Harmonet

PATIENT INFORMATION LEAFLET: USER INFORMATION

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Harmonet

75 micrograms (0.075 mg) + 20 micrograms (0.020 mg), sugar-coated 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 should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "BLOOD CLOTS").

The leaflet contents should be read before taking the medicine.

• The leaflet should be kept in case it needs to be read again.
• A doctor or pharmacist should be consulted in case of any further doubts.
• The medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If any of the undesirable effects worsen or if any undesirable effects not mentioned in the leaflet occur, a doctor, pharmacist, or nurse should be informed. See section 4.

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 available as a combined hormonal contraceptive tablet ("Tablet")
for use to prevent pregnancy.
The medicine contains two types of female sex hormones: estrogen and progestogen. These
hormones prevent pregnancy by acting in three ways: preventing the release of the egg from the ovaries;
thickening the mucus in the cervix, making it difficult 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 daily for 21 days (1 tablet), followed by 7 days without taking a 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 menstrual periods more regular, more scarce, and less painful,
• it may alleviate premenstrual symptoms.

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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 to prevent pregnancy.

2. Important information before taking Harmonet

General notes

Before starting to take Harmonet, the information about blood clots (thrombosis) in section 2 should be read. 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.
A doctor should be informed if the patient has any diseases or risk factors mentioned in this leaflet.

Before taking the Tablet

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

While taking the Tablet

• Regular doctor's visits should be attended, usually when a new prescription is needed.
• A doctor should be visited regularly for a cervical smear test.
• Once a month, the breasts and nipples should be examined - a doctor should be informed if the patient notices or feels changes, such as lumps or depressions in the skin.
• If the patient needs to have a blood test, the doctor should be informed about taking the Tablet, as it may affect the results of some tests.
• If surgery is planned, the doctor should be informed. 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 2 "BLOOD CLOTS"). The doctor will inform when it is possible to continue taking the Tablet.

When not to take Harmonet

Harmonet should not be taken if the patient has any of the following conditions. If the patient has any of the following conditions, a doctor should be informed. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows they have blood clotting disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS");
• if the patient has had a heart attack or stroke;
• if the patient has (or has had in the past) 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 the patient has 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;

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• very high levels of fats in the blood (cholesterol or triglycerides);
• a disease called hyperhomocysteinemia
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient is allergic (hypersensitive) to gestodene, ethinylestradiol, or any of the other ingredients of Harmonet (see section 6 "Other information");
• if the patient is pregnant or suspects pregnancy;
• if the patient has hormone-dependent cancer - such as some breast, endometrial, or ovarian cancers;
• if the patient has unexplained vaginal bleeding;
• if the patient has irregular heart rhythm or heart valve problems, which were caused by blood clotting problems;
• if the patient has ever had pancreatitis associated with high levels of fats in the blood (high cholesterol or triglycerides);
• if the patient has ever had severe liver disease;
• if the patient has hepatitis C and is taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Other medicines and Harmonet").

If the patient has any of the above conditions or if they occur for the first time while taking Harmonet, a doctor should be contacted as soon as possible. Harmonet should not be taken.

Warnings and precautions

The doctor should be told if the patient has any of the following conditions.

If these symptoms occur or worsen while taking Harmonet, the doctor should also be told.

• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient notices possible symptoms of blood clots, which may indicate that the patient has blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack, or stroke (see below "BLOOD CLOTS"). To find a description of these serious side effects, see "HOW TO RECOGNIZE A BLOOD CLOT".

(chronic inflammatory bowel diseases);

• if the patient has systemic lupus erythematosus (a disease that affects the natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a hereditary disease of red blood cells);
• if the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS");
• if the patient has recently given birth, as she is at increased risk of blood clots. A doctor should be consulted to find out how soon Harmonet can be started after giving birth;
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• if the patient has varicose veins;

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• if symptoms of angioedema occur, such as swelling of the face, tongue, and (or) throat, and (or) difficulty swallowing or hives, which can cause difficulty breathing, a doctor should be contacted immediately. Products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

Tablet and smoking

Women taking the Tablet are strongly advised to stop smoking.
Smoking increases the risk of serious cardiovascular side effects. This risk increases with age and the number of cigarettes smoked and is significant in women over 35 years of age.

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 "deep vein thrombosis"),
• in arteries (also known as "arterial thromboembolism" or "arterial thrombosis").

Not all patients recover fully from a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It should be remembered that the total risk of serious blood clots caused by taking Harmonet is small.

HOW TO RECOGNIZE A BLOOD CLOT

A doctor should be contacted immediately if any of the following symptoms are noticed.
Is the patient experiencing any of these
symptoms?
Why is the patient likely to be suffering
from it?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by: Deep vein thrombosis
• pain or tenderness in the leg, which may only be felt while standing or walking,
• increased temperature in the affected leg,
• change in skin color of the leg, 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;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain;

If the patient is unsure, a doctor should be contacted, 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 blood clots form in veins?

• 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 most often occur in the first year of taking 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.

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• If a blood clot moves from the leg to 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 veins highest?

The risk of forming blood clots in veins 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 the patient stops taking Harmonet, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The total risk of blood clots in the legs or lungs associated with taking Harmonet is small.

• During a year, about 2 in 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 in 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During a year, about 9-12 in 10,000 women who take combined hormonal contraceptives containing gestodene, such as Harmonet, will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots in veins" and "Factors that increase the risk of blood clots in arteries", below).

Factors that increase the risk of blood clots in veins

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

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's close family has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years of age). In this case, the patient may have inherited blood clotting disorders;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS");

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Harmonet should be stopped for a few weeks before surgery or immobilization. If the patient needs to stop taking Harmonet, a doctor should be asked when it is possible to resume taking the medicine;
with age (especially over 35 years of age);

• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Taking a long-haul flight (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell a doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop Harmonet.
A doctor should be informed if any of the above conditions change while taking Harmonet, e.g. if someone in the patient's close family is diagnosed with a blood clot without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in arteries?

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 heart attack or stroke associated with taking Harmonet is very small, but it may increase:

• with age (over about 35 years);
• if the patient smokes. While taking a hormonal contraceptive like Harmonet, smoking is not recommended. If the patient is unable to stop smoking and is over 35 years old, a doctor may recommend a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50 years of age). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their close family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, irregular heartbeat called atrial fibrillation);
• if the patient has diabetes. If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher. A doctor should be informed if any of the above conditions change while taking Harmonet, e.g. if the patient starts smoking, someone in the patient's close family is diagnosed with a blood clot without a known cause, or if the patient gains significant weight.

Tablet and cancer

Taking the Tablet for a long time reduces the risk of ovarian and endometrial cancer. However, it seems 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 the patient has or has had breast cancer, they should not take the Tablet.
The Tablet slightly increases the risk of breast cancer. This risk increases with the duration of taking the Tablet, but decreases within 10 years of 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 Tablet is small.
The risk of breast cancer is higher:

• the older the woman is,
• if a close relative of the patient has had breast cancer,
• in case of significant overweight,
• in case of first childbirth at an older age or if the patient has never given birth. A doctor should be contacted as soon as possible if any changes in the breasts are noticed, such as dents in the skin, changes in the nipples, or other lumps that can be seen or felt.

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

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 rapid discontinuation of the medicine, which reduces the harmful effect of the medicine on the liver. If liver cell damage is detected, the Tablet should be stopped, a different contraceptive method should be used, and a doctor should be consulted.
It may be necessary not to take the Tablet until liver function disorders have subsided.
If severe abdominal pain or yellowing of the skin or eyes (jaundice) occurs, a doctor should be contacted immediately. It may be necessary to stop taking Harmonet.

Tablet and vision

While taking the Tablet, discomfort or even intolerance to contact lenses may occur. If more serious eye problems occur, the Tablet should be stopped and a doctor should be contacted immediately for an examination.

High blood pressure

While taking the Tablet, blood pressure may increase. If the patient has ever had high blood pressure, it may be necessary to use a different contraceptive method. If a doctor prescribes the Tablet, blood pressure should be checked regularly, and if it increases significantly, the Tablet should be stopped and a different contraceptive method should be used (see also "When not to take Harmonet").

Migraine and headache

If the patient experiences migraine or headache, which did not occur before, the Tablet may not be suitable. In this case, the Tablet should be stopped and a doctor should be consulted.

Tablet and carbohydrate and lipid metabolism

If the patient has ever had problems with glucose tolerance or diabetes, they should tell their doctor, as close monitoring may be required (see also "When not to take Harmonet") in case of any of the following conditions.
In a small number of women, changes in blood lipid (fat) levels may occur while taking the Tablet. A doctor should be informed, who may consider using a non-hormonal contraceptive.
If the patient is being treated for high lipid levels, regular check-ups will be required while taking the Tablet.
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Vaginal bleeding

Irregular bleeding or spotting may occur, especially during the first three months of taking the Tablet. If these types of bleeding persist or recur, a doctor should be contacted to rule out non-hormonal causes, such as pregnancy or certain diseases. If necessary, a doctor may prescribe a different Tablet (see also "Irregular bleeding between periods should not last long").
If the patient did not have menstrual periods before or had irregular periods, these situations may occur again while taking the Tablet.
In case of irregular periods while taking the Tablet, see also "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 mood changes or symptoms of depression occur, a doctor should be contacted 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 necessary to use a different type of contraception.

Medical examinations

Before prescribing the Tablet for the first time, a doctor will take a complete medical history, including family history, and perform a physical examination. Regular cervical smears should be taken.
A follow-up visit should take place after three months of taking the Tablet. Once a year, a check-up should be attended, 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 taken by children or postmenopausal women.

Other medicines and Harmonet

A doctor or pharmacist should be told about all medicines that are currently being taken or have been taken recently, including those that are available without a prescription. The leaflets of all medicines being taken should also be checked to see if they can be taken with hormonal contraceptives.
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 it is necessary to take one of these medicines, it may be necessary to use additional contraception for a while. A doctor or pharmacist will inform the patient if this is necessary and for how long.
Harmonet may also affect the action of other medicines. Therefore, it is essential to tell a doctor if the Tablet is being taken 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.
Harmonet should not be taken if the patient has hepatitis C and is taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may increase liver function test results from blood (increased activity of the liver enzyme alanine aminotransferase).
A doctor should prescribe a different type of contraception before starting treatment with these medicines.
Harmonet can be taken again about 2 weeks after the end of treatment. See "When not to take Harmonet".

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, a doctor should be consulted.
Harmonet should not be taken during pregnancy. If pregnancy is suspected, a pregnancy test should be done to confirm before stopping Harmonet.
There is no evidence that Harmonet causes harm to the fetus if it is taken unintentionally during pregnancy, but if pregnancy is confirmed, Harmonet should be stopped.
Harmonet is not recommended during breastfeeding. A doctor should be consulted about a different contraceptive method. Breastfeeding does not protect against pregnancy.

Important information about some of the ingredients of Harmonet

Harmonet contains lactose monohydrate and sucrose. If the patient has been diagnosed with intolerance to some sugars, they should contact a 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. In case of doubts, a doctor should be contacted.
Harmonet should be taken daily for 21 days.
Harmonet is available in blisters containing 21 tablets. Each tablet is marked with a day of the week symbol.

• A tablet should be taken daily at about the same time.
• The tablet marked with the corresponding day of the week symbol should be started (see "Translation of day of the week symbols on the packaging" at the end of the leaflet and on the blister pack).
• The tablets should be taken in the direction of the arrows 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.

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Then there are 7 days without taking tablets
After taking all 21 tablets from the blister, there are 7 days 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 menstrual period. This bleeding may not have stopped before starting the next pack of tablets.
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-time use or starting 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 on days 2-7 of the menstrual period (e.g. starting on a 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 the previous contraceptive contained 21 tablets:Harmonet should be started the day after the last tablet of the previous pack. Contraceptive protection is immediate. Bleeding will occur only after finishing the first Harmonet blister.
• If the previous contraceptive contained 28 tablets:Harmonet should be started the day after the last active tablet of the previous pack. Contraceptive protection is immediate. Bleeding will occur only after finishing the first Harmonet blister.
• If the previous contraceptive contained only progestogen(progestogen-only tablets, subdermal implant, intrauterine device, injection):
• progestogen-only tablet: progestogen-only tablets can be stopped on any day and Harmonet can be started the next day.
• implant or intrauterine device: Harmonet should be started on the same day that the implant or intrauterine device is removed.
• injection: tablets should be started on the day of the planned next injection. Additional contraceptive methods, such as a condom, should be used until the first 7 tablets have been taken correctly.

Starting Harmonet after a miscarriage or abortion
If the miscarriage or abortion occurred within the first three monthsof pregnancy, a doctor may inform that Harmonet can be started immediately. This means that immediate contraceptive protection is provided.
If the miscarriage or abortion occurred after the third monthof pregnancy, Harmonet can be started after 28 days. It is recommended to use additional contraceptive methods, such as a condom, during the first 7 days of taking Harmonet. However, if sexual intercourse has occurred, pregnancy should be ruled out or the patient should wait for the next menstrual period to occur.
Contraception after childbirth
Harmonet can be started 28 days after a normal childbirth, if the patient is not breastfeeding and is fully recovered. It is recommended to use additional contraceptive methods during the first 7 days of taking Harmonet. However, if sexual intercourse has occurred, pregnancy should be ruled out or the patient should wait for the first menstrual period to occur after childbirth or abortion.
A doctor will provide further information on contraception.

3.3 If more Harmonet than recommended is taken

It is unlikely that taking more than one tablet will cause side effects, but a doctor should be contacted as soon as possible.

3.4 Missing a Harmonet Dose

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

• If one or more doses are missed during the first week of taking the blister pack (days 1-7) and intercourse has occurred, there is a risk of pregnancy. Contact your doctor or pharmacist as soon as possible.
• If the last dose was taken after a seven-day period during which additional contraception was used, take a seven-day break before starting the next blister pack.
• If the last dose was taken before the end of the seven-day period during which additional contraception was used, start the next pack the next day. Until the end of the second pack, withdrawal bleeding will usually not occur.

If the patient has forgotten to take any of the doses from the blister pack and has not had withdrawal bleeding during the tablet-free period, this may indicate pregnancy. Before starting the next blister pack, contact your doctor or pharmacist, or take a pregnancy test.
If the patient has started a new blister pack late, she may not be protected against pregnancy. If intercourse has occurred within the last seven days, consult a doctor or pharmacist. Also, use non-hormonal methods of birth control, such as 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 dose may not have been fully absorbed. Continue taking the doses at the usual time. Use additional non-hormonal methods of birth control, such as condoms, during the illness and for the next seven days after recovery. If more than 12 hours have passed, follow the instructions from the "Missing a Harmonet Dose" section.
Contact your doctor if gastrointestinal disturbances do not resolve or worsen. The doctor may recommend a different method of birth control.

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 doses have been taken correctly. If there is a risk of pregnancy (e.g., due to a missed dose or taking other medications), perform a pregnancy test before starting the next pack. If the patient is pregnant, stop taking Harmonet and contact a doctor.

3.7 How to Delay Withdrawal Bleeding

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

4. Possible Side Effects

Like all medications, Harmonet can cause side effects, although not everyone will experience them. If any side effects occur, especially severe or persistent ones, or changes in health that the patient considers related to the use of Harmonet, consult a doctor.

Severe Side Effects

Contact a doctor immediately if any of the following symptoms of angioedema occur: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, which can cause difficulty breathing (see also "Warnings and Precautions").
Serious side effects associated with the use of birth control pills have been described in section 2, "BLOOD CLOTS" and "The Pill and Cancer". If more information is needed, read these sections.
Like all medications, Harmonet can cause allergic reactions (hypersensitivity). These reactions can 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, stop taking Harmonet immediately and inform a doctor or go to the nearest hospital.
In all women taking combined hormonal birth control, 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 birth control, refer to section 2, "Important Information Before Taking Harmonet".

Other Possible Side Effects:

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

• headache, including migraine (if severe or unusual, or prolonged, contact a doctor immediately),
• bleeding and spotting between periods during the first few months (although usually resolves when the body gets used to Harmonet) - see "Spotting Between Periods Should Not Last Long".

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 menstrual flow; 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, swelling (e.g., of ankles or feet) caused by fluid accumulated in tissues.

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

• 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) that 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 folate levels in the blood, glucose intolerance,
• intolerance to contact lenses,
• harmful blood clots in a vein or artery, for example:
• o - in the leg or foot (e.g., deep vein thrombosis),
• o - in the lungs (e.g., pulmonary embolism),
• o - heart attack,
• o - stroke,
• o - mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack,
• o - 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 due to a deficiency 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 tumor (hepatocellular carcinoma).

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The likelihood of 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.
Inform a doctor or pharmacist if the patient is concerned that any side effect may be due to the use of Harmonet. If any existing condition worsens while taking Harmonet, also inform a doctor or pharmacist.

Spotting Between 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. Take Harmonet as usual. The condition should resolve after taking a few initial packs of Harmonet.
Unexpected bleeding may also occur if the doses are not taken regularly; therefore, try to take the doses every day at the same time. Unexpected bleeding may also be caused by taking other medications.
Consult a doctor 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, inform a doctor, pharmacist, or nurse. 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
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: +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

Store the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Store in a temperature below 25°C. Store the blister pack in the outer packaging to protect it from light.
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Medications should not be disposed of in wastewater or household waste. Ask a pharmacist how to dispose of unused medications. 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 dose contains 75 micrograms of gestodene (0.075 mg) and 20 micrograms (0.020 mg) of ethinylestradiol.
Harmonet also contains:
The core of the dose contains: lactose monohydrate, cornstarch, povidone 25, magnesium stearate.
The coating of the dose contains: sucrose, macrogol 6000, calcium carbonate, talc, povidone 90, wax E.

Appearance and Packaging of Harmonet

Coated tablets.
The tablets are white, round, coated, and have a shiny surface.
Blister pack with PVC/Aluminum foil 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. A cardboard pouch is included with the packaging, in which the blister pack should be placed after removal from the protective foil.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in Belgium, the Country of Export:

Pfizer NV/SA
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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
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Belgian marketing authorization number, the country of export: BE174115

Parallel Import Authorization Number: 48/05

Translation of Day Symbols on the Blister Pack:

Lu
Ma
Monday
Mo
Ma
Di
Tuesday
Di
Me
Wo
Wednesday
Mi
Je
Do
Thursday
Do
Ve
Vr
Friday
Fr
Sa
Za
Saturday
Sa
Di
Zo
Sunday
So

Date of Leaflet Approval: 24.04.2024

[Information about the trademark]
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