Label: information for the user

Seasonique film-coated tablets

levonorgestrel/etinilestradiol

etinilestradiol

Read this label carefully before starting to take this medication,because it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause of 4 weeks or more.

• Be aware and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

1.What is Seasonique and for what it is used

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

3.How to take Seasonique

4.Possible adverse effects

1. Storage of Seasonique

6. Contents of the package and additional information

Seasonique is an extended-cycle birth control pill that is taken continuously for 91days and is used to prevent pregnancy.

Each of the 84pink tablets contains a small amount of two different female hormones, specifically levonorgestrel and ethinyl estradiol.

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

When Not to Use Seasonique

You should not use Seasonique if you have any of the conditions listed below. Inform your doctor immediately if any of these conditions appear for the first time during the use of Seasonique. Your doctor will discuss with you what other form of contraception would be more suitable.

Do Not Take Seasonique

• If you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs;
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• If you need surgery or if you spend a lot of time without standing up (see section “Blood Clots”);
• If you have ever had a heart attack or a stroke;
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of a stroke);
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

– Severe diabetes with vascular 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) pancreatitis (inflammation of the pancreas);
• If you have or have had liver disease and your liver function is not yet normal;
• If you have or have had a liver tumor;
• If you have (or have had) or there is suspicion that you may have breast cancer or cancer of the reproductive organs;
• If you have any unexplained vaginal bleeding;
• If you are taking the medicinal herb St. John's Wort;
• If you are allergic to ethinylestradiol or levonorgestrel, or to any of the other components of this medication (including in section 6). This is recognized by itching, rash, or swelling;
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir (see also in section “Use of Seasonique with Other Medications”).

Warnings and Precautions

When to Have Special Care with Seasonique

Inform Your Doctor If You Suffer Any of the Following Conditions.

In some situations, you should have special care during the use of Seasonique or of any other combined hormonal contraceptive, and you may need to have regular check-ups.

If you are in any of the following situations, inform your doctor before starting to take Seasonique. If the condition develops or worsens while you are using Seasonique, also inform your doctor:

• If a close relative has had breast cancer;
• If you have liver disease or gallstones;
• If you have diabetes;
• If you have depression;
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system);
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• If you have sickle cell anemia (a hereditary disorder of red blood cells);
• If you have high levels of fat in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas);
• If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”);
• If you are recently postpartum, you are at higher risk of blood clots. Ask your doctor when you can start taking Seasonique after delivery;
• If you have superficial thrombophlebitis (inflammation of the veins under the skin);
• If you have varicose veins;
• If you have epilepsy (see “Use of Seasonique with Other Medications”);
• If you have a disease that appeared during pregnancy or with previous use of sex hormones; for example: hearing loss, porphyria (a blood disorder), gestational herpes (skin rash with blisters during pregnancy), Sydenham's chorea (a nervous disorder that causes sudden body movements);
• If you have melasma (brown or dark patches on the skin, especially on the face). In this case, avoid direct exposure to the sun or ultraviolet light;
• If you have hereditary angioedema, medications containing estrogens may induce or worsen the symptoms of angioedema. You shouldseek medical attention immediatelyif you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives accompanied by difficulty breathing;
• 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 accompanied by difficulty breathing, contact a doctor immediately. Estrogen-containing products may cause or worsen the symptoms of hereditary and acquired angioedema.

Blood Clots

The use of a combined hormonal contraceptive like Seasonique increases your risk of suffering a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or ATE).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

It is essential 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 Assistanceif you notice any of the following signs or symptoms.

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 thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.

• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).

• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.

• In very rare cases, a blood clot may form in a vein in another organ, such as the eye (retinal vein thrombosis).

When Is the Risk of a Blood Clot in a Vein Higher?

The risk of a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may 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 is always slightly higher than if you were not taking a combined hormonal contraceptive.

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

What Is the Risk of a Blood Clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Seasonique is small.

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

- Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or noretisterone or norgestimate, about 5-7 will develop a blood clot in a 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.

- The risk of a blood clot will depend on your personal history (see “Factors That Increase Your Risk of a Blood Clot” below)

Factors That Increase Your Risk of a Blood Clot in a Vein

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

• If you are overweight (body mass index (BMI) greater than 30 kg/m2).

• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years). In this case, you may have a hereditary disorder of blood clotting.

• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have your leg immobilized. You may need to stop taking Seasonique for several weeks before the operation or while you have less mobility. If you need to stop taking Seasonique, ask your doctor when you can start taking it again.

• As you get older (especially over about 35 years).

• If you have recently given birth.

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

Long flights (over 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

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

If any of the conditions mentioned above change while you are using Seasonique, for example, a close relative experiences a blood clot 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 blood clot in an artery can cause serious problems. For example, it may cause a heart attack or a stroke.

Factors That Increase Your Risk of a Blood Clot in an Artery

It is essential to note that the risk of a heart attack or stroke due to 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 quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive;

• If you are overweight;

• If you have high blood pressure;

• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also have a higher risk of having a heart attack or stroke;

• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides);

• If you have migraines, especially migraines with aura;

• If you have a heart problem (valve disorder, 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, the risk of a blood clot may be increased even further.

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

Seasonique and Cancer

Cancer of the breast has been observed with a slightly higher frequency in women using combined oral contraceptives, but it is unknown whether this is due to the treatment. For example, tumors may be more likely to be detected in women taking combined oral contraceptives because their doctors examine them more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives.It is essential to have regular breast examinations and to consult your doctor if you notice any lump.

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

Menstrual Bleeding

When taking Seasonique, which has an extended dosing cycle of 91 days, you should expect to have 4 scheduled menstruations per year (bleeding while taking the 7 white pills). It is likely that each menstruation will last about 3 days.

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

What to Do If You Do Not Have Menstruation After Day 84

If you do not have the scheduled menstruation (no bleeding on the days of taking the white pills), you should consider the possibility of being pregnant. Since scheduled menstruations are less frequent when taking Seasonique, inform your doctor that you have not had menstruation and are taking Seasonique. Also inform your doctor if you experience symptoms of pregnancy, such as morning nausea or unusual breast pain.It is essential to have your doctor examine you to determine if you are pregnant.

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

Mental Health Disorders

Some women who use hormonal contraceptives like Seasonique have reported depression or a depressed mood. Depression can be severe and may sometimes induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Use of Seasonique with Other Medications

Always inform your doctor who prescribes Seasonique about the medications or herbal supplements you are already taking. Also inform any other doctor or dentist who prescribes another medication (or the pharmacist who dispenses the medications) that you are taking Seasonique. They may advise you to take additional contraceptive precautions (for example, condoms), and if so, for how long.

Some medications may make Seasonique less effective in preventing pregnancy, or may cause unexpected bleeding. This includes medications for the treatment of:

• Seizure disorders (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• Tuberculosis (e.g., rifampicin);
• HIV infection (ritonavir, nevirapine) or other infections (a type of antibiotic called griseofulvin);
• Pulmonary hypertension (bosentan);
• Cancer (vemurafenib).

The medicinal herb St. John's Wort may also make Seasonique less effective.

Seasonique may interact with the effect of other medications, for example:

• Lamotrigine (an antiepileptic medication), which may increase the frequency of seizures.

Do not use Seasonique if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in liver function test results (elevated ALT levels).

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

You can restart Seasonique treatment about 2 weeks after completing this treatment. See section “Do Not Use Seasonique”.

Always inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Blood Tests

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

Pregnancy and Breastfeeding

If you are pregnantdo not takeSeasonique. If you become pregnant while taking Seasonique, stop taking it immediately and contact your doctor.

The use of Seasonique is not recommended in general when the woman is breastfeeding, as it may decrease the amount of breast milk and change its composition. If you want to take oral contraceptives while breastfeeding, consult your doctor.

Driving and Operating Machines

There is no information to suggest that the use of Seasonique affects driving or operating machines.

Seasonique Contains Lactose

Seasonique contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Seasonique Contains Red Allura (E129)

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

Each package contains 84pink tablets and 7white tablets presented in 3 blister packs in a package.

How to take the tablets

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

Which tablets to take

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

The new package starts directly after (84pink tablets and then 7white tablets). There is no break between the packages.

Since the tablets have a different composition, you need to start with the tablet number 1 from the blister marked as Month 1. Take the tablets every day. When you have taken all the tablets from Month 1, move to the Month 2 blister. Start with tablet 29. When you have taken all the tablets from the Month 2 blister, move to the Month 3 blister and start with tablet 57. To follow the correct order, follow the direction of the arrows indicated on the blister.

Preparation of the package

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

Stick the strip on the top of the Seasonique blister where it says “Put the day label here”, so that the first day is above the tablet marked as “1”.

Now you will have a day indicated above each tablet and you will be able to see if you have taken a specific tablet. The arrows will indicate the order in which you should take the tablets.

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

Once you have taken the last white tablet, you should start with the next Seasonique package, whether or not the withdrawal bleeding has finished. This means that you should start each package on the same day of the week, and the withdrawal bleeding should occur on the same days each time.

By using Seasonique in this way, you will be protected against pregnancy for all 91days.

When can you start with the first strip?

• 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 can also start on days2 to 5 of the cycle, but then you should use additional contraceptive precautions (e.g. a condom) for the first 7days of taking the tablet.

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

You can start taking Seasonique preferably on the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous pill. If you change from a vaginal ring or a transdermal contraceptive patch, follow your doctor's instructions.

• Change from a method that only contains progestin (pill only with progestin, injection, implant or IUD releasing progestin):

You can change any day of the pill-taking (if you used an implant or IUD, on the day of its removal, and in the case of an injectable on the date that would correspond to the next injection).

In all these cases, you should use additional contraceptive precautions(e.g. a condom) for the first 7days of taking the tablets.

• After a spontaneous abortion or any type of abortion:

Follow your doctor's instructions.

• After having a baby:

After having a baby, you can start with Seasonique between 21 and 28days after. If you start after day28, you should also use additional contraceptive precautions (e.g. a condom) for the first 7days that you use Seasonique. If, after giving birth, you have had sex before starting to take Seasonique, make sure you are not pregnant or wait until your next menstruation.

• If you are breastfeeding and want to start taking Seasonique (again) after giving birth:

Read the section on “Pregnancy and Lactation”.

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

If you take more Seasonique than you should

No serious consequences have been reported for taking too many Seasonique tablets.

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

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

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

If you forgot to take Seasonique

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

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

Take the pink tablet according to the following principles:

• If when you take the tabletless than 12hours have passed, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then continue taking the tablets again at the usual time.
• If when you take the tabletmore than 12hours have passed, the protection against pregnancy may have been reduced. The greater the number of pink tablets you have forgotten, the greater the risk of becoming pregnant. There is a particularly high risk of becoming pregnant if you forget the pink tablets near the white tablet phase. By adjusting the tablet-taking calendar, you can prevent this high risk.

Forgotten pink tablet(s) between days1 to 7

Take the last forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the next tablets at the usual time. Take additional contraceptive precautions for the next 7days, for example, a barrier method such as a condom. If you have had sex in the week before forgetting the tablet, you may be pregnant. Therefore, consult your doctorimmediately.

Forgotten pink tablet(s) between days8 to 77

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

Forgotten pink tablet(s) between days 78-84

There is a particularly high risk of becoming pregnant if you forget the pink tablets near the white tablet phase. By adjusting the tablet-taking calendar, you can prevent this high risk.

Take the last tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the next tablets at the usual time. If you have taken your tablets correctly in the 7 days before the first forgotten tablet, the protection against pregnancy is not reduced and you do not need to take additional contraceptive precautions. However, if this is not the case, stop taking the pink tablets and take the white tablets minus the number of tablets you have forgotten. Use additional contraceptive precautions for the next 7 days, for example, a barrier method such as a condom. Then, you can start a new cycle of Seasonique.

Consult your doctor for more information.

Chart: if more than 12hours have passed since you should have taken the pink tablets

YES

NO

YES

NO

NO

If you have forgotten any of the pink tablets, and you have not had bleeding during week13, you may be pregnant. Consult your doctor before starting the next package.

What to do in case of vomiting or intense diarrhea

If you vomit in the three or four hours after taking a tablet, or if you have intense diarrhea, there is a risk that the active ingredients of the pill will not have been fully absorbed by the body. This situation is similar to forgetting to take a tablet. After vomiting or diarrhea, you should take, as soon as possible, another tablet. Follow the instructions described in “If you forgot to take Seasonique”.

If you do not want to change your usual tablet-taking schedule, remove the additional pink tablet from the last row of the package.

If you want to stop taking Seasonique

You can stop taking Seasonique whenever you want. If you do not want to become pregnant, ask your doctor about other reliable methods of birth control.

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

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

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take Seasonique”.

Severe side effects – visit a doctor immediately if you notice:

• allergic reaction: symptoms include facial, lip, mouth, tongue, or throat inflammation; skin rash (urticaria) and itching.
• blood clot in a blood vessel in the leg (thrombosis), lungs (pulmonary embolism), or other organs. For more information on the symptoms of a blood clot, see section 2 “Blood clots”.
• Seek immediate medical attention if you experience any of the following symptoms of angioedema: facial, tongue, and/or throat swelling and/or difficulty swallowing or potentially difficulty breathing (see also the section “Warnings and precautions”).

If you think you may have 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

• intermenstrual bleeding.

Common: may affect up to 1 in 10 people

• mood changes, decreased interest in sex, depression
• headaches, migraines
• nausea, stomach pain
• acne
• heavy and prolonged menstrual bleeding, breast pain, painful menstruation
• weight gain.

Uncommon: may affect up to 1 in 100 people

• yeast infection, vaginal yeast and bacterial infection (including candidiasis), urinary tract infection, gastroenteritis, throat and breast infections
• fibrocystic breast disease, appearance or worsening of uterine fibroids (benign tumor)
• anemia
• increased appetite, anorexia, reduced 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 sensitivity to skin stimuli.
• dizziness
• irregular heartbeat, rapid heartbeat
• headaches, high blood pressure, worsening of high blood pressure, low blood pressure when standing up
• sinus congestion
• vomiting, indigestion, diarrhea, constipation
• inflammation of the gallbladder, gallstones
• exanthema, changes in hair growth and texture, unusual hair loss or fine hair, nail disorder, night sweats, skin sensitivity to light, darker skin patches
• peripheral edema, lower back pain, muscle spasms, joint pain, joint stiffness, muscle pain, neck pain
• vaginal or vulvar dryness, uterine spasms, breast pain, irregular menstruation, breast swelling, breast enlargement, painful sex, post-coital bleeding, vaginal secretions, breast secretions, genital pruritus, genital exanthema, pelvic pain, polycystic ovaries, vulvar disorder, vaginal or vulvar discomfort
• feeling tired, swelling in parts of the body, pain, chest pain, hot flashes, flu-like symptoms, discomfort, fever
• increased blood pressure, increased blood fats
• weight loss.

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

harmful blood clots in a vein or artery, for example:

• In a leg or foot (i.e. DVT).
• In the lungs (i.e. PE).
• Heart attack.
• Stroke.
• Transient ischemic attack (TIA), which is a temporary stroke-like symptom.
• Blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and the symptoms of a blood clot).

Unknown: the frequency cannot be estimated from the available data

• loss of consciousness
• hair loss
• arm or leg pain
• raised liver enzymes (elevated transaminases)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.

You can also report them directly to the Spanish Medicines Agency's System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not use this medication after the expiration date that appears on the outer case, aluminum pouch, blister pack support, and blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of empty containers and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medications. By doing so, you will help protect the environment.

Composition of Seasonique

Active Principles:

The active principles are levonorgestrel and etinilestradiol.

Each pink-coated tablet contains 150 micrograms of levonorgestrel and 30 micrograms of etinilestradiol.

Each white-coated tablet contains 10 micrograms of etinilestradiol.

Other components of the pink tablet are:

Tablet core: lactose (see section 2, “Seasonique contains lactose”), hypromellose, microcrystalline cellulose, magnesium stearate

Tablet coating: hypromellose, titanium dioxide (E171), macrogol 400, rojo Allura (E129) (see section 2, “Seasonique contains rojo Allura (E129)”), polisorbate 80, brilliant blue (E133).

Other components of the white tablet are:

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

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

Appearance of the product and contents of the package

Each package of Seasonique contains 3 blisters in total: 2 blisters, each with 28 pink tablets (Month 1 and Month 2) and 1 blister with 35 tablets, of which 28 pink tablets and 7 white tablets (Month 3).

Each blister is inside an aluminum bag, placed in a box with the leaflet.

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Responsible for manufacturing

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80., Krakow

31-546

Poland

Local Representative

Theramex Healthcare Spain, S.L.

Calle Martínez Villergas 52, Edificio C, planta 2ª izquierda.

28027 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet: December 2024

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/.”