Seasonique

Package leaflet: Information for the user

Seasonique
(150 micrograms + 30 micrograms) and 10 micrograms, coated tablets
Levonorgestrelum + Ethinylestradiolum
Ethinylestradiolum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives

• When used correctly, they are among the most reliable reversible methods of contraception.
• They slightly increase the risk of venous and arterial blood clots, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

Contents of the leaflet

1. What Seasonique is and what it is used for
2. 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

1. What Seasonique is and what it is used for

Seasonique is an extended-cycle oral contraceptive taken continuously for 91 days to prevent pregnancy.
Each of the 84 pink tablets contains a small amount of two different female hormones: levonorgestrel and ethinylestradiol.
The 7 white tablets contain a small amount of the female hormone ethinylestradiol.

2. Before you take Seasonique

General notes
Before starting Seasonique, read the information about blood clots in section 2. It is particularly important to understand the symptoms of blood clots (see section 2 "Blood clots").
Before you start taking Seasonique, your doctor will ask questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and may perform additional tests depending on your health status.
This leaflet describes several situations in which you should stop taking Seasonique or when its effectiveness may be reduced. In such cases, you should either avoid sexual intercourse or use additional non-hormonal contraception, such as a condom or another mechanical method. Do not use the rhythm method or temperature-based methods, as they may be ineffective because Seasonique affects the monthly variation in body temperature and cervical mucus characteristics.
Seasonique, like other hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted infections.

When not to take Seasonique
Do not take Seasonique if any of the following conditions apply to you. If any of these conditions develop for the first time while taking Seasonique, inform your doctor. Your doctor will discuss a more suitable contraceptive method with you.

Do not take Seasonique if you:

• currently have (or have ever had) a blood clot in a deep vein of the leg (deep vein thrombosis), in the lungs (pulmonary embolism), or in another organ;
• know you have blood clotting disorders such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• require surgery or will be immobile for a prolonged period (see section "Blood clots");
• have had a heart attack or stroke;
• have (or have had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• have any of the following conditions that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fats in the blood (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia.
• have (or have had) a type of migraine called "migraine with aura";
• have (or have had) pancreatitis;
• have or have had liver disease and your liver is still not functioning properly;
• have or have had a liver tumour;
• have (or have had) or are suspected of having breast cancer or cancer of the reproductive organs;
• have any unexplained vaginal bleeding;
• are taking a herbal product containing St. John's wort (Hypericum perforatum);
• are allergic to ethinylestradiol or levonorgestrel, or to any of the other ingredients of this medicine (listed in section 6). This may manifest as itching, rash, or swelling.
• have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir/dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Seasonique with other medicines").

Warnings and precautions
When to be cautious when taking Seasonique
When should you contact your doctor?
Seek immediate medical attention if:

• you notice possible symptoms of blood clots, which may indicate deep vein thrombosis (clot in the leg), pulmonary embolism (clot in the lungs), heart attack, or stroke (see section below "Blood clots").

For a description of the symptoms of these serious adverse effects, see "How to recognize blood clots".

Inform your doctor if you have any of the following conditions.
In certain situations, you may need to take special care when using Seasonique or any other combined hormonal contraceptive, and regular health monitoring by your doctor may be necessary.
If any of the following conditions apply to you, inform your doctor before starting Seasonique. If any of these symptoms develop or worsen during treatment, inform your doctor:

• family history of breast cancer;
• liver or gallbladder disease;
• diabetes;
• depression;
• Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• systemic lupus erythematosus (an autoimmune disease);
• haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• sickle cell anaemia (a hereditary red blood cell disorder);
• hypertriglyceridaemia (elevated blood fat levels) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of pancreatitis;
• require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• have recently given birth, as you are at increased risk of blood clots. Consult your doctor about how soon after delivery you can start taking Seasonique;
• have superficial thrombophlebitis (inflammation of veins under the skin);
• have varicose veins;
• have epilepsy (see "Seasonique with other medicines");
• have a condition that first appeared during pregnancy or previous use of sex hormones, such as hearing loss, porphyria (a blood disorder), pemphigoid gestationis (a blistering skin rash during pregnancy), or Sydenham's chorea (a nervous system disorder causing sudden involuntary movements);
• have chloasma (golden-brown patches, especially on the face, also known as "melasma"). In such cases, avoid direct exposure to sunlight or ultraviolet radiation;
• are breastfeeding (see "Pregnancy and breastfeeding");
• develop symptoms of angioedema, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or urticaria, which may cause breathing difficulties. Medicines containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS
The use of combined hormonal contraceptives such as Seasonique is associated with an increased risk of blood clots compared to not using such medication.
In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Recovery after a blood clot is not always complete. In rare cases, the consequences may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots associated with taking Seasonique is small.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical attention if you experience any of the following symptoms.

| Do you have any of these symptoms? | What condition might you have? | |------------------------------------|----------------------------------| | Swelling of the leg or swelling along a vein in the leg, particularly if accompanied by: | Deep vein thrombosis | | + pain or tenderness in the leg, felt only when standing or walking, | | | + increased warmth in the affected leg, | | | + change in skin colour of the leg, such as pallor, redness, or bluish discoloration | | | Sudden unexplained shortness of breath or rapid breathing; | Pulmonary embolism | | Sudden cough without obvious cause, possibly with coughing up blood; | | | Sudden sharp chest pain, which may worsen on deep breathing; | | | Severe dizziness or vertigo; | | | Rapid or irregular heartbeat. | | | Severe stomach pain; | |

VENOUS BLOOD CLOTS
What can happen if blood clots form in the veins?

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thrombosis). However, these adverse events are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots highest?
The risk of developing venous blood clots is greatest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, but it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Seasonique, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of venous blood clots?
The risk depends on the natural risk of developing venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Seasonique is low.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5 to 7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• The risk of venous thromboembolic disease associated with the use of Seasonique may be 1.4 times higher compared to combined hormonal contraceptives containing levonorgestrel used in a 28-day regimen.
• The risk of developing blood clots depends on a woman's individual medical history (see "Factors that increase the risk of blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Seasonique is small, however certain factors may increase this risk. The risk is higher:

• if the patient is very overweight (body mass index (BMI) above 30 kg/m²);

• if a close family member of the patient has had blood clots in the legs, lungs or other organs at a young age (e.g. under 50 years of age). In this case, the patient may have an inherited tendency to form blood clots;

• if the patient needs to undergo surgery, or is immobilised for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Seasonique several weeks before surgery or immobilisation. If the patient needs to stop taking Seasonique, ask the doctor when it is safe to restart taking the medicine.

• with increasing age (especially over 35 years);

• if the patient has given birth within the last few weeks.

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, particularly if the patient has another risk factor listed above.
It is important to tell the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue the use of Seasonique.
Inform the doctor if any of the above conditions change during treatment with Seasonique, for example, if a close family member is diagnosed with thrombosis of unknown cause, or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the arteries?
As with venous blood clots, arterial blood clots can cause serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to note that the risk of heart attack or stroke associated with the use of Seasonique is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Seasonique, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve problems, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Seasonique, for example, if the patient starts smoking, a close family member is diagnosed with thrombosis of unknown cause, or if the patient gains significant weight.

Seasonique and cancer
A slightly increased incidence of breast cancer has been observed in women using combined hormonal contraceptives, but it is not known whether this is caused by their use. For example, it is possible that more tumours are detected in women taking combined hormonal contraceptives because they are examined more frequently by a doctor. The incidence of breast tumours gradually decreases after stopping combined hormonal contraceptives. It is important to examine the breasts regularly. If the patient detects any lump, she should contact the doctor.

Benign liver tumours have been observed rarely in patients using contraceptive pills, and malignant liver tumours have been reported even more rarely. If the patient experiences an unusual, severe abdominal pain, she should contact the doctor.

Intermenstrual bleeding
When using Seasonique, which has a 91-day extended dosing cycle, the patient should expect 4 scheduled periods per year (bleeding during the 7 white tablets). Each bleeding will likely last about 3 days.
During the first few months of taking Seasonique, unscheduled bleeding may occur. Unscheduled bleeding is not uncommon, especially during the first pack of Seasonique. This bleeding or spotting usually decreases over time. Do not stop taking Seasonique because of this bleeding or spotting. If spotting lasts longer than 7 consecutive days or is heavy, contact the doctor.

What to do if bleeding does not occur after Day 84
Consider the possibility of pregnancy if the scheduled bleeding does not occur (no bleeding during the days when the patient takes the white tablets). Because scheduled bleedings are less frequent with Seasonique, inform the doctor that there has been no bleeding and that the patient is taking Seasonique. Also inform the doctor if symptoms of pregnancy occur, such as morning sickness or unusual breast tenderness. It is important that the doctor examines the patient to determine whether she is pregnant.
Do not start the next pack of Seasonique if the patient is unsure whether she is pregnant.

Psychiatric disorders
Some women using hormonal contraceptives, including Seasonique, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.

Seasonique and other medicines
Always tell the doctor prescribing Seasonique about any medicines or herbal products currently being taken. Also inform any other doctor or dentist prescribing another medicine (or the pharmacist dispensing it) that the patient is taking Seasonique. They will advise whether additional contraceptive methods (e.g. condoms) are needed and for how long they should be used.
Some medicines may reduce the effectiveness of Seasonique in preventing pregnancy or may cause unexpected bleeding. These include medicines used to treat:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g. rifampicin);
• HIV infection (ritonavir, nevirapine) or other infectious diseases (an antibiotic called griseofulvin);
• pulmonary hypertension (bosentan);
• cancer (vemurafenib).

The herbal product St. John's wort may also affect the proper functioning of Seasonique. Seasonique may affect the action of other medicines, for example:

• the antiepileptic drug lamotrigine (which may lead to an increased frequency of seizures).

Do not administer Seasonique to patients with hepatitis C virus infection who are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir with pibrentasvir, and sofosbuvir with velpatasvir and voxilaprevir, because these medicines may cause increased liver function test results in the blood (increased activity of the liver enzyme AlAT).
The doctor will prescribe another type of contraception before starting treatment with these medicines.
Seasonique may be restarted approximately 2 weeks after completion of this treatment. See section "When not to take Seasonique".
Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Effect on laboratory tests
If blood tests are required, inform the doctor or laboratory staff that the patient is taking Seasonique, as oral contraceptives may affect the results of certain tests.

Pregnancy and breast-feeding
Seasonique must not be taken during pregnancy. If pregnancy occurs while taking Seasonique, stop taking the medicine immediately and contact the doctor.
Generally, Seasonique is not recommended during breast-feeding, as it may reduce the quantity and alter the composition of breast milk. If the patient wishes to take contraceptive tablets while breast-feeding, she should contact the doctor.

Driving and operating machinery
The effect of Seasonique on the ability to drive and operate machinery is unknown.

Seasonique contains lactose
Seasonique contains lactose. If the patient has previously been diagnosed with an intolerance to certain sugars, she should contact the doctor before taking this medicine.

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

3. How to use Seasonique

Each pack contains 84 pink tablets and 7 white tablets, arranged in 3 blisters within the package.
How to take the tablets
Take one Seasonique tablet daily, swallowing it with a small amount of water if necessary.
Tablets should be taken at approximately the same time each day.
The order in which to take the tablets
Do not confuse the order of tablet intake: take the pink tablet for the first 84 days, followed by the white tablet for the last 7 days.
Begin a new pack immediately after finishing the previous one (84 pink tablets followed by 7 white tablets). Therefore, there is no break between packs.
Because the tablets have different compositions, it is essential to start with tablet number 1 from the blister labeled as “Month 1”. Tablets must be taken daily. When all tablets from the blister labeled “Month 1” have been taken, proceed to the blister labeled “Month 2”, starting with tablet number 29. After completing the tablets from the blister labeled “Month 2”, continue with the next blister, starting from tablet number 57. To maintain the correct order, follow the direction of the arrows on the blisters.
Preparing the pack for use
To help maintain the correct order of intake, 7 adhesive strips labeled with the days of the week are included. Select the strip that starts with the day on which the patient begins taking the tablets. For example, if the patient starts on Wednesday, use the strip beginning with “WED”.
Place the weekly adhesive strip along the top edge of the Seasonique blister, where it says “Place sticker here”, so that the first day is positioned above tablet number “1”.
Each tablet is thus marked with the corresponding day of the week, allowing the patient to check whether a tablet has been taken. Arrows indicate the order in which tablets should be taken.
Typically, withdrawal bleeding begins while the patient is taking the white tablets.
After taking the last white tablet, start the next pack of Seasonique immediately, regardless of whether bleeding has stopped. This means each pack should be started on the same day of the week, and withdrawal bleeding should occur on the same days each cycle.
If the patient uses Seasonique in this way, she is protected against pregnancy throughout the entire 91-day period.
When to start the first pack?

• If no hormonal contraceptive has been used in the past month: Begin taking Seasonique on the first day of the menstrual cycle (i.e., the first day of menstruation). Starting on days 2 to 5 of the cycle is also possible, but in this case, additional contraceptive methods (e.g., condoms) must be used for the first 7 days of tablet intake.
• Switching from another combined hormonal contraceptive, combined contraceptive vaginal ring, or patch: It is best to start Seasonique on the day after taking the last active tablet (the last tablet containing active ingredient) of the previously used combined hormonal contraceptive. When switching from a combined contraceptive vaginal ring or patch, follow the doctor’s recommendations.
• Switching from a progestogen-only method (progestogen-only pill, injection, progestogen-releasing implant, or intrauterine device): Switching from a progestogen-only pill can occur on any day (from an implant or intrauterine device on the day of removal; from an injectable contraceptive when the next injection is due). In all these cases, additional contraceptive methods (e.g., condoms) must be used for the first 7 days of tablet intake.
• After miscarriage or abortion: Follow the doctor’s advice.
• After childbirth: Begin taking Seasonique between days 21 and 28 after delivery. If starting later than day 28, additional contraceptive methods (e.g., condoms) must be used during the first 7 days of taking Seasonique. If sexual intercourse occurred after childbirth and before starting Seasonique (again), first ensure that pregnancy has not occurred or wait until the next menstrual bleeding.
• Breastfeeding and intention to start taking Seasonique (again) after childbirth:

Read section “Breastfeeding”.
If in doubt about when to start taking the medicine, consult a doctor.
Taking more Seasonique than recommended
There is no data on severe harmful effects from taking too many Seasonique tablets.
If several tablets are taken at once, symptoms such as nausea or vomiting may occur. In young girls, vaginal bleeding may occur.
If an excessive number of Seasonique tablets are taken or if a child has ingested several tablets, consult a doctor or pharmacist immediately.
Missed dose of Seasonique
White tablets: If the patient misses any of the white tablets (the last 7 tablets in the pack), this does not affect the effectiveness of Seasonique. Do not take the missed tablet(s), but continue taking the next tablet at the usual time.
Pink tablets: If the patient misses a pink tablet, additional contraceptive precautions (e.g., a mechanical method such as a condom) may be necessary, depending on the day of the cycle when the tablet was missed.
Follow these rules when taking pink tablets:

• If the delay in taking the tablet is less than 12 hours, contraceptive protection is not reduced. The patient should take the tablet as soon as she remembers, then continue taking tablets at the usual time.
• If the delay in taking the tablet exceeds 12 hours, contraceptive protection may be reduced. The greater the number of missed tablets, the higher the risk of pregnancy. The risk of pregnancy is particularly high if pink tablets at the beginning of the pack are missed. In such cases, follow the rules below.

Missed pink tablet(s) between days 1–7
Take the last missed tablet as soon as the patient remembers, even if this means taking two tablets at the same time. Continue taking the following tablets at the usual time. Use additional contraceptive protection for the next 7 days, e.g., a mechanical method such as a condom. If the patient had sexual intercourse in the week before missing the tablets, she may be pregnant. Contact a doctor immediately.
Missed pink tablet(s) between days 8–77
Take the missed tablet as soon as the patient remembers, even if this means taking two tablets at the same time. Then continue taking the following tablets at the usual time. If correct dosing was maintained in the 7 days before the missed tablet, contraceptive protection is not reduced, and additional contraceptive methods are not required. However, if correct dosing was not maintained or if more than one tablet was missed, use additional contraceptive methods (e.g., condoms) for 7 days.
Missed pink tablet(s) between days 78–84
There is a significant risk of pregnancy if pink tablets are missed just before the period of taking white tablets. However, this risk can be prevented by appropriately adjusting the dosing schedule.
Take the missed tablet as soon as the patient remembers, even if this means taking two tablets at the same time. Then continue taking the following tablets at the usual time. If correct dosing was maintained in the 7 days before the missed tablet, contraceptive protection is not reduced, and additional contraceptive methods are not required. However, if correct dosing was not maintained, stop taking the pink tablets and start taking the white tablets, skipping the number of tablets that were not taken. Use additional contraceptive methods (e.g., condoms) for 7 days. Then, start a new cycle of Seasonique.
Contact a doctor for further advice.
Flowchart: If delay in taking a pink tablet exceeds 12 hours
Consult a doctor for advice.
YES
Days 1–7 Did the patient have sexual intercourse in the week
before missing the tablet?
NO

• Take the last missed tablet and

continue taking tablets as usual.

• Use a mechanical method (condom) for the next 7 days.
• Finish taking all tablets in the blister.

Take the missed tablet and continue
taking tablets as usual.
Additional contraceptive methods are
not required.
Pink tablet Days 8–77
(tablets) missed (taken after
If more than one tablet was missed or
more than 12
tablets were not taken correctly in the 7
hours).
days before the missed tablet, use a
mechanical method (condom) for the
next 7 days
Take the last missed tablet and
continue taking tablets at the usual
time. Additional contraceptive methods
are not required.
and
YES
Days 78–
Were tablets taken correctly in the 7 days
before the first missed tablet?
NO

• Stop taking pink

tablets. Take white tablets, skipping the number of tablets not taken. Use a mechanical method (condom) for the next 7 days.

• Then start a new Seasonique cycle

If any pink tablet is missed and there is no bleeding in the 13th week,
this may indicate pregnancy. Contact a doctor before starting the next pack.
What to do in case of vomiting or severe diarrhoea
If vomiting or severe diarrhoea occurs within 3–4 hours after taking a tablet, there is a risk that the active ingredient in the tablet may not be fully absorbed. This situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare blister as soon as possible. Follow the instructions described in the section “Missed dose of Seasonique”.
If the patient does not wish to change her normal tablet-taking schedule, take an additional tablet from the last row of the pack.
Stopping Seasonique
Seasonique may be discontinued at any time. If the patient does not wish to become pregnant, she should consult a doctor for advice on other reliable contraceptive methods.
If there are any further doubts regarding the use of this medicine, consult a doctor, midwife, or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Seasonique, medical advice should be sought immediately.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolic disease) or blood clots in arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before using Seasonique".

Serious adverse effects – seek immediate medical advice:

• Hypersensitivity reaction (allergic reaction) – symptoms include swelling of the face, lips, mouth, tongue or throat; red, raised rash (urticaria) and itching.
• Blood clots in blood vessels of the legs (thrombophlebitis), lungs (pulmonary embolism), or other organs. For symptoms of blood clots, see section 2, "Blood clots".
• Immediate medical advice should be sought if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria possibly causing breathing difficulties (see also section "Warnings and precautions"). If the patient suspects she may be experiencing any of these symptoms, she should contact her doctor immediately. Discontinuation of Seasonique may be necessary.

Very common: may affect more than 1 in 10 people

• Breakthrough bleeding.

Common: may affect up to 1 in 10 people

• Mood changes, decreased libido, depression
• Headache, migraine
• Nausea, stomach pain
• Acne
• Heavy, prolonged intermenstrual bleeding, breast tenderness, painful menstruation
• Weight gain.

Uncommon: may affect up to 1 in 100 people

• Fungal infection, fungal and bacterial vaginal infections (including candidiasis), bladder infection, gastritis, gastrointestinal infection, throat and sinus infection
• Fibrocystic breast disorders, development or worsening of uterine fibroids (benign tumour)
• Anaemia
• Increased appetite, loss of appetite, decreased appetite, diabetes, insulin resistance
• Irritability, restlessness, low mood, worsening of depression, emotional lability, difficulty sleeping, orgasmic disorders, paranoia
• Dizziness, increased skin sensitivity, loss or reduced sensation in response to skin stimulation
• Vestibular dizziness
• Irregular heartbeat, rapid heartbeat
• Hot flushes, high blood pressure, worsening of high blood pressure, low blood pressure upon standing
• Sinus congestion
• Vomiting, dyspepsia, diarrhoea, constipation
• Cholecystitis, gallstones
• Rash, changes in hair growth and texture, unusual hair loss or thinning, nail disorders, night sweats, photosensitivity reaction, dark skin patches
• Peripheral oedema, back pain, muscle cramps, joint pain, joint stiffness, muscle pain, neck pain
• Dryness of the vulva and vagina, uterine cramps, breast pain, irregular menstruation, breast swelling, breast enlargement, pain during intercourse, post-coital bleeding, vaginal discharge, genital itching, genital rash, pelvic pain, polycystic ovaries, vulvar disorders, vulvar and vaginal discomfort
• Fatigue, swelling of various body parts, pain, chest pain, feeling of warmth, flu-like symptoms, malaise, fever
• Increased blood pressure, increased lipid levels
• Weight loss.

Rare: may affect up to 1 in 1,000 people

• Harmful blood clots in a vein or artery, for example:
  • in the leg or foot (e.g. deep vein thrombosis)
  • in the lungs (e.g. pulmonary embolism)
  • heart attack
  • stroke
  • so-called "mini-stroke" or transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).

Frequency not known: frequency cannot be estimated from available data

• Loss of consciousness
• Alopecia
• Pain in arms or legs
• Increased liver enzyme activity (aminotransferases)

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309.
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Seasonique

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the outer carton, foil sachet, cardboard blister pack, and blisters after: Expiry (EXP). The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Seasonique contains
Active substances:
The active substances in this medicine 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 tablet:
Tablet core: anhydrous 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 FCF, aluminium lake (E133).

Other ingredients in the white tablet:
Tablet core: lactose, potassium polacrilin, microcrystalline cellulose, magnesium stearate.
Tablet coating: titanium dioxide (E171), polidextrose, hypromellose, triacetin, macrogol 8000.

What Seasonique looks like and contents of the pack
Each pack contains a total of 3 blisters: 2 blisters, each containing 28 pink coated tablets (Month 1 and Month 2), and 1 blister containing 35 coated tablets in total – 28 pink coated tablets and 7 white coated tablets (Month 3).
The blisters are individually placed in foil sachets and are contained within a cardboard carton together with the leaflet.

Pink, round, biconvex tablets, approximately 5.7 mm in diameter, embossed with “172” on one side and “T” on the other side.
White, round, biconvex tablets, approximately 5.7 mm in diameter, embossed with “173” on one side and “T” on the other side.

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

Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria, Germany: Seasonique 150 Mikrogramm/30 Mikrogramm + 10 Mikrogramm Filmtabletten
Belgium: Seasonique, filmomhulde tabletten
Poland, Portugal, Czech Republic: Seasonique
France: Seasonique 150 microgrammes/30 microgrammes + 10 microgrammes, comprimé pelliculé
Spain: Seasonique comprimidos recubiertos con pelicula
Luxembourg: Seasonique, comprimés pelliculés
Romania: Seasonique 150 micrograme/30 micrograme + 10 micrograme comprimate filmate
Slovakia: Seasonique 0,15mg/0,03mg filmom obalené tablety
Hungary: Seasonique 150 mikrogramm/30 mikrogramm + 10 mikrogramm filmtabletta
Italy: Seasonique 150/30 microgrammi + 10 microgrammi, compresse rivestite con film