Seasonique

Leaflet attached to the packaging: information for the user

Seasonique

(150 micrograms + 30 micrograms) and 10 micrograms, film-coated tablets
Levonorgestrel + Ethinylestradiol
Ethinylestradiol

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more
• You should be vigilant and consult a doctor if you suspect that you have symptoms of a blood clot (see section 2 "Blood clots")

Table of contents of the leaflet

• 1. What Seasonique is and what it is used for
• 2. Important information before using Seasonique
• 3. How to use 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 pill taken continuously for 91 days to prevent pregnancy.
Each of the 84 pink tablets contains a small amount of two different female hormones, namely -
levonorgestrel and ethinylestradiol.
7 white tablets contain a small amount of female hormone – ethinylestradiol.

2. Important information before using Seasonique

General notes

Before starting to take Seasonique, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of a blood clot (see section 2 "Blood clots").
Before the patient starts using Seasonique, the doctor will ask a few questions about the patient's health and that of their close relatives. The doctor will also take the patient's blood pressure and, depending on the patient's health, may perform additional tests.
This leaflet describes several situations in which the patient should stop using Seasonique or in which the effectiveness of Seasonique may be reduced. In these situations, the patient should either not have sexual intercourse or use additional non-hormonal protection, such as a condom or another mechanical method. The calendar method or temperature measurement should not be used. These methods may be ineffective because Seasonique affects the monthly variability of body temperature and the properties of cervical mucus.

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

When not to use Seasonique

Do not take Seasonique if you have any of the conditions listed below. If any of these conditions occur for the first time, you should inform your doctor. The doctor will discuss with you which other contraceptive method will be more suitable.

When not to use Seasonique

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (a temporary stroke-like condition);
• if you have any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia.
• if you have (or have had) a type of migraine called "migraine with aura";
• if you have (or have had) pancreatitis;
• if you have (or have had) liver disease and your liver is not working properly;
• if you have (or have had) a liver tumor;
• if you have (or suspect you have) breast cancer or cancer of the genital organs;
• if you have any unexplained vaginal bleeding;
• if you are taking a herbal product containing 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 recognized by itching, rash, or swelling.
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir/dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir (see also section "Seasonique and other medicines").

Warnings and precautions

When to be particularly careful when taking Seasonique

When should you contact your doctor?
You should contact your doctor immediately

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

To find out about the symptoms of these serious side effects, see "How to recognize a blood clot".

Tell your doctor if you have any of the following conditions.

In some situations, you may need to be particularly careful when taking Seasonique or any other combined hormonal contraceptive, and you may need to have your health checked regularly by your doctor.
If any of the following conditions apply to you, you should tell your doctor before taking Seasonique. If these symptoms appear or worsen while taking Seasonique, you should also tell your doctor:

• if any of your close relatives have had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have Crohn's disease or ulcerative colitis (a chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disorder of red blood cells);
• if you have been told you have high levels of fats in your blood (hypertriglyceridemia) or if you have a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots").
• if you have just given birth, you are at a higher risk of blood clots. You should ask your doctor how soon you can start taking Seasonique after giving birth.
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Seasonique and other medicines");
• if you have a disease that first appeared during pregnancy or previous use of sex hormones, such as hearing loss, porphyria (a blood disorder), pemphigoid gestationis (a skin rash with blisters that occurs during pregnancy), Sydenham's chorea (a nerve disorder that causes sudden movements of the body);
• if you have (or have had) chloasma (brown patches on the skin, especially on the face). You should avoid direct exposure to sunlight or ultraviolet radiation;
• if you are breastfeeding (see "Pregnancy and breastfeeding");
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing, you should contact your doctor immediately. Estrogen-containing medications may cause or worsen the symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

Taking combined hormonal contraceptives like Seasonique is associated with an increased risk of blood clots compared to not taking them.
In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (also known as "venous thromboembolism" or "deep vein thrombosis")
• in arteries (also known as "arterial thromboembolism").

Not everyone who has a blood clot will recover completely. In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

Remember that the overall risk of having a harmful blood clot due to Seasonique is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.
Do you experience any of these symptoms?
What disease is the patient likely to have

• swelling of the leg or swelling along a vein in the leg or symptoms? Deep vein thrombosis, especially if accompanied by:
• pain or tenderness in the leg, which can only be felt while standing or walking,
• increased temperature in the affected leg
• change in skin color of the leg, such as pallor, redness, or discoloration
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat.
• severe abdominal pain;

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). However, these side effects are rare. They most often occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of forming a blood clot in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher than when not taking combined hormonal contraceptives.
If you stop taking Seasonique, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Seasonique is small.

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

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Seasonique is small, but some factors can increase this risk. The risk is higher:

• if you are overweight (body mass index (BMI) over 30 kg/m2);
• if someone in your close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50). In this case, you may have a genetic blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots"). It may be necessary to stop taking Seasonique for a few weeks before surgery or immobilization. If you need to stop taking Seasonique, you should ask your doctor when you can start taking it again.

as you get older (especially over 35 years of age);

• if you have just given birth.

The risk of 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, especially if the patient has another risk factor.
It is essential to tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop Seasonique.
If any of the above conditions change while taking Seasonique, you should inform your doctor, e.g., if someone in your close family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

Similarly to blood clots in veins, blood clots in arteries can have serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of a heart attack or stroke associated with Seasonique is very small, but it may increase:

• with age (over about 35 years);
• if you smoke.While taking a hormonal contraceptive like Seasonique, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your close family has had a heart attack or stroke at a young age (under 50). In this case, you may also be at increased risk of a heart attack or stroke;
• if you or someone in your close family has high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, irregular heartbeat);
• if you have diabetes.

If you have more than one of these conditions or if any of them are particularly severe, the risk of a blood clot may be even higher.
You should inform your doctor if any of these conditions change while taking Seasonique, e.g., if you start smoking, someone in your close family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

Seasonique and cancer

Breast cancer has been reported slightly more often in women taking combined hormonal contraceptives, but it is not known if this is caused by the medication. For example, it is possible that more tumors are detected in women taking combined hormonal contraceptives because they are examined by a doctor more often. The frequency of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to regularly examine your breasts.
If you feel any lump, you should contact your doctor.
Women taking oral contraceptives have reported rare cases of benign liver tumors and even rarer cases of malignant liver tumors. If you experience unusual, severe abdominal pain, you should contact your doctor.

Irregular bleeding

While taking Seasonique, which has a 91-day extended dosing cycle, you should expect 4 planned periods per year (bleeding during the 7 white tablets). Each period will probably last about 3 days.
During the first few months of taking Seasonique, you may experience irregular bleeding. Irregular bleeding is not a rare occurrence, 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 the spotting lasts longer than 7 consecutive days or is heavy, you should contact your doctor.

What to do if there is no bleeding after Day 84

You should consider the possibility of pregnancy if you do not have a planned period (no bleeding during the white tablets). Because planned periods are less frequent while taking Seasonique, you should inform your doctor if you do not have a period and if you are taking Seasonique. You should also inform your doctor if you experience symptoms of pregnancy, such as morning sickness or unusual breast tenderness. It is essential that your doctor examines you to determine if you are pregnant.
You should not start the next pack of Seasonique if you are unsure if you are pregnant.

Psychological disorders

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

Seasonique and other medicines

You should always tell your doctor who prescribed Seasonique what medicines or herbal products you are currently taking. You should also tell any other doctor or dentist who prescribes another medicine (or pharmacist who dispenses it) that you are taking Seasonique. They will tell you if you need to use additional contraception (e.g., a condom) and for how long.
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);
• high blood pressure in the blood vessels of the lungs (bosentan);
• cancer (vemurafenib). The herbal product St. John's Wort may also affect the proper functioning of Seasonique. Seasonique may affect the functioning of other medicines, such as:
• the antiepileptic medicine lamotrigine (which may lead to an increased frequency of seizures).

You should not take Seasonique if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir/dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir (see also section "Seasonique and other medicines").
Your doctor will prescribe a different type of contraception before starting treatment with these medicines.
Seasonique can be taken again about 2 weeks after finishing this treatment. See section "When not to use Seasonique".
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Effect on laboratory tests

If you need to have a blood test, you should tell your doctor or laboratory staff that you are taking Seasonique, as oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

You must not take Seasonique during pregnancy. If you become pregnant while taking Seasonique, you should stop taking the medicine immediately and contact your doctor.
Generally, it is not recommended to take Seasonique while breastfeeding, as it may reduce the amount of breast milk and change its composition. If you want to take contraceptive pills while breastfeeding, you should contact your doctor.

Driving and using machines

The effect of Seasonique on the ability to drive and use machines is not known.

Seasonique contains lactose

Seasonique contains lactose. If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the 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 take Seasonique

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

How to take the tablets

You should take one Seasonique tablet every day, with a small amount of water if necessary.
The tablets should be taken at about the same time every day.

In what order to take the tablets

Do not mix up the order of the tablets: you should take a pink tablet for the first 84 days and then a white tablet for the last 7 days.
A new pack should be started immediately after finishing the previous one (84 pink and then 7 white tablets). There is no break between packs.
Because the tablets have a different composition, it is essential to start with the tablet marked as "Week 1". The tablets should be taken daily. When you have taken all the tablets in the blister marked as "Week 1", you should start taking the tablets from the blister marked as "Week 2", starting with tablet 29. After finishing the tablets in the blister marked as "Week 2", you should start taking the tablets from the next blister, starting with tablet 57. To maintain the correct order, you should follow the direction of the arrows on the blisters.

Preparing the pack for use

To help you remember the order of the tablets, 7 adhesive strips with the days of the week are included. You should choose the strip that starts with the day you want to start taking the tablets. For example, if you want to start on a Wednesday, you should use the strip that starts with "WED".
You should place the weekly strip along the top edge of the Seasonique blister, where it says "Place the strip here", so that the first day is above the tablet marked "1".
Each tablet is marked with the day and you can check if you have taken it.
The arrows show the order in which you should take the tablets.
Usually, withdrawal bleeding starts when you take the white tablets.

When to start taking Seasonique

• If you are not taking a hormonal contraceptive in the last month:You should start taking Seasonique on the first day of your cycle (i.e., the first day of your period). You can also start between days 2 and 5 of your cycle, but you will need to use additional contraception (e.g., a condom) for the first 7 days of taking the tablets.
• Switching from another combined hormonal contraceptive, or a combined hormonal contraceptive vaginal ring or patch:You should start taking Seasonique on the day after taking the last active tablet (the last tablet containing the active substance) from your previous pack of combined hormonal contraceptive. If you are switching from a combined hormonal contraceptive vaginal ring or patch, you should follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine device):You can switch from a progestogen-only pill at any time (from an implant or intrauterine device on the day of its removal, from an injection when the next injection is due). In all these cases, you should use additional contraception (e.g., a condom) for the first 7 days of taking the tablets.
• After a miscarriage or abortion:You should follow your doctor's advice.
• After childbirth:You should start taking Seasonique between 21 and 28 days after giving birth. If you start taking the medicine later than 28 days after giving birth, you should use additional contraception (e.g., a condom) for the first 7 days of taking the tablets. If you have had sex since giving birth (again), you should make sure you are not pregnant before starting Seasonique or wait until your next period.
• Breastfeeding and intending to take Seasonique (again) after childbirth:

Read the section on "Breastfeeding".

If you are unsure when to start, you should consult your doctor.

Taking more than the prescribed dose of Seasonique

There is no data on the serious, harmful effects of taking too many Seasonique tablets.
If several tablets are taken at the same time, symptoms such as nausea or vomiting may occur. In young girls, vaginal bleeding may occur.
If you have taken too many Seasonique tablets or if you suspect that a child has taken some, you should contact your doctor or pharmacist.

Missing a dose of Seasonique

White tablets: If you forget to take any of the white tablets (the last 7 tablets in the pack), it will not affect the effectiveness of Seasonique. Do not take the missed tablet, and take the next tablet at the 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 use additional contraception, such as a mechanical method (e.g., a condom).

• If the delay in taking the tablet is less than 12 hours, the contraceptive protection is not reduced. You should take the tablet as soon as you remember and then continue taking the tablets at the usual time.
• If the delay in taking the tablet is more than 12 hours, the contraceptive protection may be reduced. The more tablets you miss, the higher 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.

Missing a pink tablet (tablets) between day 1 and 7.
The last missed tablet should be taken as soon as you remember, even if it means taking two tablets at the same time. Then, continue taking the tablets at the usual time. You should use additional contraception, such as a condom, for the next 7 days. If you had sex in the week before missing the tablets, you may be pregnant. You should contact your doctor immediately.
Missing a pink tablet (tablets) between day 8 and 77.
The tablet should be taken as soon as you remember, even if it means taking two tablets at the same time. Then, continue taking the tablets at the usual time. If you took the tablets correctly in the 7 days before missing the tablet, the contraceptive protection is not reduced, and no additional contraception is needed. However, if you did not take the tablets correctly or if you missed more than one tablet, you should use additional contraception, such as a condom, for the next 7 days.
Missing a pink tablet (tablets) between day 78 and 84.
There is a significant risk of becoming pregnant if you miss pink tablets just before the period of taking white tablets. However, by adjusting the dosing schedule, you can prevent this risk.
The tablet should be taken as soon as you remember, even if it means taking two tablets at the same time. Then, continue taking the tablets at the usual time. If you took the tablets correctly in the 7 days before missing the tablet, the contraceptive protection is not reduced, and no additional contraception is needed. However, if you did not take the tablets correctly, you should stop taking the pink tablets and start taking the white tablets, skipping the number of tablets you missed. You should use additional contraception, such as a condom, for the next 7 days. Then, you can start a new cycle of Seasonique.
You should contact your doctor for further advice.

What to do if you miss a pink tablet and do not have a period in the 13th week

This may indicate that you are pregnant. You should contact your doctor before starting the next pack.

What to do if you vomit or have severe diarrhea

If you vomit or have severe diarrhea within 3-4 hours of taking a tablet, there is a risk that the active substance in the tablet may not be fully absorbed into your body. This situation is similar to missing a tablet. After vomiting or diarrhea, you should take another tablet from a spare blister as soon as possible. You should follow the advice given in the section "Missing a dose of Seasonique".
If you do not want to change your normal tablet-taking schedule, you should take an additional tablet from the last row of the pack.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any side effects occur, especially severe and persistent or changes in health that the patient considers related to the use of Seasonique, they should consult a doctor. In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). To obtain detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before using Seasonique".

Serious side effects - consult a doctor immediately:

• Hypersensitivity reaction (allergic reaction) - symptoms include swelling of the face, lips, mouth, tongue or throat; red, lumpy rash (hives) and itching.
• Blood clots in the blood vessels of the legs (thrombophlebitis), lungs (pulmonary embolism) or other organs. Symptoms of blood clots see section 2 "Blood clots".
• Consult a doctor immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, which may cause difficulty breathing (see also "Warnings and precautions").

If the patient thinks she may have any of these symptoms, she should consult a doctor immediately.

She should consult a doctor.It may be necessary to stop using Seasonique.

Very common: may occur in more than 1 in 10 people

• Unplanned bleeding.

Common: may occur in up to 1 in 10 people

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

Uncommon: may occur in up to 1 in 100 people

• Fungal infection, fungal and bacterial infection of the vagina (including thrush), bladder infection, gastrointestinal inflammation, throat and sinus infection
• Fibrocystic breast changes, appearance or worsening of breast fibroids (benign tumor)
• Anemia
• Increased appetite, anorexia, decreased appetite, diabetes, insulin resistance
• Irritability, restlessness, low mood, worsening of depression, emotional instability, difficulty sleeping, orgasmic disorders, paranoia
• Dizziness, increased skin sensitivity, absence or decreased sensation in response to skin stimulation
• Vertigo of labyrinthine origin
• Irregular heartbeat, rapid heartbeat
• Hot flashes, high blood pressure, increased high blood pressure, low blood pressure when standing up
• Sinusitis
• Vomiting, indigestion, diarrhea, constipation
• Cholecystitis, gallstones
• Rash, changes in hair growth and structure, unusual hair loss or thinning, nail disorders, night sweats, photosensitivity reaction, darker skin patches
• Peripheral edema, back pain, muscle cramps, joint pain, joint stiffness, muscle pain, neck pain
• Vaginal and vulval dryness, uterine cramps, breast pain, irregular menstruation, breast swelling, breast enlargement, painful intercourse, post-coital bleeding, discharge, breast secretion, genital itching, genital rash, pelvic pain, polycystic ovaries, vulval disorders, discomfort of the vulva and vagina
• Fatigue, swelling of various parts of the body, pain, chest pain, feeling of heat, flu-like symptoms, malaise, fever,
• Increased blood pressure, increased lipids
• Weight loss.

Rare: may occur in up to 1 in 1000 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)
• Myocardial infarction
• Stroke
• So-called "mini-stroke" or transient stroke symptoms, known as transient ischemic attack
• Blood clots in the liver, stomach/intestine, kidneys or eye.

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

Frequency not known: frequency cannot be estimated from the available data

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

Reporting of side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Seasonique

The medicine should be stored out of 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 packaging for blisters and blisters after: Expiry Date (EXP). The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Seasonique contains

Active substances:
The active substances of the medicine are: levonorgestrel and ethinylestradiol.
Each pink film-coated tablet contains 150 micrograms of levonorgestrel and 30 micrograms of ethinylestradiol
Each white film-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, lake (E133).
Other ingredients in the white tablet:
Tablet core: lactose, polyacrylate potassium, microcrystalline cellulose, magnesium stearate
Tablet coating: titanium dioxide (E171), polydextrose, 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 film-coated tablets (Month 1 and Month 2) and 1 blister containing a total of 35 film-coated tablets - 28 pink film-coated tablets and 7 white film-coated tablets (Month 3).
The blisters are placed individually in foil sachets and are located in a cardboard packaging with a leaflet.
Pink, round, biconvex tablets, approximately 5.7 mm in diameter, with "172" embossed on one side and "T" on the other side.
White, round, biconvex tablets, approximately 5.7 mm in diameter, with "173" embossed on one side and "T" on the other side.

Marketing authorization 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
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków

This medicinal product is authorized 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
Slovak Republic: 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
Date of last revision of the leaflet:December 2024