Package leaflet: Information for the user

Eloine*

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. See section 4.

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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    7

2.    What you need to know before you take ELOINE    8

When you should not use ELOINE    10

Warnings and precautions    13

Blood clots    18

ELOINE and cancer    33

Bleeding between periods    34

What you must do if no bleeding occurs during the placebo days    35

Other medicines and ELOINE    36

ELOINE with food and drink    38

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Laboratory tests    39

Pregnancy    39

Breast-feeding    40

Driving and using machines    40

ELOINE contains lactose    40

3. How to take ELOINE    41

Preparation of the strip    42

When can you start with the first strip?    44

If you take more ELOINE than you should    47

If you forget to take ELOINE    47

What to do in the case of vomiting or severe diarrhoea 53 Delaying your period: what you need to know    54

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Changing the first day of your period: what you need to

	know	54
	If you stop taking ELOINE	55
4.	Possible side effects	57
5.	How to store ELOINE	65
6.	Contents of the pack and other information	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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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

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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.

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 (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 ulcerative colitis (chronic

inflammatory bowel disease); 14
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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

0 and ELOINE”)    0

•    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

•    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

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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?	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	Deep vein thrombosis

-    increased warmth in the affected leg -    change in colour of the skin on the leg e.g. turning pale, red or blue
•    sudden unexplained breathlessness or rapid breathing; •    sudden cough without an obvious cause, which may bring up blood; •    sharp chest pain which may increase with deep breathing; •    severe light headedness or dizziness; •    rapid or irregular heartbeat •    severe pain in your stomach;	Pulmonary embolism

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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	Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, heaviness	Heart attack

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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 of an extremity; •    severe pain in your stomach (acute abdomen)	Blood clots blocking other blood vessels

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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	Risk of developing a blood clot in a year
Women who are not using a combined hormonal pill and are not pregnant	About 2 out of 10,000 women
Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 out of 10,000 women
Women using ELOINE	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 30

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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 take ELOINE. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long, or, whether the use of another medicine you need must be changed.

Some medicines

•    can have an influence on the blood levels of Eloine and

•    can make it less effective in preventing pregnancy

•    can cause unexpected bleeding.

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These include

• medicines used for the treatment of

-    epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)

-    tuberculosis (e.g. rifampicin)

-    HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)

-    fungal infections (griseofulvin, ketoconazole)

-    arthritis, arthrosis (etoricoxib)

-    high blood pressure in the blood vessels in the lungs (bosentan)

-    the herbal remedy St. John’s wort

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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)

-    theophylline (used to treat breathing problems)

-    tizanidine (used to treat muscle pain and/or muscle cramps).

Ask your doctor or pharmacist for advice before taking any medicine.

ELOINE with food and drink

ELOINE may be taken with or without food, if necessary with a small amount of water.

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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”).

Ask your doctor or pharmacist for advice before taking any medicine.

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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.

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

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 2^nd or 3^rd 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 44

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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 (progestogen-only pill, injection, implant or a progestogen-releasing IUD)

You may switch any day from the progestogen-only pill (from an implant or an IUD on the day of its removal, from an injectable when the next injection would be due) but in all of these cases you must use extra protective measures (for example, a condom) for the first 7 days of 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 40.

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 4^th 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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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 4^th 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 4^th 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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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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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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•    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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(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 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).

Reportinq 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

Website: www.medicinesauthority.gov.mt/adrportal

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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 use 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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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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•    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 film-coated tablets in the 1^st, 2^nd, 3^rd and 4^th rows of 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.

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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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Marketing Authorisation Holder

Bayer pic, Bayer House, Strawberry Hill, Newbury, Berkshire,

RG141JA

Manufacturer

Bayer Pharma AG and Bayer Weimar GmbH und Co. KG 13342 Berlin, Germany Dobereinerstr. 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, Spain, Sweden, United Kingdom: Eloine

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)1_03.indd 72 27.08.2015 10:52:57

version: 27.08.2015/03    approval:    dimension: 85 x 60 mm