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MILLINETTE 20/75 MICROGRAM COATED TABLETS

Active substance(s): ETHINYLESTRADIOL / GESTODENE / ETHINYLESTRADIOL / GESTODENE / ETHINYLESTRADIOL / GESTODENE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MILLINETTE® 20/75
microgram coated tablets
ethinylestradiol / 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”).

What is 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. Contents of the pack and other 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 hormonal contraceptive pills like Millinette will not protect
you against sexually-transmitted diseases (such as AIDS). Only condoms can help to
do this.
You and the pill
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”.

Do 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 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 (or have ever had) a type of migraine called ‘migraine with aura’;
­­• 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 ever had) an inflammation of the pancreas (pancreatitis)
associated with very high level of fat in the blood;
­• if you have (or have ever had) liver disease and liver function test have not yet
returned to normal;
­­• if you have liver tumours or if you have ever had these;
­­• if you have (or have ever had) cancer affected by sex hormones (e.g. breast cancer
or reproductive organ cancer);
­­• if you have unusual bleeding from your vagina;
­­• if you are allergic to gestodene or ethinylestradiol or any of the other ingredients
of this medicine (listed in section 6).
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking 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”.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• ­This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are
the same as yours.
­• ­If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.

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.
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);
­• 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.
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;
­• 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 IN A VEIN
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

BLOOD CLOTS

Women who are not using a combined hormonal
pill/patch/ring and are not pregnant

About 2 out of
10,000 women

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.

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

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 Millinette is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms:
Are you experiencing any of these signs?

What are you possibly
suffering from?

• 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

• 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

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

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;
­• 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.
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.
The most important risk factor for cervical cancer is infection with human
papilloma virus (HPV).

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).

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 30 kg/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 blocking
other blood vessels

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.

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.
Migraine/headache
You should talk to your doctor immediately if your migraine worsens or if a
recurrent, persistent, or severe headache develops (see also section 2 “Blood clots”).
Immune system disorder
Millinette can induce or worsen the symptoms of angioedema (sudden swelling of
the face, tongue and windpipe that can cause difficulties in breathing and
swallowing). The risk is higher if you or your close relatives have ever had troubles
with angioedema.
Other medicines and Millinette
Please tell your doctor or pharmacist if you are taking and have recently taken
any other medicines, including medicines obtained without a prescription.
Also tell any other doctor or dentist who prescribes another medicine that you use
Millinette. They can tell you if you need to take additional contraceptive
precautions (for example condoms) and if so, for how long, or whether the use of
another medicine you need must be changed.
Some medicines can have an influence on the blood levels of Millinette and can
make it less effective in preventing pregnancy, or can cause unexpected bleeding.
These include medicines used for the treatment of:
­• epilepsy (e.g. barbiturates, carbamazepine, phenytoin, primidone, felbamat,
oxcarbazepine, topiramate);
­• tuberculosis (e.g. rifampicin, rifabutin);
­• HIV and Hepatitis C Virus infections (so-called protease inhibitors and nonnucleoside reverse transcriptase inhibitors such as ritonavir, nevirapin, efavirenz);
­• fungal infections (e.g. griseofulvin);
­• medicine used for the treatment of pulmonary artery hypertension (bosentan);
­• arthritis, arthrosis (etoricoxib)
The herbal remedy St. John’s wort. If you want to use herbal products containing
St. John’s wort while you are already using Millinette you should consult your
doctor first.
Millinette may influence the efficacy of other medicines, e.g.
­­• ciclosporin (medicine used for the treatment of suppression of tissue rejection
following transplant surgery);
­­• theophyllin (a medicine for the treatment of asthma);
­• lamotrigine (medicine for the treatment of epilepsy- this could lead to an
increased frequency of seizures);
­­• tizanidine (medicine used to treat muscle pain and/or muscle cramps).
Ask your doctor or pharmacist for advice before taking any medicine.
Before you have any laboratory tests
Tell your doctor or the laboratory staff that you are taking an oral contraceptive,
because oral contraceptives can affect the results of some tests.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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.

If you have had an injection, an implant or an intrauterine system, you can start to
take Millinette on the day that your next injection is due, or on the day that your
implant or intrauterine system is removed, but in all of these cases you must use
extra protective measures (for example, a condom) for the first 7 days of tablettaking.

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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.

Very rare side effects (may affect up to 1 in 10,000 people):
Benignus or malignant tumour of liver, aggravation of varicose veins, exacerbation
of systemic lupus erythematosus -SLE (a disorder where blood clots cause the
kidneys to fail), exacerbation of porpfyria, exacerbation of chorea (an involuntary
movement disorder), inflammation in the nerve of eye, blood clots in the blood
vessels of the eye, weight decrease, pancreatitis (inflammation of the pancreas),
inflammatory intestinal disorder (Crohns disease, ulcerative colitis), gallbladder
disorder, gall stones, blood disorder called haemolytic uraemic syndrome – HUS (a
disorder where blood clots cause the kidneys to fail).

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 you forgot to take the tablet at the usual time and are less than 12 hours late in
doing so, you should take it as soon as you remember. Then continue taking tablets
at the usual time.

If you take the last tablet from the blister pack during this 7-day period, you should
start taking tablets from a new blister pack as soon as the current pack is finished;
no gap should be left between blister packs. It is unlikely you will experience a
withdrawal bleed while taking tablets from the second blister pack, but you may
experience blood spots or breakthrough bleeding. If you do not experience a
withdrawal bleed after completing the second pack, you should talk to your doctor.
The possibility of pregnancy should be excluded before resuming Millinette.
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.

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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
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.

3. HOW TO TAKE MILLINETTE
Always take this medicine exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist 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 the tablet-free period of your
previous pill finishes (or after the last inactive tablet of your previous pill).
Changing to Millinette from progestogen-only preparations (progestogen-only pills,
injection, implant)
You may switch any day from the progestogen-only pill but you must use extra
protective measures (for example, a condom) for the first 7 days of tablet-taking.

Not known (frequency cannot be estimated from available data):
Liver damage (such as hepatitis, abnormal liver function).
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 this medicine out of the sight and reach of children.

If you forgot to take the tablet at the usual time and are more than 12 hours late in
doing so, or if you forgot to take more than one tablet, contraceptive protection
may be reduced. You should take the last missed tablet as soon as you remember,
even if this means taking two tablets in one day. Then continue taking tablets at the
usual time. Additionally, a non-hormonal back-up birth control method should be
used for the next 7 days (e.g., condoms or cervical cap with spermicide).

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.

Millinette contains lactose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.

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).

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”.

Store below 25°C. Store in the original package in order to protect from light and
moisture.
Do not use this medicine after the expiry date which is stated on the label. The
expiry day refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Millinette contains
The active substances are: 20 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 (E171),
Macrogol 6000, Talc, Calcium carbonate (E170), Sucrose.
What Millinette looks like and contents of the pack
Pale 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 and Manufacturer:
Gedeon Richter Plc.,
19-21 Gyömrői út,
1103 Budapest,
Hungary
Distributed by:
Consilient Health (UK) Ltd.,
No.1 Church Road,
Richmond Upon Thames
Surrey.
TW9 2QE.

This leaflet was last revised in October 2016.

The following is a list of the side effects that have been linked with the use of
Millinette.
Very common side effects (may affect more than 1 in 10 people):
Headache, irregular bleeding and spotting between periods.
Common side effects (may affect up to 1 in 10 people):
Vaginitis, fungal infection of vagina, mood altered including depression,
nervousness, dizziness, nausea, upper abdominal pain, acne, painful menstruation,
changes in vaginal secretion, absence of menstruation, weight increase, breast
tenderness, breast pain, breast swelling, breast discharge.
Uncommon side effects (may affect up to 1 in 100 people):
Migraine, fluid retention, changed appetite (increased or reduced), increase in
blood pressure, vomiting, diarrhoea, rash, nettle-rash (urticaria), chloasma
(yellowish-brown patches on the skin), excessive hair growth, hair loss, changes in
serum lipid levels including hypertriglyceridemia, change in the interest in sex
(reduced libido).
Rare side effects (may affect up to 1 in 1,000 people):
Anaphylactic reactions (reaction with very rare cases of hives, swelling of face,
tongue, severe circulatory and respiratory disorders), glucose intolerance, jaundice,
eye irritation when wearing contact lenses, general disease in ear and labyrinth,
various skin diseases (such as erythema multiforme (characterized by rash with
target-shaped reddening or sores), erythema nodosum (characterized by painful
reddish skin nodules)), decrease in serum folate levels, other disease in the
gastrointestinal tract, change in interest in sex (increased libido).
Harmful blood clots in a vein or artery for example:

P0443

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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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