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 include any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Lucette ED is and what it is used for

2.    What you need to know before you use Lucette ED

3.    How to take Lucette ED

4.    Possible side effects

5.    How to store Lucette ED

6.    Contents of the pack and other information

1.    WHAT LUCETTE ED IS AND WHAT IT IS USED FOR

•    Lucette ED is a contraceptive pill and is used to prevent pregnancy.

•    Each white tablet contains a small amount of two different female hormones, namely ethinylestradiol and drospirenone.

•    The green tablets contain no active substance and are also called placebo tablets.

•    Contraceptive pills that contain two hormones are called "combination” pills.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE LUCETTE ED

General notes

Before you start using Lucette ED 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 Lucette ED, 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 Lucette ED, or where the reliability of Lucette ED 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 Lucette ED alters the monthly changes of body temperature and cervical mucus.

Lucette ED, like other hormonal contraceptives, does not protect against HIV infection (AIDs) or any other sexually transmitted disease.

Do not use Lucette ED

You should not use Lucette ED 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 are allergic to ethinylestradiol or drospirenone, peanut or soya, or any of the other ingredients of this medicine (listed in section 6.). This may cause itching, rash or swelling.

•    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) 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lucette ED.

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”.

Tell your doctor if any of the following conditions apply to you.

If some situations you need to take special care while using Lucette ED or any other combination pill, and your doctor may need to examine you regularly. If any of the following conditions applies to you, you must inform your doctor before starting to use Lucette ED.

If the condition develops, or gets worse while you are using Lucette ED, 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 epilepsy (see "Other medicines and Lucette ED”);

•    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 disease of the nerves in which sudden movements of the body occur (Sydenham's chorea));

•    if you have or have ever had chloasma (discolouration of the skin, especially on the face or neck known as "pregnancy patches”). If so, avoid direct 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;

•    if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)

•    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 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 Lucette ED;

•    if you have an inflammation in the veins under the skin (superficial thrombophlebitis);

•    if you have varicose veins.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Lucette ED 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 Lucette ED 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 Lucette ED 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 Lucette ED 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 Lucette ED 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)

	Risk of developing a blood clot in a year
Women who are not using a combined hormonal pill/patch/ring 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 Lucette ED	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 Lucette ED 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 (e.g. 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 Lucette ED may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Lucette ED 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 Lucette ED needs to be stopped.

If any of the above conditions change while you are using Lucette ED, 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 Lucette ED is very small but can increase:

•    with increasing age (beyond about 35 years);

•    if you smoke. When using a combined hormonal contraceptive like Lucette ED 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;

•    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 Lucette ED, 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.

Lucette ED and cancer

Breast cancer has been observed slightly more often in women using combination pills, but it is not known whether this is caused by the treatment. For example it may be that more tumours are detected in women on combination pills because they are examined by their doctor more often.

The occurrence of breast tumours becomes gradually less after stopping the combination hormonal contraceptives. It is important to regularly check your breasts and you should contact your doctor if you feel any lump.

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 Lucette ED, you may have unexpected bleeding (bleeding outside the gap week). If this bleeding occurs for more than a few months, or if it begins after some months, contact your doctor so that they can find out if anything is wrong.

What you must do if no bleeding occurs in the placebo week

If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea and you have not taken any other medicines, it is highly unlikely that you are pregnant.

If the expected bleeding does not happen twice in succession, you may be pregnant. Contact your doctor immediately. Do not start the next strip until you are sure that you are not pregnant.

Other medicines and Lucette ED

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Always tell your doctor, who prescribes Lucette ED, which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use Lucette ED. 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 Lucette ED 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.

Lucette ED 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.

Taking Lucette ED with food and drink

Lucette ED 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 and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

If you are pregnant, you must not take Lucette ED. If you become pregnant while taking Lucette ED stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Lucette ED at any time (see also "If you want to stop taking Lucette ED”).

Breast-feeding

Use of Lucette ED 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 Lucette ED affects driving or use of machines.

Lucette ED contains lactose, soya lecithin and sunset yellow

In Lucette ED the white active film-coated tablets contain 48.17 mg of lactose monohydrate and the green inactive ones contain 37.26 mg of lactose anhydrous per film-coated tablets. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

In Lucette ED the white active film-coated tablets contain soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

The hormone-free (placebo) film-coated tablets contain "sunset yellow” colouring agent which may cause allergic reaction

3. how to take lucette ed

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Each blister contains 21 active white tablets and 7 green placebo tablets.

The two different kinds of coloured tablets in Lucette ED are arranged in order. The pack contains 28 tablets.

Take one tablet of Lucette ED every day, if necessary with a small amount of water. You may take the tablets with or without food, but you should take the tablets every day around the same time.

Do not confuse the tablets:

Take a white tablet for the first 21 days, then a green tablet for the last 7 days. You must then start a new strip straightaway (21 white and then 7 green tablets). There is therefore no gap between two strips.

Because of the different composition of the tablets, it is necessary to begin with the first tablet on the upper left and 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 control the daily taking of the pill, use the arrows on the pack. The arrows show the order in which the tablets should be taken.

You must know on which day of the week you will take the first tablet (You can mark the first day on the pack).

During the 7 days that when you are taking the green placebo tablets (the placebo week), bleeding should begin (so-called withdrawal bleeding). This usually starts on the 2nd or 3rd day after the last white active tablet of Lucette ED. Once you have taken the last green tablet, you should start with the following strip, whether your bleeding has stopped or not. This means that you should start the following strip on the same day of the week, and that the withdrawal bleed should occur on the same days each month.

If you use Lucette ED in this manner, you are protected against pregnancy also during the 7 days that you are taking a placebo tablet.

When can you start with the first strip?

•    If you have not used a contraceptive with hormones in the previous month

Begin with Lucette ED on the first day of the cycle (that is, the first day of your period). If you start Lucette ED on the first day of your menstruation you are immediately protected against pregnancy. You may also begin on day 2-5 of the cycle, but then you must use extra protective measures (for example, a condom) for the first 7 days.

•    Changing from a combined hormonal contraceptive, or combined contraceptive vaginal ring or patch

You can start Lucette ED on the day after the last active tablet (the last tablet contaning 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 you change 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 an IUS on the day of its removal, from an injectable when the next injection would be due), but in all of these cases you must use extra protective measures (for example, a condom) for the first 7 days of tablet-taking.

•    After a miscarriage or abortion

Follow the advice of your doctor.

•    After having a baby

You can start taking Lucette ED between 21 and 28 days after having a baby. If you start later than day 28, use a so-called barrier method (for example, a condom) during the first seven days of taking Lucette ED.

If, after having a baby, you have had sex before starting Lucette ED (again), you must first be sure that you are not pregnant or you must wait until your next period.

•    If you are breast-feeding and want to start taking Lucette ED 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 Lucette ED than you should

There are no reports of serious harmful results of taking too many Lucette ED tablets.

If you take several tablets at once then you may have symptoms of nausea or vomiting. Young girls may have bleeding from the vagina.

If you have taken too many Lucette ED tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take Lucette ED

The last seven tablets of the strip are placebo tablets. If you forget to take one of these tablets, this has no effect on the reliability of Lucette ED . You should throw away the forgotten placebo tablet so that you do not make the placebo week longer. This might have a negative effect on the reliability of Lucette ED.

If you miss a white active tablet from the strip (film-coated tablet 1-21) you must follow the following advice:

•    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 in 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 to take a tablet from the beginning of the pack or at the end of the third week. Therefore, you should keep to the following rules (see also the diagram below):

•    More than one tablet are 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 against pregnancy is not reduced, and you do not need to take extra precautions.

•    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. Continue taking the tablets at the usual time. Instead of taking the placebo tablets, throw them away, and start the next strip.

Most likely, you will have a period at the end of the second strip- while taking the green placebo tablets, but you may have light or menstruation like bleeding during the second strip.

2.    You can also stop the active white tablets and go directly to the 7 green placebo tablets (before taking the placebo tablets, record the day on which you forgot your tablet). If you want to start a new strip on the day you always start, take the placebo tablets for less than 7 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 bleeding in the normal placebo week, this may mean that you are pregnant. You must contact your doctor before you go on to the next strip.

What to do in the case of vomiting or severe diarrhoea

If you vomit within 3-4 hours of taking an active white tablet or you have severe diarrhoea, there is a risk that the active substances in the pill are not fully taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea, you must take another white tablet from a reserve strip as soon as possible. If possible take it within 12 hours of when you normally take your pill. If this is not possible or 12 hours have passed, you should follow the advice given under "If you forget to take Lucette ED

Delaying a menstrual period: what you need to know

Even if not recommended, you can delay your period by not taking the green placebo tablets (tablets 22-28) and going straight on to a new strip of Lucette ED and finishing it. You may experience light or mentruation-like bleeding while using this second strip. Finish this second strip by taking the 7 green tablets. 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 menstrual period: what you need to know

If you take the tablets according to the instructions, your period will begin during the placebo week. If you have to change this day, reduce the number of placebo days - when you take the green placebo tablets - (but never increase them - 7 is the maximum!) For example, if you normally start taking the placebo tablets on a Friday, and you want to change this to a Tuesday (3 days earlier), start the new strip 3 days earlier than usual. If you make the placebo period very short (for example,

3 days or less), you may not have any bleeding during these days. You may then experience light or mentsruation-like bleeding.

If you are not sure what to do, consult your doctor.

if you want to stop taking Lucette ED

You can stop taking Lucette ED whenever you want. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control.

If you want to become pregnant, stop taking Lucette ED and wait for a 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.

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 Lucette ED, 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 use Lucette ED"

The following is a list of the side effects that have been linked with the combined use of ethinylestradiol and drospirenone:

Common side effects (may affect up to 1 in 10 people):

•    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 (may affect up to 1 in 100 people):

•    breast enlargement, changes in interest in sex,

•    high blood pressure, low blood pressure,

•    vomiting, diarrhoea,

•    acne (pimples), skin rash, severe itching, hair loss (alopecia),

•    inflammation of the vagina,

•    fluid retention and body weight changes.

Rare side effects (may affect up to 1 in 1,000 people):

•    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))allergic reactions (hypersensitivity), asthma,

•    breast secretion,

•    hearing impairement,

•    blockage of blood vessels by a clot formed elsewhere in the body,

•    the skin conditions erythema nodosum (characterized by painful reddish skin nodules) or erythema multiforme (characterized by rash with target-shaped reddening or sores).

The following serious adverse events have been reported in women using combined oral contraceptives (COCs), which are discussed in section 2 "What you need to know before you take Lucette ED":

•    Venous and arterial thrombosis, high blood pressure, liver tumours;

•    Occurrence or deterioration of the following diseases have been reported, however the causal relationship with the use of the pill is not unambiguous: chronic inflammatory bowel disease, epilepsy, migraine, benign tumour of the womb, porphyria (metabolic disease with disorder of the formation of the pigment of the red blood cells), systemic lupus erythematosis (with a characteristic butterfly rash, a particular autoimmune disease), movement disorder called Sydenham's chorea, haemolytic uraemic syndrome (a particular form of damage to the red blood cells and the kidneys), cholestatic icterus (jaundice).

The frequency of diagnosis of breast cancer is very slightly increased among OC users. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. Causation with COC use is unknown. For further information, see section 2 "Do not take Lucette ED", "Warnings and precautions" and "What do you need to know before you take Lucette ED".

In women with hereditary angioedema estrogens may induce or exacerbate symptoms of angioedema (see section 2 "What do you need to know before you take Lucette ED").

If you have any unusual symptoms such as unexplained pains in the chest, abdomen or legs, you must consult your doctor immediately.

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 the Yellow Card Scheme at: 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 lucette ED

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after "EXP". The expiry date refers to the last day of that month.

Store below 30 °C. Store in the original package in order to protect from light.

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.

6.    contents of the pack and other information

What Lucette ED contains

•    The active substances are 0.03 mg ethinylestradiol and 3 mg drospirenone in each white tablet.

•    The other ingredients are:

Active film-coated tablets:

Tablet core:

lactose monohydrate, maize starch,

pregelatinised maize starch, povidone K-25, magnesium stearate.

Film-coating:

poly(vinyl alcohol), titanium dioxide (E171), talc (E553b), macrogol 3350, lecithin (soya).

Placebo film-coated tablets:

Tablet core:

microcrystalline cellulose, lactose anhydrous, pregelatinised maize starch, magnesium stearate, colloidal anhydrous silica.

Film-coating:

poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc (E553b), indigo carmine (E132), quinoline yellow (E104), iron oxide black (E172), sunset yellow FCF (E110).

What Lucette ED looks like and contents of the pack

The active film-coated tablet is white or almost white, round, biconvex film-coated tablet, diameter about 6 mm. Engraving on one side: "G63", other side is without engraving.

The placebo film-coated tablet is green, round, biconvex film-coated tablet, diameter about 6 mm, without engraving.

Lucette ED 0.03 mg/3 mg film-coated tablets are packed in PVC/PVDC-Al blister packs. The blisters are packed into folding box with patient leaflet and etui storage bag is enclosed in each box.

Pack sizes:

21+7 film-coated tablets 3x21+7 film-coated tablets 6x21+7 film-coated tablets 13x21+7 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Gedeon Richter Plc.

1103 Budapest,

Gyomroi ut 19-21.

Hungary

This leaflet was last revised in April 2014.

© GEDEON RICHTER