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

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82539492

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Package leaflet: Information for the user

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

1

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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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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”).

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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
When do you need to take special care with ELOINE
Blood clots
ELOINE and cancer
Bleeding between periods
What you must do if no bleeding occurs during the
placebo days
Other medicines and ELOINE
ELOINE with food and drink

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8
10
13
18
33
34
35
36
38

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Laboratory tests
Pregnancy
Breast-feeding
Driving and using machines
ELOINE contains lactose
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
What to do in the case of vomiting or severe diarrhoea
Delaying your period: what you need to know

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38
39
39
40
41
42
44
47
47
53
54
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Changing the first day of your period: what you need to
know
If you stop taking ELOINE
4. Possible side effects
5. How to store ELOINE
6. Contents of the pack and other information

54
55
57
65
66

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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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2. What you need to know before you take
ELOINE
General notes
Before you start using ELOINE, you should read the
information on blood clots in section 2. It is particularly
important to read the symptoms of a blood clot – see
section 2 “Blood clots”.
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.

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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 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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When you should not use ELOINE
You should not use ELOINE 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.
Do not take ELOINE:
 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;
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if you need an operation or if you are off your feet for a
long time (see section ‘Blood clots’);
if you have ever had a heart attack or stroke;
if you have (or have ever had) angina pectoris (a condition
that causes severe chest pain and may be a first sign of a
heart attack) or transient ischaemic attack
(TIA – temporary stroke symptoms);
if you have any of the following diseases that may
increase your risk of a clot in the arteries;
– severe diabetes with blood vessel damage
– very high blood pressure
– a very high level of fat in the blood (cholesterol or
triglycerides)
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– a condition known as hyperhomocysteinaemia
if you have (or have ever had) a type of migraine called
‘migraine with aura’;
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
if you are allergic to ethinylestradiol or drospirenone, or
any of the other ingredients of this medicine (listed in









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section 6, page 66 ).This may cause itching, rash or
swelling.
When do you need to take special care with ELOINE
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”.
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Tell your doctor if any of the following conditions apply
to you
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 the condition develops, or
gets worse while you are using ELOINE, you should also tell
your doctor.
 if a close relative has or has ever 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 or ulcerative colitis (chronic
inflammatory bowel disease);
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if you have systemic lupus erythematosus (SLE - a
disease affecting your natural defence system);
if you have haemolytic uraemic syndrome (HUS - a
disorder of blood clotting causing failure of kidneys);
if you have sickle cell anaemia (an inherited disease of the
red blood cells);
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);
if you need an operation, or you are off your feet for a long
time (see in section 2 ‘Blood clots’);
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if you have 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 ELOINE;
If you have an inflammation in the veins under the skin
(superficial thrombophlebitis);
If you have varicose veins;
if you have epilepsy (see page 36 “Other medicines and
ELOINE”)
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))








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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 swollen face, tongue
and/or pharynx and/or difficulty swallowing or hives
together with difficulty breathing.
Talk to your doctor before taking ELOINE.


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BLOOD CLOTS
Using a combined hormonal contraceptive such as ELOINE
increases your risk of developing a blood clot compared with
not using one. In rare cases a blood clot can block vessels
and cause serious problems.
Blood clots can develop
 in veins (referred to as a ‘venous thrombosis’, ‘venous
thromboembolism’ or VTE);
 in the arteries (referred to as an ‘arterial thrombosis’,
‘arterial thromboembolism’ or ATE);
Recovery from blood clots is not always complete. Rarely,
there may be serious lasting effects or, very rarely, they may
be fatal;
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It is important to remember that the overall risk of having
a harmful blood clot due to ELOINE 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?


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

What are you
possibly
suffering from?
Deep vein
thrombosis

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– increased warmth in the affected
leg
– change in colour of the skin on the
leg e.g. turning pale, red or blue
Pulmonary
sudden unexplained breathlessness
embolism
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;

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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
 chest pain, discomfort, pressure,
heaviness

Retinal vein
thrombosis
(blood clot in the
eye)
Heart attack

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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

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sudden weakness or numbness of the Stroke
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.
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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 Blood clots
blocking other
of an extremity;
blood vessels
 severe pain in your stomach (acute
abdomen)
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
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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
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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 ELOINE 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 ELOINE is small.

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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 drospirenone such
as ELOINE, 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).
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Women who are not using a
combined hormonal pill and are
not pregnant
Women using a combined
hormonal contraceptive pill
containing levonorgestrel,
norethisterone or norgestimate
Women using ELOINE

Risk of developing a
blood clot in a year
About 2 out of 10,000
women
About 5-7 out of 10,000
women

About 9-12 out of
10,000 women

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Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with ELOINE is small but some
conditions will increase the risk. Your risk is higher:
 if you are very overweight (body mass index or BMI over
30kg/m2);
 if one of your immediate family has had a blood clot in the
leg, lung or other organ at a young age (eg. 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 ELOINE may need to be
stopped several weeks before surgery or while you are
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less mobile. If you need to stop ELOINE 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.
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 ELOINE needs to be stopped.
If any of the above conditions change while you are using
ELOINE, for example a close family member experiences a
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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.
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 ELOINE is very small but can increase:
 with increasing age (beyond about 35 years);

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if you smoke. When using a combined hormonal
contraceptive like ELOINE, 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;










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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
ELOINE, 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.


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
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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.
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
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if it begins after some months, your doctor must find out what
is wrong.
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)
– tuberculosis (e.g. rifampicin)



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– 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 become
pregnant, you can stop taking ELOINE at any time (see also
page 55 “If you stop taking ELOINE”).
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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.
Driving and using machines
There is no information suggesting that use of ELOINE
affects driving or use of machines.

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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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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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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.
If you use ELOINE in this manner, you are protected against
pregnancy also during the 4 days when you are taking a
placebo tablet.
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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.



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



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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 (progestogenonly 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 tablettaking.
After a miscarriage
Follow the advice of your doctor.
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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 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 39.
Ask your doctor what to do if you are not sure when to start.


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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.
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.
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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.
 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 52):
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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


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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 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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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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Ask your doctor for advice

More than
1 light
pink tablet
forgotten
in 1 strip

Day
1-7

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

Day
8-14

R Take the forgotten tablet
R Finish the strip

Day
15-24

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

52

yes
Had sex in the previous week before forgetting?
no
R Take the forgotten tablet
R Use a barrier method (condom) for the following 7 days
and
R Finish the strip

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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 47.

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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 menstruation-like 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.
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
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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.
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
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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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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 ELOINE, please talk
to your doctor.
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 take ELOINE”.
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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
Uncommon side effects (between 1 and 10 in every 1,000
users may be affected):
 depression, nervousness, sleepiness
 dizziness, ‘pins and needles’
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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 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
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PZ: 2537A-4C
name: LF-BRO-Eloine FTB 28
colors: Black
version: 17.06.2014/05
approval:

Bayer Pharma AG
code-no.: 235
country: GB

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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
 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
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version: 17.06.2014/05
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code-no.: 235
country: GB

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inflammation of a vein, nosebleed, fainting
enlarged abdomen, bowel disorder, feeling bloated,
stomach hernia, fungal infection of the mouth,
constipation, dry mouth
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
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code-no.: 235
country: GB

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(hyperplasia), malignant lumps in the breast, abnormal
growth on the mucosal surface of the neck of the womb,
shrinkage or wasting of the lining of the womb, ovarian
cysts, enlargement of the womb
feeling generally unwell
weight loss
harmful blood clots in a vein or artery for example:
– in a leg or foot (i.e. DVT)
– in a lung (i.e. PE)
– heart attack
– stroke
– mini-stroke or temporary stroke-like symptoms, known
as a transient ischaemic attack (TIA)





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– 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).
The following side effects have also been reported, but their
frequency cannot be estimated from the available data:
hypersensitivity, erythema multiforme (rash with targetshaped reddening or sores).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly (see details
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below). By reporting side effects, you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
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PZ: 2537A-4C
name: LF-BRO-Eloine FTB 28
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code-no.: 235
country: GB

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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 to
protect the environment.

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code-no.: 235
country: GB

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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:
 Tablet core: lactose monohydrate, maize starch,
magnesium stearate (E470b)


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Bayer Pharma AG
code-no.: 235
country: GB

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Tablet film-coating: hypromellose (E464), talc (E553b),
titanium dioxide (E171) and iron oxide red (E172).
 White inactive film-coated tablets:
 Tablet core: lactose monohydrate, microcrystalline
cellulose, 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 filmcoated tablets in the 1st, 2nd, 3rd and 4th rows of the strip
and 4 white placebo film-coated tablets in row 4.
 ELOINE tablets, both the light pink and the white, are filmcoated tablets; the core of the tablet is coated.


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Bayer Pharma AG
code-no.: 235
country: GB

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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.: 235
country: GB

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Marketing Authorisation Holder
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire,
RG14 1JA
Manufacturer
Bayer Pharma AG and Bayer Weimar GmbH und Co. KG
13342 Berlin, Germany
Döbereinerstr. 20, 99427
Weimar, Germany
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
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name: LF-BRO-Eloine FTB 28
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version: 17.06.2014/05
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Bayer Pharma AG
code-no.: 235
country: GB

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Cyprus, Finland, Greece, Poland, Portugal, Slovak
Republic, Slovenia: Linatera
 France: Rimendia
This leaflet was last revised in June 2014


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Bayer Pharma AG
code-no.: 235
country: GB

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Bayer Pharma AG
code-no.: 235
country: GB

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82539492

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PZ: 2537A-4C
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version: 17.06.2014/05
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Bayer Pharma AG
code-no.: 235
country: GB

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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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