Harmonet

Package leaflet: Information for the user

Warning! Keep this 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 about 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 your doctor if you suspect symptoms of blood clots (see section 2 "BLOOD CLOTS")

Read this leaflet before taking 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 the same.
• If any side effects worsen or if any side effects not listed in this leaflet occur, inform your doctor or pharmacist.

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 stopping the release of an egg from the ovaries;
by thickening 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 break without tablets.
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,
• Usually makes periods 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 THE MEDICINE 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 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 deciding to continue its use. Although the Tablet is suitable for most healthy women, it is not suitable for all of them.
You should inform your doctor if any of the conditions or risk factors mentioned in this leaflet apply to you.

Before taking the Tablet
Your doctor will ask 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 taking the Tablet

• You should attend regular medical check-ups, usually when a new prescription is needed.
• You should have regular cervical smear tests as recommended 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 a blood test, inform your doctor that you are taking the Tablet, 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 Tablet 4–6 weeks before the procedure. This reduces the risk of blood clots (see section "THE TABLET AND THROMBOSIS"). Your doctor will advise when you can resume taking the Tablet.

When not to use Harmonet
Do not use Harmonet if any of the following conditions apply to you. If any of these conditions apply, inform your doctor. Your doctor will discuss 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 a clotting disorder—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 "BLOOD CLOTS");
• if you have had a heart attack or stroke;
• if you have (or have previously had) 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 diseases 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 previously 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 suspect you might be pregnant;
• if you have a hormone-dependent cancer—such as certain breast cancers, endometrial (lining of the uterus) or ovarian cancer;
• 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 (clot formation);
• if you have ever had pancreatitis associated with high levels of fats in the blood (high cholesterol or triglyceride levels);
• 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 any of the above conditions apply to you or develop for the first time 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 deep vein thrombosis in the leg, pulmonary embolism in the lungs, heart attack, or stroke (see section below "BLOOD CLOTS"). For a description of symptoms of these serious adverse events, see "How to recognize the occurrence of blood clots".

Inform your doctor if any of the following conditions apply to you.
If these symptoms 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 defense system);
• if you have hemolytic uremic 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 levels of fats in the blood (hypertriglyceridemia) or have a family history of this condition. Hypertriglyceridemia is associated with an increased risk of 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 about when it is safe to start taking Harmonet after childbirth;
• 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, seek immediate medical attention. Medicinal 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 such therapy. 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").
  Full recovery from 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.

| Do you have any of these symptoms? | What might be the likely 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 occur only when standing or walking | | | Increased temperature in the affected leg | | | Change in skin colour of the leg, such as pallor, redness, or cyanosis | | | Sudden unexplained shortness of breath or rapid breathing | Pulmonary embolism |

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 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 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 developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of using 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 remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Harmonet, the risk of developing 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 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 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 woman’s medical history (see “Factors that increase 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 family member 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 recently given birth (within the past few weeks).

The risk of developing 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 listed above.
It is important to inform the doctor if any of the listed factors apply to the patient, 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 family member is diagnosed with thrombosis without a known cause, or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What could happen if blood clots form in the arteries?
As with venous blood clots, arterial clots may 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 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 cannot 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 fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder 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 arterial 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 family member is diagnosed with thrombosis without a known cause, 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 smear tests.
The Pill should 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 years of age, so the risk of additional cases in women currently or recently using the Pill is small.

The risk of breast cancer is higher:

• the older the woman;
• if a close relative (mother, sister or grandmother) has had breast cancer;
• 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 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 also been associated with certain types of liver cancer in women who have used the Pill for a long time.

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 drug, reducing its harmful effects on the liver. If liver cell damage is diagnosed, the Pill should be discontinued, a non-hormonal contraceptive method should be used, and medical advice sought.
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 develop, stop taking the Pill and contact a doctor immediately for evaluation.

High blood pressure
Blood pressure may increase while taking the Pill. If there has ever been a problem with 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, the Pill should be discontinued and another contraceptive method used (see also section “Do not use Harmonet if any of the following conditions apply”).

Migraine and headache
If migraine or headache of a type not previously experienced occurs, the Pill may be inappropriate. In such cases, stop taking the Pill and contact the doctor.

The Pill and its effect on carbohydrates and lipids
If there has ever been a problem with glucose tolerance 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”).
In a small proportion of women, changes in blood lipid (fat) levels may occur while taking the Pill. Inform the doctor, who may consider using a non-hormonal contraceptive.
If the patient is being treated for high lipid levels, regular check-ups will be required while taking the 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 exclude non-hormonal causes such as pregnancy or 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 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 as soon as possible 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 inappropriate, and another form of contraception may be needed.

Medical examinations
Before prescribing the Pill for the first time, the doctor will conduct a full medical and family history and perform a physical examination. Regular cervical smear tests should be performed.
The next visit should be after three months of starting the Pill. Annual check-ups are recommended, similar to 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 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 inappropriate, and additional contraception may be needed for a 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 taking the Pill with other medicines.
Taking troleandomycin while using the Pill increases the risk of liver dysfunction (reduced bile secretion by the liver).
Taking flunarizine while using the Pill may sometimes cause milk production in women who have not recently given birth.
Harmonet should not be used if the patient has hepatitis C and is taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these may increase liver function test results (increased alanine aminotransferase enzyme activity).
The doctor should prescribe another form 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.
Harmonet should not be used during pregnancy. If pregnancy is suspected, a pregnancy test should be performed to confirm before stopping Harmonet.
There is no evidence that Harmonet harms the unborn child if accidental conception occurs while taking the medicine, but if pregnancy is confirmed, Harmonet should be discontinued.
Harmonet is not recommended during breastfeeding. Discuss alternative contraceptive methods with the doctor. Breastfeeding does not protect against pregnancy.

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

3. HOW TO TAKE HARMONET
3.1. How to take Harmonet
Harmonet should always be taken according to the doctor’s instructions. If in doubt, consult the doctor.
Harmonet should be taken daily for 21 days.
Harmonet is available in blisters containing 21 tablets. Each tablet is marked with a day-of-the-week symbol.

• Take one tablet daily at approximately the same time.
• Start by taking the tablet marked with the correct day-of-the-week symbol. For example, if bleeding starts on Friday, take the tablet marked Ve/Vr/Fr (meaning Friday; see “Translation of day-of-the-week symbols on each tablet on the packaging and blister pack” at the end of the leaflet).
• Take the tablets in the direction of 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, a 7-day break without tablets follows
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 the following Saturday.
Withdrawal bleeding, similar to a period, will occur within a few days after the last tablet. This bleeding may not stop before starting the next pack.
There is no need for additional contraception during these 7 tablet-free days, as long as tablets have been taken correctly and the next pack is started on time.

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

3.2. How to start taking Harmonet
First use or restarting 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 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 pack: 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 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 taking 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 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, providing immediate contraceptive protection.
If a miscarriage or abortion occurred after the third month of pregnancy, Harmonet can be started after 28 days. Use additional contraceptive methods such as condoms during the first 7 days of taking Harmonet. If sexual intercourse has occurred, exclude pregnancy or wait for the next menstrual period.

Contraception after childbirth
Harmonet may be started 28 days after uncomplicated vaginal delivery if the patient is not breastfeeding and is fully mobile. Use additional contraceptive methods during the first 7 days of taking Harmonet.
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 Harmonet than recommended
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 tablet 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. Take the most recently 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 of the pack (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 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 interval, 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 in the last 7 days, seek advice from the doctor or pharmacist. Also use barrier methods such as condoms for 7 days.

3.5. What to do if vomiting or diarrhoea occurs
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 illness and for 7 days after recovery. If more than 12 hours have passed, follow the instructions in section “Missed dose of Harmonet”.
Contact the doctor if gastrointestinal symptoms persist or worsen. The doctor may recommend another contraceptive method.

3.6. Delayed withdrawal bleeding – could pregnancy be possible?
Occasionally, withdrawal bleeding may not occur. This may indicate pregnancy, but it is very unlikely if tablets have been 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, discontinue 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 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 status that the patient considers related to the use of Harmonet, medical advice should be sought from a doctor.

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

Serious adverse reactions associated with taking oral contraceptives are described in section 2, "The pill and thrombosis" and "The pill and cancer". For further information, 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, treatment with Harmonet must be stopped immediately and the patient must inform her doctor immediately or 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, please refer to section 2, "Important information before using 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 in 100 women):

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

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

• Changes in blood fat levels (plasma lipids), including hypertriglyceridaemia; 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 (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 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 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 ischaemic attack (TIA)
  • Blood clots in the liver, stomach/intestine, kidneys or eye
• Yellowing of the skin (cholestatic jaundice)
• Inflammation of subcutaneous fat cells (nodular erythema).

Very rare (occurring in less than 1 in 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 (varicose veins)
• Pancreatitis; inflammation of the large intestine due to reduced blood flow to the intestine (ischaemic colitis)
• Gallbladder disease, 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 other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of clot formation).

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, inform a doctor or pharmacist.

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. 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 a few 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 after stopping Harmonet.

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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 to provide more information on the safety of the 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.
Do not store above 25°C. Keep 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.

6. CONTENTS OF THE PACKAGE 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 tablet also contains the following ingredients:
Tablet core: lactose monohydrate, maize starch, povidone 25, magnesium stearate.
Tablet coating: sucrose, povidone 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, with a shiny surface.

Packaged in PVC/Al blisters with a silica gel desiccant sachet, placed in a cardboard box.
Each pack of Harmonet contains either 1 x 21 or 3 x 21 coated tablets.
A cardboard sachet is included with the package, in which the blister should be placed.

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

Marketing Authorisation Holder in Belgium, 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.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Belgium Marketing Authorisation Number (country of export): BE174115
Parallel Import Authorisation Number: 333/19

Translation of the day-of-the-week symbols printed on each tablet in 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