Harmonet

Warning! Keep the package leaflet. Information on the immediate packaging in a foreign language.
Harmonet
75 micrograms (0.075 mg) + 20 micrograms (0.020 mg), coated tablets
Gestodenum + Ethinylestradiolum
Important information regarding combined hormonal contraceptives

• When used correctly, they represent 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 a woman suspects symptoms of blood clot formation (see section 2 "BLOOD CLOTS").

Read the package leaflet 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. It may harm someone else, even if their symptoms appear identical.
• If any of the listed side effects worsen, or if any unlisted side effects occur, inform your doctor, pharmacist, or nurse. See section 4.

Table of 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. Contents of the pack and other information

1. What Harmonet is and what it is 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 cervical mucus, making it harder for sperm to enter the uterus; and by preventing thickening of the lining of the uterus 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.
• It does not require interruption of sexual intercourse.
• It usually makes menstrual periods more regular, lighter, and less painful.
• It may relieve premenstrual symptoms.

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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 to take Harmonet, you should read the information about
blood clots (thrombosis) in section 2. It is particularly important to understand the symptoms
of blood clots (see section 2 "BLOOD CLOTS").
It is important to understand the benefits and risks of using the Pill
before starting or continuing its use. Although the Pill is suitable for
most healthy women, it is not suitable for everyone.
You should inform your doctor if you have any of the diseases or risk factors mentioned
in this leaflet.

Before taking the Pill
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 Pill

• You should attend regular medical check-ups, usually when a new prescription is needed.
• You should have regular cervical smear tests as advised by your doctor.
• You should 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 blood tests, inform your doctor that you are taking the Pill, as it may affect the results of certain tests.
• If you are scheduled for surgery, inform your doctor. You may need to stop taking the Pill 4–6 weeks before the operation. This reduces the risk of blood clots (see section 2 "BLOOD CLOTS"). Your doctor will advise you when you can resume taking the Pill.

When not to use Harmonet
Do not use Harmonet if you have any of the following conditions. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative contraceptive method 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 require surgery or will be immobile for a prolonged period (see section 2 "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 and are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Other medicines and Harmonet").

If you have any of the above conditions or develop one for the first time
while taking Harmonet, contact your doctor immediately. Do not take Harmonet.

Warnings and precautions
When should you contact your doctor?
Seek medical advice immediately:

• if you notice possible symptoms of a blood clot, 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 THE OCCURRENCE OF BLOOD CLOTS".

Tell your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Harmonet, you should also
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 defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing 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 require 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 for advice on how soon after delivery you can start taking Harmonet;
• if you have phlebitis (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, seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

The Pill and smoking
Women using the Pill are strongly advised to stop smoking.
Smoking increases the risk of serious adverse effects on the heart and
circulatory system. 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 thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").
  Full recovery after a blood clot is not always possible. 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 caused by using Harmonet is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.

| Are you experiencing any of these symptoms? | Possible cause | |---------------------------------------------|----------------| | Swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by: | Deep vein thrombosis | | + pain or tenderness in the leg, which may only be felt 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; | Pulmonary embolism | | Sudden coughing without obvious cause, possibly accompanied by coughing up blood; | | | Sharp chest pain, which may worsen on deep breathing; | | | Severe dizziness or vertigo; | | | Rapid or irregular heartbeat; | | | Severe stomach 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. a cold).
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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 developing blood clots in veins (venous thrombosis). Although these adverse events are rare, they occur most frequently 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. Page 5 of 17
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest 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, although it remains higher than in women who do not use combined hormonal contraceptives.
If a patient stops taking Harmonet, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on a woman's natural risk of 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 a one-year period, about 2 out of 10,000 women who do not use combined hormonal contraceptives and who are not pregnant will develop blood clots.
• In a one-year period, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In a one-year period, 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 patient (see "Factors increasing the risk of venous blood clots" and "Factors increasing the risk of arterial blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Harmonet is low, 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 family member of the patient has had blood clots in the legs, lungs or other organs at a young age (e.g. under 50 years). In this case, the patient may have an inherited clotting disorder;
• 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, ask the doctor when it is safe to restart;
• with increasing age (particularly over 35 years);
• if the patient has given birth within the last few weeks. Page 6 of 17

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
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, e.g. if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can cause 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 the use of Harmonet is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Harmonet, it is recommended to stop smoking. 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 family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known 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, e.g. if the patient starts smoking, a close family member is diagnosed with 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 appears to 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 chronic infection with human papillomavirus. All women should have regular cervical smears.
If the patient has or has had breast cancer, the Pill should not be used.
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 risk of additional cases in women currently or recently using the Pill is low.
The risk of breast cancer is higher:

• the older the woman is,
• if a close relative (mother, sister or grandmother) has had breast cancer,

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• in case 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 breast changes are noticed, such as skin dimpling, changes in nipples or any lumps that can be seen or felt.

Very rarely, the use of the Pill has also been associated with certain types of liver cancer in women using the medication long-term.

The Pill and liver disease
Rarely, the use of the Pill has also been associated with liver disorders such as jaundice and benign liver tumours.
Early diagnosis of liver cell damage allows prompt discontinuation of the medication, reducing harmful effects on the liver. If liver cell damage is diagnosed, stop taking the Pill, use alternative contraception and consult a doctor.
It may be necessary to avoid using the Pill until liver function abnormalities resolve.
If severe abdominal pain or yellowing of the skin or eyes (jaundice) occurs, seek medical advice immediately. It may be necessary to discontinue Harmonet.

The Pill and vision
When wearing contact lenses, discomfort or even intolerance may occur while taking the Pill. If more serious eye problems occur, stop taking the Pill and contact a doctor immediately for evaluation.

High blood pressure
Blood pressure may increase while taking the Pill. If there have been previous problems with high blood pressure, another method of contraception may be required. If the doctor prescribes the Pill, blood pressure should be monitored regularly, and if significantly elevated, stop taking the Pill and use another method of contraception (see also section “When not to use Harmonet”) if any of the following conditions occur.

Migraine and headache
If migraine or new-onset headache occurs, the Pill may be inappropriate. In this case, stop taking the Pill and contact the doctor.

The Pill and effects on carbohydrates and lipids
If there have been previous problems with glucose tolerance or diabetes, inform the doctor, as close monitoring is required (see also section “When not to use Harmonet”) if any of the following conditions occur.
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 these types of bleeding persist or recur, contact the doctor to exclude non-hormonal causes such as pregnancy or
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certain diseases. If necessary, the doctor may prescribe a different Pill (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 while taking the Pill, 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 sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the doctor promptly for further 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 type of contraception may be needed.

Medical examinations
Before prescribing the Pill for the first time, the doctor will perform a full medical and family history and a physical examination. Regular visits to the doctor for cervical smear tests are recommended.
The next visit should occur three months after starting the Pill. Annual check-ups are required, which will include the same assessments as the initial examination.

Children and postmenopausal women
Harmonet is intended for use only in women of reproductive age. It should 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 those available without a prescription. 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 drugs used to treat HIV (AIDS),
• 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 inform the patient if this is necessary and for how long.
Harmonet may also affect the action of other medicines. It is therefore very important to inform the doctor if the Pill is taken with other medicines.
Taking a medicine called troleandomycin while using the Pill increases the risk of liver function disorders (reduced bile excretion from the liver).
Taking a medicine called flunarizine while using the Pill may sometimes cause milk production in women who have not recently given birth.
Do not use Harmonet if the patient has hepatitis C virus 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 in blood (increased activity of the liver enzyme alanine aminotransferase).
The doctor should prescribe another type of contraception before starting treatment with these medicines.
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 instructions regarding taking Harmonet with food or drink.

Pregnancy and breastfeeding
Consult a doctor before taking any medicine.
Do not use Harmonet during pregnancy. If pregnancy is suspected, perform a pregnancy test to confirm before stopping Harmonet.
There is no evidence that Harmonet harms the foetus if accidental fertilisation occurs during use, 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 should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor.
Take Harmonet daily for 21 days.
Harmonet is available in blisters containing 21 tablets. Each tablet is marked with a day of the week symbol.

• Take one tablet daily at approximately the same time.
• Start by taking the tablet marked with the correct day of the week symbol (see “Explanation of day-of-the-week symbols on the packaging and blister card” at the end of the leaflet).
• 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 tablets whole, with water if needed. Do not chew.

Then take a 7-day break without tablets
After taking all 21 tablets from the blister, there is a 7-day break without tablets. If the last tablet from the first pack was taken on Friday, the first tablet from the next pack should be taken on Saturday of the following week.
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Withdrawal bleeding resembling a period will occur a few days after the last tablet. This bleeding may not have finished before starting the next pack.
There is no need for additional contraception during these 7 tablet-free days, provided 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 blister pack of Harmonet – even if bleeding has not stopped. Always start a new pack on time.
As long as Harmonet is taken correctly, each new pack will always start 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 in 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 Sunday). In this case, use additional contraceptive methods such as condoms until the first seven tablets have been taken correctly.

Switching from another contraceptive to Harmonet

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

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. This provides immediate contraceptive protection.
If a miscarriage or abortion occurred after the third month of pregnancy, Harmonet can be started after 28 days. Additional contraceptive methods such as condoms are recommended during the first 7 days of taking Harmonet. However, if sexual intercourse has occurred, exclude pregnancy or wait for the next menstrual period.

Contraception after childbirth
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Harmonet may be started 28 days after an uncomplicated vaginal delivery, provided the patient is not breastfeeding and is fully mobile. Additional contraceptive methods are recommended during the first 7 days of taking Harmonet.
However, if sexual intercourse has occurred, exclude pregnancy or wait for the first menstrual period after childbirth or abortion.
The doctor will provide further information on contraception.

3.3 Taking more than the recommended dose of Harmonet
It is unlikely that taking more than one tablet will cause adverse effects, but consult a 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 tablets at the usual time. Contraceptive protection is not reduced.
If more than 12 hours have passed since the missed tablet, or if two or more active tablets are 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 earlier missed tablets in the blister and continue taking the remaining tablets as usual. Additionally, use non-hormonal contraception such as condoms for the next seven days.
Then follow these rules:

• If one or more tablets were missed in the first week of the blister (days 1–7) and sexual intercourse occurred, there is a risk of pregnancy. Contact the doctor or pharmacist as soon as possible.
• If the last tablet was taken after completing the seven days of additional contraception, take a 7-day break before starting the next blister.
• If the last tablet was taken before completing these seven days of additional contraception, 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 from the blister and no bleeding occurred during the tablet-free period, this may indicate pregnancy. Before starting the next blister, contact the doctor or pharmacist or perform a pregnancy test.
If the patient started the next blister late, protection against pregnancy may be lost. If sexual intercourse occurred within the last seven days, seek advice from the doctor or pharmacist. Also use additional contraception such as condoms for seven days.

3.5 Actions in case of 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 such as condoms during the illness and for seven days after recovery. If more than 12 hours have passed, follow the instructions in section “Missed dose of Harmonet”.
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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 may indicate pregnancy, but is very unlikely if tablets were taken correctly. If there is a risk of pregnancy (e.g. due to 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
If the patient wishes to delay withdrawal bleeding, skip the 7-day break and immediately start taking tablets from a new pack of Harmonet. Withdrawal bleeding can be delayed for any length of time, up to the duration of a full pack. Breakthrough bleeding or spotting may occur during this time. Resume regular use of Harmonet after the usual 7-day break.
If the patient has further questions about using this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Harmonet may cause adverse effects, although not everyone will experience them. If any adverse effects occur, especially severe or persistent ones, or any changes in health that the patient considers related to the use of Harmonet, a doctor should be consulted.

Serious adverse effects

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 cause breathing difficulties (see also section "Warnings and precautions").

Serious adverse effects associated with the use of oral contraceptive tablets are described in section 2, “BLOOD CLOTS” and “The pill and cancer”. If further information is needed, please read these sections.

Like all medicines, Harmonet may cause allergic (hypersensitivity) reactions. These reactions may, in very rare cases, include hives, 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 occur, Harmonet should be discontinued immediately and a doctor should be informed without delay or the patient should go to the nearest hospital.

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

Other possible adverse effects:

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

• Headache, including migraine (if sudden or 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 (may occur in up to 1 in 10 people):

• Change in body weight (increase or decrease),
• Mood changes, including depression and changes in libido (sexual drive),
• Nervousness or dizziness,
• Breast pain, breast tenderness, breast enlargement, nipple discharge; change in bleeding pattern; change in vaginal discharge; absence of periods, painful periods,
• Vaginitis, including yeast infection (candidiasis),
• Stomach problems such as nausea, vomiting, or abdominal pain,
• Acne,
• Fluid retention, swelling (e.g. ankles or legs) due to fluid accumulation in tissues.

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

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

• Severe allergic reactions, including very rare cases of hives, sudden tissue swelling (angioedema), and severe reactions affecting the respiratory and circulatory systems, such as: low blood pressure, dizziness, nausea, and breathing difficulties,
• Decreased folic acid levels in the blood, 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 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 caused by deficiency of certain enzymes),
• Worsening of chorea (movement disorder),
• Optic neuritis, blood clots in retinal vessels,
• Worsening 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 risk of developing blood clots may be higher if the patient has any other conditions that increase this risk (see section 2 for further information on risk factors for blood clots and symptoms of their occurrence).

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, which cannot be estimated based on available data.

Inform a doctor or pharmacist if the patient is concerned that any adverse effect may be related to the use of Harmonet. If any pre-existing condition worsens during treatment with Harmonet, inform a doctor or pharmacist as well.

Bleeding between periods should not last long

Some women may experience slight unexpected bleeding or spotting while taking Harmonet, especially during the first few months. Usually, this is not a cause for concern and will stop after one or two days. Continue taking Harmonet as usual. The problem should resolve after taking the first 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,
• Begins after several months of taking Harmonet,
• Continues even after stopping Harmonet.

Reporting of adverse effects

If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can also 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 effects helps provide more information on the safety of the medicine.

5. How to store Harmonet

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

What Harmonet contains
The active substances are gestodene and ethinylestradiol.
Each tablet contains 75 micrograms of gestodene (0.075 mg) and 20 micrograms (0.020 mg) of
ethinylestradiol.
Additionally, the medicine contains:
Tablet core: monohydrate lactose, maize starch, povidone 25, magnesium stearate.
Tablet coating: sucrose, macrogol 6000, calcium carbonate, talc, povidone 90, wax E.

What Harmonet looks like and contents of the pack
Film-coated tablets.
The tablets are white, round, film-coated with a shiny surface.
Aluminum/foil PVC blister pack with a silica gel desiccant sachet, in a cardboard box.
Each Harmonet blister contains 21 white tablets.
Each Harmonet carton contains 1x21 or 3x21 tablets. A cardboard pouch is included with the package, in which the blister should be placed after removal from the protective foil.
For more detailed information, contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in Belgium, 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
Poland

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

Belgium, country of export, marketing authorisation number: BE174115
Parallel import authorisation number: 48/05

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