Out of 10,000 women who are not using any combined hormonal contraceptive
and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who are using a combined hormonal contraceptive that
contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a
blood clot in a year.
• Out of 10,000 women who are using a combined hormonal contraceptive that
contains gestodene, such as Millinette between about 9 and 12 women will
develop a blood clot in a year.
• The risk of having a blood clot will vary according to your personal medical
history (see “Factors that increase your risk of a blood clot” below)
Risk of developing a
blood clot in a year
Women who are not using a combined hormonal
pill/patch/ring and are not pregnant

About 2 out of
10,000 women

Women using a combined hormonal contraceptive
pill containing levonorgestrel, norethisterone or
norgestimate

About 5-7 out of
10,000 women

Women using Millinette

About 9-12 out of
10,000 women

HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms:

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Millinette is small but some conditions will increase
the risk. Your risk is higher:
• if you are very overweight (body mass index or BMI over 30kg/m2);
• if one of your immediate family has had a blood clot in the leg, lung or other
organ at a young age (e.g. below the age of about 50). In this case you could have
a hereditary blood clotting disorder;
• if you need to 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 cast. The use of Millinette
may need to be stopped several weeks before surgery or while you are less
mobile. If you need to stop Millinette ask your doctor when you can start using
it again.
• as you get older (particularly above about 35 years);
• if you gave birth less than a few weeks ago.

BLOOD CLOTS IN A VEIN

The risk of developing a blood clot increases the more conditions you have.

Are you experiencing any of these signs?

What are you possibly
suffering from?

Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly
if you have some of the other factors listed.

• swelling of one leg or along a vein
in the leg or foot especially when
accompanied by:
• pain or tenderness in the leg which
may be felt only when standing or
walking;
• increased warmth in the affected leg;
• change in colour of the skin on the leg
e.g. turning pale, red or blue.

Deep vein thrombosis

It is important to tell your doctor if any of these conditions apply to you, even if
you are unsure. Your doctor may decide that Millinette needs to be stopped.

• sudden unexplained breathlessness or
rapid breathing;
• sudden cough without an obvious cause,
which may bring up blood;
• sharp chest pain which may increase with
deep breathing;
• severe light headedness or dizziness;
• rapid or irregular heartbeat;
• severe pain in your stomach.

Pulmonary embolism

If any of the above conditions change while you are using Millinette, for example a
close family member experiences a thrombosis for no known reason; or you gain a
lot of weight, tell your doctor.
BLOOD CLOTS IN AN ARTERY

If you are unsure, talk to a doctor as some
of these symptoms such as coughing or
being short of breath may be mistaken for
a milder condition such as a respiratory
tract infection (e.g. a ‘common cold’).
Symptoms most commonly occur in
one eye:
• immediate loss of vision or
• painless blurring of vision which can
progress to loss of vision.

Retinal vein thrombosis
(blood clot in the eye)

• chest pain, discomfort, pressure,
heaviness;
• sensation of squeezing or fullness in the
chest, arm or below the breastbone;
• fullness, indigestion or choking feeling;
• upper body discomfort radiating to the
back, jaw, throat, arm and stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety, or shortness
of breath;
• rapid or irregular heartbeats.

Heart attack

• sudden weakness or numbness of the
face, arm or leg, especially on one
side of the body;
• sudden confusion, trouble speaking or
understanding;
• sudden trouble seeing in one or both
eyes;
• sudden trouble walking, dizziness, loss of
balance or coordination;
• sudden, severe or prolonged headache
with no known cause;
• loss of consciousness or fainting with or
without seizure.

Stroke

Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke from using Millinette
is very small but can increase:
• with increasing age (beyond about 35 years);

­ if you smoke. When using a combined hormonal contraceptive like Millinette
you are advised to stop smoking. If you are unable to stop smoking and are older
than 35 your doctor may advise you to use a different type of contraceptive;

­ if you are overweight;

­ if you have high blood pressure that is not controlled through treatment;

­ if a member of your immediate family has had a heart attack or stroke at a young
age (less than about 50). In this case you could also have a higher risk of having a
heart attack or stroke;

­ if you, or someone in your immediate family, have a high level of fat in the blood
(cholesterol or triglycerides);

­ if you get migraines, especially migraines with aura;

­ if you have a problem with your heart (valve disorder, disturbance of the rhythm
called atrial fibrillation);

­ if you have diabetes.
If you have more than one of these conditions or if any of them are particularly
severe the risk of developing a blood clot may be increased even more.
If any of the above conditions change while you are using Millinette, for example
you start smoking, a close family member experiences a thrombosis for no known
reason or you gain a lot of weight, tell your doctor.

Sometimes the symptoms of stroke can be
brief with an almost immediate and full
recovery, but you should still seek urgent
medical attention as you may be at risk
of another stroke.
• swelling and slight blue discolouration of
an extremity;
• severe pain in your stomach (acute
abdomen).

What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems. For
example, it can cause a heart attack or a stroke.

Blood clots blocking
other blood vessels

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.

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.

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.

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.

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.

If you forget to take Millinette
If you forget to take a pill please follow these instructions.

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.

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.

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.

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 tablet free 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.

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; harmful blood clots in a vein or artery for example: in a leg or foot (i.e.
DVT), in a lung (i.e. PE), heart attack, stroke, mini-stroke or temporary stroke-like
symptoms, known as a transient ischaemic attack (TIA), blood clots in the liver,
stomach/intestine, kidneys or eye. (The chance of having a blood clot may be higher
if you have any other conditions that increase this risk (See section 2 for more
information on the conditions that increase risk for blood clots and the symptoms
of a 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.

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 : 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 Millinette
Keep out of the reach and sight of children.

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.

Store below 25°C. Store in the original package in order to protect from light and
moisture.

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.

Do not use after the expiry date stated on the package after Exp. The expiry date
refers to the last date of that month.

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.

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 (E104), Povidone K-90, Titanium dioxide (E171),
Macrogol 6000, Talc, Calcium carbonate (E170), Sucrose.

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.

3. How to take Millinette

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.

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.

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.

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.

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.

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 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.

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.

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.

Marketing Authorisation Holder and Manufacturer:
Gedeon Richter Plc.,
19-21 Gyömrői út,
1103 Budapest, Hungary
Distributed by:
Consilient Health (UK) Ltd.,
500 Chiswick High Road,
London W4 5RG

This leaflet was last revised in January 2014

4. Possible side effects
Like all medicines, Millinette can cause side effects, although not everybody gets
them.

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.

If you get any side effect, particularly if severe and persistent, or have any change to
your health that you think may be due to Millinette, please talk to your doctor.

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.

The following serious adverse events have been reported in women using
combined hormonal contraceptives, see section 2 under “Blood clots” 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).

An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or
blood clots in your arteries (arterial thromboembolism (ATE)) is present for all
women taking combined hormonal contraceptives. For more detailed information
on the different risks from taking combined hormonal contraceptives please see
section 2 “What you need to know before you use Millinette”.

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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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