ELOINE 0.02 MG / 3 MG FILM COATED TABLETS

Active substance: ETHINYLESTRADIOL

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0.02 mg / 3 mg film-coated tablets
Ethinylestradiol / Drospirenone

Packaging Technology Berlin DY
Seite U1
client: 0021
item No.: 81215499
PZ: 2537A-4C
Bezeichnung: GI-BRO-Eloine FTB 28
colors: black / PANT 7435 C
version: 02.08.2012/01
approval:

5499_01.indd U1

Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:14:5

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PZ: 2537A-4C
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colors: black / PANT 7435 C
version: 02.08.2012/01
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Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:2

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Bayer Pharma AG
Code-No.: 165
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02.08.2012 08:15:2

81215499

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Package leaflet:
Information for the user

®
0.02 mg / 3 mg film-coated tablets
Ethinylestradiol / Drospirenone


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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.
● If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.


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What is in this leaflet
1. What ELOINE is and what it is used for
2. What you need to know before you
take ELOINE
When you should not use ELOINE
Warnings and precautions
ELOINE and venous and arterial blood clots
ELOINE and cancer
Bleeding between periods
What you must do if no bleeding occurs during
the placebo days
Other medicines and ELOINE

6
7
9
12
15
21
22
23
24

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ELOINE with food and drink
Laboratory tests
Pregnancy
Breast-feeding
Driving and using machines
ELOINE contains lactose

26
26
26
27
28
28

3. How to take ELOINE
Preparation of the strip
When can you start with the first strip?
If you take more ELOINE than you should
If you forget to take ELOINE

29
30
32
35
36


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What to do in the case of vomiting or severe
diarrhoea
Delaying your period: what you need to know
Changing the first day of your period: what you
need to know
If you stop taking ELOINE

42
43
44
45

4. Possible side effects

46

5. How to store ELOINE

52

6. Contents of the pack and other information

53


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Code-No.: 165
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1. What ELOINE is and what it is used for
● ELOINE is a contraceptive pill and is used to
prevent pregnancy.
● Each of the 24 light pink tablets contains a small
amount of two different female hormones, namely
drospirenone and ethinylestradiol.
● The 4 white tablets contain no active substances
and are also called placebo tablets.
● Contraceptive pills that contain two hormones are
called “combination” pills.


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02.08.2012 08:15:3

2. What you need to know before you take
ELOINE
General notes
Before you can begin taking ELOINE, your doctor
will ask you some questions about your personal
health history 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 ELOINE, or where the
reliability of ELOINE may be decreased. In such
situations you should either not have sex or you
should take extra non-hormonal contraceptive

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precautions, e.g., use a condom or another barrier
method. Do not use rhythm or temperature methods.
These methods can be unreliable because ELOINE
alters the monthly changes of body temperature and
of cervical mucus.
ELOINE, like other hormonal contraceptives,
does not protect against HIV infection (AIDS) or
any other sexually transmitted disease.


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replaces: 80817932

02.08.2012 08:15:3

When you should not use ELOINE
Do not take ELOINE:
● if you have (or have ever had) a blood clot in a
blood vessel of the leg (thrombosis), of the lung
(pulmonary embolism) or other organs
● if you have (or have ever had) a heart attack or
stroke
● if you have (or have ever had) a disease that can be
an indicator of a heart attack in the future (for
example, angina pectoris, which causes severe pain
in the chest) or of a stroke (for example, a passing
slight stroke with no residual effects)


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● if you have a disease that may increase the risk of a
clot in the arteries. This applies to the following
diseases:
– diabetes with damaged blood vessels
– very high blood pressure
– a very high level of fat in the blood (cholesterol or
triglycerides)
● if you have a disturbance of blood clotting (for
example, protein C deficiency)
● if you have (or have ever had) a certain form of
migraine (with so-called focal neurological
symptoms)

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● if you have (or have ever had) an inflammation of
the pancreas (pancreatitis)
● if you have (or have ever had) liver disease and
your liver function is still not normal
● if your kidneys are not working well (renal failure)
● if you have (or have ever had) a tumour in the liver
● if you have (or have ever had) or if you are
suspected of having breast cancer or cancer of the
genital organs
● if you have any unexplained bleeding from the
vagina

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● if you are allergic to ethinylestradiol or drospirenone,
or any of the other ingredients of this medicine
(listed in section 6, page 53.). This may cause itching,
rash or swelling.
Warnings and precautions
In some situations you need to take special care while
using ELOINE or any other combination pill, and your
doctor may need to examine you regularly. If any of the
following conditions applies to you, you must inform
your doctor before starting to use ELOINE. Also, if any
of the following conditions develops or worsens while
you are using ELOINE you must consult your doctor:
● if a close relative has or has ever had breast cancer
● if you have a disease of the liver or the gallbladder
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● if you have diabetes
● if you have depression
● if you have Crohn’s disease or inflammatory bowel
disease (ulcerative colitis)
● if you have a blood disease called HUS (haemolytic
uraemic syndrome) that causes kidney damage
● if you have a blood disease called sickle cell
anaemia
● if you have epilepsy (see page 24 “Other medicines
and ELOINE”)
● if you have a disease of the immune system, called
SLE (systemic lupus erythematosus)
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● if you have a disease that first appeared during
pregnancy or earlier use of sex hormones (for
example, hearing loss, a blood disease called
porphyria, skin rash with blisters during pregnancy
(gestational herpes), a nerve disease causing
sudden movements of the body (Sydenham’s
chorea)
● if you have or have ever had golden brown pigment
patches (chloasma), 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 oestrogens may cause or worsen the
symptoms. You should see your doctor immediately
if you experience symptoms of angioedema such as
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swollen face, tongue and/or pharynx and/or difficulty
swallowing or hives together with difficulty breathing.
Talk to your doctor before taking ELOINE.
ELOINE and venous and arterial blood clots
The use of any combination pill, including ELOINE,
increases a woman’s risk of developing a venous
blood clot (venous thrombosis) compared with
women who do not take any contraceptive pill.
The risk of venous thrombosis in users of combination
pills increases:
● with increasing age
● if you are overweight
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● if one of your close relatives had a blood clot in the
leg, lung (pulmonary embolism), or other organ at a
young age
● if you must have surgery, if you have had a serious
accident or if you are immobilized for a long time. It
is important to tell your doctor in advance that you
are using ELOINE as the treatment may have to be
stopped. Your doctor will tell you when to start
ELOINE again. This is usually about two weeks after
you are back on your feet.

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Your chances of having a blood clot are increased by
taking the pill.
● Of 100,000 women who are not on the pill and not
pregnant, about 5-10 may have a blood clot in a
year.
● Of 100,000 women taking a pill like ELOINE, 30-40
may have a blood clot in a year, the exact number is
unknown.
● Of 100,000 women who are pregnant, around 60
may have a blood clot in a year.
A blood clot in the veins may travel to the lungs and
may block blood vessels (called a lung embolus).
Formation of blood clots in the veins may be fatal in
1-2% of cases.
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The level of risk may vary according to the type of pill
you take. Discuss with your doctor the available
options.
The use of combination pills has been connected with
an increase of the risk of an arterial blood clot
(arterial thrombosis), for example, in the blood
vessels of the heart (heart attack) or the brain (stroke).

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The risk of an arterial blood clot in users of
combination pills increases:
● if you smoke. You are strongly advised to stop
smoking when you use ELOINE, especially if
you are older than 35 years.
● if you have high levels of blood cholesterol or
triglycerides
● if you are overweight
● if one of your close relatives had a heart attack or
stroke at a young age
● if you have high blood pressure
● if you suffer from migraine
● if you have a problem with your heart (valve
disorder, a disturbance of the cardiac rhythm)

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Stop taking ELOINE and contact your doctor
immediately if you notice possible signs of a
blood clot, 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 migraine
● partial or complete blindness or double vision
● difficulty in speaking or inability to speak
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● giddiness or fainting
● weakness, strange feeling, or numbness in any
part of the body
ELOINE and cancer
Breast cancer has been observed slightly more often in
women using combination 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
combination 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.
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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 unusually
severe abdominal pain.
Bleeding between periods
During the first few months that you are taking
ELOINE, you may have unexpected bleeding (bleeding
outside the placebo days). If this bleeding occurs for
more than a few months, or if it begins after some
months, your doctor must find out what is wrong.

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What you must do if no bleeding occurs during the
placebo days
If you have taken all the light pink active 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. Only start the next strip if you are sure
that you are not pregnant.

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Other medicines and ELOINE
Always tell your doctor which medicines or herbal
products you are already using. Also tell any other
doctor or dentist who prescribes another medicine
(or the pharmacist) that you use ELOINE. They can
tell you if you need to take additional contraceptive
precautions (for example condoms) and if so, for
how long.
● Some medicines can make ELOINE less effective in
preventing pregnancy, or can cause unexpected
bleeding. These include medicines used for the
treatment of
– epilepsy (e.g. primidone, phenytoin, barbiturates,
carbamazepine, oxcarbazepine)
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– tuberculosis (e.g. rifampicin)
– HIV infections (ritonavir, nevirapine) or other
infections (antibiotics such as griseofulvin,
penicillin, tetracycline)
– high blood pressure in the blood vessels in the
lungs (bosentan)
– and the herbal remedy St. John’s wort
● ELOINE may influence the effect of other medicines,
e.g.
– medicines containing ciclosporin
– the anti-epileptic lamotrigine (this could lead to an
increased frequency of seizures)
Ask your doctor or pharmacist for advice before taking
any medicine.

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ELOINE with food and drink
ELOINE may be taken with or without food, if
necessary with a small amount of water.
Laboratory tests
If you need a blood test, tell your doctor or the
laboratory staff that you are taking the pill, because
hormonal contraceptives can affect the results of some
tests.
Pregnancy
If you are pregnant, you must not take ELOINE. If you
become pregnant while taking ELOINE you must stop
immediately and contact your doctor. If you want to
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become pregnant, you can stop taking ELOINE at any
time (see also page 45 “If you stop taking ELOINE”).
Ask your doctor or pharmacist for advice before taking
any medicine.
Breast-feeding
Use of ELOINE is generally not advisable when a
woman is breast-feeding. If you want to take the pill
while you are breast-feeding you should contact your
doctor.
Ask your doctor or pharmacist for advice before taking
any medicine.

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Driving and using machines
There is no information suggesting that use of ELOINE
affects driving or use of machines.
ELOINE contains lactose
If you cannot tolerate certain sugars, contact your
doctor before you take ELOINE.

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3. How to take ELOINE
Each blister contains 24 active light pink tablets and
4 white placebo tablets.
The two differently coloured tablets of ELOINE are
arranged in order. A strip contains 28 tablets.
Take one tablet of ELOINE 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 light pink tablet for
the first 24 days and then a white tablet for the last
4 days. You must then start a new strip straightaway
(24 light pink and then 4 white tablets). There is
therefore no gap between two strips.
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Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

Because of the different composition of the tablets it is
necessary to begin with the first tablet on the upper left
and that you take the tablets every day. For the correct
order, follow the direction of the arrows on the strip.
Preparation of the strip
To help you keep track, there are 7 stickers each with
the 7 days of the week for each strip of ELOINE.
Choose the week sticker that starts with the day you
begin taking the tablets. For example, if you start on a
Wednesday, use the week sticker that starts with
“WED”.
Stick the week sticker along the top of the ELOINE
strip where it reads “Place week sticker here”, so that
the first day is above the tablet marked “1”.
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Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

There is now a day indicated above every tablet and
you can see whether you have taken a certain pill. The
arrows show the order you are to take the pills.
During the 4 days when you are taking the white
placebo tablets (the placebo days), bleeding should
begin (so-called withdrawal bleeding). This usually
starts on the 2nd or 3rd day after the last light pink active
tablet of ELOINE. Once you have taken the last white
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 days each month.

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Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

If you use ELOINE 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 ELOINE on the first day of the cycle (that
is, the first day of your period). If you start ELOINE
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.
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Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

● Changing from a combined hormonal contraceptive,
or combined contraceptive vaginal ring or patch
You can start ELOINE preferably on the day after
the last active tablet (the last tablet containing the
active substances) of your previous pill, but at the
latest 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 combined
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
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country: GB
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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 ELOINE 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 ELOINE use.
If, after having a baby, you have had sex before
starting ELOINE (again), you must first be sure that
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country: GB
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02.08.2012 08:15:3

you are not pregnant or you must wait until your
next period.
● If you are breast-feeding and want to start ELOINE
(again) after having a baby
Read the section on “Breast-feeding”, page 27.
Ask your doctor what to do if you are not sure when to
start.
If you take more ELOINE than you should
There are no reports of serious harmful results of
taking too many ELOINE 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.
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Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

If you have taken too many ELOINE tablets, or you
discover that a child has taken some, ask your doctor
or pharmacist for advice
If you forget to take ELOINE
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 ELOINE. Throw away
the forgotten placebo tablet.
If you miss a light pink, active tablet (tablets 1-24 of
your blister-strip), you must do the following:
● If you are less than 24 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.
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country: GB
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02.08.2012 08:15:3

● If you are more than 24 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 light pink tablet at the beginning
or at the end of the strip. Therefore, you should keep to
the following rules (see also the diagram on page 41):
● 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,
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02.08.2012 08:15:3

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.
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Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

● 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 white placebo
tablets on 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 white placebo tablets
- but you may have light or menstruation-like
bleeding during the second strip.

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Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

2. You can also stop the active light pink tablets and go
directly to the 4 white 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.

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country: GB
replaces: 80817932

02.08.2012 08:15:3

Only 1 light
pink
tablet
forgotten
(taken more
than 24
hours late)

yes



Ask your doctor for advice
Day
1-7

Had sex in the previous week before forgetting?
no



More than
1 light pink
tablet
forgotten in
1 strip

● Take the forgotten tablet
● Use a barrier method (condom) for the following 7 days and
● Finish the strip
Day
8 - 14

Day
15 - 24

● Take the forgotten tablet
● Finish the strip
● Take the forgotten tablet and
● Finish taking the light pink tablets
● Throw away the 4 white tablets
● Start the next strip
or
● Stop the light pink tablets immediately
● Go directly to the 4 white tablets
● Then start the next strip

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Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

What to do in the case of vomiting or severe
diarrhoea
If you vomit within 3-4 hours of taking an active light
pink 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 light pink tablet from a reserve
strip as soon as possible. If possible take it within
24 hours of when you normally take your pill. If this is
not possible or 24 hours have passed, you should
follow the advice given under “If you forget to take
ELOINE”, page 36.

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Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

Delaying your period: what you need to know
Even if it is not recommended, you can delay your
period by not taking the white placebo tablets from the
4th row and going straight to a new strip of ELOINE and
finishing it. You may experience light or menstruationlike bleeding while using this second strip. Finish this
second strip by taking the 4 white tablets from the 4th
row. Then start your next strip.
You might ask your doctor for advice before
deciding to delay your menstrual period.

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Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

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 white 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.
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Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

If you stop taking ELOINE
You can stop taking ELOINE 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 want to become pregnant, stop taking ELOINE
and wait for a menstrual period before trying to
become pregnant. You will be able to calculate the
expected delivery date more easily.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

4. Possible side effects
Like all medicines, this medicine can cause side effects
although not everybody gets them.
The following is a list of the side effects that have been
linked with the use of ELOINE:
Common side effects (between 1 and 10 in every 100
users may be affected)
● mood swings
● headache
● nausea
● breast pain, problems with your periods, such as
irregular periods, absence of periods
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Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

Uncommon side effects (between 1 and 10 in every
1,000 users may be affected):
● depression, nervousness, sleepiness
● dizziness, ‘pins and needles’
● migraine, varicose veins, increased blood pressure
● stomach ache, vomiting, indigestion, intestinal gas,
inflammation of the stomach, diarrhoea
● acne, itching, rash
● aches and pains, e.g. back pain, limb pain, muscle
cramps
● vaginal fungal infection, pelvic pain, breast
enlargement, benign breast lumps, uterine/vaginal
bleeding (which usually subsides during continued
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Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

treatment), genital discharge, hot flushes,
inflammation of the vagina (vaginitis), problems with
your periods, painful periods, reduced periods, very
heavy periods, vaginal dryness, abnormal cervical
smear, decreased interest in sex
● lack of energy, increased sweating, fluid retention
● weight increase
Rare side effects (between 1 and 10 in every 10,000
users may be affected):
● candida (fungal infection)
● anaemia, increase in the number of platelets in the
blood
● allergic reaction
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Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

● hormonal (endocrine) disorder
● increased appetite, loss of appetite, abnormally high
concentration of potassium in the blood, abnormally
low concentration of sodium in the blood
● failure to experience an orgasm, insomnia
● giddiness, tremor
● eye disorders, e.g. inflammation of the eyelid, dry
eyes
● abnormally rapid heartbeat
● inflammation of a vein, nosebleed, fainting
● enlarged abdomen, bowel disorder, feeling bloated,
stomach hernia, fungal infection of the mouth,
constipation, dry mouth
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Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

● pain of bile ducts or the gallbladder, inflammation of
the gallbladder
● yellow brown patches on the skin, eczema, hair
loss, acne-like inflammation of the skin, dry skin,
lumpy inflammation of the skin, excessive hair
growth, skin disorder, stretch marks on the skin, skin
inflammation, light-sensitive skin inflammation, skin
nodules
● difficult or painful sex, inflammation of the vagina
(vulvovaginitis), bleeding following intercourse,
withdrawal bleeding, breast cyst, increased number
of breast cells (hyperplasia), malignant lumps in the
breast, abnormal growth on the mucosal surface of
the neck of the womb, shrinkage or wasting of the
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Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

lining of the womb, ovarian cysts, enlargement of
the womb
● feeling generally unwell
● weight loss
The following side effects have also been reported, but
their frequency cannot be estimated from the available
data: hypersensitivity, erythema multiforme (rash with
target-shaped reddening or sores).
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.

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Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

5. How to store ELOINE
Keep this medicine out of the sight and reach of
children.
This medical product does not require any special
storage conditions
Do not take this medicine after the expiry date which is
stated on the packaging after “Do not use after:” or
“EXP.:”. The expiry date 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.
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Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

6. Contents of the pack and other
information
What ELOINE contains
● The active substances are ethinylestradiol (as
betadex clathrate) and drospirenone.
Each light pink active film-coated tablet contains
0.020 milligram ethinylestradiol (as betadex
clathrate) and 3 milligram drospirenone.
● The white film-coated tablets do not contain active
substances.
● The other ingredients are:
● Light pink active film-coated tablets:
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replaces: 80817932

02.08.2012 08:15:3

● Tablet core: lactose monohydrate, maize starch,
magnesium stearate (E470b)
● Tablet film-coating: hypromellose (E464), talc
(E553b), titanium dioxide (E171) and iron oxide red
(E172).
● White inactive film-coated tablets:
● Tablet core: lactose monohydrate, maize starch,
povidone K25, magnesium stearate (E470b)
● Tablet film-coating: hypromellose (E464), talc
(E553b) and titanium dioxide (E171).
What ELOINE looks like and content of the pack
● Each blister of ELOINE contains 24 light pink, active
film-coated tablets in the 1st, 2nd, 3rd and 4th rows of
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Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

the strip and 4 white placebo film-coated tablets in
row 4.
● ELOINE tablets, both the light pink and the white,
are film-coated tablets; the core of the tablet is
coated.
● The active tablet is light pink, round with convex
surfaces; one side is embossed with the letters “DS”
in a regular hexagon.
● The placebo tablet is white, round with convex
surfaces; one side is embossed with the letters “DP”
in a regular hexagon.
● ELOINE is available in packs of 1, 3, and 6 blisters
each with 28 tablets.
Not all pack sizes may be marketed.
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Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

Marketing Authorisation Holder
Bayer plc, Bayer House, Strawberry Hill, Newbury,
Berkshire, RG14 1JA
Manufacturer
Bayer Pharma AG
13342 Berlin, Germany
and
Bayer Weimar GmbH und Co. KG
Döbereinerstr. 20, 99427 Weimar, Germany

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client: 0021
item No.: 81215499
PZ: 2537A-4C
Bezeichnung: GI-BRO-Eloine FTB 28
colors: black
version: 02.08.2012/01
approval:

5499_01.indd 56

Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

This medicinal product is authorised in the Member
States of the EEA under the following names:
● The Netherlands: Ethinylestradiol/Drospirenon
24+4 0,02 mg/3 mg Berlipharm
● Austria, Bulgaria, Czech Republic, Denmark,
Germany, Iceland, Italy, Malta, Norway, Spain,
Sweden, United Kingdom: Eloine
● Cyprus, Finland, Greece, Poland, Portugal, Slovak
Republic, Slovenia: Linatera
● France: Rimendia
This leaflet was last revised in July 2012



Packaging Technology Berlin DY
Seite 57
client: 0021
item No.: 81215499
PZ: 2537A-4C
Bezeichnung: GI-BRO-Eloine FTB 28
colors: black
version: 02.08.2012/01
approval:

5499_01.indd 57

Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3



Packaging Technology Berlin DY
Seite 58
client: 0021
item No.: 81215499
PZ: 2537A-4C
Bezeichnung: GI-BRO-Eloine FTB 28
colors: black
version: 02.08.2012/01
approval:

5499_01.indd 58

Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3



Packaging Technology Berlin DY
Seite 59
client: 0021
item No.: 81215499
PZ: 2537A-4C
Bezeichnung: GI-BRO-Eloine FTB 28
colors: black
version: 02.08.2012/01
approval:

5499_01.indd 59

Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

81215499


Packaging Technology Berlin DY
Seite 60
client: 0021
item No.: 81215499
PZ: 2537A-4C
Bezeichnung: GI-BRO-Eloine FTB 28
colors: black
version: 02.08.2012/01
approval:

5499_01.indd 60

Bayer Pharma AG
Code-No.: 165
country: GB
replaces: 80817932

02.08.2012 08:15:3

Expand view ⇕

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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