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ELLANITE 0.03 MG/3 MG FILM-COATED TABLETS

Active substance(s): DROSPIRENONE / ETHINYLESTRADIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ELLANITE 0.03 mg / 3 mg film-coated tablets
Ethinylestradiol / Drospirenone

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”)
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. See section 4.

Are you experiencing any of
these signs?

What are you possibly
suffering from?

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

Deep vein thrombosis

Pulmonary embolism

1. WHAT ELLANITE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELLANITE
3. HOW TO TAKE ELLANITE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ELLANITE
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

1. WHAT ELLANITE IS AND WHAT IT IS USED FOR
Ellanite is a contraceptive pill and is used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones,
namely drospirenone and ethinylestradiol. Contraceptive pills that contain
two hormones are called “combination” pills.

Symptoms most commonly occur
in one eye:
• immediate loss of vision or
• painless blurring of vision which can
progress to loss of vision

Retinal vein thrombosis
(blood clot in the eye)

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELLANITE

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

Heart attack

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

Stroke

• swelling and slight blue
discolouration of an extremity;
• severe pain in your stomach
(acute abdomen)

Blood clots blocking
other blood vessels

What is in this leaflet?

General notes
Before you start using Ellanite 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
Ellanite, 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
Ellanite, or where the reliability of Ellanite 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 Ellanite alters the monthly changes of the body
temperature and of the cervical mucus. Ellanite, like other hormonal
contraceptives, does not protect against HIV infection (AIDS) or
any other sexually transmitted disease.
When you should not use Ellanite
You should not use Ellanite if you have any of the conditions listed below. If
you do have any of the conditions listed below, you must tell your doctor. Your
doctor will discuss with you what other form of birth control would be more
appropriate.
• if you have (or have ever had) a blood clot in a blood vessel of your legs
(deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other
organs;
• if you know you have a disorder affecting your blood clotting – for instance,
protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor
V Leiden or antiphospholipid antibodies;
• if you need an operation or if you are off your feet for a long time
(see section ‘Blood clots’);
• if you have ever had a heart attack or a stroke;
• if you have (or have ever had) angina pectoris (a condition that causes
severe chest pain and may be a first sign of a heart attack) or transient
ischaemic attack (TIA – temporary stroke symptoms);
• if you have any of the following diseases that may increase your risk of a
clot in the arteries:
- severe diabetes with blood vessel damage
- very high blood pressure
- a very high level of fat in the blood (cholesterol or triglycerides)
- a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called ‘migraine with
aura’;
• if you 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) 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 section 6). This can be recognised
by itching, rash or swelling.
Additional information on special populations
Use in children
Ellanite is not intended for use in females whose periods have not yet started.
Warnings and precautions
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 (ie deep vein thrombosis), a blood
clot in the lung (ie pulmonary embolism), a heart attack or a stroke (see
‘Blood clot (thrombosis) section below.
For a description of the symptoms of these serious side effects please go to
“How to recognise a blood clot”.
Tell your doctor if any of the following conditions apply to you.
Talk to your doctor before taking Ellanite. In some situations you need to take
special care while using Ellanite 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 Ellanite, you
should also tell your doctor:
Do not take Ellanite
• 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 (chronic inflammatory
bowel disease)
• if you have haemolytic uraemic syndrome (HUS - a disorder of blood
clotting causing failure of the 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’).
• 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
Ellanite.
• if you have an inflammation in the veins under the skin (superficial
thrombophlebitis).
• if you have varicose veins.
• if you have epilepsy (see “Taking other medicines”)
• if you have systemic lupus erythematosus (SLE –; a disease affecting your
natural defence 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.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Ellanite increases your risk
of developing a blood clot compared with not using one. In rare cases a blood
clot can block blood vessels and cause serious problems.
Blood clots can develop
• in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’
or VTE)
• in the arteries (referred to as an ‘arterial thrombosis’,
‘arterial thromboembolism’ or ATE).
Recovery from blood clots is not always complete. Rarely, there may be
serious lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of a harmful blood clot
due to Ellanite is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or
symptoms.

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
• The use of combined hormonal contraceptives has been connected with
an increase in the risk of blood clots in the vein (venous thrombosis).
However, these side effects are rare. Most frequently, they occur in the
first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot it can cause a deep vein
thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung it can cause a
pulmonary embolism.
• Very rarely a clot may form in a vein in another organ such as the eye
(retinal vein thrombosis).
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of
taking a combined hormonal contraceptive for the first time. The risk may also
be higher if you restart taking a combined hormonal contraceptive (the same
product or a different product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if
you were not using a combined hormonal contraceptive.
When you stop Ellanite 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 Ellanite is
small.
- Out of 10,000 women who are not using any combined hormonal
contraceptive and are not pregnant, about 2 will develop a blood clot
in a year.
- Out of 10,000 women who are using a combined hormonal contraceptive
that contains levonorgestrel, norethisterone, or norgestimate about 5-7 will
develop a blood clot in a year.
- Out of 10,000 women who are using a combined hormonal contraceptive
that contains drospirenone such as Ellanite 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).

Women who are not using
a combined hormonal pill/patch/ring
and are not pregnant
Women using a combined hormonal
contraceptive pill containing
levonorgestrel, norethisterone
or norgestimate
Women using Ellanite

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

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Ellanite 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 Ellanite may need to be stopped several weeks before surgery or while
you are less mobile. If you need to stop Ellanite 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 Ellanite needs to be stopped.
If any of the above conditions change while you are using Ellanite, for example
a close family member experiences a thrombosis for no known reason; or you
gain a lot of weight tell your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems.
For example, it can cause a heart attack or a stroke.
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
Ellanite is very small but can increase:
• with increasing age (beyond about 35 years);
• if you smoke. When using a combined hormonal contraceptive like Ellanite
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 then about 50). In this case you could also have a higher
risk of having a heart attack or stroke;
• if you, or someone in your immediate family, have a high level of fat in the
blood (cholesterol or triglycerides);
• if you get migraines, especially migraines with aura;
• if you have a problem with your heart (valve disorder, disturbance of the
rhythm called atrial fibrillation)
• if you have diabetes.
If you have more than one of these conditions or if any of them are particularly
severe the risk ofdeveloping a blood clot may be increased even more.
.../...

If any of the above conditions change while you are using Ellanite, for example
you startsmoking, a close family member experiences a thrombosis for no
known reason; or you gain a lot of weight, tell your doctor.
Ellanite 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 Ellanite, you may have
unexpected bleeding (bleeding outside the seven pill-free days). If this
bleeding lasts longer than a few months, or if it begins after some months,
contact your doctor as they must find out if anything is wrong.
What to do if no bleeding occurs during the seven pill-free days
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. Only start the next strip if you are
sure that you are not pregnant.

If you have forgotten any of the tablets in a strip, and you do not have bleeding
in the first tablet-free period, this may mean that you are pregnant. Contact
your doctor before you start the next strip.
More than
1 tablet forgotten
in 1 strip

Ask your doctor for advice
YES
Days 1-7

NO

Only 1 tablet
forgotten (taken
more than
12 hours late)

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

Some medicines can make Ellanite 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)
• HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as
griseofulvin, penicillin, tetracycline)
• high blood pressure in the blood vessels in the lungs (bosentan)
• the herbal remedy St. John’s wort
• Ellanite 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.
Ellanite with food and drink
Ellanite 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 oral contraceptives can affect the results of some
tests.
Pregnancy and breast-feeding
Pregnancy
If you are pregnant, do not take Ellanite. If you become pregnant while taking
Ellanite stop taking it immediately and contact your doctor. If you want to
become pregnant, you can stop taking Ellanite at any time.
Breast-feeding
Use of Ellanite 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 Ellanite affects driving or use of
machines.
Ellanite contains lactose
If you cannot tolerate certain sugars, contact your doctor before you take
Ellanite.
3. HOW TO TAKE ELLANITE
Take one tablet of Ellanite 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.
The strip contains 21 tablets. Next to each tablet is printed the day of the
week that it should be taken. If, for example you start on a Wednesday, take a
tablet with “WED” next to it. Follow the direction of the arrow on the strip
until all 21 tablets have been taken.
Then take no tablets for 7 days. In the course of these 7 tablet-free days
(otherwise called a stop or gap week) bleeding should begin. This so-called
“withdrawal bleeding” usually starts on the 2nd or 3rd day of the gap week.
On the 8th day after the last Ellanite tablet (that is, after the 7-day gap week),
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 Ellanite in this manner, you are also protected against pregnancy
during the 7 days when you are not taking a tablet.
When can you start with the first strip
If you have not used a contraceptive with hormones in the previous month
Begin with Ellanite on the first day of the cycle (that is, the first day of your
menstruation). If you start Ellanite 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 Ellanite 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 intrauterine system IUS)
You may switch any day from the progestogen-only pill (from an implant or the
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 taking Ellanite.
After a miscarriage or abortion
If you have had a miscarriage or abortion during the first three months of
pregnancy, your doctor may tell you to start taking Ellanite straight away. This
means that you will have contraceptive protection with your first pill.
After having a baby
You can start taking Ellanite 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 Ellanite use.
If, after having a baby you have had sex before starting Ellanite (again), you
must first be sure that you are not pregnant or wait until the your next
menstrual bleed.
If you are breast-feeding and want to start Ellanite 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 Ellanite than you should
There are no reports of serious harmful results of taking too many Ellanite
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 Ellanite tablets, or you discover that a child has
taken some, ask your doctor or pharmacist for advice.
If you forget to take Ellanite
• If you are less than 12 hours late taking a tablet, the protection from
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 from
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
tablet at the beginning or the end of the strip. Therefore, you should adhere to
the following rules (see also the diagram further down):
More than one tablet forgotten in this strip
Contact your doctor.
One tablet forgotten in week 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 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 may
be pregnant. In that case, contact your doctor.
One tablet forgotten in week 2
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 from pregnancy is not reduced, and you do not
need to take extra precautions. If you forget more than one tablet use an
additional barrier method such as a condom for 7 days.
One tablet forgotten in week 3
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. Take the tablets again
at the usual time. Instead of having seven pill-free days start the next strip
as soon as you have taken the last tablet.
Most likely, you will have a period (withdrawal bleed) at the end of the
second strip but you may also have light or menstruation-like bleeding
during the second strip.
2. You can also stop the strip and go directly to the tablet-free period of 7
days (record the day on which you forgot your tablet). If you want to
start a new strip on your fixed start day, make the tablet-free period less
than 7 days.
If you follow one of these two recommendations, you will remain protected
against pregnancy.

• Take the forgotten tablet
• Finish the strip
• Take the forgotten tablet
and
• Finish the strip
• Instead of the 7 tablet-free
days
• Start the next strip

Other medicines and Ellanite
Tell your doctor if you are using, have recently used or might use any other
medicines.
Also tell any other doctor or dentist who prescribes another medicine (or
the dispensing pharmacist) that you use Ellanite. They can tell you if you
need to take additional contraceptive precautions (for example condoms)
and if so, for how long.

Had sex in the previous
week before forgetting?

Days 15-21

OR
• Stop the strip immediately
• Begin the gap week
(not longer than 7 days)
• Then start the next strip

What to do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking a 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, take another tablet from a reserve strip as soon as
possible. If possible take it within 12 hours of when you normally take your
pill. If that is not possible or 12 hours have passed, you should follow the
advice given under “If you forget to take Ellanite”.
Delaying your period: what you need to know
Even if not recommended, you can delay your menstrual period by skipping the
seven pill-free days and going straight to a new strip of Ellanite and finishing
it. You may experience light or menstruation-like bleeding while using this
second strip. After the usual pill-free period of 7 days start your next strip.
It is advisable to consult your doctor for advice before deciding to
delay your menstrual period.
Changing the first day of your menstrual period: what you must know
If you take the tablets according to the instructions, then your period will begin
during the seven pill-free days. If you have to change this day, make the
pill-free period shorter – (but never longer – 7 days is the maximum!).
For example, if you start the seven pill-free days on a Friday, and you want to
change this to a Tuesday (3 days earlier) start a new strip 3 days earlier than
usual. If you make the pill-free period very short (for example, 3 days or less)
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, contact your doctor for advice.
If you stop taking Ellanite
You can stop taking Ellanite 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 Ellanite 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 product, ask your doctor or
pharmacist.
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
Ellanite, 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
Ellanite”.
The following is a list of the side effects that have been linked with the use of
Ellanite:
Common side effects (between 1 and 10 in every 100 users may be
affected):
• menstrual disorders, bleeding between periods, breast pain, breast
tenderness
• headache, depressive mood
• migraine
• nausea
• thick, whitish vaginal discharge and vaginal yeast infection.
Uncommon side effects (between 1 and 10 in every 1,000 users may
be affected):
• breast enlargement, changes in interest in sex
• high blood pressure, low blood pressure
• vomiting, diarrhoea
• acne, skin rash, severe itching, hair loss (alopecia)
• infection of the vagina
• fluid retention and body weight changes.
Rare side effects (between 1 and 10 in every 10,000 users may be
affected):
• allergic reactions (hypersensitivity), asthma
• breast secretion
• hearing impairment
• the skin conditions erythema nodosum (characterized by painful reddish
skin nodules) or erythema
• multiforme (characterized by rash with target-shaped reddening or sores).
• harmful blood clots in a vein or artery for example:
- in a leg or foot (i.e. DVT)
- in a lung (i.e. PE)
- heart attack
- stroke
- mini-stroke or temporary stroke-like symptoms, known as a transient
ischaemic attack (TIA)
- blood clots in the liver, stomach/intestine, kidneys or eye.
The chance of having a blood clot may be higher if you have any other
conditions that increase this risk (See section 2 for more information on the
conditions that increase risk for blood clots and the symptoms of a blood clot).
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 via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety
of this medicine.
5. HOW TO STORE ELLANITE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after 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.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ellanite contains
The active substances are ethinylestradiol (0.03 mg) and drospirenone (3 mg)
The other ingredients are:
Core: Lactose monohydrate, maize starch, povidone 30, magnesioum
stearate
Film-coating: Hydroxypropylmethylcellulose, hydroxypropylcellulose, talc,
cottonseed oil, titanium dioxide (E 171), yellow iron oxide (E 172)
What Ellanite looks like and content of the pack
One blister pack of Ellanite contains 21 yellow, round film-coated tablets
(with a diameter of about 6 mm).
Each pack contains 1, 3, and 6 blisters.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
STRAGEN UK Ltd
Castle Court
41 London Road
Reigate, Surrey RH2 9RJ
Phone: +44 (0)870 351 87 44
Email: info@stragenuk.com
Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
D-48159 Münster
Germany
This leaflet was last revised in
11/2014.

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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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