Harmonet

PATIENT INFORMATION LEAFLET: USER INFORMATION

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
• Caution and consultation with a doctor are necessary if the patient suspects symptoms of blood clots (see section 2 "Blood clots")

You should read the leaflet before taking the medicine.

• You should keep this leaflet to be able to read it again if needed.
• 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. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, 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 taking Harmonet
• 3. How to take Harmonet
• 4. Possible side effects
• 5. How to store Harmonet
• 6. Contents of the pack and other information

1. WHAT IS HARMONET AND WHAT IS IT USED FOR

Harmonet is a combined hormonal contraceptive pill ("the Pill")
used to prevent pregnancy.
It contains two types of female sex hormones: estrogen and progestogen. These hormones
prevent pregnancy by acting in three ways: preventing the release of an egg from the ovaries;
thickening the mucus in the cervix, making it harder for sperm to penetrate the uterus; preventing
the thickening of the uterine lining so that a fertilized egg cannot develop in it.
Harmonet should be taken every day for 21 days (1 tablet), followed by 7 days without taking a tablet.

Benefits of taking the Pill:

• 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, lighter, and less painful,
• it may 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 as directed to prevent pregnancy.

2. IMPORTANT INFORMATION BEFORE TAKING 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 Pill before starting or deciding to continue.
Although the Pill 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 Pill

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

While taking the Pill

• 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 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 Pill, as it may affect the results of some tests.
• If you are scheduled to have surgery, you should inform your doctor. You may need to stop taking the Pill 4-6 weeks before the operation. This will reduce the risk of blood clots (see section "Pill and thrombosis"). Your doctor will tell you when you can resume taking the Pill.

When not to take Harmonet

You should not take 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 for you.

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have a blood clotting disorder - for example, deficiency of protein C, protein S, antithrombin III, presence of 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 (or have had in the past) angina pectoris (a disease that causes severe chest pain and may be a sign of a heart attack) or a transient ischemic attack (a temporary stroke-like condition);
• if you have any of the following diseases that 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);
• a disease called hyperhomocysteinemia;
• if you have (or have had in the past) 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 a hormone-dependent cancer - such as some breast cancers; endometrial or ovarian cancer;
• if you have unexplained vaginal bleeding;
• if you have irregular heart rhythm or heart valve problems caused by blood clotting disorders;
• 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, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (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 contact your doctor immediately:

• -if you notice any of the symptoms of a blood clot, which may indicate that you have a blood clot in the leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see section below "Blood clots (thrombosis)"). To find out about the symptoms of these serious side effects, see "How to recognize a blood clot".

You should 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 genetic 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 condition. 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, as you are at increased risk of blood clots. You should consult your doctor about when 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 breathing, you should contact your doctor immediately. Estrogen-containing products may cause or worsen the symptoms of both hereditary and acquired angioedema.

Pill and smoking

Women taking the Pill are strongly advised to stop 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 (called "venous thromboembolism" or "deep vein thrombosis")
• in arteries (called "arterial thromboembolism" or "arterial thrombosis"). Not all people who have a blood clot will recover fully. 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 contact your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these
symptoms?
Why might you be suffering from
them?

• 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 only be felt when standing or walking,
• increased temperature in the affected leg
• change in the color of the leg skin, such as paleness, redness, or discoloration

Deep vein thrombosis

• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe stomach pain.

BLOOD CLOTS IN VEINS

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

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). Although these side effects are rare, they can occur. They are most likely to occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this can lead to deep vein thrombosis.
• If a blood clot moves from the leg to the lungs, this 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 veins 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 restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher than when not taking combined hormonal contraceptives.
If you stop taking Harmonet, the risk of blood clots returns to normal within a few weeks.

What factors increase 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 overweight (body mass index (BMI) over 30 kg/m);
• if someone in your close family has had a blood clot 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 (see section 2 "Blood clots");
• with increasing 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.
Long-distance 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 you from taking Harmonet.
You should inform your doctor if any of these conditions change while taking Harmonet, e.g., if someone in your close family is diagnosed with a blood clot without a known cause or if you gain a lot of 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 consequences, 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 about 35 years old);
• if you smoke.While taking a hormonal contraceptive like Harmonet, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your close 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 close 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, irregular heartbeat called atrial fibrillation)
• if you have diabetes. If you have more than one of these conditions or if any of them are particularly severe, your risk of having a blood clot may be even higher. You should inform your doctor if any of these conditions change while taking Harmonet, e.g., if you start smoking, if someone in your close family is diagnosed with a blood clot without a known cause, or if you gain a lot of weight.

Pill and cancer

Taking the Pill 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 Pill. The most important risk factor for cervical cancer is persistent human papillomavirus infection.
All women should have regular cervical smears.
If you have (or have had in the past) breast cancer, you should not take the Pill.
The Pill slightly increases the risk of breast cancer. This risk increases with the duration of taking the Pill, but decreases within 10 years after stopping it.
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 Pill is small.
The risk of breast cancer is higher:

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

Very rarely, taking the Pill has also been linked to certain types of liver cancerin women taking it for a long time.

Pill and liver disease

Very rarely, taking the Pill has also been linked to liver diseases, such as jaundice and non-cancerous liver tumors.
Early detection of liver cell damage allows for the prompt discontinuation of the Pill, which reduces the harmful effect on the liver. If liver cell damage is detected, you should stop taking the Pill, use another method of contraception, and consult your doctor.
It may be necessary not to take the Pill until liver function has returned to normal.
If you experience severe stomach pain or yellowing of the skin or eyes (jaundice), you should contact your doctor as soon as possible. It may be necessary to stop taking Harmonet.

Pill and vision

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

High blood pressure

While taking the Pill, your blood pressure may increase. If you have ever had high blood pressure, you may need to use another method of contraception. If your doctor prescribes the Pill, you should have your blood pressure checked regularly, and if it increases significantly, you should stop taking the Pill and use another method of contraception (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 Pill may not be suitable for you. In this case, you should stop taking the Pill and consult your doctor.

Pill and carbohydrate and lipid metabolism

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

Vaginal bleeding

You may experience irregular bleeding or spotting, especially during the first three months of taking the Pill. If these types of bleeding continue or recur, you should consult your doctor to rule out non-hormonal causes, such as pregnancy or certain diseases. If necessary, your doctor may prescribe another Pill (see also section "Irregular bleeding between periods should not last long").
If you have never had regular periods or have irregular periods, these conditions may recur while taking the Pill.
If you experience irregular periods while taking the Pill, see also section "If you forget to take 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 or symptoms of depression, you should contact your doctor as soon as possible for further medical advice.
Women with a history of depression should be closely monitored, and if they experience severe symptoms of recurrent depression, they should stop taking the Pill. The Pill may not be suitable, and another type of contraception may be needed.

Medical examinations

Before prescribing the Pill 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 be after three months of taking the Pill. Once a year, you should visit your doctor for a check-up, which will be similar to the first examination.

Children and postmenopausal women

Harmonet is intended for use only in women of childbearing age. It should not be taken 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 taken with hormonal contraceptives.
Some medicines may make Harmonet less effective in preventing pregnancy, such as:

• 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 lipid levels in the blood),
• vitamin C or paracetamol,
• theophylline (a medicine used to treat asthma),
• cyclosporin.

If you need to take any of these medicines, it may be necessary to use additional contraception for a certain period. Your doctor or pharmacist will tell you if this is necessary and for how long.
Harmonet may also affect the action of other medicines. Therefore, it is essential to tell your doctor if you are taking the Pill with other medicines.
Taking a medicine called troleandomycin while taking the Pill increases the risk of liver disorders (reduced bile secretion by the liver).
Taking a medicine called flunaryzine while taking the Pill 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, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as they may increase liver function test results (increase in liver enzyme alanine aminotransferase).
Your doctor should prescribe another type of contraception before starting treatment with these medicines.
Harmonet can 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 instructions for taking Harmonet with food and drink.

Pregnancy and breastfeeding

Before taking any medicine, you should consult your doctor.
You should not take Harmonet if you are pregnant. If you suspect you are pregnant, you should have a pregnancy test before stopping Harmonet.
There is no evidence that Harmonet causes harm to the fetus if you become pregnant while taking the Pill, but if you become pregnant, you should stop taking Harmonet.
You should not take Harmonet while breastfeeding. You should talk to your doctor about another method of contraception. Breastfeeding does not protect against pregnancy.

3. HOW TO TAKE HARMONET

3.1 How to Use Harmonet

Harmonet should always be used in accordance with the doctor's recommendations. In case of doubts, the doctor should be contacted.
Harmonet should be taken daily for 21 days.
Harmonet is available in blisters containing 21 tablets. Each of them is marked with a day of the week.

• The tablet should be taken daily at approximately the same time.
• It is recommended to start taking the tablet marked with the correct day of the week.
• The tablets should be taken in the direction of the arrows indicated on the packaging. One tablet should be taken daily until all 21 tablets have been taken.
• The tablets should be swallowed whole, if necessary with a glass of water. They should not be chewed.

Then there is a 7-day break from taking tablets
After taking all 21 tablets from the blister, there is a 7-day break from 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, resembling a menstrual period. This bleeding may not end 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 the next pack should be started
After 7 days without tablets, the next Harmonet blister should be started - 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 Application or Resumption of Tablets After a Break
Taking Harmonet should be started on the first day of the next menstrual period. By starting this way, immediate contraceptive protection is obtained.
It is also possible to start taking Harmonet between the 2nd and 7th day of the menstrual period (e.g., starting on Sunday). In this case, additional contraceptive methods, such as a condom, should be used until the first 7 tablets have been taken correctly.
Switching from Another Contraceptive to Harmonet

• If a 21-tablet medication was taken previously: Harmonet should be started the next day after finishing the previous pack. Contraceptive protection is immediate. Bleeding will occur only after completing the first Harmonet blister.
• If a 28-tablet medication was taken previously: Harmonet should be started the next day after taking the last active tablet. Contraceptive protection is immediate. Bleeding will occur only after completing the first Harmonet blister.
• If only a progestin-containing contraceptive was used(progestin-only tablets, subdermal implant, intrauterine device, injection):
• progestin-only tablet: the progestin-only tablets can be stopped at any time and Harmonet can be started the next day.
• implant or intrauterine device: Harmonet should be started on the same day the implant or intrauterine device is removed.
• injection: tablet taking should be started on the day the next injection is scheduled. Additional contraceptive methods, such as a condom, should be used until the first 7 tablets have been taken correctly.

Starting Harmonet After Miscarriage or Abortion
If a miscarriage or abortion occurred within the first three monthsof pregnancy, the doctor may inform that Harmonet can be started immediately. This means that immediate contraceptive protection is obtained.
If a miscarriage or abortion occurred after the third monthof pregnancy, Harmonet can be started after 28 days. It is recommended to use additional pregnancy prevention methods, such as a condom, during the first 7 days of taking Harmonet. If intercourse has occurred, pregnancy should be ruled out or wait for the next menstrual period to appear.
Contraception After Childbirth
Harmonet can be started 28 days after a natural childbirth without complications, if the patient is not breastfeeding and is fully recovered. It is recommended to use additional pregnancy prevention methods during the first 7 days of taking Harmonet. If intercourse has occurred, pregnancy should be ruled out or wait for the first menstrual period after childbirth or abortion to appear.
The 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 talk to your doctor as soon as possible.

3.4 If You Forget to Take Harmonet

In case a tablet is missed, the following instructions should be followed.
If less than 12 hourshave passed since the missed tablet, the missed tablet should be taken as soon as possible. The next tablets should be taken at the usual time. Contraceptive protection has not been reduced.
If more than 12 hourshave passed since the missed tablet or two or more active tablets have been missed, contraceptive protection may be reduced. Therefore, only the last missed tablet should be taken as soon as possible, which may mean taking two tablets on the same day. Previously missed tablets should be left in the blister and the next tablets should be taken as usual. Additionally, non-hormonal contraceptive methods, such as condoms, should be used for the next 7 days.

• If one or more tablets are missed during the first week of taking the blister (days 1-7) and intercourse has occurred, there is a risk of pregnancy. The doctor or pharmacist should be contacted as soon as possible.
• If the last tablet was taken after 7 days of using additional contraception, a 7-day break should be taken before starting the next blister.
• If the last tablet was taken before the end of the 7 days of using additional contraception, the next pack should be started the next day. Until the end of the second blister, withdrawal bleeding will usually not occur.

If the patient has forgotten to take any of the tablets from the blister and no bleeding has occurred during the tablet-free period, it may mean that the patient is pregnant. Before starting the tablets from the next blister, the doctor or pharmacist should be contacted, or a pregnancy test should be performed.
If the patient has started a new blister late, they may not be protected against pregnancy. If intercourse has occurred in the last 7 days, the doctor or pharmacist should be consulted. Condoms should also be used for 7 days.

3.5 What to Do If You Vomit or Have Diarrhea

If vomiting or severe diarrhea occurs, the hormones from the tablet may not have been fully absorbed. The tablets should be continued to be taken at the usual time. Additional contraception, such as condoms, should be used during the illness and for the next 7 days after recovery. If more than 12 hours have passed, the instructions from the "Missed Harmonet" section should be followed.
The doctor should be contacted 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 mean that the patient is pregnant, but it is very unlikely if the tablets have been taken correctly. If there is a risk of pregnancy (e.g., due to a missed tablet or taking other medications) before starting the next pack, a pregnancy test should be performed. If the patient is pregnant, Harmonet should be stopped and the doctor should be contacted.

3.7 How to Delay Withdrawal Bleeding

If the patient wants to delay the withdrawal bleeding, they should skip the 7-day break and immediately start taking tablets from a new Harmonet pack. The withdrawal bleeding can be delayed for any length of time, up to the time all the tablets from the new pack have been taken. During this time, breakthrough bleeding or spotting may occur. Regular Harmonet intake should be resumed after a usual 7-day break.
If the patient has more questions about using this medication, they should talk to their 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 status that the patient considers to be related to the use of Harmonet, the doctor should be consulted.

Severe Side Effects

The doctor should be contacted immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that 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 "The Pill and Thrombosis" and "The Pill and Cancer". If further information is needed, these sections should be read.
Like all medicines, Harmonet can cause allergic reactions (hypersensitivity). These reactions may include, in very rare cases, hives, sudden swelling of tissues, and severe reactions from the respiratory and cardiovascular systems, such as: decreased blood pressure, dizziness, nausea, and difficulty breathing. If any symptoms of an allergic reaction are noticed, Harmonet should be stopped immediately and the doctor should be informed or the nearest hospital should be visited.
In all women using combined hormonal contraceptives, there is an increased risk of 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, section 2 "Important Information Before Using Harmonet" should be consulted.

Other Possible Side Effects:

Very Common(may occur more often than in 1 in 10 people)

• headache, including migraine (if it is severe or unusual or prolonged, the doctor should be contacted as soon as possible)
• bleeding and spotting between menstrual periods for the first few months (although they usually disappear when the body gets used to Harmonet) - see "Bleeding Between Menstrual Periods Should Not Last Long" section.

Common(may occur in up to 1 in 10 people)

• 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 bleeding intensity; 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., of the ankles or feet) caused by fluid accumulated in tissues.

Uncommon(may occur in up to 1 in 100 people)

• change in blood lipid levels (lipids in serum), including hypertriglyceridemia; 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(may occur in up to 1 in 1,000 people)

• severe allergic reactions, including very rare cases of hives, sudden swelling of tissues (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(may occur in up to 1 in 10,000 people)

• 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 blood clots may be higher if the patient has any other risk factors (see section 2 for further 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 doctor or pharmacist should be informed if the patient is concerned that any side effect may be related to the use of Harmonet. If any existing disorders worsen while taking Harmonet, the doctor or pharmacist should also be informed.

Bleeding Between Menstrual Periods Should Not Last Long

In some women, unexpected light bleeding or spotting may occur 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. Harmonet should be taken as usual. The problem should resolve after taking a few initial blisters of Harmonet.
Unexpected bleeding may also occur if the tablets are not taken regularly, so it is recommended to take the tablets daily at the same time. Unexpected bleeding may also be caused by taking other medications.
The doctor should be consulted if bleeding or spotting:

• lasts longer than a few initial 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 doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help gather more information on the safety of the medication.

5. HOW TO STORE HARMONET

Store in a place inaccessible to children.
Do not use Harmonet after the expiration date (EXP) stated on the blister or carton.
Do not store above 25°C.
Store the blister in the outer packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. PACKAGE CONTENTS AND 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 core of the tablet contains: lactose monohydrate, cornstarch, povidone K-25, magnesium stearate.
The coating of the tablet contains: sucrose, polyethylene glycol 6000, calcium carbonate, talc, povidone K-90, wax E.

What Harmonet Looks Like and What the Package Contains

Coated tablets
The tablets are white, round, coated, and have a shiny surface.
Blisters of PVC/Aluminum foil in a cardboard box.
Blisters of PVC/Aluminum foil, in an aluminum sachet with silica gel as a desiccant, in a cardboard box.
Each Harmonet blister contains 21 white tablets.
Each Harmonet carton contains 1x21 or 3x21 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer

Pfizer Ireland Pharmaceuticals
Little Connell
Newbridge, Co. Kildare
Ireland
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
To obtain more detailed information, the local representative of the marketing authorization holder should be contacted:
Pfizer Polska Sp. z o.o.
phone: 22 335 61 00

Date of Last Update of the Leaflet:

Detailed and up-to-date information about this product can be obtained by scanning the QR code on the outer packaging using a mobile device. The same information is also available at the URL: https://pfi.sr/ulotka-harmonet and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://www.urpl.gov.pl .