SEASONIQUE FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Seasonique film-coated tablets

levonorgestrel/ethinylestradiol

ethinylestradiol

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Important things to 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 having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and see your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood clots”).

Package Leaflet Contents

1. What is Seasonique and what is it used for
2. What you need to know before you start taking Seasonique
3. How to take Seasonique
4. Possible side effects
   1. Storage of Seasonique

1. Contents of the pack and further information

1. What is Seasonique and what is it used for

Seasonique is an extended-cycle birth control pill that is 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, namely 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 should read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 "Blood clots").

Before starting to take Seasonique, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure and, depending on your personal situation, may also perform other tests.

This prospectus describes several situations in which you should stop taking Seasonique or in which the reliability of Seasonique may be reduced. In these situations, you should not have sexual intercourse or, if you do, you should take additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use rhythm or temperature methods. These methods are unreliable, as Seasonique alters the monthly fluctuations of 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

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 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 that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need an operation or if you spend a lot of time without getting 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 stroke symptoms);
• if you have any of the following diseases that may increase your risk of forming a 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 liver tumor;
• if you have (or have had) or are suspected of having breast cancer or cancer of the genital organs;
• if you have any vaginal bleeding without an apparent cause;
• if you are taking the herbal medicine St. John's Wort;
• if you are allergic to ethinylestradiol or levonorgestrel, or to any of the other components of this medicine (listed 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 section "Use of Seasonique with other medications").

Warnings and precautions

When you should be particularly careful with Seasonique

Tell your doctor if you suffer from any of the following conditions.

In some situations, you should have special precautions during the use of Seasonique or any other combined hormonal contraceptive, and it may be necessary for your doctor to regularly monitor you.

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

• if a close relative 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 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 disease of red blood cells);
• 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 need an operation or spend a lot of time without getting up (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 when you can start taking Seasonique after childbirth;
• if you have inflammation of the veins that are under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see "Use of Seasonique with other medications");
• if you suffer from a disease that appeared for the first time during pregnancy or with previous use of sex hormones; for example: hearing loss, porphyria (a blood disease), gestational herpes (skin rash with blisters during pregnancy), Sydenham's chorea (a nerve disease in which sudden body movements are produced);
• if you have (or have ever had) chloasma (brown-gold pigmented patches, called "pregnancy patches", especially on the face). In this case, avoid direct exposure to the sun or ultraviolet light;
• if you have hereditary angioedema, medications containing estrogens can induce or worsen the symptoms of angioedema. You should see your doctor immediatelyif you experience symptoms of angioedema, such as swelling of the face, tongue, and/or pharynx, and/or difficulty swallowing or hives accompanied by difficulty breathing;
• if you are breastfeeding (see "Pregnancy and lactation").
• if you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria with difficulty breathing, contact a doctor immediately. Products containing estrogens can 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 having 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 the veins (which is called "venous thrombosis", "venous thromboembolism", or VTE).
• in the arteries (which is called "arterial thrombosis", "arterial thromboembolism", or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

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 attention if 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 the veins (venous thrombosis). However, these side 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 can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of having a blood clot in a vein is higher during the first year you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after an interruption 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 having a blood clot returns to normal within a few weeks.

What is the risk of having 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 having 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 are not pregnant, about 2 will have a blood clot in a year.

• Of every 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 will have 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 that contains levonorgestrel.
• The risk of having 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 or BMI over 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 the age of 50). In this case, you may have a hereditary disorder of blood clotting.
• if you need an operation or if you spend a lot of time without getting up due to an injury or illness or if you have a leg in a cast. You may need to interrupt the use of Seasonique several weeks before the surgery or while you have less mobility. If you need to interrupt the use of Seasonique, ask your doctor when you can start using it again.
• as you get older (especially over 35 years).
• if you have given birth in the past few weeks.

The risk of having a blood clot increases with the number of conditions you have.

Long-distance flights (more than 4 hours) can 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 suffer from any of the above conditions, even if you are not sure. Your doctor may decide to interrupt the use of 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 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 can increase:

• with age (over 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 50 years). In this case, you may also be at 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 having a blood clot may be increased further.

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

Breast cancer has been observed with slightly higher frequency in women who use combined pills, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who take combined pills because the doctor examines them more frequently. The occurrence of breast tumors decreases gradually after stopping the use of combined hormonal contraceptives. It is essential to have regular breast exams and 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 doctorif you feel severe and unusual abdominal pain.

Bleeding between menstruations

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

During the first few months of use, you may experience some irregular bleeding, such as spotting or breakthrough bleeding. This is usually temporary and may decrease with time. If you experience persistent or heavy bleeding, you should consult your doctor.

3. How to take Seasonique

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

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 should I take

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

A new pack is started directly after (84 pink tablets and then 7 white tablets). There is no interval between taking packs.

Since the tablets have a different composition, it is necessary to start with tablet number 1 of the blister marked as Month 1. Take the tablets every day. When you have taken all the tablets of Month 1, move on to the blister of Month 2. Start with tablet 29. When you have taken all the tablets of the Month 2 blister, move on 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.

Preparing the pack

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

Stick the strip on the top of the Seasonique blister where it says "Place day label here", so that the first day is over the tablet marked as "1".

Now you will have a day indicated above each tablet, and you can see if you have taken a particular tablet. The arrows indicate the order in which you should take the tablets.

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

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

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

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 days 2 to 5 of your cycle, but then you must use additional contraceptive precautions (e.g., a condom) during the first 7 days of taking the tablet.

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

You can start taking Seasonique preferably the day after you have taken 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 patch contraceptive, follow your doctor's instructions.

• Changing from a progestin-only method (progestin-only pill, injection, implant, or IUD that releases progestin):

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

In all these cases, you must use additional contraceptive precautions (e.g., a condom) during the first 7 days 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 28 days later. If you start after day 28, you must also use additional contraceptive precautions (e.g., a condom) during the first 7 days you use Seasonique. If, after giving birth, you have had sexual intercourse 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 Breastfeeding".

If you are unsure 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 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, 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 forget to take Seasonique

White tablets:If you have forgotten any of the white tablets (the last 7 tablets of the pack), this has no effect on the reliability of Seasonique. Do not take the missed white tablet or 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 missed the tablet, you may need to take additional contraceptive precautions, for example, a barrier method like a condom.

Take the pink tablet according to the following principles:

• If, when taking the tablet, less than 12hourshave 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 taking the tablet, more than 12hourshave passed, the protection against pregnancy may be reduced. The more tablets you have missed, 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. Therefore, you must follow the rules indicated below.

Pink tablet(s) missed between days1 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 next tablets at the usual time. Take additional contraceptive precautions during the next 7 days, e.g., a barrier method like a condom. If you have had sexual intercourse in the week before missing the tablet, you may be pregnant. Therefore, consult your doctor immediately.

Pink tablet(s) missed between days8 to 77

Take the tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the next tablets at the usual time. If you have taken your tablets correctly in the 7 days before the first missed 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 missed more than one tablet, use additional contraceptive precautions during the next 7 days, such as a barrier method like a condom.

Pink tablet(s) missed between days 78-84

There is a particularly high risk of becoming pregnant if you miss pink tablets near the phase of white tablets. By adjusting the tablet-taking schedule, this high risk can be prevented.

Take the last tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the next tablets at the usual time. If you have taken your tablets correctly in the 7 days before the first missed 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 missed. Use additional contraceptive precautions during the next 7 days, such as a barrier method like 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 missed any of the pink tablets, and you have not had bleeding during week13, 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 or 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 fully absorbed into the body. This situation is similar to if you forget to take a tablet. After vomiting or having diarrhea, you should take another tablet as soon as possible. Follow the instructions described in “If you forget to take Seasonique”.

If you do not want to change your normal tablet-taking schedule, take the extra pink tablet from the last row of the pack.

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 for advice on other reliable methods of birth control.

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

4. Possible Adverse Effects

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

All women who take 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 taking Seasonique".

Severe Adverse Effects – Visit a Doctor Immediately if You Observe:

• Hypersensitivity reaction (allergic reaction): symptoms include swelling of the face, lips, mouth, tongue, or throat; skin rash (hives) and itching.
• Blood clot in a blood vessel of the leg (thrombosis), lungs (pulmonary embolism), or other organs. To see the 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 potentially life-threatening hives with 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

• Bleeding between menstrual periods.

Common: May Affect Up to 1 in 10 People

• Mood changes, decreased interest in sexual relations, 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, vaginal fungal and bacterial infection (including candidiasis), bladder infection, gastroenteritis, throat and sinus infection
• Fibrocystic breast disorder, 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.
• Vertigo
• Irregular heartbeat, rapid heartbeat
• Hot flashes, 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
• Rash, changes in hair growth and texture, unusual hair loss or thinning, nail disorder, night sweats, skin sensitivity to light, darker skin spots
• 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 intercourse, bleeding after intercourse, vaginal discharge, breast discharge, genital itching, genital rash, pelvic pain, polycystic ovaries, vulvar disorder, vaginal or vulvar discomfort
• Feeling of fatigue, swelling of body parts, 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 a lung (i.e., PE).
• Heart attack.
• Stroke.
• Mild or temporary stroke-like symptoms, known as a transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances 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).

Not Known: Frequency Cannot Be Estimated from Available Data

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

Reporting Adverse Effects

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

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 package to protect it from light and moisture.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Seasonique

Active Ingredients:

The active ingredients 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 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 Ingredients of the White Tablet:

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

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

Appearance and Package Contents

Each Seasonique package 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 placed inside an aluminum bag, which is placed in a box with the leaflet.

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

The white tablet is round, biconvex, approximately 5.7 mm in diameter, engraved 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

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 Medicine 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

Date of the Last Revision of this Leaflet: December 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.