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MILLINETTE ED 15 / 60 MICROGRAMS FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MILLINETTE® ED 15/60
micrograms film-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 or pharmacist.
• 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 or pharmacist.

In this leaflet:
1. What Millinette ED is and what it is used for
2. Before you take Millinette ED
3. How to take Millinette ED
4. Possible side effects
5. How to store Millinette ED
6. Further information
1. WHAT Millinette ED IS AND WHAT IT
IS USED FOR
Millinette ED is a combined oral
contraceptive, also called the pill.
The combined contraceptive pill protects
you against getting pregnant in three ways.
These hormones:
1. stop the ovary from releasing an egg
each month (ovulation)
2. thicken the fluid (at the neck of the
womb) making it more difficult for the
sperm to reach the egg
3. alter the lining of the womb to make it
less likely to accept a fertilised egg.
2. BEFORE YOU TAKE Millinette ED
General information
Before you can begin taking Millinette ED,
your doctor will ask you some questions
about your personal health and that of your
close relatives. The doctor will also measure
your blood pressure and depending upon
your personal situation, may also carry out
some other tests.
In this leaflet, several situations are described
where you should stop using Millinette ED,
or where the reliability of Millinette ED may
be decreased. In such situations you should
either not have intercourse or you should
take extra non-hormonal contraceptive
precautions, e.g., use a condom, or another
barrier method. Do not use rhythm or
temperature methods. These methods can
be unreliable because Millinette ED alters the
monthly changes of the cervical mucus.
Millinette ED like other hormonal
contraceptives does not protect against
HIV infection (AIDS) or any other sexually
transmitted disease.
Do not take Millinette ED
• if you are allergic (hypersensitive) to
gestodene or ethinylestradiol or any of
the other ingredients of Millinette ED
• if you have or have had in the past a blood
clot (thrombosis) in a blood vessel of the
leg, lung (embolus) or other organs
• if you have or have had in the past a
heart attack or stroke
• if you have or have had in the past a
disease that can be a predictor of a heart
attack (for example, angina pectoris,
which causes severe pain in the chest) or
of a stroke (for example, a transient slight
stroke with no residual effects)
• if you have a disease that may increase
the risk of a thrombosis in the arteries.
This applies to the following diseases:
• diabetes with damaged blood vessels
• very high blood pressure
• very high level of fat in the blood
(cholesterol or triglycerides)
• if you have a disease of the heart or the
heart valves or a heart rhythm disturbance
• if you have or have ever had a migraine
with disorders of perception, sensation,
or movement
• if you have or have had an eye disorder
(e.g. a disease of the retina called
retinopathy)
• if you have or have had a liver tumour
• if you have or have had a liver disease and
your liver function is still not normal
• if you have or have had an inflammation
of the pancreas (pancreatitis)
• if your kidneys are not working well
(renal failure)
• if you have or may have breast cancer
or another cancer, for example, ovarian
cancer, cervical cancer, or cancer of the
uterus (womb)
• if you have unexplained bleeding from
your vagina.
Take special care with Millinette ED
In some situations you need to take special
care while using Millinette ED or any other
combined hormonal contraceptive, and
it may be necessary that you are regularly
checked by your doctor. If any of the
following conditions applies to you, you
must inform your doctor before starting to
use Millinette ED. Also if any of the following
conditions develops or worsens during the
use of Millinette ED you must consult your
doctor.
• if a close relative has or has had breast
cancer
• if you have a disease of the liver or the
gallbladder
• if you have diabetes
• if you have depression
• if you have Crohn’s disease or ulcerative
colitis (inflammatory bowel disease)
• if you have HUS (haemolytic uraemic
syndrome; a blood disease that causes
kidney damage)
• if you have sickle cell anaemia (an
inherited disease of the red blood cells)
• if you have epilepsy (see “Taking other
medicines”)
• if you have SLE (systemic lupus
erythematosus; a disease of the


























immune system)
if you have a disease that first appeared
during pregnancy or earlier use of
sex hormones (for example, hearing
loss, porphyria (a disease of the blood),
gestational herpes (skin rash with
vesicles during pregnancy), Sydenham’s
chorea (a disease of the nerves in which
sudden movements of the body occur)
if you have or have ever had chloasma
(golden brown pigment patches, so
called “pregnancy patches”, especially
on the face). If this is the case, avoid
direct exposure to sunlight or
ultraviolet light.
If you have hereditary angioedema,
products containing estrogens
may induce or worsen symptoms of
angioedema. You should see your
doctor immediately if you experience
symptoms of angioedema such as
swollen face, tongue and/or pharynx
and/or difficulty swallowing or hives
together with difficulty breathing.

The pill and thrombosis
Venous thrombosis
The use of any combined pill, including
Millinette ED, increases a woman’s risk of
developing a venous thrombosis (formation
of a blood clot in the vessels) compared
with a woman who does not take any
(contraceptive) pill.
The risk of venous thrombosis in users of
combined pills increases:
• with increasing age
• if you are overweight
• if one of your close relatives has had a
blood clot (thrombosis) in the leg, lung,
or other organ at a young age
• if you must have an operation (surgery),
any prolonged period of immobilization,
or if you have had a serious accident. It is
important to tell your doctor in advance
that you are using Millinette ED as the
treatment may have to be stopped.
Your doctor will tell you when to start
Millinette ED again. This is usually about
two weeks after you are back on your feet.
Arterial thrombosis
The use of combined pills has been
connected with an increase of the risk of
arterial thrombosis (obstruction of an
artery), for example, in the blood vessels of
the heart (heart attack) or the brain (stroke).
The risk of arterial thrombosis in users of
combined pills increases:
• If you smoke. You are strongly advised
to stop smoking when you use
Millinette ED, especially if you are older
than 35 years.
• if you have an increased fat content in
your blood (cholesterol or triglycerides)
• if you have high blood pressure
• if you suffer from migraines
• if you have a problem with your heart
(valve disorder, a disturbance of the
heart rhythm).
Stop taking Millinette ED and contact your
doctor immediately if you notice possible
signs of thrombosis, such as:
• severe pain and/or swelling in one of
your legs
• sudden severe pain in the chest which
may reach the left arm
• sudden breathlessness
• sudden cough without an obvious cause
• any unusual, severe or long-lasting
headache or worsening of a migraine
• partial or complete blindness or double
vision
• difficulty in speaking or inability to speak
• giddiness or fainting
• weakness, strange feeling, or numbness
in any part of the body.
The pill and cancer
Breast cancer has been observed slightly
more often in women using combined pills,
but it is not known whether this is caused by
the treatment. For example it may be that
more tumours are detected in women on
combined pills because they are examined
by their doctor more often. The occurrence
of breast tumours becomes gradually less
after stopping the combination hormonal
contraceptives. It is important to regularly
check your breasts and you should contact
your doctor if you feel any lump.
In rare cases, benign liver tumours, and in
even fewer cases malignant liver tumours
have been reported in pill users. Contact
your doctor if you have unusual severe
abdominal pain.
Bleeding between periods
During the first few months that you
are taking Millinette ED, you may have
unexpected bleeding (bleeding outside the
placebo period). If this bleeding lasts longer
than a few months, or if it begins after some
months, your doctor must investigate the
cause.
What you must do if no bleeding occurs in
the placebo period
If you have taken all the tablets correctly,
have not had vomiting or severe diarrhoea
and you have not taken any other medicines,
it is highly unlikely that you are pregnant.
If the expected bleeding does not happen

twice in succession, you may be pregnant.
Contact your doctor immediately. Do not
start the next strip until you are sure that
you are not pregnant.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Always tell your doctor or pharmacist if you
are using any of the following medicines:
• phenobarbital, phenytoin, primidone,
carbamazepine, bosentan, nevirapine,
fosphenytoin, oxcarbazepine, topiramate,
rifabutin, rifampicin, griseofulvin,
lamotrigine, ritonavir, modafinil, St. John’s
wort (Hypericum perforatum).
These medicines can reduce the efficacy
of this pill. It may then be necessary to use
another method of contraception.
Laboratory tests
If you need a blood test, tell your doctor or
the laboratory staff that you are taking the
pill, because oral contraceptives can affect
the results of some tests.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
You must not use Millinette ED when you
are pregnant. If you become pregnant or
you think you might be pregnant, stop
taking Millinette ED and talk to your doctor
immediately.
Millinette ED should not be taken during
breast-feeding. If you are breast-feeding and
want to take the pill, you should discuss this
with your doctor.
Driving and using machines
You can drive or operate machinery while
taking Millinette ED.
Important information about some of the
ingredients of Millinette ED
In Millinette ED the yellow active filmcoated tablets contain 34.909 mg of lactose
monohydrate and the green inactive ones
contain 37.26 mg of lactose anhydrous per
film-coated tablet. If you have been told by
your doctor that you have an intolerance
to some sugars, contact your doctor before
taking this medicinal product.
The ingredient sunset yellow may cause
allergic reactions.
3. HOW TO TAKE Millinette ED
Always take Millinette ED exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
Each blister contains 24 active yellow
film-coated tablets and 4 green placebo
film-coated tablets.
The two differently coloured tablets of
Millinette ED are arranged in order. A strip
contains 28 tablets.
Take one tablet of Millinette ED every day, if
necessary with a small amount of water. You
may take the tablets with or without food,
but you should take the tablets every day
around the same time.
Do not confuse the tablets: take a yellow
tablet for the first 24 days and then a green
tablet for the last 4 days. You must then start
a new strip straightaway (24 yellow and then
4 green tablets). There is therefore no gap
between two strips.
Because of the different composition of the
tablets it is necessary to begin with the first
tablet on the upper left and to take the
tablets every day. For the correct order, follow
the direction of the arrows on the strip.
Preparation of the strip
To control the daily intake of the
contraceptive, use the arrows on the pack.
The arrows show the order you are to take
the pills. During the 4 days when you are
taking the green placebo tablets (the placebo
days), bleeding should begin (so-called
withdrawal bleeding). This usually starts on
the 2nd or 3rd day after the last yellow active
tablet of Millinette ED. Once you have taken
the last green tablet, you should start with
the following strip, whether your bleeding
has stopped or not. This means that you
should start every strip on the same day of
the week, and that the withdrawal bleed
should occur on the same day each month.
If you use Millinette ED in this manner, you
are protected against pregnancy also during
the 4 days when you are taking a placebo
tablet.
When can you start with the first strip?
• If you have not used a contraceptive
with hormones in the previous month
Begin with Millinette ED on the first
day of the cycle (that is, the first day
of your period). If you start Millinette ED
on the first day of your menstruation,
you are immediately protected against
pregnancy. You may also begin on day
2-5 of the cycle, but then you must use
extra protective measures (for example,
a condom) for the first 7 days.
• Changing from a combined hormonal
contraceptive, or combined
contraceptive vaginal ring or patch
You can start Millinette ED on the day
after the tablet-free days of your previous





































pill finish (or after the last inactive tablet
of your previous pill).
When changing from a combination
contraceptive vaginal ring or patch,
follow the advice of your doctor.
Changing from a progestogen-only method
(progestogen-only pill, injection, implant or
a progestogen-releasing IUD)
You may switch any day from the
progestogen-only pill (from an implant
or an IUD on the day of its removal,
from an injectable when the next
injection would be due) but in all of
these cases you must use extra
protective measures (for example, a
condom) for the first 7 days of tablet
taking.
After a miscarriage
Follow the advice of your doctor.
After having a baby
You can start Millinette ED between 21
and 28 days after having a baby. If you
start later than day 28, you must use a
so-called barrier method (for example, a
condom) during the first seven days of
Millinette ED use.
If, after having a baby, you have had sex
before starting Millinette ED (again), you
must first be sure that you are not pregnant
or you must wait until your next period.
If you are breast-feeding and want to start
Millinette ED (again) after having a baby
Read the section on “Breast-feeding”.
Ask your doctor what to do if you are
not sure when to start.

If you take more Millinette ED than you
should
There are no reports of serious harmful
results of taking too many Millinette ED
tablets.
If you take several tablets at once then you
may have symptoms of nausea or vomiting.
Young girls may have bleeding from the vagina.
If you have taken too many Millinette ED
tablets, or you discover that a child has taken
some, ask your doctor or pharmacist for
advice.
If you forget to take Millinette ED
The last 4 tablets in the 4th row of the strip
are the placebo tablets. If you forget one
of these tablets, this has no effect on the
reliability of Millinette ED.
Throw away the forgotten placebo tablet.
If you miss a yellow, active tablet (tablets
1-24 of your blister strip), you must do the
following:
• If you are less than 12 hours late taking
a tablet, the protection against
pregnancy is not reduced.
Take the tablet as soon as you
remember and then take the following
tablets again at the usual time.
• If you are more than 12 hours late
taking a tablet, the protection against
pregnancy may be reduced. The
greater the number of tablets that you
have forgotten, the greater is the risk of
becoming pregnant.
The risk of incomplete protection against
pregnancy is greatest if you forget a yellow
tablet at the beginning or at the end of the
strip. Therefore, you should keep to the
following rules:
• More than one tablet forgotten in this strip
Contact your doctor.
• One tablet forgotten between days 1 - 7
(first row)
Take the forgotten tablet as soon as you
remember, even if that means that you
have to take two tablets at the same
time. Continue taking the tablets at the
usual time and use extra precautions
for the next 7 days, for example, a
condom. If you have had sex in the week
before forgetting the tablet you must
realize that there is a risk of pregnancy. In
that case, contact your doctor.
• One tablet forgotten between days 8 14 (second row)
Take the forgotten tablet as soon as you
remember, even if that means that you
have to take two tablets at the same
time. Continue taking the tablets at
the usual time. The protection against
pregnancy is not reduced, and you do
not need to take extra precautions.
• One tablet forgotten between days 15 -
24 (third or fourth row)
You can choose between two possibilities:
1. Take the forgotten tablet as soon as
you remember, even if that means that
you have to take two tablets at the
same time. Continue taking the tablets
at the usual time. Instead of taking the
green placebo tablets in this strip,
throw them away, and start the next
strip (the starting day will be different).
Most likely, you will have a period at
the end of the second strip - while
taking the green placebo tablets
- but you may have light or
menstruation-like bleeding during
the second strip.
2. You can also stop the active yellow
tablets and go directly to the 4 green
placebo tablets (before taking the
placebo tablets, record the day on
which you forgot your tablet). If you
want to start a new strip on the day
you always start, take the placebo
tablets for less than 4 days.
If you follow one of these two
recommendations, you will remain
protected against pregnancy.
• If you have forgotten any of the
tablets in a strip, and you do not
have a bleeding during the placebo
days, this may mean that you are
pregnant. You must contact your
doctor before you start the next strip.

Several yellow tablets
forgotten in 1 strip

Ask your doctor for advice

Yes

Day
1-7

Had sex in the previous
week before forgetting?

No

• Take the forgotten tablet
• use a barrier method
(condom) for the following
7 days
• finish the strip
Only 1 yellow
tablet forgotten
(taken more than
12 hours late)

Day
8-14

Day
15-24

• Take the forgotten tablet and
• finish the strip

• Take the forgotten tablet and
• finish the yellow tablets of
the strip
• discard the placebo tablets
• start the next pack
immediately.
Or
• Stop taking the tablets in the
pack immediately
• start a placebo tablet period
(of no more than 4 days,
including the day of the
forgotten tablet)
• afterwards, continue on to
the next pack.

What to do in the case of vomiting or severe
diarrhoea
If you vomit within 3-4 hours of taking
an active yellow tablet or you have severe
diarrhoea, there is a risk that the active
substances in the pill will not be fully taken
up by your body.
The situation is almost the same as forgetting
a tablet. After vomiting or diarrhoea, you
must take another yellow tablet from a
reserve strip as soon as possible. If possible
take it within 12 hours of when you normally
take your pill. If this is not possible or 12
hours have passed, you should follow the
advice given under “If you forget to take
Millinette ED”.
Delaying your period: what you need to know
Even if it is not recommended, you can delay
your period by not taking the green placebo
tablets from the 4th row and going straight
to a new strip of Millinette ED and finishing
it. You may experience light or menstruationlike bleeding while using this second strip.
Finish this second strip by taking the 4 green
tablets from the 4th row. Then start your
next strip.
You might ask your doctor for advice before
deciding to delay your menstrual period.
Changing the first day of your period: what
you need to know
If you take the tablets according to the
instructions, then your period will begin
during the placebo days. If you have to
change this day, reduce the number of
placebo days – when you take the green
placebo tablets – (but never increase them
– 4 is the maximum!). For example, if you
start taking the placebo tablets on a Friday,
and you want to change this to a Tuesday
(3 days earlier), you must start a new strip 3
days earlier than usual. You may not have any
bleeding during this time. You may then
experience light or menstruation-like bleeding.
If you are not sure what to do, consult your
doctor.
If you want to stop taking Millinette ED
You can stop taking Millinette ED whenever
you want. If you do not want to become
pregnant, ask your doctor for advice about
other reliable methods of birth control.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Millinette ED can cause
side effects, although not everybody gets
them.
Some relatively rare side effects require the
withdrawal of treatment and a rapid visit to
the doctor (see subsection “Take special care
with Millinette ED”):
• heart and blood vessel conditions: high
blood pressure, coronary artery disease,
myocardial infarction, cerebrovascular
accident, phlebitis, pulmonary embolism
• severe and unusual headaches
• vertigo
• vision disorders
• aggravation of epilepsy, systemic lupus
erythematosus, chorea, porphyria
• pancreas conditions
• jaundice, benign liver condition
• haemolytic and uraemic syndrome.
very common: affects more than 1 user in 10
common:
affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare:
affects 1 to 10 users in 10,000
very rare:
affects less than 1 user in

10,000
not known: frequency cannot be

estimated from the

available data
Serious side effects
The serious side effects and disorders
associated with the pill are listed in section 2
“Take special care with Millinette ED”
Other possible side effects
Common, occurs in 1 to 10 per 100 users:
• vaginal inflammation including fungal
infection (candidiasis)
• mood swings, including depression and
changes in sexual desire (libido)














dizziness
nausea
vomiting
headache
acne
breast pain
breast tenderness
breast secretion
menstrual pain
changed strength of menstrual bleeding
weight changes
oedema.

Uncommon, occurs in 1 to 10 per 1,000 users:
• changes in appetite
• changed blood lipid values
• migraine
• high blood pressure
• cramps in the abdomen
• swelling
• skin rash
• brown-yellowish pigment spots in the
face (chloasma)
• hair loss
• increased body hairs.
Rare, occurs in 1 to 10 per 10,000 users:
• very severe allergic reactions with very
rare cases of nettle rash, painful
swelling of skin and mucous membranes
(angioedema) and respiratory and
circulatory symptoms
• increased blood glucose level (glucose
intolerance)
• irritation of the eyes if you wear contact
lenses
• nodal fever (erythema nodosum)
• jaundice.
Very rare, occurs in less than 1 in 10,000 users:
• liver disease
• connective tissue disease (systemic
lupus erythematosus)
• metabolic disease known as porphyria
• movement disease
• eye problems
• inflammation of the pancreas
• gallstones and gallbladder disease
• skin disorders.
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 ED
Keep out of the reach and sight of children.
Store below 25°C. Store in the original
package in order to protect from light.
Do not use Millinette ED after the expiry
date which is stated on the blister and
carton. The expiry date refers to the last day
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 ED contains
• The active substances are 60 micrograms
gestodene and 15 micrograms
ethinylestradiol in each yellow tablet.
• The other ingredients are:
Active film-coated tablets: lactose
monohydrate, microcrystalline cellulose,
hypromellose, polacrilin potassium,
magnesium stearate, titanium dioxide
(E171), triacetin, quinoline yellow (E104).
Placebo film-coated tablets:
microcrystalline cellulose, lactose
anhydrous, pregelatinised maize starch,
magnesium stearate, colloidal anhydrous
silica, polyvinyl alcohol, titanium dioxide
(E171), macrogol 3350, talc, indigo carmine
(E132), quinoline yellow (E104), iron oxide
black (E172), sunset yellow FCF (E110).
What Millinette ED looks like and contents
of the pack
The active film-coated tablet is yellow,
round, biconvex film-coated tablet, diameter
about 5.5 mm. Engraving on one side: “G43”,
other side is without engraving.
The placebo film-coated tablet is green,
round, biconvex film-coated tablet, diameter
about 6 mm, without engraving.
Millinette ED 60 micrograms/15 micrograms
film-coated tablets are packed in PVC/
PE/PVDC-Al blister packs. The blisters are
packed into folded carton box with etui
storage bag enclosed.
Pack sizes:
1 × (24+4) film-coated tablets
3 x (24+4) film-coated tablets
6 × (24+4) film-coated tablets
13 × (24+4) film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
Gedeon Richter Plc.
1103 Budapest
Gyömroi út 19-21.
˝
Hungary
Distributor:
Consilient Health (UK) Ltd.
500 Chiswick High Road
London
W4 5RG
This leaflet was last revised in April 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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