SEASONIQUE® 150 micrograms/30 micrograms AND 10 micrograms FILM-COATED TABLETS

levonorgestrel/ethinylestradiol

ethinylestradiol

PACKAGE LEAFLET: INFORMATION FOR THE USER

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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, even if their signs of illness are the same as yours.

•    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.

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").

What is in this leaflet

1.    What Seasonique is and what it is used for

2.    What you need to know before you take Seasonique

3.    How to take Seasonique

4.    Possible side effects

5.    How to store Seasonique

6.    Contents of the pack and other information

What Seasonique is and what it is used for

Seasonique is an extended-regimen contraceptive pill taken continuously for 91 days and is used to prevent pregnancy.

Each of the 84 pink tablets contains a small amount of two different female hormones, namely levonorgestrel and ethinylestradiol.

The 7 white tablets contain a small amount of female hormone ethinylestradiol.

^2 What you need to know before you take Seasonique

General notes

Before you start using Seasonique 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 Seasonique, 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 Seasonique, or where the reliability of Seasonique may be decreased. In such situations you should either not have sex or you should take additional 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 Seasonique alters the monthly changes of body temperature and cervical mucus.

Seasonique, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

When you should not use Seasonique

You should not use Seasonique if you have any of the conditions listed below. Should any of the conditions appear for the first time during use of Seasonique, you must tell your doctor

PHARMACODE

area

immediately. Your doctor will discuss with you what other form of birth control would be more appropriate.

Do not take Seasonique

•    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 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 (had) an inflammation of the pancreas (pancreatitis)

•    if you have or have had in the past a liver disease and your liver function is still not normal

•    if you have or have had a tumour in the liver

•    if you have (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 taking the herbal product St. John's Wort

•    if you are allergic to ethinylestradiol or levonorgestrel, or any of the other ingredients of this medicine (listed in section 6). This can be recognised by itching, rash or swelling.

Warnings and precautions

When to take special care with Seasonique

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 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.

In some situations you need to take special care while using Seasonique or any other combined hormonal contraceptive, and it may be necessary that you are regularly checked by your doctor.

If any of the following conditions applies to you, you must inform your doctor before starting to use Seasonique. Also, if any of the following conditions develops, or gets worse while you are using Seasonique, you should also tell your doctor:

•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 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 Seasonique

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

•    if you have varicose veins

•    if you have epilepsy (see "Other medicines and Seasonique")

•    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

•    if you are breast-feeding (See "Pregnancy and breast-feeding").

Blood clots

Using a combined hormonal contraceptive such as Seasonique 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 Seasonique 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 •    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.
•    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 (e.g. a 'common cold').	Pulmonary embolism.
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 •    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.

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 Seasonique 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

Seasonique 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.

•    It is not yet known how the risk of a blood clot with Seasonique compares to the risk with other levonorgestrel-containing CHCs.

•    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 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 Seasonique	Not yet known

Factors that increase your risk of a blood clot in a vein

The risk of a blood clot with Seasonique 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 Seasonique may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Seasonique 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 Seasonique needs to be stopped.

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

•    with increasing age (beyond about 35 years)

•    if you smoke. When using a combined hormonal contraceptive like Seasonique 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 of developing a blood clot may be increased even more.

If any of the above conditions change while you are using Seasonique, 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.

Seasonique 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 contraceptive pill users. Contact your doctor if you have unusual severe abdominal pain.

Bleeding between periods

When you take Seasonique, which has a 91-day extended dosing cycle, you should expect to have 4 scheduled periods per year

(bleeding when you are taking the 7 white pills). Each period is likely to last about 3 days.

During the first few months that you are taking Seasonique, you may have unexpected bleeding. It is not unusual to experience unexpected bleeding especially during the first Seasonique pack. This bleeding or spotting tends to decrease with time. Do not stop taking Seasonique because of this bleeding or spotting. If the spotting continues for more than 7 consecutive days or if the bleeding is heavy, contact your doctor.

What you must do if no bleeding occurs after Day 84

You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days when you are taking white tablets). Since scheduled periods are less frequent when you are taking Seasonique, notify your doctor that you have missed your period and that you are taking Seasonique. Also notify your doctor if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider evaluates you to determine if you are pregnant.

Do not start the next Seasonique pack until you are sure that you are not pregnant.

Other medicines and Seasonique

Always tell the doctor, who prescribes Seasonique, 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 Seasonique. 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 Seasonique 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, topiramate, felbamate)

•    tuberculosis (e.g. rifampicin)

•    HIV infections (ritonavir, nevirapine) or other infections (an antibiotic named griseofulvin)

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

•    cancer (vemurafenib).

The herbal product St. John's Wort may also stop Seasonique from working properly.

Seasonique may influence the effect of other medicines, e.g.:

•    the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures).

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

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking Seasonique, because oral contraceptives can affect the results of some tests.

Pregnancy and breast-feeding

If you are pregnant, you must not take Seasonique. If you become pregnant while taking Seasonique you must stop immediately and contact your doctor.

Use of Seasonique is generally not advisable when a woman is breast-feeding as it may decrease quantity of breast milk and change its composition. If you want to take contraceptive pills while you are breast-feeding you should contact your doctor.

Driving and using machines

There is no information suggesting that use of Seasonique affects driving or use of machines.

Seasonique contains lactose

Seasonique contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Seasonique contains allura red AC (E129) and brilliant blue FCF (E133)

Seasonique pink tablets contain a red colour called allura red AC (E129) and a blue colour called brilliant blue FCF (E133), which may cause allergic reactions.

^3 How to take Seasonique

Each pack contains 84 pink tablets and 7 white tablets placed in 3 blisters in a pack.

How to take the tablets

Take one tablet of Seasonique every day, if necessary with a small amount of water. You should take the tablets every day around the same time.

Which tablets to take

Do not confuse the tablets: take a pink tablet for the first 84 days and then a white tablet for the last 7 days.

A new pack is started straightaway (84 pink and then 7 white tablets). There is therefore no gap between two packs.

Because of the different composition of the tablets it is necessary to begin with the first tablet on the upper left corner of the first blister in the pack and that you take the tablets every day. For the correct order, follow the direction of the arrows on the blister.

Preparation of the pack

To help you keep track, there are 7 weekday sticker strips marked with the 7 days of the week. 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 Seasonique pack where it reads "Place week sticker here" so that the first day is above the tablet marked "1"

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.

Usually, so-called withdrawal bleeding starts when you are taking white tablets.

Once you have taken the last white tablet, you should start with the following Seasonique pack, whether your bleeding has stopped or not. This means that you should start every pack on the same day of the week, and that the withdrawal bleed should occur on the same days each time.

If you use Seasonique in this manner, you are protected against pregnancy during the whole 91 days.

When can you start with the first strip?

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

Begin with Seasonique on the first day of the cycle (that is the first day of your menstruation).

You may also begin on day 2-5 of the cycle, but then you must use additional contraceptive precautions (for example, a condom) for the first 7 days of tablet taking.

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

You can start Seasonique preferably on the day after the last active tablet (the last tablet containing the active substances) 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 the IUD on the day of its removal, from an injectable when the next injection would be due).

In all of these cases you must use additional contraceptive precautions (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:

After having a baby, you can start Seasonique between 21 and 28 days later. If you start later than day 28, you must use additional contraceptive precautions (for example, a condom) during the first 7 days of Seasonique use. If, after having a baby, you have had intercourse before starting Seasonique (again), you must first be sure that you are not pregnant or you must wait until the next menstrual bleed.

•    If you are breast-feeding and want to start Seasonique (again) after having a baby:

Read the section on "Pregnancy and breast-feeding"

If you are not sure when to start, check with your doctor.

If you take more Seasonique than you should

There are no reports of serious harmful results of taking too many Seasonique 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 Seasonique tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take Seasonique

White tablets: If you forget any of the white tablets (last 7 tablets in the pack), this has no effect on the reliability of Seasonique. Do not take the forgotten white tablet(s) and continue with the next tablet at the usual time.

Pink tablets: If you miss a pink tablet, depending on the day of the cycle on which the tablet has been missed, you may need to take additional contraceptive precautions, for example a barrier method such as a condom.

Take the pink tablets according to the following principles:

•    If you are less than 12 hours late when taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then continue taking the tablets again at the usual time.

•    If you are more than 12 hours late taking a tablet, the protection against pregnancy may be reduced. The greater the number of tablets you have forgotten the greater is the risk of becoming pregnant. There is a particularly high risk of becoming pregnant if you miss pink tablets at the beginning of the pack. Therefore you should follow the rules given below.

Pink tablet(s) forgotten between days 1-7

Take the last missed tablet as soon as you remember even if this means taking two tablets at the same time. Continue taking the following tablets at the usual time. Use additional contraceptive precautions for the following 7 days e.g. a barrier method such as a condom. If you have had sex in the week before forgetting the tablet you may be pregnant. So contact your doctor immediately.

Pink tablet(s) forgotten between days 8-77

Take the tablet as soon as you remember even if this means taking two tablets at the same time. Continue taking the following tablets at the usual time. If you have taken your tablets correctly in the 7 days preceding the first missed tablet, the protection against pregnancy is not reduced and you do not need to take additional contraceptive precautions. However, if this is not the case or if you have missed more than one tablet, use additional contraceptive precautions for the following 7 days e.g. a barrier method such as a condom.

Pink tablet(s) forgotten between days 78-84

There is a particularly high risk of becoming pregnant if you miss the pink tablets close to the white tablet phase. By adjusting your tablet-intake schedule this higher risk can be prevented.

Take the last tablet as soon as you remember even if this means taking two tablets at the same time. Continue taking the following tablets at the usual time. If you have taken your tablets correctly in the 7 days preceding the first missed tablet, the protection against pregnancy is not reduced and you do not need to take additional contraceptive precautions. However, if this is not the case stop taking the pink tablets and take white tablets minus the number of tablets you have missed. Use additional contraceptive precautions for the following 7 days e.g. a barrier method such as a condom.

You can then start a new cycle of Seasonique.

Contact your doctor for further advice.

Chart: if you are more than 12 hours late taking pink tablets

If you have forgotten any of the pink tablets, and you have no bleeding during week 13, you may be pregnant. Contact your doctor before you start the next pack.

What you must 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 are not fully absorbed into your body. The situation is similar to if you forget a tablet. After vomiting or diarrhoea, you must take another tablet as soon as possible. The advice given under "If you forget to take Seasonique" should be followed.

If you don't want to change your normal tablet-taking pattern take the extra pink tablet from the last row in the pack.

If you want to stop taking Seasonique

You can stop taking Seasonique 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 have any further questions on the use of this product, ask your doctor, midwife or pharmacist.

4 Possible side effects

Like all medicines, Seasonique 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 Seasonique, 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 Seasonique"

Serious side effects - see a doctor straight away:

•    hypersensitivity reaction (allergic reaction) - signs include swelling of the face, lips, mouth, tongue or throat; a red bumpy rash (hives) and itching

•    blood clot in a blood vessel of the leg (thrombosis), of the lung (pulmonary embolism) or other organs. For signs of a blood clot (see section 2 'Blood clots').

If you think you may have any of these, see a doctor straight away. You may need to stop taking Seasonique.

Very common: may affect more than 1 in 10 people

•    bleeding between your periods.

Common: may affect up to 1 in 10 people

•    mood change, decreased interest in sex, depression

•    headache, migraine

•    nausea, stomach ache

•    acne

•    heavy prolonged menstrual bleeding, breast tenderness, painful periods

•    weight increased.

Uncommon: may affect up to 1 in 100 people

•    fungal infection, fungal and bacterial vaginal infection (including candidiasis), bladder infection, gastroenteritis, throat and sinus infection

•    fibrocystic breast disorder, uterine fibroids (benign tumour) occurrence or aggravation

•    anaemia

•    increased appetite, anorexia, decreased appetite, diabetes mellitus, resistance to insulin

•    irritability, anxiety, depressed mood, worsening of depression emotional distress, difficulty sleeping, abnormal orgasm, paranoia

•    dizziness, skin feeling more sensitive, absent or reduced sensitivity to skin stimulation

•    vertigo

•    irregular heartbeat, fast heartbeat

•    hot flushes, high blood pressure, worsening of high blood pressure, low blood pressure when standing up

•    sinus congestion

•    vomiting, indigestion, diarrhoea, constipation

•    inflammation of the gallbladder, gallstones

•    rash, changes in hair growth and texture, unusual hair loss or thinning, nail disorder, night sweats, skin sensitivity to light, skin hyperpigmentation

•    peripheral swelling, back pain, muscle cramps, pain in joints, joint stiffness, muscle pain, neck pain

•    vulvovaginal dryness, spasm of uterus, breast pain, irregular periods, breast swelling, breast enlargement, painful intercourse, bleeding following intercourse, vaginal discharge, breast discharge, genital itching, genital rash, pelvic pain, polycystic ovaries, vulvar disorder, vulvovaginal discomfort

•    feeling tired, swelling of parts of your body, pain, chest pain, feeling hot, flu-like symptoms, feeling unwell, fever

•    blood pressure increased, increase in blood fats

•    weight loss.

Rare: 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).

Not known: frequency cannot be estimated from the available data

•    hypersensitivity reaction (allergic reaction)

•    loss of consciousness

•    baldness

•    pains in arms or legs.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

How to store Seasonique

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

Store in the original package in order to protect from light and moisture.

Do not use this medicine after the expiry date that is stated on the outer carton, foil pouch, blister pack holder and blister after EXP The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Seasonique contains Active substances:

One pink film-coated tablet contains 150 micrograms levonorgestrel and 30 micrograms ethinylestradiol.

One white film-coated tablet contains 10 micrograms ethinylestradiol.

Other ingredients (excipients) in the pink tablet:

Tablet core: anhydrous lactose, hypromellose, microcrystalline cellulose, magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), macrogol 400, allura red AC aluminium lake (E129), polysorbate 80, brilliant blue FCF aluminium lake (E133).

Other ingredients (excipients) in the white tablet:

Tablet core: anhydrous lactose, polacrilin potassium, microcrystalline cellulose, magnesium stearate.

Tablet coating: titanium dioxide (E171), polydextrose FCC, hypromellose, triacetin, macrogol 8000.

What Seasonique looks like and contents of the pack

Seasonique pack contains 3 blisters in total: 2 blisters each holding 28 pink tablets and 1 blister holding 35 tablets in total- 28 pink tablets and 7 white tablets.

Three blisters are placed inside a carton folder, placed into foil pouch and box with leaflet.

The pink tablet is round, biconvex tablet, around 5.7 mm in diameter, embossed "172" on one side and "T" on the other side. The white tablet is round, biconvex tablet, around 5.7 mm in diameter, embossed "173" on one side and "T" on the other side.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer

Teva Operations Poland Sp. z.o.o, ul. Mogilska 80., Krakow, 31-546, Poland

This leaflet was last revised in 02/2016

PL 00289/1900

TEUZD    20606-B

TEVA UK LIMITED    408 x 406