SEASONIQUE 150 MICROGRAMS/30 MICROGRAMS+10 MICROGRAMS Film-coated tablets

Зміст інструкції

1. Seasonique 150/30 micrograms + 10 micrograms, film-coated tablets
   1. What is Seasonique and what is it used for?
   2. What you need to know before you take Seasonique
   3. How to take Seasonique
   4. Possible side effects
   5. How to store Seasonique
   6. Contents of the pack and other information

Seasonique 150/30 micrograms + 10 micrograms, film-coated tablets

levonorgestrel/ethinylestradiol
ethinylestradiol

Read this 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. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception, if used correctly.
• They slightly increase the risk of blood clots forming in the veins and arteries, especially during the first year of use or when you restart a combined hormonal contraceptive after a break of 4 or more weeks.
• Pay attention and see your doctor if you think you have symptoms due to a blood clot (see section 2 “Blood clots”).

Contents of this leaflet:

• 1. What Seasonique is and what it is used for
• 2. What you need to know before you take Seasonique
• 3. How to take Seasonique
• 4. Possible side effects
• 5. How to store Seasonique
• 6. Contents of the pack and other information

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

Seasonique is an extended-regimen oral contraceptive pill, to be 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, called
levonorgestrel and ethinylestradiol.
The 7 white tablets contain a small amount of the female hormone ethinylestradiol.

2. What you need to know before you take Seasonique

General notes
Before starting to use Seasonique, read the information on blood clots in paragraph 2. It is
particularly important that you read the symptoms due to a blood clot (see paragraph 2 “Blood
clots”).
Before taking Seasonique, your doctor will ask you some questions about your personal and
family medical history. The doctor will also measure your blood pressure and, depending on your
personal situation, may also perform other tests.
This leaflet describes various situations that require stopping Seasonique or in which
the reliability of Seasonique may be reduced. In such situations, you should refrain from sexual
intercourse, or use additional non-hormonal contraceptive measures, such as a condom or another
barrier method. Do not use the rhythm or basal temperature method. In fact, these methods can be
unreliable, as Seasonique alters the monthly variations in body temperature and cervical
mucus.

Seasonique, like all hormonal contraceptives, does not offer any protection against HIV
(AIDS) or other sexually transmitted diseases.
Do not use Seasonique
Do not use Seasonique if you have any of the conditions listed below. If any of the conditions
listed occur for the first time during the use of Seasonique, you should consult your doctor immediately.
The doctor will discuss with you other methods of birth control that may be more suitable for
your case.

Do not take Seasonique

• if you have (or have ever had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE) or other organs;
• if you know you have a disorder that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
• if you are going to have an operation or if you will be bedridden for a long period (see paragraph “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or a transient ischemic attack (TIA - symptoms of a temporary stroke);
• if you have one of the following diseases, which may increase the risk of blood clots forming in the arteries:
• severe diabetes with damage to blood vessels;
• very high blood pressure;
• very high levels of fats (cholesterol or triglycerides) in the blood;
• a condition known as hyperhomocysteinemia;
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have had in the past) inflammation of the pancreas (pancreatitis);
• if you have (or have had in the past) a liver disease and liver function is still abnormal;
• if you have or have had in the past a liver tumor;
• if you have (or have had in the past) or suspect you have breast or genital cancer;
• if you have unexplained vaginal bleeding;
• if you are taking the herbal product St. John's Wort (hypericum);
• if you are allergic to ethinylestradiol or levonorgestrel or any of the excipients of this medicine (listed in paragraph 6). Such an allergy is recognizable by itching, rash or swelling;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir (see also paragraph “Other medicines and Seasonique”).

Warnings and precautions
When to be particularly careful with Seasonique
When should you contact a doctor?
Contact your doctor urgently

• if you notice possible signs of a blood clot that may indicate you have a blood clot in your leg (deep vein thrombosis), a blood clot in your lung (pulmonary embolism), a heart attack or a stroke (see the following paragraph "Blood clot (thrombosis)"). For a description of the symptoms of these serious side effects, see the paragraph “How to recognize a blood clot”.

Tell your doctor if any of the following conditions apply to you.
In some situations, you will need to take special precautions when using Seasonique or any other
combined hormonal contraceptive, and you may need regular check-ups with your doctor.
If any of the following conditions apply to you, you must tell your doctor before starting to use
Seasonique. You should also tell your doctor if any of these conditions appear or
worsen during the use of Seasonique:

• if a close relative has or has had breast cancer;
• if you have a liver or gallbladder disease;
• if you have diabetes;
• if you suffer from 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 the body's defense system);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disease);
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are going to have an operation or if you will be bedridden for a long period (see paragraph 2 “Blood clots”);
• if you have just given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Seasonique;
• if you have inflammation of the superficial veins (superficial thrombophlebitis);
• if you have varicose veins;
• if you suffer from epilepsy (see “Other medicines and Seasonique”);
• if you have a disease that first appeared during pregnancy or a previous use of sex hormones, for example hearing loss, porphyria (a blood disease), herpes gestationis (skin rash with blisters during pregnancy), Sydenham's chorea (a nervous disease that manifests with sudden movements of the body);
• if you have or have had chloasma (brownish-golden patches on the skin, known as “mask of pregnancy”, especially on the face). In this case, avoid direct exposure to sunlight or ultraviolet rays;
• if you are breastfeeding (see “Pregnancy and breastfeeding”).
• if you notice symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen the symptoms of hereditary or acquired angioedema.

Blood clots
The use of a combined hormonal contraceptive like Seasonique increases the risk of developing a blood clot
compared to not using one. In rare cases, a blood clot can block blood vessels and cause
serious problems.
Blood clots can develop

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

Recovery from blood clots is not always complete. Rarely, serious long-term effects can occur, or, very rarely, these effects can be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with
Seasonique is low.
HOW TO RECOGNIZE A BLOOD CLOT
Contact your doctor immediately if you notice any of the following signs or symptoms
Do you have any of these signs? What could you be suffering from?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by: Deep vein thrombosis
• pain or sensitivity in the leg that can only be felt when standing or walking;
• increased warmth in the affected leg;
• change in skin color of the leg, such as paleness, redness or blueness.
• sudden shortness of breath or rapid breathing;
• sudden cough without a clear cause, with possible blood production;
• severe chest pain that may increase when breathing deeply;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain

If you are not sure, tell your doctor as some of these symptoms such as
cough or shortness of breath can be mistaken for a
milder condition such as a respiratory infection (e.g. a
“common cold”).
Pulmonary embolism
Symptoms that occur more frequently in one eye:

• sudden loss of vision or
• painless blurred vision that may progress to loss of vision. Retinal vein thrombosis (blood clot in the eye)
• pain, discomfort, pressure or heaviness in the chest
• feeling of tightness or fullness in the chest, arm or below the sternum;
• feeling of fullness, indigestion or choking;
• discomfort in the upper body, radiating to the back, jaw, throat, arms and stomach;
• sweating, nausea, vomiting or dizziness; Heart attack

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. In most cases, they occur in the first year of using 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.
• Very rarely, the clot can form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year you take
a combined hormonal contraceptive for the first time. The risk may be higher if you start
using a combined hormonal contraceptive again (the same medicine or a different medicine) after a break of
4 or more weeks.
After the first year, the risk decreases but is still slightly higher than if you were not
using a combined hormonal contraceptive.
When you stop taking Seasonique, the risk of developing a blood clot returns to
normal levels within a few weeks.

What is the risk of developing 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 developing a blood clot in the leg or lung (DVT or PE) with
Seasonique is low.
In about 2 out of 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.
In 10,000 women who use a combined hormonal contraceptive containing levonorgestrel,
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 28-day combined hormonal contraceptives containing levonorgestrel. The risk of a blood clot forming depends on your personal medical history (see “Factors that increase the risk of a blood clot”)

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Seasonique is low but some conditions cause an
increase. Your risk is higher:

• if you are severely overweight (body mass index or BMI greater than 30 kg/m²);
• if a close relative of yours has had a blood clot in a leg, lung, or another organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you need to undergo surgery or if you need to stay in bed for a long period due to an injury or illness or if you have a leg in a cast. You may need to stop taking Seasonique several weeks before surgery or during the time you are less mobile. If you need to stop taking Seasonique, ask your doctor when you can start taking it again;
• with increasing age (especially over 35 years);
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (duration >4 hours) can temporarily increase the risk of a blood clot forming,
especially if you have some of the other risk factors listed.
It is important that you inform your doctor if any of these conditions apply to you, even if you
are not sure. The doctor may decide to stop you from taking Seasonique.
If any of the above conditions change while you are using Seasonique, for example if a
close relative develops thrombosis for no known reason or if you gain a lot of weight, contact your
doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems, for example,
they can cause a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Seasonique is very
low but can increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive like Seasonique it is advisable that you quit smoking. If you cannot quit smoking and you 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 a close relative of yours has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high risk of heart attack or stroke;
• if you, or a close relative, have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valve defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly serious, the risk of developing
a blood clot may be even higher.
If any of the above conditions change while you are using Seasonique, for example if you start to
smoke, if a close relative develops thrombosis for no known reason or if you gain a lot of weight,
contact your doctor.

Seasonique and cancer
Breast cancer is observed with a slightly higher frequency in women who use combined
pills, but it is not known whether this is due to the treatment. For example, it is possible that women who
use combined pills are diagnosed with more tumors because they undergo more
frequent medical check-ups. The incidence of breast cancer gradually decreases after discontinuation of
treatment with combined hormonal contraceptives. It is important that you check your breasts regularly and
contact your doctor if you feel any lumps.
In women using the pill, benign liver tumors and, more rarely, malignant liver tumors have been observed. Contact your doctorif you experience unusual and severe abdominal pain.

Intermenstrual bleeding
When you take Seasonique, which has an extended delivery cycle of 91 days, you should expect to have
4 scheduled periods per year (bleeding while taking the 7 white pills). Each
period will last about 3 days.
During the first few months of taking Seasonique, unexpected bleeding may occur. It is not
unusual to have unexpected bleeding, especially when taking the first pack of
Seasonique. This bleeding or spotting tends to decrease over time. Do not stop taking
Seasonique because of bleeding or spotting. If the spotting continues for more than 7 consecutive days, or if
the bleeding is very heavy, contact your doctor.

What to do if no bleeding occurs after Day 84
If your scheduled period does not occur (no bleeding on the days you take the
white tablets), you should consider the possibility of being pregnant. Since scheduled periods are less frequent when you take Seasonique, inform your doctor that you have
not had your period and that you are taking Seasonique. Also inform your doctor if you experience symptoms of
pregnancy such as morning sickness or unusual breast tenderness. It is important that your
attending physician assess the possibility of pregnancy.
Do not start the next pack of Seasonique until you are sure you are not pregnant.

Psychiatric disorders
Some women who use hormonal contraceptives including Seasonique have reported depression or depressed mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you experience
mood changes and depressive symptoms, see your doctor as soon as possible for further medical advice.

Other medicines and Seasonique
Always tell the doctor who prescribed Seasonique to you if you are taking any other medicines,
including herbal medicines. Also tell any other doctor or dentist who prescribes you another
medicine (or the pharmacist) that you are taking Seasonique. They may tell you if you need to
take additional contraceptive measures (for example a condom) and for how long.
Some medicines can reduce the effectiveness of Seasonique in preventing pregnancy or can cause
unexpected bleeding. These include drugs for the treatment of:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g. rifampicin);
• HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as griseofulvin);
• high blood pressure in the arteries of the lungs (bosentan);
• cancer (vemurafenib). Even the herbal product St. John's Wort (hypericum) can cause Seasonique to malfunction. Seasonique can affect the effect of other drugs, for example:
• the antiepileptic lamotrigine (this can lead to an increase in the frequency of seizures).

Do not use Seasonique if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir,
dasabuvir, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir, as these products can
cause increases in blood test results of liver function (increased liver enzyme ALT).
Your doctor will prescribe you another type of contraceptive before starting treatment with these medicines.
Seasonique can be resumed about 2 weeks after completion of this treatment. See the
paragraph “Do not take Seasonique”.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Laboratory tests
If you need to undergo a blood test, tell your doctor or laboratory personnel that you are taking
Seasonique, as hormonal contraceptives can affect the results of some tests.

Pregnancy and breastfeeding
If you are pregnant, you must notuse Seasonique. If you become pregnant while taking Seasonique,
you must stop taking the pill immediately and contact your doctor.
The use of Seasonique is generally not recommended during breastfeeding as it may decrease the
amount of breast milk and change its composition. If you want to take contraceptive pills during
breastfeeding, you should consult your doctor.

Driving and operating machinery
There is no evidence to suggest that the use of Seasonique affects the ability to drive vehicles or
operate machinery.

Seasonique contains lactose
Seasonique contains lactose. If you have been diagnosed with intolerance to some sugars, contact your
doctor 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 placed in 3 blisters per pack.

How to take the tablets
Take one Seasonique tablet every day, if necessary with a little water. You must take the
tablets at about the same time each day.

Which tablet to take
Do not confuse the tablets:take one pink tablet a day for the first 84 days and then one
white tablet a day for the last 7 days.
Start a new pack immediately (84 pink tablets and then 7 white tablets). There is no
scheduled break between two packs.
Due to the different composition of the tablets, it is necessary to start with the first tablet in the top left
corner of the first blister of the pack and take one tablet every day. For the correct
order of taking the tablets, follow the direction indicated by the arrows on the blister.

Preparing the pack
To help you keep track of the tablets, there are weekly adhesive strips marked with the 7 days
of the week. Choose the sticker that starts with the day you begin taking the tablets. For
example, if you start on Wednesday, use the weekly sticker that starts with the word “WED”.
Apply the sticker along the top of the Seasonique pack above the words “Apply the
week sticker here”, so that the first day is above the tablet marked with the
number “1”.
The sticker thus indicates the corresponding day for each tablet and you can check if you have taken a
particular pill. The arrows indicate the order of taking the pills.
Usually, the so-called withdrawal bleeding starts when you take the white tablets.
After taking the last white tablet, start the next pack of Seasonique, regardless
of whether menstruation has stopped or not. In this way you will always start a new pack of
Seasonique on the same day of the week, and the withdrawal bleeding will occur on the same
days each time.
If you use Seasonique in this way, you will be protected against unwanted pregnancies for the entire duration of the 91
days.

When to start the first blister

• If you have not used a hormonal contraceptive in the previous month: Start taking Seasonique on the first day of your cycle (i.e. the first day of your period). You can also start between the 2nd and 5th day of your cycle, but in this case you should use additional contraceptive precautions (e.g. a condom) for the first 7 days of taking the tablet.
• Switching from a combined hormonal contraceptive, or from a combined contraceptive vaginal ring, or from a patch:You can start taking Seasonique preferably the day after the last active tablet (the last tablet containing active ingredients) of the previous pill. When switching from a combined contraceptive vaginal ring or patch, follow your doctor's advice.
• Switching from a progestin-only method (progestin-only pill, injection, implant or progestin-releasing IUS):You can switch from a progestin-only pill to Seasonique at any time (in the case of an implant or a progestin-releasing intrauterine device, you can start on the day the implant or device is removed, or, in the case of an injectable, on the day the next injection is due). In all these cases, you should use additional contraceptive precautions (e.g. a condom) for the first 7 days of taking the tablets.
• After a spontaneous or induced abortion: Follow your doctor's advice.
• After childbirth: After childbirth, you can start Seasonique 21 to 28 days later. If you start later than the 28th day, you should use additional contraceptive precautions (e.g. a condom) during the first 7 days of taking Seasonique. If, after childbirth, you have had intercourse before starting (or restarting) taking Seasonique, you should first make sure you are not pregnant, or wait for your next period.
• If you are breastfeeding and want to start (or restart) taking Seasonique after childbirth: Read the “Pregnancy and Breastfeeding” section.

Ask your doctor for advice if you are not sure when to start.
If you take more Seasonique than you should
There are no reports of serious adverse effects following the taking of too many Seasonique tablets.
If you take several tablets at once, you may experience nausea or vomiting. Young girls may experience
vaginal bleeding.
If you have taken too many Seasonique tablets or discover that some tablets have been taken by a child, seek
immediate medical or pharmaceutical advice.

If you forget to take Seasonique
White tablets:if you forget 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 forgotten white tablet(s) and continue with the next tablet at the usual time.

Pink tablets:if you forget to take a pink tablet, depending on the day of the cycle in which you
forgot the tablet, you may need to take additional contraceptive measures, such as a barrier method like a condom.
Take the pink tablets according to these rules:

• If the delay in taking a tablet is less than 12 hours, contraceptive protection is maintained. Take the tablet as soon as you remember and then continue taking the tablets at the usual time.
• If the delay in taking a tablet is more than 12 hours, contraceptive protection may be reduced. The greater the number of tablets forgotten, the greater the risk that the contraceptive effect is reduced. If you forget pink tablets at the beginning of the pack, the risk of becoming pregnant is particularly high. In this case, follow the rules indicated below.

Forgotten pink tablet(s) between days 1-7
Take the last forgotten tablet as soon as you remember, even if this means taking two
tablets at the same time. Then continue taking the tablets at the usual time.
Take additional contraceptive precautions for the next 7 days, e.g. a barrier method like a
condom. If you had intercourse in the week before, you may have become pregnant.
Contact your doctor immediately.

Forgotten pink tablet(s) between days 8-77
Take the forgotten tablet as soon as you remember, even if this means taking two tablets
at the same time. Then continue taking the tablets at the usual time. If you have taken
the tablets correctly for the 7 days before the first forgotten tablet, the contraceptive safety
of the pill is maintained and you do not therefore need to take additional contraceptive
precautions. Otherwise, or if you have forgotten more than one tablet, take additional contraceptive
precautions for the next 7 days, for example a barrier method like 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 phase of the white tablets. This high risk can be prevented by adjusting the schedule of
taking the tablets.
Take the forgotten tablet as soon as you remember, even if this means taking two tablets
at the same time. Then continue taking the tablets at the usual time. If you have taken
the tablets correctly for the 7 days before the first forgotten tablet, the contraceptive safety
of the pill is maintained and you do not therefore need to take additional contraceptive
precautions. Otherwise, stop taking the pink tablets and take the white tablets
subtracting the number of forgotten tablets. Take additional contraceptive precautions for the next 7
days, for example a barrier method like a condom.
Then you can start a new cycle of Seasonique.
Ask your doctor for further advice.

Table: if more than 12 hours have passed since you forgot to take the pink tablets
Ask your doctor for advice.
YES
Days 1-7
Did you have intercourse the week
before forgetting the tablets?
NO

• Take the last forgotten tablet and continue taking the tablets as usual.
• Use a barrier method (condom) for the next 7 days.
• Finish the blister

Take the forgotten tablet and
continue taking the tablets as
usual.
No additional contraceptive method is
necessary.
If you have forgotten more than one tablet or
have not taken the tablets correctly
in the 7 days before, use a barrier method
(condom) for the next 7
days.
Days 8-
77
Take the last forgotten tablet and
continue taking the tablets as
usual. No additional methods need to be used
contraceptive.
YES
Days 78-
84
In the 7 days before the first forgotten
tablet, did you take the tablets correctly?
NO

• Stop taking the pink tablets. Take the white tablets minus the number of forgotten tablets. Use a barrier method (condom) for the next 7 days.
• Start a new cycle of Seasonique

If you forget to take any of the pink tablets and during week 13 your period does not appear, you may be pregnant. See your doctor before starting a new
pack.
What to do in case of severe vomiting or diarrhea
If you vomit within 3-4 hours of taking a tablet or have severe diarrhea, it is possible that the active ingredients
of the pill are not completely absorbed by your body. The situation is comparable to that
which occurs when you forget to take a tablet. After vomiting or diarrhea, take another
tablet as soon as possible. You must follow the instructions in the “If you forget to take
Seasonique” section.
If you do not want to change the normal rhythm of taking the tablets, take the extra pink
tablet from the last row of the pack.

If you want to stop taking Seasonique
You can stop taking Seasonique at any time. If you still want to avoid pregnancy, you should
consult your doctor for advice on other safe methods of birth control.
If you have any doubts about the use of this medicine, ask your doctor, midwife or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think may be due to Seasonique, tell your doctor.
A higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) is present in all women who take combined hormonal contraceptives. For more detailed information on the different risks associated with taking
combined hormonal contraceptives, see section 2 “What you need to know before taking Seasonique”.

Serious side effects - go to a doctor immediately.

• hypersensitivity reactions (allergic reactions) - signs include swelling of the face, lips, mouth, tongue or throat, a red and bumpy rash (urticaria) and itching.
• blood clot in a blood vessel in the leg (thrombosis), in the lung (pulmonary embolism) or other organs. For signs of a blood clot see section 2 “Blood clots”.
• Contact your doctor immediately if you notice any of the following symptoms of angioedema: swelling of the face, tongue and/or pharynx and/or difficulty swallowing or urticaria with possible difficulty breathing (see also “Warnings and precautions”). If you think you have any of these side effects, go to a doctor immediately.You may need to stop taking Seasonique.

Very common: may affect more than 1 in 10 people

• Breakthrough bleeding.

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• fungal infections, vaginal fungal and bacterial infection (including candidiasis), urinary tract infection, throat infection and sinus infections
• fibrocystic breast disease, onset or worsening of uterine fibroids (benign tumor)
• anemia
• increased appetite, anorexia, decreased appetite, diabetes mellitus, insulin resistance
• irritability, anxiety, depressed mood, worsening of depression, emotional distress, sleep disorders, altered orgasm, paranoia
• dizziness, increased skin sensitivity, absent or reduced skin sensitivity
• vertigo
• irregular heartbeat, accelerated heartbeat
• hot flashes, high blood pressure, worsening of high blood pressure, low blood pressure when getting up (postural hypotension)
• sinusitis
• vomiting, indigestion, diarrhea, constipation
• inflammation of the gallbladder, gallstones
• skin rash, changes in hair growth and structure, unusual hair loss or thinning, nail disorders, night sweats, skin sensitivity to light, darker skin patches
• peripheral edema, back pain, muscle spasms, arthralgia, joint stiffness, myalgia, neck pain
• vaginal or vulvar dryness, uterine spasms, breast pain, irregular periods, breast congestion, enlarged breasts, pain during intercourse, bleeding after intercourse, vaginal discharge, breast discharge, genital itching, genital rash, pelvic pain, polycystic ovary, vulvar disorders, discomfort of the vagina or vulva
• feeling tired, swelling of some parts of the body, pain, chest pain, 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 an artery, for example: in a leg or foot (DVT) or in the lung (PE) or heart attack or stroke or mini-stroke or temporary symptoms similar to those of a stroke, known as a transient ischemic attack (TIA) or blood clots in the liver, stomach/intestine, kidneys or eye.

The possibility of developing 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 the available data

• loss of consciousness
• alopecia
• pain in the arms or legs

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Seasonique

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light and moisture.
Do not use this medicine after the expiry date which is stated on the outer packaging, on the aluminium pouch, on the blister container and on the blisters after SCAD. The expiry date refers to the last
day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Seasonique contains

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 in the pink tablets are:
Tablet core: lactose (see paragraph 2 “Seasonique contains lactose”), hypromellose,
microcrystalline cellulose, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171), Macrogol 400, Allura Red (E129)
(see paragraph 2 “Seasonique contains Allura Red (E129)”), polysorbate 80, Brilliant Blue (E133).

Other ingredients in the white tablets are:
Tablet core: lactose, potassium polyacrilin, microcrystalline cellulose, magnesium stearate.
Tablet coating: titanium dioxide (E171), polydextrose FCC, hypromellose, triacetin, macrogol

• 8000.

Description of the appearance of Seasonique and contents of the pack
The Seasonique pack contains a total of 3 blisters: 2 blisters contain 28 pink tablets and 1 blister
contains 35 tablets in total - 28 pink tablets and 7 white tablets.
The three blisters are inside a cardboard container, inserted into an aluminum pouch and into a
The pink tablet is round, biconvex, with a diameter of approximately 5.7 mm, with “172” engraved on one side and “T”
on the other side.
The white tablet is round, biconvex, with a diameter of approximately 5.7 mm, with “173” engraved on one side and “T”
on the other side.

Marketing authorisation holder and manufacturer
Theramex Ireland Limited
Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland

Manufacturer:
Teva Operations Poland
Mogilska 80, 31-546 Krakow
Poland
Teva Pharmaceuticals Europe B.V.
Swensweg 5, 2031 GA Haarlem
Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Austria, Germany: Seasonique 150 micrograms/30 micrograms + 10 micrograms film-coated tablets
Belgium, Netherlands: Seasonique film-coated tablets
Croatia: Seasonique 0.15 mg/0.03 mg + 0.01 mg film-coated tablets
Czech Republic, Denmark, Estonia, Poland, Portugal, Sweden: Seasonique
France: Seasonique 150 micrograms/30 micrograms + 10 micrograms, film-coated tablet
Finland: Seasonique 150 micrograms/30 micrograms + 10 micrograms tablet, film-coated
Hungary: Seasonique 150 micrograms/30 micrograms + 10 micrograms film-coated tablet
Italy: Seasonique 150/30 micrograms + 10 micrograms, film-coated tablets
Latvia: Seasonique 150 micrograms/30 micrograms + 10 micrograms coated tablets
Luxembourg: Seasonique, film-coated tablets
Romania: Seasonique 150/30 micrograms + 10 micrograms film-coated tablets
Slovak Republic: Seasonique 0.15mg/0.03mg +0.01 mg film-coated tablets
Slovenia: Seasonique 0.15 mg/0.03 mg and 0.01 mg film-coated tablets
Spain: Seasonique film-coated tablets
United Kingdom: Seasonique 150 micrograms/30 micrograms and 10 micrograms Film-coated Tablets