Harmonet

PATIENT INFORMATION LEAFLET: USER INFORMATION

IMPORTANT: Keep the leaflet, information on the immediate packaging in a foreign language

Harmonet

75 micrograms + 20 micrograms, effervescent tablets

Gestodene + Ethinylestradiol

Important information about combined hormonal contraceptives

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

You should read the contents of the leaflet before using the medicine.

• You should keep this leaflet so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If any of the undesirable effects worsen or if any undesirable effects not mentioned in the leaflet occur, you should tell your doctor or pharmacist.

Table of contents of the leaflet:

• 1. What is Harmonet and what is it used for
• 2. Important information before using Harmonet
• 3. How to take Harmonet
• 4. Possible side effects
• 5. How to store Harmonet
• 6. Other information

1. WHAT IS HARMONET AND WHAT IS IT USED FOR

Harmonet is available as a combined hormonal contraceptive tablet ("Tablet")
for use in order to prevent pregnancy.
The medicine contains two types of female sex hormones: estrogen and progestogen. These
hormones prevent pregnancy by acting in three ways: they prevent the release of the egg from the ovaries;
thicken the mucus in the cervix, making it difficult for sperm to penetrate the uterus; prevent
thickening of the uterine lining so that a fertilized egg cannot develop in it.
Harmonet should be taken daily for 21 days (1 tablet), after which there is a 7-day break without
taking the tablet.

Benefits of taking the Tablet:

• it is one of the most reliable, reversible methods of contraception, if used correctly,
• it does not require interrupting sexual intercourse,
• it usually makes periods more regular, more scarce and less painful,
• it can alleviate premenstrual symptoms.

Harmonet does not protect against sexually transmitted infections, such as chlamydia or HIV. Only condoms protect against these infections.

Harmonet should be taken according to the recommendations in order to prevent pregnancy.

2. IMPORTANT INFORMATION BEFORE USING HARMONET

General notes

Before starting to take Harmonet, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
It is essential to understand the benefits and risks of taking the Tablet before starting to take it or deciding to continue. Although the Tablet is suitable for most healthy women, it is not suitable for all of them.
You should inform your doctor if you have any diseases or risk factors mentioned in this leaflet.

Before taking the Tablet

The doctor will ask you a few questions about your health and the health of your close relatives and measure your blood pressure, and should also perform other examinations, such as a breast examination.

While taking the Tablet

• You should regularly visit your doctor, usually when a new prescription is needed.
• You should regularly have a cervical smear test.
• Once a month, you should examine your breasts and nipples - you should inform your doctor if you notice or feel any changes, such as lumps or indentations in the skin.
• If you need to have a blood test, you should inform your doctor that you are taking the Tablet, as it may affect the results of some tests.
• If you are scheduled to have surgery, you should inform your doctor. It may be necessary to stop taking the Tablet 4-6 weeks before the operation. This will reduce the risk of blood clots (see section "Blood clots"). Your doctor will inform you when you can resume taking the Tablet.

When not to use Harmonet

You should not use Harmonet if you have any of the following conditions. If you have any of the following conditions, you should inform your doctor. Your doctor will discuss with you which other contraceptive method will be more suitable.

• •if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• •if you know you have a blood clotting disorder - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• •if you need to have surgery or will be immobilized for a long time (see section "Blood clots");
• •if you have had a heart attack or stroke;
• •if you have angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (temporary stroke symptoms);
• •if you have any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage;
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• hyperhomocysteinemia;
• •if you have had a type of migraine called "migraine with aura";
• •if you are allergic (hypersensitive) to gestodene, ethinylestradiol, or any of the other ingredients of Harmonet (see section 6. Other information);
• •if you are pregnant or think you may be pregnant;
• •if you have hormone-dependent cancer - such as some breast cancers, endometrial cancer, or ovarian cancer;
• •if you have unexplained vaginal bleeding;
• •if you have irregular heart rhythm or heart valve problems, which were caused by blood clotting problems;
• •if you have ever had pancreatitis associated with high levels of fats in the blood (high cholesterol or triglycerides);
• •if you have ever had severe liver disease;
• •if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section "Other medicines and Harmonet")

If you have any of the above conditions or if they occur for the first time while taking Harmonet, you should contact your doctor as soon as possible. Do not take Harmonet.

Warnings and precautions

When should you contact your doctor?

• you should see your doctor immediately if you notice any of the following symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), blood clot in your lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots (thrombosis)"). To find a description of these serious side effects, see "How to recognize a blood clot".

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

If these symptoms occur or worsen while taking Harmonet, you should also tell your doctor.

• •if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• •if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• •if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• •if you have sickle cell anemia (a hereditary disease of red blood cells);
• •if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis; if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• •if you have recently given birth, you are at increased risk of blood clots. You should consult your doctor about how soon you can start taking Harmonet after giving birth;
• •if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• •if you have varicose veins;
• •if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, which may cause difficulty breathing, you should

contact your doctor immediately. Products containing estrogens may cause or worsen the symptoms of both hereditary and acquired angioedema.

Tablet and smoking

Women taking the tablet are strongly advised to quit smoking.
Smoking increases the risk of serious side effects from the heart and circulatory system. This risk increases with age and the number of cigarettes smoked and is significant in women over 35 years old.

BLOOD CLOTS

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

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

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

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

HOW TO RECOGNIZE A BLOOD CLOT

You should see your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these
symptoms?
What is the likely cause of the
symptoms?

• •swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may Deep vein thrombosis

only be felt when standing or walking,

• increased temperature in the affected leg,
• change in the color of the leg skin, such as pallor, redness, or cyanosis,
• •sudden unexplained shortness of breath or rapid breathing;
• •sudden unexplained cough, which may be accompanied by coughing up blood;
• •severe chest pain, which may worsen with deep breathing;
• •severe dizziness or fainting;
• •rapid or irregular heartbeat;
• •severe abdominal pain.

If you are unsure, you should see your doctor, as some of these symptoms, such as coughing or shortness of breath, can be mistaken for milder conditions, such as a respiratory infection (e.g. a cold).

BLOOD CLOTS IN VEINS

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

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

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

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

What affects the risk of blood clots in veins?

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

• •if you are significantly overweight (body mass index (BMI) over 30 kg/m);
• •if someone in your immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years old). In this case, you may have a hereditary blood clotting disorder;
• •if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop taking Harmonet for a few weeks before surgery or immobilization. If you need to stop taking Harmonet, you should ask your doctor when you can resume taking it;
• •with age (especially over 35 years old);
• •if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in you.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is essential to tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop Harmonet.
You should inform your doctor if any of the above conditions change while taking Harmonet, e.g. if you start smoking, if someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain significant weight.

BLOOD CLOTS IN ARTERIES

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

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

Factors that increase the risk of blood clots in arteries

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

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

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

Tablet and cancer

Taking the tablet for a long time reduces the risk of ovarian and endometrial cancer. However, it appears to slightly increase the risk of cervical cancer– although this may be due to sexual behavior rather than taking the tablet. The most important risk factor for cervical cancer is persistent human papillomavirus infection. All women should have regular cervical smears.
If you have had or have breast cancer, you should not take the tablet.
The tablet slightly increases the risk of breast cancer. This risk increases with the duration of tablet use, but decreases within 10 years of stopping use. Breast cancer is rare in women under 40 years old, so the risk of additional breast cancer cases in women currently or recently taking the tablet is small.
The risk of breast cancer is higher:

• the older you are,
• if a close relative has had breast cancer,
• if you are significantly overweight,
• if you have had your first child at an older age or have never given birth. You should see your doctor as soon as possible if you notice any changes in your breasts, such as dimpling of the skin, changes in the nipples, or other lumps that can be seen or felt.

Very rarely, taking the tablet has also been associated with certain types of liver cancerin women taking it for a long time.

Tablet and liver disease

Very rarely, taking the tablet has also been associated with liver disease, such as jaundice and non-cancerous liver tumors.
Early detection of liver cell damage allows for the tablet to be stopped quickly, which reduces the harmful effect of the tablet on the liver. If liver cell damage is detected, you should stop taking the tablet, use a different contraceptive method, and consult your doctor.
It may be necessary not to take the tablet until liver function disorders have subsided.
If you experience severe abdominal pain or yellowing of the skin or eyes (jaundice), you should see your doctor immediately. It may be necessary to stop taking Harmonet.

Tablet and vision

While taking the tablet, you may experience discomfort or even intolerance to contact lenses. If you experience more serious eye problems, you should stop taking the tablet and see your doctor immediately.

High blood pressure

While taking the tablet, you may experience an increase in blood pressure. If you have ever had high blood pressure, you may need to use a different contraceptive method. If your doctor prescribes the tablet, you should have your blood pressure checked regularly, and if it increases significantly, you should stop taking the tablet and use a different contraceptive method (see also section "Do not take Harmonet if you have any of the following conditions").

Migraine and headache

If you experience migraine or headache, in a form that has not occurred before, the tablet may not be suitable. In this case, you should stop taking the tablet and see your doctor.

Tablet and carbohydrate and lipid metabolism

If you have ever had problems with glucose tolerance or diabetes, you should tell your doctor, as close monitoring of you will be required (see also section "Do not take Harmonet if you have any of the following conditions").
In a small number of women, taking the tablet can cause changes in blood lipid levels. You should inform your doctor, who may consider using a non-hormonal contraceptive.
If you are being treated for high lipid levels, you will need regular check-ups while taking the tablet.

Vaginal bleeding

You may experience irregular bleeding or spotting, especially during the first three months of taking the tablet. If these types of bleeding persist or recur, you should see your doctor to rule out non-hormonal causes, such as pregnancy or certain diseases. If necessary, your doctor may prescribe a different tablet (see also section "Irregular bleeding between periods should not last long").
If you previously did not have periods or had irregular periods, these situations may occur again while taking the tablet.
If you experience irregular periods while taking the tablet, see also section "Missing a dose of Harmonet".

Psychiatric disorders

Some women taking hormonal contraceptives, including Harmonet, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes and symptoms of depression, you should see your doctor as soon as possible for further medical advice.
Women with a history of depression should be closely monitored, and if severe symptoms of recurring depression occur, the product should be stopped. It may be found that the tablet is not suitable, and a different type of contraception will be needed.

Medical examinations

Before prescribing the tablet for the first time, your doctor will take a complete medical history, including a family history, and perform a physical examination. You should regularly have a cervical smear test.
Your next visit should take place after three months from the start of taking the tablet. Once a year, you should see your doctor for a check-up, which will be the same as the first examination.

Children and postmenopausal women

Harmonet is intended for use only in women of childbearing age.
It should not be used by children or postmenopausal women.

Other medicines and Harmonet

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those that are available without a prescription. You should also check the leaflets of all medicines you are taking to see if they can be used with hormonal contraception.
Some medicines may make Harmonet less effective in preventing pregnancy, for example:

• medicines used to treat constipation (laxatives),
• certain medicines used to treat epilepsy,
• certain medicines used to treat tuberculosis,
• certain medicines used to treat HIV (AIDS),
• certain antifungal medicines,
• certain sedatives (called "barbiturates"),
• certain anti-inflammatory medicines,
• St. John's Wort (a herbal medicine),
• atorvastatin (a medicine that lowers blood lipid levels),
• vitamin C or paracetamol,
• theophylline (a medicine used to treat asthma),
• cyclosporin.

If you need to take any of these medicines, it may be found that Harmonet is not suitable, and you may need to use additional contraception for a while. Your doctor or pharmacist will inform you if this is necessary and for how long.
Harmonet may also affect the action of other medicines. Therefore, it is crucial to tell your doctor if you are taking the tablet with other medicines.
Taking a medicine called troleandomycin while taking the tablet increases the risk of liver function disorders (reduced bile secretion by the liver).
Taking a medicine called flunaryzine while taking the tablet may sometimes cause milk production in the breasts of women who have not recently given birth.
You should not take Harmonet if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as they may increase liver function test results from blood (increased activity of the liver enzyme alanine aminotransferase). Your doctor should prescribe a different contraceptive method before starting treatment with these medicines. Harmonet may be taken again after about 2 weeks after the end of treatment. See section "Do not take Harmonet if you have any of the following conditions".

Taking Harmonet with food and drink

There are no special recommendations for taking Harmonet with food and drink.

Pregnancy and breastfeeding

Before taking any medicine, you should consult your doctor.
You should not take Harmonet during pregnancy. If you suspect you are pregnant, you should have a pregnancy test to confirm before stopping Harmonet.
There is no evidence that Harmonet causes harm to the fetus if you become pregnant while taking the medicine, but if pregnancy is confirmed, you should stop taking Harmonet.
You should not take Harmonet while breastfeeding. You should discuss other contraceptive methods with your doctor. Breastfeeding does not protect against pregnancy.

Important information about some of the ingredients of Harmonet

Harmonet contains lactose monohydrate and sucrose. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. HOW TO TAKE HARMONET

3.1 How to use Harmonet

Harmonet should always be taken according to the doctor's instructions. If you are unsure, you should consult your doctor.
Harmonet should be taken daily for 21 days.
Harmonet is available in blisters containing 21 tablets. Each tablet is marked with the day of the week.

• The tablet should be taken daily at approximately the same time.
• You should start by taking the tablet marked with the correct day of the week.
• The tablets should be taken in the direction of the arrows on the packaging. You should take one tablet daily until all 21 tablets have been taken.
• The tablets should be swallowed whole, if necessary with a little water. They should not be chewed.

Then there is a 7-day break without taking tablets
After taking all 21 tablets from the blister, there is a 7-day break without taking tablets. If the last tablet from the first pack was taken on a Friday, the first tablet from the next pack should be taken on the following Saturday.
Within a few days of taking the last tablet from the blister, withdrawal bleeding will occur, which looks like a period. This bleeding may not have stopped before the next pack of tablets is started.
There is no need to use additional contraception during these 7 days without tablets, as long as the tablets are taken correctly and the next pack is started on time.
Then you should start the next pack
After the 7-day break, you should start the next Harmonet blister - even if the bleeding has not stopped. A new blister should always be started on time.
As long as Harmonet is taken correctly, each subsequent pack will always start on the same day of the week.

3.2 How to start taking Harmonet

First use or starting to take the tablet after a break
Harmonet should be started on the first day of the next menstrual period. Starting in this way provides immediate contraceptive protection.
It is acceptable to start taking Harmonet between the 2nd and 7th day of the menstrual period (e.g. starting on a Sunday). In this case, you should use additional contraceptive methods, such as a condom, until the first 7 tablets have been taken correctly.
Changing from another contraceptive to Harmonet

• If you were previously taking a medicine containing 21 tablets: you should start taking Harmonet the next day after finishing the previous pack. Contraceptive protection is immediate. Bleeding will occur only after completing the first Harmonet blister.
• If you were previously taking a medicine containing 28 tablets: you should start taking Harmonet the next day after finishing the active tablets. Contraceptive protection is immediate. Bleeding will occur only after completing the first Harmonet blister.
• If you were previously taking a progestogen-only contraceptive(progestogen-only pill, subdermal implant, intrauterine device, injection):
• progestogen-only pill: you can stop taking the progestogen-only pill on any day and start taking Harmonet the next day.
• implant or intrauterine device: you should start taking Harmonet on the same day that the implant or intrauterine device is removed.
• injection: you should start taking the tablets on the day that the next injection is scheduled. You should use additional contraceptive methods, such as a condom, until the first 7 tablets have been taken correctly.

Starting to take Harmonet after a miscarriage or abortion
If the miscarriage or abortion occurred within the first three monthsof pregnancy, your doctor may advise you to start taking Harmonet immediately. This means that you will have immediate contraceptive protection.
If the miscarriage or abortion occurred after the third monthof pregnancy, you can start taking Harmonet after 28 days. It is recommended to use additional contraceptive methods, such as a condom, during the first 7 days of taking the tablet. However, if you have had sexual intercourse, you should rule out pregnancy or wait for your next period.
Contraception after childbirth
You can start taking Harmonet 28 days after a normal childbirth without complications, if you are not breastfeeding and are fully recovered. It is recommended to use additional contraceptive methods during the first 7 days of taking the tablet. However, if you have had sexual intercourse, you should rule out pregnancy or wait for your first period after childbirth or abortion.
Your doctor will provide further information on contraception.

3.3 If you take more Harmonet than you should

It is unlikely that taking more than one tablet will cause side effects, but you should see your doctor as soon as possible.

3.4 Missing a Dose of Harmonet

In case of missing a tablet, follow the instructions below.
If it has been less than 12 hourssince missing the tablet, take the missed tablet as soon as possible. Continue taking the next tablets at the usual time. Contraceptive protection has not been reduced.
If it has been more than 12 hourssince missing the tablet or if two or more active tablets have been missed, contraceptive protection may be reduced. Therefore, take only the last missed tablet as soon as possible, which may mean taking two tablets on the same day. Leave the previously missed tablets in the blister pack and continue taking the next tablets as usual. Additionally, use non-hormonal methods of pregnancy prevention, such as condoms, for the next seven days.
Then, follow the rules below:

• If one or more tablets were missed during the first week of using the blister pack (days 1-7) and sexual intercourse took place, there is a risk of pregnancy. Contact your doctor or pharmacist as soon as possible.
• If the last tablet was taken after seven days of using additional contraception, take a 7-day break before starting the next blister pack.
• If the last tablet was taken before the seven days of using additional contraception, start the next pack the next day. Until the end of the second pack, withdrawal bleeding usually does not occur.

If the patient forgot to take any of the tablets from the blister pack and did not experience bleeding during the tablet-free period, it may mean that she is pregnant. Before starting to take tablets from the next blister pack, she should contact her doctor or pharmacist, or take a pregnancy test.
If the patient started a new blister pack late, she may not be protected against pregnancy. If sexual intercourse took place within the last seven days, she should consult her doctor or pharmacist. She should also use condoms for seven days.

3.5 What to Do in Case of Vomiting or Diarrhea

If vomiting or severe diarrhea occurs, the hormones from the tablet may not have been fully absorbed. Continue taking the tablets at the usual time. Use additional non-hormonal contraception, such as condoms, during the illness and for the next seven days after recovery. If it has been more than 12 hours, follow the instructions from the "Missing a dose of Harmonet" section.
Contact your doctor if the gastrointestinal disturbances do not resolve or worsen. The doctor may recommend a different contraceptive method.

3.6 Delayed Withdrawal Bleeding – Is Pregnancy Possible?

Occasionally, withdrawal bleeding may not occur. This may indicate pregnancy, but it is very unlikely if the tablets have been taken correctly. If there is a risk of pregnancy (e.g., due to missing a tablet or taking other medications) before starting the next pack, a pregnancy test should be performed. If the patient is pregnant, she should stop taking Harmonet and contact her doctor.

3.7 How to Delay Withdrawal Bleeding

If the patient wants to delay the onset of withdrawal bleeding, she should skip the 7-day break and immediately start taking tablets from a new pack of Harmonet.
Withdrawal bleeding can be delayed for any length of time, up to the time all the tablets in the new pack have been taken. During this time, breakthrough bleeding or spotting may occur. Regular intake of Harmonet should be resumed after the usual 7-day break.
If the patient has more questions about using this medication, she should talk to her doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Harmonet can cause side effects, although not everybody gets them. If side effects occur, especially severe and persistent ones or changes in health that the patient considers related to the use of Harmonet, she should consult her doctor.

Severe Side Effects

The patient should contact her doctor immediately if she experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, which may cause difficulty breathing (see also "Warnings and Precautions").
Serious side effects related to the use of the contraceptive pill have been described in section 2, "Blood Clots" and "Pill and Cancer". If more information is needed, the patient should read these sections.
Like all medicines, Harmonet can cause allergic reactions (hypersensitivity). These reactions may include, in very rare cases, hives, sudden swelling of the skin, and severe reactions from the respiratory and cardiovascular systems, such as: decreased blood pressure, dizziness, nausea, and difficulty breathing. If the patient notices any symptoms of an allergic reaction, she should stop taking Harmonet immediately and tell her doctor or go to the nearest hospital.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2, "Important Information Before Taking Harmonet".

Other Possible Side Effects:

Very Common (occurring in more than 1 in 10 women):

• headache, including migraine (if severe or unusual, or prolonged, the patient should contact her doctor as soon as possible)
• bleeding and spotting between periods during the first few months (although usually they disappear when the body gets used to Harmonet) - see "Spotting or Bleeding Between Periods Should Not Last Long".

Common (occurring in 1 to 10 in 100 women):

• weight change (increase or decrease)
• mood changes, including depression, changes in libido (sex drive)
• nervousness or dizziness
• breast pain, breast tenderness, breast enlargement, nipple discharge; change in the intensity of bleeding; change in vaginal discharge; absence of menstruation, painful menstruation
• vaginitis, including yeast infection (candidiasis)
• stomach problems, such as nausea, vomiting, or abdominal pain
• acne
• fluid retention, edema (e.g., swelling of the ankles or feet) caused by fluid accumulation in tissues.

Uncommon (occurring in 1 to 10 in 1,000 women):

• change in blood lipid levels; change in appetite (increase or decrease)
• increased blood pressure
• stomach cramps; bloating
• rash; brown, irregular spots on the skin (melasma/chloasma), which may persist; excessive hair growth (hirsutism); excessive hair loss (alopecia).

Rare (occurring in 1 to 10 in 10,000 women):

• severe allergic reactions, including very rare cases of hives, sudden swelling of the skin (angioedema), and severe reactions from the respiratory and cardiovascular systems, such as: decreased blood pressure, dizziness, nausea, and difficulty breathing
• decreased blood folate levels, glucose intolerance
• intolerance to contact lenses
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g., deep vein thrombosis)
• in the lungs (e.g., pulmonary embolism)
• heart attack
• stroke
• mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack
• blood clots in the liver, stomach/intestine, kidneys, or eye
• jaundice (cholestatic jaundice)
• inflammation of fat cells under the skin (erythema nodosum).

Very Rare (occurring in less than 1 in 10,000 women):

• worsening of systemic lupus erythematosus (a chronic autoimmune disorder)
• worsening of porphyria (a disorder resulting from the lack of certain enzymes)
• worsening of chorea (a movement disorder)
• inflammation of the optic nerve, blood clots in the blood vessels of the retina
• worsening of varicose veins (varicose veins)
• pancreatitis; inflammation of the intestine due to reduced blood flow to the intestine (ischemic colitis)
• gallbladder disease, including gallstones
• erythema multiforme (a skin disease)
• hemolytic-uremic syndrome (a kidney disease)
• liver cell cancer (hepatocellular carcinoma).

The risk of developing blood clots may be higher if the patient has other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).
Harmonet may also cause inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) and liver cell damage (e.g., hepatitis, liver function disorders) with an unknown frequency, which cannot be determined from the available data.
The patient should inform her doctor or pharmacist if she suspects that any side effect may be related to the use of Harmonet. If any existing condition worsens while taking Harmonet, the patient should also inform her doctor or pharmacist.

Spotting or Bleeding Between Periods Should Not Last Long

Some women may experience unexpected light bleeding or spotting while taking Harmonet, especially during the first few months. Usually, this bleeding is not a cause for concern and will stop after one or two days. The patient should continue taking Harmonet as usual. The condition should improve after taking a few initial blister packs.
Unexpected bleeding may also occur if the tablets are not taken regularly, so the patient should try to take the tablets every day at the same time. Unexpected bleeding may also be caused by taking other medications.
The patient should consult her doctor if bleeding or spotting:

• lasts longer than a few months
• starts after a few months of taking Harmonet
• continues even after stopping Harmonet.

Reporting Side Effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should tell her doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medication.

5. HOW TO STORE HARMONET

Keep out of sight and reach of children.
Do not use Harmonet after the expiration date stated on the packaging. The expiration date refers to the last day of the given month.
Store in a temperature below 25°C. Store the blister pack in the outer packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask her pharmacist how to dispose of unused medicines. This will help protect the environment.

6. OTHER INFORMATION

What Harmonet Contains

The active substances of Harmonet are gestodene and ethinylestradiol.
Each tablet contains 75 micrograms of gestodene and 20 micrograms of ethinylestradiol.
In addition, Harmonet contains:
The tablet core contains: lactose monohydrate, cornstarch, povidone K 25, magnesium stearate.
The tablet coating contains: sucrose, povidone K 90, macrogol 6000, calcium carbonate, talc, wax E.

What Harmonet Looks Like and What the Packaging Contains

Coated tablets
The tablets are white, round, coated, and have a shiny surface.
A blister pack of PVC/Aluminum, in a carton with silica gel as a desiccant, in a cardboard box.
Each Harmonet blister pack contains 21 white tablets.
Each Harmonet box contains 1x21 or 3x21 tablets. The packaging includes a cardboard sachet in which the blister pack should be placed after removal from the protective foil.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Belgium, the Country of Export:

Pfizer S.A., Boulevard de la Plaine 17, 1050 Brussels, Belgium

Manufacturer:

Haupt Pharma Münster GmbH, Schleebrüggenkamp 15, 48159 Münster, Germany
Pfizer Ireland Pharmaceuticals, Newbridge, Little Connell, Co. Kildare, Ireland

Parallel Importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań
CEFEA Sp. z o.o. sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 Warsaw
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź
Marketing Authorization Number in Belgium, the Country of Export:BE174115
Parallel Import Authorization Number:582/12

Translation of Day of the Week Symbols on the Blister Pack:

Lu / Ma / Mo –Monday
Ma / Di / Di – Tuesday
Me / Wo / Mi – Wednesday
Je / Do / Do – Thursday
Ve / Vr / Fr – Friday
Sa / Za / Sa – Saturday
Di / Zo / So – Sunday
Date of Leaflet Approval: 20.10.2022
[Information about the trademark]