Seasonique film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Seasonique film-coated tablets

levonorgestrel/ethinylestradiol

ethinylestradiol

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Important things you should know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of developing a blood clot in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and contact your doctor if you think you may be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the 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 oral contraceptive 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, specifically levonorgestrel and ethinylestradiol.

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

2. What you need to know before starting to take Seasonique

General considerations

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 you start 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 other tests.

This patient information leaflet describes various situations in which you should stop taking Seasonique or in which the effectiveness of Seasonique may be reduced. In these situations, you should not have sexual intercourse, or if you do, you must use additional non-hormonal contraceptive precautions, such as a condom or another barrier method. Do not use rhythm or temperature methods. These methods are unreliable because Seasonique alters the monthly fluctuations in body temperature and cervical mucus.

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

When not to use Seasonique

Do not use Seasonique if you have any of the conditions listed below. Inform your doctor immediately if any of these conditions occur for the first time while taking Seasonique. Your doctor will discuss with you which alternative contraceptive method would be most suitable.

Do not take Seasonique

• if you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs;

• if you know you have a disorder affecting blood clotting, for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;

• if you need surgery or will be immobile for a long time (see section “Blood clots”);

• if you have ever had a heart attack or stroke;

• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischemic attack (TIA, temporary stroke-like symptoms);

• if you have any of the following conditions that may increase your risk of forming a blood clot in the arteries:

• severe diabetes with blood vessel damage.

• very high blood pressure.

• very high levels of fat in the blood (cholesterol or triglycerides).

• a condition called hyperhomocysteinemia.

  • 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 liver disease and your liver function is still not normal;
  • if you have or have had a tumor in the liver;
  • if you have (or have had) or there is suspicion that you may have breast cancer or cancer of the genital organs;
  • if you have unexplained vaginal bleeding;
  • if you are taking the herbal remedy St. John's wort;
  • if you are allergic to ethinylestradiol or levonorgestrel, or to any of the other ingredients of this medicine (listed in section 6). This may be recognized by 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 “Use of Seasonique with other medicines”).

Warnings and precautions

When you should be especially careful with Seasonique

When should you consult your doctor? Seek urgent medical attention If you notice possible signs of a blood clot, which may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clot (thrombosis)” below). For a description of 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 certain situations, you must take special precautions when using Seasonique or any other combined hormonal contraceptive, and your doctor may need to monitor you regularly.

If you are in any of the following situations, you must inform your doctor before starting Seasonique. If any of these conditions develop or worsen while you are using Seasonique, you must also inform your doctor:

• if a close family member has or has had breast cancer;
• if you have a liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting your body's natural defense system);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disorder);
• if you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas);
• if you require surgery or will be immobile for a long time (see section 2 “Blood clots”);
• if you have recently given birth, you are at higher risk of developing blood clots. Ask your doctor when you can start taking Seasonique after childbirth;
• if you have inflammation of veins beneath the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see “Use of Seasonique with other medicines”);
• if you have a condition that first occurred during pregnancy or during previous use of sex hormones; for example: hearing loss, porphyria (a blood disorder), herpes gestationis (blistering skin rash during pregnancy), Sydenham's chorea (a nerve disorder causing sudden, involuntary body movements);
• if you have (or have ever had) chloasma (brownish-yellow pigmented patches, called “melasma” or “pregnancy mask,” especially on the face). In this case, avoid direct exposure to sunlight or ultraviolet light;
• if you have hereditary angioedema, medications containing estrogens may trigger or worsen angioedema symptoms. You must seek medical attention immediately if you experience symptoms of angioedema, such as swelling of the face, tongue and/or pharynx, and/or difficulty swallowing, or hives accompanied by breathing difficulties;
• 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 with breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Blood clots

Using a combined hormonal contraceptive such as Seasonique increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

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

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Seasonique is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What might you be suffering from?
swelling in one leg or foot or along a vein in the leg or foot, especially when accompanied by: pain or tenderness in the leg, which may only be noticeable when standing or walking. increased warmth in the affected leg. change in skin color of the leg, e.g. turning pale, red, or blue.	Deep vein thrombosis
sudden shortness of breath without known cause or rapid breathing. sudden cough without clear cause, possibly bringing up blood. sudden sharp chest pain that may worsen upon deep breathing. severe dizziness or lightheadedness. rapid or irregular heartbeat. severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition such as a respiratory infection (e.g. a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: sudden loss of vision, or painless blurred vision, which may progress to loss of vision.	Retinal vein thrombosis (blood clot in the eye).
pain, discomfort, pressure, heaviness in the chest. feeling of tightness or fullness in the chest, arm, or below the breastbone. feeling of fullness, indigestion, or suffocation. upper body discomfort radiating to the back, jaw, throat, arm, or stomach. sweating, nausea, vomiting, or dizziness. extreme weakness, anxiety, or shortness of breath. rapid or irregular heartbeat.	Heart attack.
sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. sudden confusion, difficulty speaking or understanding speech. sudden vision problems in one or both eyes. sudden difficulty walking, dizziness, loss of balance or coordination. sudden, severe, or prolonged headache without known cause. loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
swelling and slight bluish discoloration of a limb. severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels.

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse effects are rare. They occur more frequently 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 a vein of another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein higher?

The risk of developing a blood clot in a vein is higher during the first year of first-time use of a combined hormonal contraceptive. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it remains somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Seasonique, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of venous thromboembolism (VTE) 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 small.

• Among every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot within one year.

• Among every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5 to 7 will develop a blood clot within one year.

• The risk of VTE associated with the use of Seasonique may be 1.4 times higher than that observed with a 28-day combined hormonal contraceptive containing levonorgestrel.

• Your risk of developing a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill and who are not pregnant	About 2 in 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5 - 7 in 10,000 women
Women who use Seasonique	About 5 – 15 in 10,000 women

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

The risk of having a blood clot with Seasonique is small, but certain conditions increase the risk. Your risk is higher:

• if you are overweight (body mass index or BMI above 30 kg/m²).
• if a close relative has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you might have an inherited blood clotting disorder.
• if you need surgery or will be immobile for a long time due to injury or illness, or if your leg is in a cast. You may need to stop using Seasonique several weeks before surgery or while you are less mobile. If you need to stop using Seasonique, ask your doctor when you can start taking it again.
• as you get older (especially over about 35 years of age).
• if you have given birth within the last few weeks.

The risk of developing a blood clot increases the more of these conditions you have.

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is important to inform your doctor if you have any of the above conditions, even if you are unsure. Your doctor may decide that you should stop using Seasonique.

If any of the above conditions change while you are using Seasonique—for example, a close relative experiences a thrombosis without a known cause or you gain a lot of weight—inform your doctor.

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can lead to a heart attack or stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of heart attack or stroke while using Seasonique is very small, but it may increase:

• with age (over about 35 years);
• if you smoke. When using a combined hormonal contraceptive like Seasonique, you are advised to stop smoking. If you are unable to stop smoking and are 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 has 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 has high levels of fat in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have a heart condition (valve disorders, heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have one or more of these conditions, or if any of them are particularly severe, your risk of developing a blood clot may be further increased.

If any of the above conditions change while you are using Seasonique—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight—inform your doctor.

Seasonique and cancer

A slightly higher frequency of breast cancer has been observed in women using combined oral contraceptives, but it is unknown whether this is due to the treatment. For example, more tumors may be detected in women taking combined pills because they are examined more frequently by their doctor. The occurrence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to have regular breast examinations and you should consult your doctor if you notice any lumps.

In rare cases, benign liver tumors have been reported in users of oral contraceptives, and even more rarely, malignant liver tumors. Consult your doctor if you experience unusual and severe abdominal pain.

Bleeding between periods

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 is likely to last about 3 days.

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

What to do if bleeding does not occur after day 84

If the scheduled period does not occur (no bleeding during the days you take the white pills), you should consider the possibility of pregnancy. Since scheduled periods are less frequent when taking Seasonique, inform your doctor that you have not had your period and that you are taking Seasonique. Also inform your doctor if you have symptoms of pregnancy, such as morning sickness or unusual breast tenderness. It is important that your doctor examines you to determine whether you are pregnant.

Do not start the next pack of Seasonique until you are certain you are not pregnant.

Psychiatric disorders

Some women using hormonal contraceptives such as Seasonique have reported depression or a depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor for additional medical advice as soon as possible.

Use of Seasonique with other medicines

Always inform the doctor prescribing Seasonique about any medicines or herbal remedies you are already taking. Also inform any other doctor or dentist who prescribes you another medicine (or the pharmacist dispensing your medicines) that you are taking Seasonique. They can advise you whether you need to take additional contraceptive precautions (e.g., condoms), and if so, for how long.

Some medicines may make Seasonique less effective in preventing pregnancy or may cause unexpected bleeding. This includes medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin);
• HIV infection (ritonavir, nevirapine) or other infections (an antibiotic called griseofulvin);
• high blood pressure in the blood vessels of the lungs (pulmonary hypertension) (bosentan);
• cancer (vemurafenib).

The herbal remedy St. John's wort may also reduce the effectiveness of Seasonique.

Seasonique may affect the action of other medicines, for example:

• the antiepileptic lamotrigine (this could lead to an increased frequency of 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 test results (elevated liver enzyme ALT).

Your doctor will prescribe a different type of contraceptive before starting treatment with these medications.

You may resume treatment with Seasonique approximately 2 weeks after completing this treatment. See section “Do not use Seasonique.”

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

Blood tests

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

Pregnancy and breastfeeding

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

The use of Seasonique is generally not recommended while breastfeeding, as it may reduce the amount of breast milk and alter its composition. If you wish to take contraceptive pills while breastfeeding, consult your doctor.

Driving and use of machines

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

Seasonique contains lactose

Seasonique contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him 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 presented in 3 blister packs within a carton.

How to take the tablets

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

Which tablets should I take?

Do not confuse the tablets: Take one pink tablet for the first 84 days, followed by one white tablet for the final 7 days.

Start the next pack immediately afterwards (84 pink tablets followed by 7 white tablets). There is no break between packs.

Because the tablets have different compositions, you must begin with tablet number 1 in the blister labeled Month 1. Take the tablets every day. When you have taken all the tablets from Month 1, move to the blister pack for Month 2 and begin with tablet 29. When you have taken all the tablets from the Month 2 blister, move to the Month 3 blister and begin with tablet 57. To follow the correct order, follow the direction of the arrows indicated on the blister.

Preparing the pack

To help you orient yourself, there are 7 weekly adhesive strips with the 7 days of the week marked. Choose the label that starts with the day on which you begin taking the tablets. For example, if you start on a Wednesday, use the label beginning with “WED”.

Apply the label to the top of the Seasonique blister where it says “Apply day label here”, so that the first day is positioned over the tablet marked “1”.

Now a day will be indicated above each tablet, allowing you to see whether you have taken a particular pill. The arrows indicate the order in which the pills should be taken.

Usually, the so-called withdrawal bleeding begins while you are taking the white tablets.

After taking the last white tablet, you must start the next pack of Seasonique, regardless of whether bleeding has stopped or not. This means you should start each pack on the same day of the week, and withdrawal bleeding should occur on the same days each time.

If you use Seasonique in this way, you will be protected against pregnancy throughout all 91 days.

When can you start the first pack?

• If you have not used any hormonal contraceptive in the previous month:

Start taking Seasonique on the first day of your cycle (i.e., the first day of your menstruation).

You may also start between days 2 and 5 of your cycle, but in this case you must use additional contraceptive precautions (e.g., a condom) during the first 7 days of tablet intake.

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

You may preferably start taking Seasonique the day after taking the last active tablet (the last tablet containing active ingredients) of your previous pill. If switching from a vaginal ring or a combined transdermal contraceptive patch, follow your doctor’s instructions.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing IUD):

You may switch on any day from taking the progestogen-only pill (if using an implant or IUD, on the day of removal; in the case of an injectable, on the date the next injection would have been due).

In all these cases, you must use additional contraceptive precautions (e.g., a condom) during the first 7 days of tablet intake.

• After a spontaneous or induced abortion:

Follow your doctor’s instructions.

• After having a baby:

You may start taking Seasonique between 21 and 28 days after childbirth. If you start after day 28, you must also use additional contraceptive precautions (e.g., a condom) during the first 7 days of using Seasonique. If you have had sexual intercourse after giving birth and before starting Seasonique, make sure you are not pregnant or wait until your next menstruation.

• If you are breastfeeding and wish to start (or restart) taking Seasonique after childbirth:

Read the section on “Pregnancy and Lactation”.

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

If you take more Seasonique than you should

No serious harmful effects have been reported from taking too many Seasonique tablets.

If you take several tablets at once, you may experience symptoms such as nausea or vomiting. Young women may have vaginal bleeding.

If you have taken too many Seasonique tablets or discover that a child has taken some, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Seasonique

White tablets: If you forget one or more 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 missed white tablet(s), and continue with the next tablet at your usual time.

Pink tablets: If you forget a pink tablet, depending on the day of the cycle when you missed it, you may need to use additional contraceptive precautions, such as a barrier method like a condom.

Take the pink tablet according to the following principles:

• If less than 12 hours have passed since you were supposed to take the tablet, protection against pregnancy is not reduced. Take the tablet as soon as you remember, then continue taking the tablets at your usual time.
• If more than 12 hours have passed since you were supposed to take the tablet, protection against pregnancy may have been reduced. The greater the number of tablets you have forgotten, the higher the risk of becoming pregnant. The risk is especially high if you miss pink tablets at the beginning of the pack. Therefore, follow the rules outlined below.

Missed pink tablet(s) between days 1 to 7

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

Missed pink tablet(s) between days 8 to 77

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

Missed pink tablet(s) 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. Adjusting the tablet-taking schedule can prevent this high risk.

Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time. If you took your tablets correctly during the 7 days before the first missed tablet, protection against pregnancy is not reduced, and you do not need to use additional contraceptive precautions. However, if this is not the case, stop taking the pink tablets and take the white tablets, excluding the number of tablets you missed. Use additional contraceptive precautions for the next 7 days, such as a barrier method like a condom. After this, you may start a new Seasonique cycle.

Consult your doctor for further information.

Flowchart: If more than 12 hours have passed since you were supposed to take the pink tablets

YES

NO

YES

NO

NO

If you have forgotten any of the pink tablets and have not had bleeding during week 13, you may be pregnant. Consult your doctor before starting the next pack.

What to do in case of vomiting or severe diarrhea

If you vomit within three to four hours after taking a tablet, or if you have severe diarrhea, there is a risk that the active ingredients of the pill have not been completely absorbed into your body. This situation is similar to missing a tablet. After vomiting or having diarrhea, take another tablet as soon as possible. Follow the instructions described under “If you forget to take Seasonique”.

If you do not wish to change your normal tablet-taking schedule, take an 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 do not wish to become pregnant, consult your doctor about other reliable methods of contraception.

If you have any further questions about the use of this medicine, ask your doctor, midwife, or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think may be due to Seasonique, consult your doctor.

All women who take 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 about the different risks of taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take Seasonique”.

Serious adverse effects – see a doctor immediately if you notice:

• hypersensitivity reaction (allergic reaction): symptoms include swelling of the face, lips, mouth, tongue or throat; skin rash (urticaria) and itching.
• blood clot in a blood vessel in the leg (thrombosis), in the lungs (pulmonary embolism), or in other organs. For symptoms of a blood clot, see section 2 “Blood clots”.
• Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives potentially with difficulty breathing (see also the section “Warnings and precautions”).

If you think you may be experiencing any of these symptoms, consult a doctor immediately. You may need to stop taking Seasonique.

Very common: may affect more than 1 in 10 people

• bleeding between periods.

Common: may affect up to 1 in 10 people

• mood changes, decreased interest in sexual activity, depression
• headache, migraine
• nausea, stomach pain
• acne
• heavy and prolonged menstrual bleeding, breast pain, painful menstruation
• weight gain.

Uncommon: may affect up to 1 in 100 people

• fungal infection, fungal and bacterial vaginal infection (including candidiasis), bladder infection, gastroenteritis, throat and sinus infections
• fibrocystic breast disorder, development or worsening of uterine fibroids (benign tumor)
• anaemia
• increased appetite, anorexia, decreased appetite, diabetes mellitus, insulin resistance
• irritability, anxiety, depressive mood, worsening of depression, emotional distress, difficulty sleeping, abnormal orgasm, paranoia
• dizziness, increased skin sensitivity, absent or reduced skin sensitivity to stimuli
• vertigo
• irregular heartbeat, rapid heartbeat
• hot flushes, high blood pressure, worsening of high blood pressure, low blood pressure upon standing
• sinus congestion
• vomiting, indigestion, diarrhoea, constipation
• gallbladder inflammation, gallstones
• rash, changes in hair growth and texture, unusual hair loss or fine hair, nail disorders, night sweats, skin sensitivity to light, dark patches on the skin
• peripheral swelling, lower back pain, muscle spasms, joint pain, joint stiffness, muscle pain, neck pain
• vaginal or vulvar dryness, uterine spasm, breast pain, irregular menstruation, breast swelling, breast enlargement, painful sexual intercourse, vaginal discharge, breast discharge, genital itching, genital rash, pelvic pain, polycystic ovaries, vulvar disorder, vaginal or vulvar discomfort
• feeling of tiredness, swelling of 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 (i.e., DVT).
• In a lung (i.e., PE).
• Heart attack.
• Stroke.
• Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).
• 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 about conditions that increase the risk of blood clots and symptoms of a blood clot).

Not known: frequency cannot be estimated from available data

• Loss of consciousness
• Baldness
• Pain in arms or legs
• Elevated liver enzymes (elevated transaminases)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Seasonique

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

Store in the original packaging to protect it from light and moisture.

Do not use this medicine after the expiry date stated on the outer carton, aluminium bag, blister pack holder, and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Seasonique

Active substances:

The active substances 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 components of the pink tablet:

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 components of the white tablet:

Tablet core: lactose, potassium polacrylin, microcrystalline cellulose, magnesium stearate.

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

Appearance of the product and contents of the pack

Each pack of Seasonique contains a total of 3 blisters: 2 blisters, each containing 28 pink tablets (Month 1 and Month 2), and 1 blister containing 35 tablets, of which 28 are pink tablets and 7 are white tablets (Month 3).

Each blister is placed inside an aluminium pouch, which is contained in a carton with the package leaflet.

The pink tablet is round, biconvex, approximately 5.7 mm in diameter, marked with "172" on one side and "T" on the other.

The white tablet is round, biconvex, approximately 5.7 mm in diameter, marked with "173" on one side and "T" on the other.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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

Manufacturer

Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany

Local Representative

Theramex Healthcare Spain, S.L.
Calle Martínez Villergas 52, Edificio C, planta 2ª izquierda.
28027 Madrid
Spain

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, Netherlands: Seasonique filmomhulde tabletten

Czech Republic, Poland, Portugal: Seasonique

France: Seasonique 150 microgrammes/30 microgrammes + 10 microgrammes, comprimé pelliculé

Hungary: Seasonique 150 mikrogramm/30 mikrogramm + 10 mikrogramm filmtabletta

Italy: Seasonique 150/30 microgrammi + 10 microgrammi, compresse rivestite con film

Luxembourg: Seasonique, comprimés pelliculés

Romania: Seasonique 150 /30 micrograme + 10 micrograme comprimate filmate

Slovak Republic: Seasonique 0,15 mg/0,03mg +0,01 mg filmom obalené tablety

Spain: Seasonique comprimidos recubiertos con película

Date of the most recent review of this leaflet: December 2024

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) at http://www.aemps.es/.”