Harmonet

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet, 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")

You should read the leaflet before taking 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. 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, please 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") for use in preventing 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 particularly 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 to take it or deciding to continue taking it. 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 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 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 "The Pill and thrombosis"). Your doctor will tell you when you can start taking the Pill again.

When not to take Harmonet

You should not take Harmonet if you have any of the conditions listed below. If you have any of the conditions listed below, 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 2 "BLOOD CLOTS");
• if you have had a heart attack or stroke;
• if you have (or have had) angina pectoris (a disease that causes severe chest pain and may be a sign of a heart attack) or 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);
• hyperhomocysteinemia;
• if you have (or 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 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 that 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, 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 your leg (deep vein thrombosis), a blood clot in your lungs (pulmonary embolism), a heart attack, or a 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 disorder 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 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 that 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.

The Pill and smoking

Women taking the Pill 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 everyone who has a blood clot will recover completely. In rare cases, the effects of a blood clot can be long-lasting 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 is the patient likely to be suffering from
Deep vein thrombosis

• 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 skin of the leg, such as pallor, redness, or cyanosis

Pulmonary embolism

• sudden unexplained shortness of breath or rapid breathing;

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 the veins (venous thromboembolism). Although these side effects are rare, they can occur.
• If blood clots form in the veins in the leg or foot, it can lead to deep vein thrombosis.
• If a blood clot breaks loose from the leg and travels 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 a vein highest?

The risk of blood clots 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 a vein?

The risk of blood clots in a vein is small, but some factors can increase this risk. The risk is higher:

• if you are severely overweight (body mass index (BMI) over 30 kg/m2);
• if someone in your close family has had a blood clot in the leg, lung, or other organ at a young age (e.g. under 50 years of age). 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 of age);
• if you have recently given birth.

The risk of blood clots in a vein increases with the number of risk factors present in a woman.
Long-haul flights (>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 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 weight significantly.

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

• with age (over approximately 35 years);
• if you smoke.If you are 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 of age). 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);
• if you have diabetes.

If you have more than one of these 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 these conditions change while taking Harmonet, e.g. if you start smoking, someone in your close family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

The 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 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) breast cancer, you should not take the Pill.
The Pill slightly increases the risk of breast cancer. This risk increases with the duration of Pill use but decreases within 10 years of stopping Pill use. Breast cancer is rare in women under 40 years of age, 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 a late 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 nipples, 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.

The Pill and liver disease

Very rarely, taking the Pill has also been linked to liver disease, such as jaundice and non-cancerous liver tumors.
Early detection of liver cell damage allows for prompt withdrawal of the Pill, which reduces the harmful effect of the Pill 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 disorders have resolved.

The Pill and vision

If you wear contact lenses, you may experience discomfort or even intolerance while taking the Pill. 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, which you have not had before, the Pill may not be suitable for you. In this case, you should stop taking the Pill and contact your doctor.

The Pill and carbohydrates and lipids

If you have ever had problems with glucose tolerance or diabetes, you should tell your doctor, as close monitoring may be necessary (see also section "Do not take Harmonet if you have any of the following conditions").
In a small number of women, taking the Pill can cause changes in blood lipid levels. 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 contact your doctor to rule out non-hormonal causes, such as pregnancy or certain diseases. If necessary, your doctor may prescribe a different 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 have irregular periods while taking the Pill, see also section "If you miss 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 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. It may be necessary to use a different type of contraception.

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 have regular cervical smears.
Your next visit should be after three months of taking the Pill. Once a year, you should have a check-up with your doctor, 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 the 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 the medicines you are taking to see if they can be used 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 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 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 a different 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 to confirm 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 if you are breastfeeding. You should discuss other methods of contraception with your doctor. Breastfeeding does not protect against pregnancy.

Important information about some of the ingredients of Harmonet

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

3. HOW TO TAKE HARMONET

3.1. How to take Harmonet

Harmonet should always be taken as directed by your doctor. If you are unsure, you should contact your doctor.

Harmonet should be taken every day for 21 days.

Harmonet is available in blisters containing 21 tablets. Each tablet is marked with a symbol of the day of the week.

• You should take one tablet every day at about the same time.
• You should start with the tablet marked with the correct symbol of the day of the week. For example, if your period starts on a Friday, you should take one tablet marked as Ve/Vr/Fr (which means Friday; see "Translation of the day of the week symbols on the packaging" at the end of the leaflet and on the blister pack).
• You should take the tablets in the direction of the arrows on the packaging. You should take one tablet every day until you have finished all 21 tablets.
• You should swallow the tablets whole, if necessary with a little water. You should not chew them.

Then there are 7 days without taking tablets

After taking all 21 tablets from the blister pack, there are 7 days without taking tablets. If you took the last tablet from the first pack on a Friday, you should take the first tablet from the next pack on the following Saturday.
Within a few days of taking the last tablet from the blister pack, you will experience withdrawal bleeding, which will be like a period. This bleeding may not have stopped before you start the next pack of tablets.
There is no need to use additional contraception during these 7 days without tablets, as long as the tablets have been taken correctly and the next pack is started on time.

Then you should start the next pack

After 7 days without tablets, you should start the next Harmonet blister pack - even if the bleeding has not stopped. You should always start a new pack on time.
As long as Harmonet is taken correctly, each subsequent pack will start on the same day of the week.

3.2. How to start taking Harmonet

First-time use or starting after a break

You should start taking Harmonet on the first day of your next period. Starting in this way gives you immediate contraceptive protection.
It is also possible to start taking Harmonet between days 2-7 of your period (e.g. starting on a Sunday). In this case, you should use additional contraceptive methods, such as a condom, until you have taken the first 7 tablets correctly.

Switching from another contraceptive

• If you were taking a contraceptive that contains 21 tablets: you should start taking Harmonet the next day after finishing the previous pack. Contraceptive protection is immediate. You will experience bleeding after finishing the first pack of Harmonet.
• If you were taking a contraceptive that contains 28 tablets: you should start taking Harmonet the next day after finishing the active tablets. Contraceptive protection is immediate. You will experience bleeding after finishing the first pack of Harmonet.
• If you were taking a progestogen-only contraceptive(progestogen-only pill, 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 tablets on the day that the next injection is scheduled. You should use additional contraceptive methods, such as a condom, until you have taken the first 7 tablets correctly.

Starting Harmonet after a miscarriage or abortion

If the miscarriage or abortion occurred within the first three monthsof pregnancy, your doctor may tell you that you can 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 Harmonet. If you have had sex, you should rule out pregnancy or wait for your next period.

Contraception after childbirth

You can start taking Harmonet 28 days after a normal vaginal delivery, provided that you are not breastfeeding and are fully recovered. It is recommended to use additional contraceptive methods during the first 7 days of taking Harmonet.
If you have had sex, you should rule out pregnancy or wait for your first period after childbirth or abortion.
Your doctor will provide further information about 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 contact your doctor as soon as possible.

3.4. Missing a Harmonet Dose

In case a tablet is missed, follow the instructions below.
If it has been less than 12 hourssince the missed 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 the missed tablet or 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 contraception, such as condoms, for the next seven days.
Then, follow these rules:

• If one or more tablets 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 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 end of 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 has forgotten to take any of the tablets from the blister pack and has not had bleeding during the tablet-free period, this may indicate pregnancy. Before starting to take tablets from the next blister pack, contact your doctor or pharmacist, or take a pregnancy test.
If the patient has started a new blister pack late, they may not be protected against pregnancy. If intercourse has occurred within the last seven days, consult a doctor or pharmacist. Also, use measures 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 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 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 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 a missed tablet or taking other medications) before starting the next pack, take a pregnancy test. 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 7-day break and start taking tablets from a new pack of Harmonet immediately. Withdrawal bleeding can be delayed for any length of time, up to the time all tablets 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 normal 7-day break.
If the patient has more questions about using this medication, they should talk to a 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, 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 that may cause difficulty breathing (see also "Warnings and Precautions").
Serious side effects related to taking the contraceptive pill have been described in section 2, "The Pill and Thrombosis" and "The Pill and Cancer". If more information is needed, read these sections.
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, stop taking Harmonet immediately and tell a doctor or go to the nearest hospital.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism) or blood clots in arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, see 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, contact a doctor as soon as possible)
• bleeding and spotting between periods for the first few months (although usually resolves when the body gets used to Harmonet) - see "Spotting or Breakthrough Bleeding 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 menstrual flow; change in vaginal discharge; absence of menstruation, painful menstruation
• vaginal infection, including yeast infection (candidiasis)
• stomach problems, such as nausea, vomiting, or abdominal pain
• acne
• fluid retention, edema (e.g., swelling of 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
• abdominal 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 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: 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 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
• 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).

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

Spotting or Breakthrough Bleeding 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. Take Harmonet as usual. The condition should resolve after taking the first few packs of Harmonet.
Unexpected bleeding may also occur if the tablets are not taken regularly; therefore, try to take the tablets 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 months
• starts after a few months of taking Harmonet
• continues even after stopping Harmonet.

Reporting Side Effects

If any side effects occur, including any side effects not listed in the leaflet, tell a doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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

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.
Do not store above 25°C. Store in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Harmonet Contains

The active substances are gestodene and ethinylestradiol.
Each tablet contains 75 micrograms (0.075 mg) of gestodene and 20 micrograms (0.020 mg) of ethinylestradiol.
The medication also contains:
The tablet core contains: lactose monohydrate, cornstarch, povidone 25, magnesium stearate.
The tablet coating contains: sucrose, povidone 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 with a shiny surface.
Blister pack with PVC/Al foil in a carton with silica gel as a desiccant.
Each pack of Harmonet contains 1 x 21 or 3 x 21 coated tablets.
A carton sleeve is provided with the packaging.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in Belgium, the Country of Export:

Pfizer 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:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Marketing authorization number in Belgium, the country of export: BE174115

Parallel Import Authorization Number: 333/19

Translation of day-of-the-week symbols on the packaging:
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

Leaflet Approval Date: 13.08.2024

[Information about the trademark]