Seasonique

Package leaflet: Information for the user

Seasonique 150/30 micrograms + 10 micrograms, film-coated tablets

levonorgestrel/ethinylestradiol
ethinylestradiol
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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 developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet:

1. What Seasonique is and what it is used for
2. What you need to know before taking Seasonique
3. How to take Seasonique
4. Possible side effects
5. How to store Seasonique
6. Contents of the pack and other information

1. What Seasonique is and what it is used for

Seasonique is an extended-cycle 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 called levonorgestrel and ethinylestradiol.
The 7 white tablets contain a small amount of the female hormone ethinylestradiol.

2. What you should know before taking Seasonique

General information
Before starting to use Seasonique, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
Before taking Seasonique, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out additional tests.
This leaflet describes various situations that require discontinuation of Seasonique or in which the reliability of Seasonique may be reduced. In such cases, you must abstain from sexual intercourse, or use additional non-hormonal contraceptive measures, such as a condom or another barrier method. Do not use the rhythm method or basal body temperature method. These methods may be unreliable because Seasonique alters the monthly fluctuations in body temperature and cervical mucus.
Seasonique, like all hormonal contraceptives, offers no protection against HIV (AIDS) or other sexually transmitted infections.

Do not use Seasonique
Do not use Seasonique if you have any of the conditions listed below. If any of the listed conditions occurs for the first time while you are using Seasonique, you must contact your doctor immediately. Your doctor will discuss with you other methods of birth control that might be more suitable for your case.

Do not take Seasonique

• if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are about to undergo surgery or will be bedridden for a prolonged period (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 causing severe chest pain that may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which could increase the risk of developing clots in the arteries:
• severe diabetes with blood vessel damage;
• very high blood pressure;
• very high levels of fats (cholesterol or triglycerides) in the blood;
• 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 had) inflammation of the pancreas (pancreatitis);
• if you have (or have had) a liver disease and liver function is still abnormal;
• if you have or have had a liver tumour;
• if you have (or have had) or are suspected of having breast cancer or cancer of the genital organs;
• if you have unexplained vaginal bleeding;
• if you are taking the herbal product St. John’s wort (Hypericum perforatum);
• if you are allergic to ethinylestradiol or levonorgestrel or any of the excipients of this medicine (listed in section 6). Such allergy may manifest as itching, rash, or swelling;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Seasonique”).

Warnings and precautions
When to be especially careful with Seasonique
When should you contact a doctor?
Contact a doctor urgently

• if you notice possible signs of a blood clot that may indicate you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section "Blood clot (thrombosis)"). For a description of the symptoms of these serious adverse effects, go to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
In certain situations, you will need to take special precautions when using Seasonique or any other combined hormonal contraceptive, and regular check-ups by your doctor may be necessary.
If any of the following conditions apply to you, you must inform your doctor before starting to use Seasonique. You must also inform your doctor if any of these conditions develop or worsen while using Seasonique:

• if a close relative has or has had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you suffer from depression;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are about to undergo surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Seasonique;
• if you have inflammation of the veins just under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see “Other medicines and Seasonique”);
• if you have a condition that first appeared during pregnancy or previous use of sex hormones, for example, hearing loss, porphyria (a blood disorder), herpes gestationis (a blistering skin rash during pregnancy), Sydenham’s chorea (a nerve disorder causing sudden involuntary movements);
• if you have or have had chloasma (golden-brown patches on the skin, known as “melasma” or “pregnancy mask”, especially on the face). In such cases, avoid direct exposure to sunlight or ultraviolet radiation;
• if you are breastfeeding (see “Pregnancy and breastfeeding”);
• if you notice symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with breathing difficulties, contact a doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Blood clots
Using a combined hormonal contraceptive such as Seasonique increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Seasonique is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms
Do you have one of these signs? What could it mean?

• swelling in one leg or along a vein in the leg or foot, Deep vein thrombosis especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased warmth in the affected leg;
• change in skin colour of the leg, such as paleness, redness, or bluish discoloration.
• sudden and unexplained shortness of breath or rapid breathing; Pulmonary embolism
• sudden cough without an obvious cause, possibly with coughing up of blood;
• sharp chest pain that may worsen when breathing deeply;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, contact your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition such as a respiratory tract infection (e.g. a “common cold”).

Symptoms occurring more frequently in an eye: Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision or
• painless blurring of vision that may progress to loss of vision.

Chest pain, discomfort, pressure, or heaviness; Heart attack
Feeling of tightness, fullness, or squeezing in the chest, arm, or under the breastbone;
Feeling of fullness, indigestion, or choking;
Discomfort in the upper body spreading to the back, jaw, throat, arms, or stomach;
Sweating, nausea, vomiting, or dizziness;

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form 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 a combined hormonal contraceptive (the same or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Seasonique, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE (venous thromboembolism) and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Seasonique is low.
Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot over one year.
Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone or norgestimate, about 5–7 will develop a blood clot over one year.

• The risk of VTE associated with the use of Seasonique may be 1.4 times higher than that observed with 28-day combined hormonal contraceptives containing levonorgestrel. The likelihood of a blood clot forming depends on your personal medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Seasonique is low, but certain conditions can increase it. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under about 50 years). In this case, you might have an inherited blood-clotting disorder;
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in plaster. You may need to stop taking Seasonique several weeks before surgery or during periods of reduced mobility. If you need to stop taking Seasonique, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have other listed risk factors.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide that you should stop taking Seasonique.
If any of the above conditions change while you are using Seasonique—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they can lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Seasonique is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive like Seasonique, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions, or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using Seasonique—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Seasonique and cancer
Breast cancer is observed slightly more frequently in women using combined pills, but it is not known whether this is due to the treatment. For example, it is possible that more tumors are diagnosed in women using combined pills because they undergo more frequent medical check-ups. The incidence of breast cancer gradually decreases after stopping treatment with combined hormonal contraceptives. It is important that you regularly examine your breasts and contact your doctor if you notice lumps.
Benign liver tumors have been observed rarely in women using the pill, and malignant liver tumors even more rarely. Contact your doctor if you experience unusual and severe abdominal pain.

Intermenstrual bleeding
When taking Seasonique, which has an extended 91-day dosing cycle, you should expect to have 4 scheduled periods per year (bleeding during the 7 white pills). Each period will last about 3 days.
During the first few months of taking Seasonique, unexpected bleeding may occur. It is not unusual to experience unexpected bleeding, especially during the first pack of Seasonique. This bleeding or spotting tends to decrease over time. Do not stop taking Seasonique because of bleeding or spotting. If spotting continues for more than 7 consecutive days, or if the bleeding is very heavy, contact your doctor.

What to do if no bleeding occurs after Day 84
If the scheduled period does not occur (no bleeding during the days when you take the white pills), consider the possibility of pregnancy. Since scheduled periods are less frequent when taking Seasonique, inform your doctor that you have missed your period and that you are taking Seasonique. Also inform your doctor if you experience symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your primary doctor evaluates the possibility of pregnancy.
Do not start the next pack of Seasonique until you are sure you are not pregnant.

Psychiatric disorders
Some women using hormonal contraceptives, including Seasonique, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, consult your doctor as soon as possible for further medical advice.

Other medicines and Seasonique
Always inform the doctor who prescribed Seasonique if you are taking any other medicines, including herbal remedies. Also inform any other doctor or dentist who may prescribe you another medicine (or the pharmacist) that you are taking Seasonique. They will advise you whether you need to use additional contraceptive measures (e.g., condoms) and for how long.
Some medicines can reduce the effectiveness of Seasonique in preventing pregnancy or may cause unexpected bleeding. These include medications used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin);
• HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as griseofulvin);
• high blood pressure in the pulmonary arteries (bosentan);
• cancer (vemurafenib).
  The herbal remedy St. John’s wort (Hypericum perforatum) may also cause Seasonique to fail.
  Seasonique may affect the action of other drugs, for example:
• the antiepileptic lamotrigine (this may lead to an increased frequency of epileptic seizures).

Do not use Seasonique if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in liver function blood test results (elevated liver enzyme ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medications.
Seasonique may be resumed approximately 2 weeks after completing this treatment. See the section “Do not take Seasonique”.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Laboratory tests
If you need to have a blood test, inform your doctor or laboratory staff that you are taking Seasonique, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
If you are pregnant, you must not use Seasonique. If you become pregnant while taking Seasonique, you must stop taking the pill immediately and contact your doctor.
The use of Seasonique is generally not recommended during breastfeeding, as it may reduce the quantity of breast milk and alter its composition. If you wish to take contraceptive pills during breastfeeding, consult your doctor.

Driving and operating machinery
There is no evidence to suggest that the use of Seasonique affects the ability to drive vehicles or operate machinery.

Seasonique contains lactose
Seasonique contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

Seasonique contains Allura Red (E129)
The pink tablets of Seasonique contain a red dye called Allura Red (E129), which may cause allergic reactions.

3. How to take Seasonique

Each pack contains 84 pink tablets and 7 white tablets arranged in 3 blister packs per pack.
How to take the tablets
Take one tablet of Seasonique every day, if necessary with a little water. You must take the tablets at approximately the same time each day.
Which tablet to take
Do not confuse the tablets: take one pink tablet daily for the first 84 days, then one white tablet daily for the final 7 days.
Start a new pack immediately (84 pink tablets followed by 7 white tablets). There is no break period between two packs.
Due to the different composition of the tablets, you must start with the first tablet in the top left corner of the first blister of the pack and take one tablet each day. For the correct order of tablet intake, follow the direction indicated by the arrows on the blister.
Preparing the pack
To help you keep track of the tablets, there are weekly adhesive strips marked with the 7 days of the week. Choose the strip that starts with the day on which you begin taking the tablets. For example, if you start on Wednesday, use the weekly strip starting with “WED”.
Apply the strip along the top of the Seasonique pack, above the text “Apply weekly sticker here”, so that the first day is positioned above the tablet marked with the number “1”.
The strip thus indicates the corresponding day for each tablet, allowing you to verify whether you have taken a particular tablet. The arrows indicate the order of tablet intake.
Usually, the so-called withdrawal bleeding starts during the intake of the white tablets. After taking the last white tablet, start the next pack of Seasonique immediately, regardless of whether your menstruation has stopped or not. In this way, you will always start a new pack of Seasonique on the same day of the week, and withdrawal bleeding will occur on the same days each time.
If you use Seasonique in this way, you will be protected against unintended pregnancy throughout the entire 91-day period.
When to start the first blister

• If you have not used a hormonal contraceptive in the previous month: Start taking Seasonique on the first day of your cycle (i.e. the first day of menstruation). You may also start between day 2 and day 5 of your cycle, but in this case you must use additional contraceptive precautions (e.g. a condom) for the first 7 days of tablet intake.
• Switching from a combined hormonal contraceptive, or from a combined vaginal contraceptive ring, or from a contraceptive patch: You may preferably start taking Seasonique the day after the last active tablet (the last tablet containing active ingredients) of your previous pill. When switching from a combined vaginal contraceptive ring or from a patch, follow your doctor’s advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant or progestin-releasing IUS): You may switch at any time from the progestogen-only pill to Seasonique (in the case of an implant or progestin-releasing intrauterine device, you may start on the day the implant or device is removed, or in the case of an injectable, on the day the next injection would have been due). In all these cases, you must use additional contraceptive precautions (e.g. a condom) for the first 7 days of tablet intake.
• After spontaneous or induced abortion: Follow your doctor’s advice.
• After childbirth: After childbirth, you may start Seasonique between 21 and 28 days later. If you start later than day 28, you must use additional contraceptive precautions (e.g. a condom) during the first 7 days of taking Seasonique. If, after childbirth, you have had intercourse before starting (or restarting) Seasonique, you must first ensure you are not pregnant, or wait for the next menstruation.
• If you are breastfeeding and wish to start (or restart) taking Seasonique after childbirth: Read the section “Pregnancy and Breastfeeding”.

Ask your doctor for advice if you are unsure about when to start.
If you take more Seasonique than you should
There are no reports of serious harmful effects following an overdose of Seasonique tablets.
If you take several tablets at once, you may experience nausea or vomiting. Young girls may experience vaginal bleeding.
If you have taken too many Seasonique tablets or discover that a child has taken any tablets, contact your doctor or pharmacist immediately.
If you forget to take Seasonique
White tablets: If you forget any of the white tablets (the last 7 tablets in the pack), this will have no effect on the reliability of Seasonique. Do not take the forgotten white tablet(s), and continue with the next tablet at your usual time.
Pink tablets: If you forget to take a pink tablet, depending on the day of your cycle when you missed the tablet, you may need to take additional contraceptive precautions, for example a barrier method such as a condom.
Take the pink tablets according to these rules:

• If the delay in taking a tablet is less than 12 hours, contraceptive protection remains effective. Take the tablet as soon as you remember, then continue taking the following tablets at your usual time.
• If the delay in taking a tablet is more than 12 hours, contraceptive protection may be reduced. The greater the number of tablets missed, the higher the risk that contraceptive effectiveness is reduced. If you miss pink tablets at the beginning of the pack, the risk of becoming pregnant is particularly high. In this case, follow the rules indicated below.

Pink tablet(s) forgotten between days 1-7
Take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the following tablets at your usual time. Use additional contraceptive precautions for the next 7 days, e.g. a barrier method such as a condom. If you had intercourse during the previous week, pregnancy may have occurred. Contact your doctor immediately.
Pink tablet(s) forgotten between days 8-77
Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the following tablets at your usual time. If you have taken the tablets correctly during the 7 days prior to the first missed tablet, contraceptive protection remains effective and no additional contraceptive precautions are necessary. Otherwise, or if you have missed more than one tablet, use additional contraceptive precautions for the next 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 pink tablets close to the phase of white tablets. This high risk can be prevented by adjusting the tablet-taking schedule.
Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the following tablets at your usual time. If you have taken the tablets correctly during the 7 days prior to the first missed tablet, contraceptive protection remains effective and no additional contraceptive precautions are necessary. Otherwise, stop taking the pink tablets and take the white tablets, subtracting the number of missed tablets. Use additional contraceptive precautions for the next 7 days, e.g. a barrier method such as a condom.
Then start a new cycle of Seasonique.
Ask your doctor for further advice.
Table: if more than 12 hours have passed since you forgot to take the pink tablets
Ask your doctor for advice.
YES
Did you have sexual intercourse during the week
Days 1-7 before forgetting the tablets?
NO

• Take the last forgotten tablet and continue taking tablets as usual.
• Use a barrier method (condom) for the next 7 days.
• Finish the blister

Take the forgotten tablet and
continue taking tablets as usual.
No additional contraceptive method
is necessary.
Days 8-
77 If you missed more than one tablet or
did not take the tablets correctly
during the 7 days before, use a barrier method (condom) for the next 7
days.
Take the last forgotten tablet and
continue taking tablets as usual. No additional contraceptive methods
are necessary.
YES
During the 7 days before the first missed
Days 78- tablet, did you take the tablets correctly?
84
NO

• Stop taking the pink tablets. Take the white tablets, subtracting the number of missed tablets. Use a barrier method (condom) for the next 7 days.
• Start a new cycle of Seasonique

If you have forgotten any of the pink tablets and menstruation does not occur during week 13,
you may be pregnant. Consult your doctor before starting a new pack.
What to do in case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking a tablet or have severe diarrhoea, the active ingredients of the tablet may not be completely absorbed by your body. This situation is similar to forgetting to take a tablet. After vomiting or severe diarrhoea, take another tablet as soon as possible. Follow the instructions given in the section “If you forget to take Seasonique”.
If you do not wish to change your normal tablet-taking rhythm, take the extra pink tablet from the last row of the pack.
If you wish to stop taking Seasonique
You may stop taking Seasonique at any time. If you still wish to avoid pregnancy, consult your doctor for advice on other reliable methods of birth control.
If you have any doubts about using this medicine, consult your doctor, midwife, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think may be due to Seasonique, inform your doctor.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before taking Seasonique”.
Serious side effects – seek immediate medical advice

• Hypersensitivity reactions (allergic reactions) – signs include swelling of the face, lips, mouth, tongue or throat, red and irregular rash (urticaria), and itching.
• Blood clot in a blood vessel of the leg (thrombosis), lung (pulmonary embolism), or other organs. For signs of a blood clot, see section 2 “Blood clots”.
• Contact your doctor immediately if you notice any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria possibly associated with breathing difficulties (see also “Warnings and precautions”). If you think you are experiencing any of these side effects, seek medical advice immediately. You may need to stop taking Seasonique.

Very common: may affect more than 1 in 10 people

• Intermenstrual bleeding.

Common: may affect up to 1 in 10 people

• Mood changes, decreased interest in sex, depression
• Headache, migraine
• Nausea, stomach ache
• Acne
• Heavy and prolonged menstrual bleeding, breast tenderness, painful menstruation
• Weight gain.

Uncommon: may affect up to 1 in 100 people

• Fungal infections, fungal and bacterial vaginal infections (including candidiasis), bladder infection, gastroenteritis, throat and sinus infections
• Fibrocystic breast disease, onset or worsening of uterine fibroids (benign tumour)
• Anaemia
• Increased appetite, anorexia, decreased appetite, diabetes mellitus, insulin resistance
• Irritability, anxiety, depressed mood, worsening of depression, emotional distress, sleep disorders, altered orgasm, paranoia
• Dizziness, increased skin sensitivity, absent or reduced sensitivity to skin stimulation
• Vertigo
• Irregular heartbeat, rapid heartbeat
• Hot flushes, high blood pressure, worsening of high blood pressure, low blood pressure when standing up (postural hypotension)
• Sinusitis
• Vomiting, indigestion, diarrhoea, constipation
• Inflammation of the gallbladder, gallstones
• Rash, changes in hair growth and structure, unusual hair loss or thinning, nail disorders, night sweats, skin sensitivity to light, dark skin patches
• Peripheral swelling, back pain, muscle spasms, arthralgia, joint stiffness, myalgia, neck pain
• Dryness of the vagina or vulva, uterine spasms, breast pain, irregular menstruation, breast congestion, breast enlargement, pain during sexual intercourse, bleeding after sexual intercourse, vaginal discharge, nipple discharge, genital itching, genital rash, pelvic pain, polycystic ovary, vulvar disorders, vaginal or vulvar discomfort
• Feeling of tiredness, swelling of certain body parts, pain, chest pain, hot flushes, flu-like symptoms, malaise, fever
• Increased blood pressure, increased blood lipids
• 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 (DVT), in a lung (PE), heart attack, stroke, mini-stroke, or temporary symptoms similar to stroke known as transient ischaemic attack (TIA), or blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).
Not known: frequency cannot be estimated from the available data

• Loss of consciousness
• Alopecia
• Pain in arms or legs

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Seasonique

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light and moisture.
Do not use this medicine after the expiry date stated on the outer carton, the aluminium bag, the blister container, and the blister packs after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Seasonique contains
Active substances:
The active substances are levonorgestrel and ethinylestradiol.
Each pink coated tablet contains 150 micrograms of levonorgestrel and 30 micrograms of
ethinylestradiol.
Each white coated tablet contains 10 micrograms of ethinylestradiol.
Other ingredients in the pink tablets:
Tablet core: lactose (see section 2 “Seasonique contains lactose”), hypromellose, microcrystalline cellulose, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171), Macrogol 400, Allura Red (E129) (see section 2 “Seasonique contains Allura Red (E129)”), polysorbate 80, Brilliant Blue (E133).
Other ingredients in the white tablets:
Tablet core: lactose, potassium polacrilin, microcrystalline cellulose, magnesium stearate.
Tablet coating: titanium dioxide (E171), polydextrose FCC, hypromellose, triacetin, macrogol 8000.

Description of the appearance of Seasonique and contents of the pack
The Seasonique pack contains a total of 3 blisters: 2 blisters contain 28 pink tablets each and 1 blister contains 35 tablets in total – 28 pink tablets and 7 white tablets.
The three blisters are contained within a cardboard container, enclosed in an aluminium foil pouch and placed in a box with the package leaflet.
The pink tablet is round, biconvex, with a diameter of approximately 5.7 mm, marked “172” on one side and “T” on the other.
The white tablet is round, biconvex, with a diameter of approximately 5.7 mm, marked “173” on one side and “T” on the other.

Marketing Authorisation Holder and Manufacturer
Theramex Ireland Limited
Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland

Manufacturer:
Teva Operations Poland
Mogilska 80, 31-546 Krakow
Poland
Teva Pharmaceuticals Europe B.V.
Swensweg 5, 2031 GA Haarlem
The Netherlands

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria, Germany: Seasonique 150 Mikrogramm/30 Mikrogramm + 10 Mikrogramm Filmtabletten
Belgium, Netherlands: Seasonique filmomhulde tabletten
Croatia: Seasonique 0,15 mg/0,03 mg + 0,01 mg filmom obložene tablete
Czech Republic, Denmark, Estonia, Poland, Portugal, Sweden: Seasonique
France: Seasonique 150 microgrammes/30 microgrammes + 10 microgrammes, comprimé pelliculé
Finland: Seasonique 150 mikrog/30 mikrog + 10 mikrog tabletti, kalvopäällysteinen
Hungary: Seasonique 150 mikrogramm/30 mikrogramm + 10 mikrogramm filmtabletta
Italy: Seasonique 150/30 microgrammi + 10 microgrammi, compresse rivestite con film
Latvia: Seasonique 150 mikrogrami/30 mikrogrami + 10 mikrogrami apvalkotās tabletes
Luxembourg: Seasonique, comprimés pelliculés
Romania: Seasonique 150/30 micrograme + 10 micrograme comprimate filmate
Slovakia: Seasonique 0,15mg/0,03mg +0,01 mg filmom obalené tablety
Slovenia: Seasonique 0,15 mg/0,03 mg in 0,01 mg filmsko obložene tablete
Spain: Seasonique comprimidos recubiertos con pelicula
United Kingdom: Seasonique 150 micrograms/30 micrograms and 10 micrograms Film-coated Tablets