Harmonet

WARNING: Keep the leaflet, information on the immediate packaging in a foreign language
Harmonet
75 micrograms + 20 micrograms, coated tablets
Gestodenum + Ethinylestradiolum
Important information regarding combined hormonal contraceptives

• When used correctly, they are one of the most reliable reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the patient suspects symptoms of blood clot formation (see section 2 "Blood clots").

Read the leaflet carefully before using the medicine.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are similar.
• If any adverse reaction worsens or if any adverse reactions not listed in the leaflet occur, inform your doctor or pharmacist.

Contents of the leaflet:

1. What Harmonet is and what it is used for
2. What you need to know before taking Harmonet
3. How to take Harmonet
4. Possible side effects
5. How to store Harmonet
6. Further information

1. WHAT IS HARMONET AND WHAT IS IT USED FOR?

Harmonet is a combined oral contraceptive pill (the "Pill")
used to prevent pregnancy.
Harmonet contains two types of female sex hormones: an oestrogen and a progestogen. These hormones
prevent pregnancy in three ways: by preventing the release of an egg from the ovaries; by thickening
the cervical mucus, making it harder for sperm to enter the uterus; and by preventing the lining of the
uterus from thickening, so that a fertilised egg cannot implant.
Harmonet should be taken daily for 21 days (1 tablet per day), followed by a 7-day tablet-free interval.

Benefits of taking the Pill:

• It is one of the most reliable reversible methods of contraception when used correctly.
• No need to interrupt sexual intercourse.
• Periods usually become more regular, lighter and less painful.
• May reduce premenstrual symptoms.

Harmonet does not protect against sexually transmitted infections such as chlamydia or HIV. Only condoms provide protection against these infections.
Harmonet must be taken as directed to prevent pregnancy.

2. IMPORTANT INFORMATION BEFORE USING HARMONET

General Notes
Before starting treatment with Harmonet, you should read the information regarding
blood clots (thrombosis) in section 2. It is especially important to be aware of the symptoms
of blood clots (see section 2 "Blood clots").
It is essential to understand the benefits and risks associated with using the Tablet
before starting or continuing treatment. Although the Tablet is suitable for most healthy women,
it is not appropriate for everyone.
You should inform your doctor if you have any of the medical conditions or risk factors mentioned
in this leaflet.

Before Taking the Tablet
Your doctor will ask you several questions about your health and that of your close relatives and will measure your blood pressure. Other examinations, such as a breast examination, may also be performed.

While Using the Tablet

• You should attend regular medical check-ups, usually when a new prescription is needed.
• You should have regular cervical smear tests (Pap smears) as advised by your doctor.
• Examine your breasts and nipples once a month. Inform your doctor if you notice or feel any changes, such as lumps or skin dimpling.
• If you need to have a blood test, inform your doctor that you are taking the Tablet, as it may affect the results of certain tests.
• If you are planning to undergo surgery, inform your doctor. You may need to stop taking the Tablet 4–6 weeks before the procedure to reduce the risk of blood clots (see section "Blood clots"). Your doctor will advise when you can resume taking the Tablet.

When Not to Use Harmonet
Do not use Harmonet if you have any of the conditions listed below. If you have any of these conditions, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you currently have (or have ever had) a blood clot in the veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders — for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a prolonged period (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 condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage;
  • very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• a condition called hyperhomocysteinemia;
  • if you currently 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 suspect you might be pregnant;
  • if you have a hormone-dependent cancer — such as certain breast, endometrial, or ovarian cancers;
  • if you have unexplained vaginal bleeding not diagnosed by a doctor;
  • if you have irregular heart rhythm (arrhythmia) or heart valve problems caused by blood clotting disorders;
  • if you have ever had pancreatitis associated with high fat levels in the blood (high cholesterol or triglycerides);
  • if you have ever had severe liver disease;
  • if you have hepatitis C virus infection and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section "Other medicines and Harmonet")

If you have any of the above conditions, or if any of them develop while taking Harmonet, contact your doctor immediately. Do not take Harmonet.

Warnings and Precautions
When to Contact Your Doctor
Seek immediate medical advice:

• if you notice possible symptoms of blood clots, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots"). For a description of symptoms of these serious adverse effects, see "How to recognize blood clots".

Inform your doctor if you have any of the following conditions.
If any of these conditions appear or worsen during treatment with Harmonet, inform your doctor.

• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the body's natural immune system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have been diagnosed with high blood fat levels (hypertriglyceridaemia) or have a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you are undergoing surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor about when it is safe to start taking Harmonet after delivery;
• if you have superficial thrombophlebitis (inflammation of 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 breathing difficulties, you should

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

The Tablet and Smoking
Women using the Tablet are strongly advised not to smoke.
Smoking increases the risk of serious cardiovascular side effects. This risk increases with age and the number of cigarettes smoked and is particularly significant in women over 35 years of age.

BLOOD CLOTS
Using combined hormonal contraceptives, such as Harmonet, is associated with an increased risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thromboembolism" or "venous thrombosis");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots associated with using Harmonet is low.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical attention if you experience any of the following symptoms.
Are you experiencing any of these symptoms? Why might you be experiencing them?

• swelling of the leg or swelling along a vein in the leg, Deep vein thrombosis
  or foot, especially if accompanied by:
  • pain or tenderness in the leg, which may
    be felt only when standing or walking;
• increased warmth in the affected leg;
• change in skin colour of the leg, e.g., paleness, redness, or blueness;
  • sudden unexplained shortness of breath or
    rapid breathing;
  • sudden coughing without an obvious cause, possibly accompanied by coughing up blood;
  • sharp chest pain, which may worsen with deep breathing;
  • severe dizziness or lightheadedness;
  • rapid or irregular heartbeat;
  • severe abdominal pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or breathlessness, may be mistaken for milder conditions, such as a respiratory tract infection (e.g.

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of first-time use of combined hormonal contraceptives. 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, although it remains higher compared to not using combined hormonal contraceptives at all.
If a woman stops taking Harmonet, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of blood clots in veins?
The risk depends on the individual's natural risk of developing venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Harmonet is low.

• In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and who are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing gestodene, such as Harmonet, will develop blood clots.
• The risk of developing blood clots depends on the individual medical history of the woman (see "Factors increasing the risk of blood clots", below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Harmonet is small, but certain factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative has had blood clots in the legs, lungs or other organs at a young age (e.g. under 50 years). In such cases, the patient may have an inherited tendency to form blood clots;
• if the patient requires surgery, is immobilised for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Harmonet several weeks before surgery or immobilisation. If the patient must stop taking Harmonet, consult the doctor about when it is safe to restart;
• with increasing age (particularly over the age of 35);
• if the patient has recently given birth (within the last few weeks).

The risk of blood clots increases with the number of risk factors present.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if another risk factor is present.
It is important to inform the doctor if any of these risk factors apply, even if uncertain. The doctor may decide to discontinue Harmonet.
Inform the doctor if any of the above conditions change during treatment with Harmonet, for example, if a close relative develops unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if a blood clot forms in an artery?
As with venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to note that the risk of heart attack or stroke associated with taking Harmonet is very small, but may increase:

• with increasing age (over approximately 35 years);
• if the patient smokes. Smoking is strongly discouraged while using hormonal contraceptives such as Harmonet. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In such cases, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve problems, heart rhythm disorders such as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Harmonet, for example, if the patient starts smoking, a close relative develops unexplained thrombosis, or if the patient gains significant weight.

The Pill and cancer
Long-term use of the Pill reduces the risk of ovarian and endometrial cancer. However, it may slightly increase the risk of cervical cancer – although this may be more related to sexual behaviour than to the Pill itself. The most important risk factor for cervical cancer is persistent infection with human papillomavirus (HPV). All women should have regular cervical smears.
The Pill must not be used if the patient has or has had breast cancer.
The Pill slightly increases the risk of breast cancer. This risk increases with the duration of use but decreases within 10 years after stopping. Breast cancer is rare in women under 40, so the additional risk in women currently or recently using the Pill is small.
The risk of breast cancer is higher:

• the older the woman is,
• if a close female relative (mother, sister or grandmother) has had breast cancer,
• in cases of significant overweight,
• if the first child was born at an older age or if the patient has never given birth.

Seek medical advice promptly if any changes in the breasts are noticed, such as skin dimpling, changes in the nipples or any lumps that can be seen or felt.

Very rarely, the use of the Pill has been associated with certain types of liver cancer in women who have used hormonal contraceptives for a long time.

The Pill and liver disease
Rarely, the use of the Pill has been associated with liver disorders such as jaundice and benign liver tumours.
Early diagnosis of liver cell damage allows for prompt discontinuation of the drug, reducing harmful effects on the liver. If liver cell damage is diagnosed, stop taking the Pill, use an alternative method of contraception and consult the doctor.
It may not be possible to use the Pill again until liver function abnormalities have resolved.
If severe abdominal pain or yellowing of the skin or eyes (jaundice) occurs, seek medical advice immediately. Discontinuation of Harmonet may be necessary.

The Pill and vision
Contact lens wearers may experience discomfort or even intolerance while taking the Pill. If more serious eye problems occur, stop taking the Pill and contact the doctor immediately for evaluation.

High blood pressure
Blood pressure may increase while taking the Pill. If the patient has a history of high blood pressure, another method of contraception may be needed. If the doctor prescribes the Pill, blood pressure should be monitored regularly, and if a significant increase occurs, stop taking the Pill and use another method of contraception (see also section "Do not use Harmonet if any of the following conditions apply").

Migraine and headache
If migraine or a new type of headache develops, the Pill may be unsuitable. In such cases, stop taking the Pill and contact the doctor.

The Pill and effects on carbohydrates and lipids
If the patient has a history of glucose intolerance or diabetes, inform the doctor, as close monitoring may be required (see also section "Do not use Harmonet if any of the following conditions apply").
A small proportion of women may experience changes in blood lipid (fat) levels while taking the Pill. Inform the doctor, who may consider non-hormonal contraception.
If the patient is being treated for high lipid levels, regular check-ups will be required while taking the Pill.

Vaginal bleeding
Breakthrough bleeding or spotting may occur, especially during the first three months of taking the Pill. If such bleeding persists or recurs, contact the doctor to rule out non-hormonal causes such as pregnancy or certain diseases. The doctor may prescribe a different Pill if necessary (see also section "Bleeding between periods should not last long").
If the patient previously had no periods or irregular periods, these may recur during Pill use.
For irregular bleeding during Pill use, see also section "Missed dose of Harmonet".

Psychiatric disorders
Some women using hormonal contraceptives, including Harmonet, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the doctor promptly for medical advice.
Women with a history of depression should be closely monitored, and if severe symptoms of recurrent depression occur, the product should be discontinued. The Pill may be unsuitable, and another method of contraception may be needed.

Medical examinations
Before prescribing the Pill for the first time, the doctor will perform a complete medical and family history and a physical examination. Regular cervical smears should be performed.
A follow-up visit should occur three months after starting the Pill. Annual check-ups are recommended, similar to the initial examination.

Children and postmenopausal women
Harmonet is intended only for use in women of reproductive age. It must not be used by children or postmenopausal women.

Other medicines and Harmonet
Inform the doctor or pharmacist about all medicines currently or recently taken, including over-the-counter medicines. Also check the leaflets of all medicines to see if they can be used with hormonal contraception.
Some medicines may reduce the effectiveness of Harmonet in preventing pregnancy, for example:

• laxatives used for constipation,
• certain antiepileptic drugs,
• certain drugs used to treat tuberculosis,
• certain HIV (AIDS) medications,
• certain antifungal drugs,
• certain sedatives (called "barbiturates"),
• certain anti-inflammatory drugs,
• St. John's wort (herbal remedy),
• atorvastatin (a lipid-lowering drug),
• vitamin C or paracetamol,
• theophylline (used to treat asthma),
• cyclosporine.

If one of these medicines must be taken, Harmonet may be unsuitable, and additional contraception may be needed for a certain period. The doctor or pharmacist will advise whether this is necessary and for how long.
Harmonet may also affect the action of other medicines. It is very important to inform the doctor if taking the Pill together with other medicines.
Taking troleandomycin while using the Pill increases the risk of liver dysfunction (reduced bile secretion).
Taking flunarizine while using the Pill may occasionally cause milk production in women who have not recently given birth.
Do not use Harmonet if the patient has hepatitis C and is taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as these may increase liver function test results (increased alanine aminotransferase enzyme activity). The doctor should prescribe another type of contraception before starting these medications. Harmonet may be restarted approximately 2 weeks after stopping treatment. See section "When not to use Harmonet".

Taking Harmonet with food and drink
There are no special requirements regarding food or drink when taking Harmonet.

Pregnancy and breastfeeding
Consult the doctor before taking any medicine.
Do not use Harmonet during pregnancy. If pregnancy is suspected, perform a pregnancy test before stopping Harmonet.
There is no evidence that Harmonet harms the unborn child if accidental conception occurs while taking the Pill, but if pregnancy is confirmed, stop taking Harmonet.
Harmonet is not recommended during breastfeeding. Discuss alternative contraception with the doctor. Breastfeeding does not protect against pregnancy.

Important information about certain ingredients in Harmonet
Harmonet contains monohydrate lactose and sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, consult the doctor before taking the medicine.

3. HOW TO TAKE HARMONET
3.1 How to take Harmonet
Harmonet must always be taken as directed by the doctor. If in doubt, consult the doctor.
Harmonet must be taken daily for 21 days.
Harmonet is available in blisters containing 21 tablets. Each tablet is marked with a day of the week.

• Take one tablet daily at approximately the same time.
• Start by taking the tablet marked with the correct day of the week.
• Take the tablets in the order indicated by the arrows on the packaging. Take one tablet daily until all 21 tablets are finished.
• Swallow the tablet whole, with water if needed. Do not chew.

Then, a 7-day break follows
After taking all 21 tablets, there is a 7-day break without tablets. The withdrawal bleeding, similar to a period, usually occurs a few days after the last tablet.
There is no need for additional contraception during these 7 days, provided the tablets have been taken correctly and the next pack is started on time.

Then start the next pack
After the 7-day break, start the next Harmonet blister pack—even if bleeding has not stopped. Always start the new pack on time.
As long as Harmonet is taken correctly, each new pack will always begin on the same day of the week.

3.2 How to start taking Harmonet
First use or restarting the Pill after a break
Start taking Harmonet on the first day of the next menstrual bleeding. Starting this way provides immediate contraceptive protection.
It is acceptable to start taking Harmonet on days 2–7 of the menstrual cycle (e.g. starting on a Sunday). In this case, use additional contraceptive methods such as condoms for the first 7 days of tablet taking.

Switching from another contraceptive to Harmonet

• If previously using a 21-tablet pack: Start Harmonet the day after finishing the previous pack. Contraceptive protection is immediate. Withdrawal bleeding will occur only after completing the first Harmonet blister.
• If previously using a 28-tablet pack: Start Harmonet the day after finishing the active tablets. Contraceptive protection is immediate. Withdrawal bleeding will occur only after completing the first Harmonet blister.
• If previously using a progestogen-only contraceptive (progestogen-only pill, subdermal implant, intrauterine device, injection):
  • progestogen-only pill: stop the progestogen-only pill on any day and start Harmonet the next day.
  • implant or intrauterine device: start Harmonet on the same day the implant or device is removed.
  • injection: start taking tablets on the day the next injection would have been due. Use additional contraceptive methods such as condoms for the first 7 days of tablet taking.

Starting Harmonet after miscarriage or abortion
If a miscarriage or abortion occurred within the first three months of pregnancy, the doctor may advise that Harmonet can be started immediately, providing immediate contraceptive protection.
If a miscarriage or abortion occurred after the third month of pregnancy, start Harmonet after 28 days. Use additional contraceptive methods such as condoms during the first 7 days of taking Harmonet. If sexual intercourse has occurred, rule out pregnancy or wait for the next menstrual period.

Contraception after childbirth
Harmonet may be started 28 days after an uncomplicated vaginal delivery, provided the patient is fully mobile, not breastfeeding, and in good health. Use additional contraceptive methods during the first 7 days of taking Harmonet.
If sexual intercourse has occurred, rule out pregnancy or wait for the first menstrual period after childbirth or abortion.
The doctor will provide further advice on contraception.

3.3 Taking more Harmonet than prescribed
It is unlikely that taking more than one tablet will cause adverse effects, but consult the doctor as soon as possible.

3.4 Missed dose of Harmonet
If a tablet is missed, follow the instructions below.
If less than 12 hours have passed since the missed tablet, take the missed tablet as soon as possible. Take the next tablet at the usual time. Contraceptive protection is not reduced.
If more than 12 hours have passed or two or more active tablets are missed, contraceptive protection may be reduced. Take the last missed tablet as soon as possible (this may mean taking two tablets on the same day). Leave the earlier missed tablets in the blister and continue taking the tablets as usual. Additionally, use non-hormonal contraception (e.g. condoms) for the next 7 days.
Then follow these rules:

• If one or more tablets were missed in the first week (days 1–7) and sexual intercourse occurred, there is a risk of pregnancy. Contact the doctor or pharmacist immediately.
• If the last tablet was taken after completing the 7 days of additional contraception, take a 7-day break before starting the next blister.
• If the last tablet was taken before completing these 7 days, start the next pack the next day. Withdrawal bleeding usually does not occur until after finishing the second blister.

If the patient forgot to take any tablet and no withdrawal bleeding occurred during the tablet-free interval, pregnancy may be possible. Before starting the next pack, contact the doctor or pharmacist or perform a pregnancy test.
If the patient started the next pack late, protection against pregnancy may be lost. If sexual intercourse occurred within the last 7 days, seek advice from the doctor or pharmacist and use additional contraception (e.g. condoms) for 7 days.

3.5 Vomiting or diarrhoea
If vomiting or severe diarrhoea occurs, the hormones from the tablet may not have been fully absorbed. Continue taking tablets at the usual time. Use additional contraception (e.g. condoms) during the illness and for 7 days after recovery. If more than 12 hours have passed since the last tablet, follow the instructions under "Missed dose of Harmonet".
Contact the doctor if gastrointestinal symptoms persist or worsen. The doctor may recommend another method of contraception.

3.6 Delayed withdrawal bleeding – could pregnancy be possible?
Occasionally, withdrawal bleeding may not occur. This could indicate pregnancy, but is very unlikely if tablets were taken correctly. If there is a risk of pregnancy (e.g. missed tablets or concomitant medication), perform a pregnancy test before starting the next pack. If pregnancy is confirmed, stop taking Harmonet and contact the doctor.

3.7 How to delay withdrawal bleeding
To delay withdrawal bleeding, skip the 7-day break and immediately start taking tablets from a new Harmonet pack. Withdrawal bleeding can be delayed for as long as desired, up to the end of the new pack. Breakthrough bleeding or spotting may occur during this time. Resume regular Harmonet use after the usual 7-day break.
If the patient has further questions about using this medicine, consult the doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Harmonet may cause adverse reactions, although not everyone experiences them. If any adverse reactions occur, especially severe or persistent ones, or changes in health that the patient considers related to the use of Harmonet, medical advice should be sought.

Serious adverse reactions
Seek immediate medical attention 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, which may lead to breathing difficulties (see also section "Warnings and precautions").

Serious adverse reactions associated with taking a combined oral contraceptive tablet are described in section 2 under "Blood clots" and "The pill and cancer". For further information, please read these sections.

Like all medicines, Harmonet may cause allergic reactions (hypersensitivity). These reactions may, in very rare cases, include urticaria, sudden swelling of tissues, and severe reactions affecting the respiratory and circulatory systems, such as low blood pressure, dizziness, nausea, and breathing difficulties. If any symptoms of an allergic reaction are observed, treatment with Harmonet must be stopped immediately and a doctor must be informed without delay or the patient should go to the nearest hospital.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic events). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2, "Important information before taking Harmonet".

Other possible adverse reactions:
Very common (occurring in more than 1 in 10 women):

• headache, including migraine (if sudden, different from usual, or prolonged, contact a doctor as soon as possible)
• bleeding and spotting between periods during the first few months (although this usually resolves as the body adjusts to Harmonet) – see section "Bleeding between periods should not last long".

Common (occurring in 1 to 10 out of 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; changes in bleeding pattern; changes in vaginal discharge; absence of menstruation, painful periods
• vaginal inflammation, including yeast infection (candidiasis)
• stomach problems such as nausea, vomiting, or abdominal pain
• acne
• fluid retention, swelling (e.g. in ankles or legs) due to fluid accumulation in tissues.

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

• changes in blood fat levels (plasma lipids), including hypertriglyceridaemia; changes in appetite (increase or decrease)
• increased blood pressure
• stomach cramps; bloating
• rash; brownish irregular skin patches (melasma/chloasma), which may persist; excessive hair growth (hirsutism); excessive hair loss (alopecia).

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

• severe allergic reactions, including very rare cases of urticaria, sudden swelling of tissues (angioedema), and severe reactions affecting the respiratory and circulatory systems, such as: low blood pressure, dizziness, nausea, and breathing difficulties
• decreased blood folate levels, glucose intolerance
• intolerance to contact lenses
• harmful blood clots in veins or arteries, 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 transient ischaemic attack
• blood clots in the liver, stomach/intestine, kidneys or eye
• yellowing of the skin (cholestatic jaundice)
• inflammation of subcutaneous fat cells (erythema nodosum).

Very rare (occurring in less than 1 out of 10,000 women):

• exacerbation of systemic lupus erythematosus (a chronic autoimmune disorder)
• exacerbation of porphyria (a disorder caused by deficiency of certain enzymes)
• exacerbation of chorea (a movement disorder)
• optic neuritis, blood clots in retinal vessels
• exacerbation of varicose veins (varices)
• pancreatitis; inflammation of the large intestine due to reduced blood flow to the intestine (ischaemic colitis)
• gallbladder diseases, including gallstones
• erythema multiforme (a skin disorder)
• haemolytic-uraemic syndrome (a kidney disorder)
• liver cell tumour (hepatocellular carcinoma).

The likelihood of developing 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 unknown frequency that cannot be estimated from available data.

Inform a doctor or pharmacist if the patient is concerned that any adverse reaction may be due to the use of Harmonet. If any pre-existing condition worsens during treatment with Harmonet, the doctor or pharmacist should also be informed.

Bleeding between periods should not last long
Some women may experience light unexpected bleeding or spotting while taking Harmonet, especially during the first few months. Generally, this is not a cause for concern and will usually stop after one or two days. Continue taking Harmonet as usual. The problem should resolve after taking a few blister packs of the medicine.

Unexpected bleeding may also occur if tablets are not taken regularly, so it is important to take the tablets at the same time every day. Unexpected bleeding may also be caused by taking other medicines.

Consult a doctor if bleeding or spotting:

• persists beyond the first few months
• starts after several months of taking Harmonet
• continues after stopping Harmonet.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE HARMONET

Keep out of the sight and reach of children.
Do not use Harmonet after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25°C. Keep the blister in the outer carton to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. OTHER INFORMATION

What Harmonet contains
The active substances in this medicine are gestodene and ethinylestradiol.
Each tablet contains 75 micrograms of gestodene and 20 micrograms of ethinylestradiol.
Additionally, the medicine contains:
Tablet core: monohydrate lactose, maize starch, povidone K 25, magnesium stearate.
Tablet coating: sucrose, povidone K 90, macrogol 6000, calcium carbonate, talc, wax E.

What Harmonet looks like and contents of the pack
Coated tablets
The tablets are white, round, coated and have a shiny surface.
Blister pack made of PVC/Aluminium foil, with a silica gel desiccant in a sachet, inside a cardboard box.
Each Harmonet blister contains 21 white tablets.
Each Harmonet carton contains either 1x21 or 3x21 tablets. A cardboard sachet is included in the package, into which the blister should be placed after removal from its protective foil.

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorization Holder in Belgium, country of export:
Pfizer S.A., Boulevard de la Plaine 17, 1050 Brussels, Belgium

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

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

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

Marketing Authorization number in Belgium, country of export: BE174115
Parallel Import Authorization number: 582/12

Translation of weekday symbols printed next to each tablet on the immediate 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