Harmonet

Package leaflet: Information for the user

HARMONET 0,075 mg + 0,02 mg film-coated tablets

Gestodene/Ethinylestradiol
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods when used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
  Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this 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 contains the active substances ethinylestradiol and gestodene, which belong to a group of medicines called combined hormonal contraceptives.
Harmonet is a contraceptive pill used to prevent pregnancy by inhibiting ovulation.
Harmonet is a combined pill, as each coated tablet contains a combination of two different female hormones: gestodene (a substance similar to progesterone) and ethinylestradiol (an estrogen).

2. What you should know before taking Harmonet

General information
Before starting Harmonet, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).

Do not take Harmonet
Do not take Harmonet if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other methods of birth control that may be more suitable for your situation.

• if you are allergic to any of the active substances (gestodene or ethinylestradiol) or to any of the other ingredients of this medicine (listed in section 6);
• if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), the lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to undergo surgery or will be confined to bed for a prolonged period (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and which may be an early sign of a heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which may increase the risk of forming blood clots in arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinaemia, which causes high levels of homocysteine in the blood
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have any of the following conditions that may increase the risk of developing a blood clot in a blood vessel:
  • conditions related to high blood pressure
  • kidney problems
• if you have one or more conditions that may increase the risk of developing a blood clot in a vein or artery (see section “Warnings and precautions”);
• if you have an eye disorder caused by circulation problems within the eye;
• if you have or have ever had serious liver disease, until liver function returns to normal;
• if you have or have ever had pancreatitis (inflammation of the pancreas) associated with a serious disorder of fat metabolism (hypertriglyceridaemia);
• if you have or have ever had a benign or malignant liver tumour;
• if you have or suspect you may have a hormone-sensitive tumour of the breast or uterus (estrogen- and progestin-sensitive tumours that may grow faster under hormonal influence);
• if you have ever experienced yellowing or yellowish discoloration of the skin and mucous membranes (jaundice);
• if you have vaginal bleeding of unknown cause;
• if you are or think you may be pregnant;
• if you are being treated with ritonavir, a medicine used to treat HIV infection;
• if you have hepatitis C and are taking other medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see section “Other medicines and Harmonet”)

Warnings and precautions
Talk to your doctor or pharmacist before taking Harmonet.
Stop taking Harmonet and contact your doctor immediately if you notice any possible signs of a
blood clot, such as:

• severe pain and/or swelling in one leg
• sudden severe chest pain that may extend to the left arm
• sudden shortness of breath
• sudden cough without an obvious cause
• any unusual, severe, or persistent headache, or worsening of migraine
• partial or complete blindness or double vision
• difficulty or inability to speak
• dizziness or fainting
• weakness, unusual sensation, or numbness in any part of the body

Inform your doctor if any of the following conditions apply to you, as your doctor may monitor you
closely. Your doctor may recommend a different, non-hormonal contraceptive method. Contact your doctor also if any of the following conditions develop or worsen while using Harmonet:

• smoking
• overweight
• impaired glucose tolerance (a sugar metabolism disorder). If you have diabetes or pre-existing glucose intolerance, your doctor will monitor you closely during treatment with this medicine
• heart valve disorders or heart rhythm problems
• inflammation of veins under the skin (superficial phlebitis)
• if migraine (severe headache on one side of the head) occurs for the first time or worsens. Your doctor may advise you to stop treatment with this medicine
• if you have varicose veins
• if you notice changes in mood (psychiatric depression) or worsening of pre-existing depression. Harmonet should be discontinued if severe depression develops
• high blood pressure. If your blood pressure increases, you must stop treatment with this medicine
• if you have epilepsy
• if you have breast lumps
• if a close relative has had breast cancer
• liver or gallbladder disease
• if you have hearing loss due to a condition known as otosclerosis
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system)
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure)
• if you have sickle cell anaemia (an inherited red blood cell disorder)
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
• certain medical conditions characterized by resistance to Activated Protein C, hyperhomocysteinaemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibody syndrome (anticardiolipin antibodies, lupus anticoagulant), which predispose to venous or arterial thrombosis
• if you are due to undergo surgery or will be confined to bed for a prolonged period (see section 2 “Blood clots”)
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Harmonet
• if you have inflammation of veins under the skin (superficial thrombophlebitis)
• if you have impaired glucose tolerance (a sugar metabolism disorder). If you have diabetes or pre-existing glucose intolerance
• if you experience fluid retention in the body. Caution is needed if you have other disorders that may worsen due to increased fluid in the body
• if you have a skin condition causing itching, red patches, and blisters (herpes gestationis). You may have experienced this during a previous pregnancy
• if yellowish and/or brown patches appear on the skin (chloasma). These patches are more likely to reappear during treatment with Harmonet if you had them during a previous pregnancy. In this case, avoid direct exposure to sunlight or ultraviolet rays (e.g., in a solarium) while using this medicine
• if you have gallstones (small stones developing in the gallbladder, a small organ involved in fat digestion)
• if you have porphyria (a disorder that occurs in attacks and affects haemoglobin production)
• if you have Sydenham’s chorea (a disorder characterized by sudden, irregular, involuntary movements)
• if you have low folate levels (vitamin B) in the blood
• if you notice yellowing or yellowish discoloration of the skin and mucous membranes (jaundice), with or without itching. These symptoms may be caused by impaired bile flow (a substance produced by the liver and involved in digestion) and may indicate liver problems. If you experience this condition, stop treatment with this medicine
• if blood tests show that levels of certain substances normally produced by the liver are significantly elevated. In this case, treatment with Harmonet should be temporarily stopped until these values return to normal
• if you experience vision problems such as double vision, bulging eyes, or retinal changes

Psychiatric disorders
Some women using hormonal contraceptives, including Harmonet, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, consult your doctor as soon as possible for further medical advice.
If you have hereditary angioedema, medicines containing oestrogens may trigger or worsen angioedema symptoms. Seek immediate medical attention if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives accompanied by breathing difficulties.

Use of hormonal oral contraceptives increases your risk of:
BLOOD CLOTS
Using a combined hormonal contraceptive such as Harmonet increases your risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop:

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE). Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, these effects can be fatal. It is important to remember that the overall risk of a harmful blood clot associated with Harmonet is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.
Do you have any of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg or deep vein thrombosis of the foot, especially if accompanied by:
  • 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, such as paleness, redness, or bluish discoloration
• sudden and unexplained shortness of breath or rapid breathing
• sudden cough without an obvious cause, possibly with blood
• sharp chest pain that may worsen when breathing deeply
• severe dizziness or vertigo
• rapid or irregular heartbeat
• severe stomach pain

If you are unsure, inform your doctor, as some of
these symptoms, such as cough or shortness of breath,
may be mistaken for a milder condition such as a
respiratory tract infection (e.g., a “common cold”).
Symptoms occurring more frequently in: Retinal vein thrombosis
(eye) (blood clot in the eye)

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots forming in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of
taking a combined hormonal contraceptive for the first time. The risk may also
be higher when restarting a combined hormonal contraceptive (the same or a different
product) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not
using a combined hormonal contraceptive.
When you stop taking Harmonet, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your individual baseline risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Harmonet is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in a year.
• Among 10,000 women who use a combined hormonal contraceptive containing gestodene, such as Harmonet, about 9–12 will develop a blood clot in a year.
• The likelihood of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot in a vein”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Harmonet is low, but certain conditions can increase it. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);

• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder;

• if you are scheduled for surgery or need to remain immobile for a prolonged period due to injury or illness, or if you have a leg in a cast. It may be necessary
  to stop taking Harmonet several weeks before surgery or during periods of reduced mobility. If you need to stop taking Harmonet, ask your doctor when you can start taking it again;

• increasing age, especially over 35 years;

• other conditions associated with blood clots in a vein;

• if you have given birth less than 6 weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting > 4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to stop your use of Harmonet.
If any of the above conditions change while you are using Harmonet—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they may lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Harmonet is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Harmonet, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fat in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are taking Harmonet—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Harmonet and cancer
A slight increase in the risk of breast cancer has been observed in women using combined oral contraceptives compared to women of the same age who do not use them. This risk gradually decreases after stopping treatment and disappears approximately 10 years later.
Studies have reported an increased risk of cervical cancer (a part of the uterus) in women who use combined oral contraceptives for a relatively long time. It is currently unclear whether this is caused by the pill or due to sexual behavior and other factors (e.g., human papillomavirus infection, a virus that can cause uterine lesions).
Rarely, benign or malignant liver tumors have been reported in women using combined oral contraceptives. These tumors may also cause life-threatening internal bleeding. If you experience unusually severe pain in the upper abdomen or notice liver enlargement, contact your doctor.

Irregular bleeding
During the first few months of taking Harmonet, unexpected bleeding may occur, i.e., outside the days when you do not take the tablets. Consult your doctor if such irregular bleeding persists beyond 3 treatment cycles or reappears after a previous period of regularity.
Sometimes, menstruation may not occur during the tablet-free days. It is unlikely that you are pregnant if you have taken this medicine correctly. However, if you realize you have not taken the medicine correctly or if withdrawal bleeding does not occur for the second time, you must confirm that you are not pregnant before continuing to take Harmonet.
After stopping the oral contraceptive, absence of menstruation (amenorrhea) may occur, possibly with lack of ovulation or menstrual cycle irregularities (oligomenorrhea), especially if such conditions were already present before starting the pill.

Reduced or lost effectiveness
The contraceptive effect of Harmonet may be reduced if you forget to take a tablet, if you vomit or have diarrhea, or if you take certain other medicines.
Preparations containing Hypericum perforatum (St. John's wort) reduce the effectiveness of oral contraceptives. Therefore, if you need to take such preparations, your doctor will advise you to use an alternative contraceptive method to Harmonet.
Preparations containing Hypericum perforatum induce enzymes responsible for drug metabolism, and this effect may persist for at least 2 weeks after stopping treatment; thus, the contraceptive activity of Harmonet may be reduced. Unintended pregnancies and resumption of menstruation have been reported.
See also the section “Other medicines and Harmonet” and section 3 “What to do in case of vomiting and diarrhea.”

Medical examinations and check-ups
Before starting treatment with Harmonet, your doctor will ask you questions about your medical history and that of your family. Your doctor will also perform a thorough examination to assess your general health and to rule out possible pregnancy. While taking this medicine, you will undergo regular medical check-ups to monitor your general health. Your first follow-up visit should be scheduled 3 months after starting Harmonet.

Harmonet does not protect you from infections such as HIV (AIDS) or other sexually transmitted diseases.

Children
The safety and efficacy of Harmonet have been established only in women of reproductive age. Therefore, the use of this medicine is not indicated in girls before the onset of their first menstrual period.

Elderly
The safety and efficacy of Harmonet have been established only in women of reproductive age. Therefore, use of this medicine is not recommended in women after the onset of menopause.

Other medicines and Harmonet
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Interactions between Harmonet and other medicines may lead to irregular bleeding between periods and loss of contraceptive effectiveness, resulting in the risk of unintended pregnancies.

The following medicine must not be taken together with Harmonet (see section “Do not take Harmonet”):

• ritonavir (a medicine for HIV infection), because it reduces the effectiveness of Harmonet.

The following medicines may reduce the effectiveness of Harmonet, and therefore their concomitant use is not recommended:

• phenobarbital, phenytoin, primidone, carbamazepine, topiramate, oxcarbazepine, and felbamate (medicines for seizures and epilepsy);
• barbiturates (medicines used as sedatives and tranquilizers);
• rifabutin and rifampicin (antibiotics used to treat tuberculosis);
• griseofulvin (a medicine for fungal infections);
• dexamethasone (an anti-inflammatory medicine) and phenylbutazone (an anti-inflammatory and pain medicine);
• modafinil (a medicine for excessive sleepiness);
• some protease inhibitors and nevirapine (medicines used to treat HIV/AIDS);
• herbal preparations containing Hypericum perforatum (St. John's wort), a natural substance used for depression.

Always inform the doctor prescribing the pill about any medicines you are already taking, and also inform any other doctors or dentists who prescribe medicines that you are using HARMONET, so they can determine whether and for how long you need to use additional contraceptive methods.

The following medicines may increase the effectiveness and/or side effects caused by Harmonet:

• atorvastatin (a medicine used to reduce blood fat levels);
• vitamin C;
• paracetamol (a medicine used for pain and fever reduction);
• indinavir (a medicine used to treat HIV infection);
• fluconazole and voriconazole (medicines used for fungal infections);
• troleandomycin (an antibiotic). Concomitant administration of Harmonet and troleandomycin may increase the risk of bile retention in the liver (intrahepatic cholestasis).

Harmonet may interfere with the effectiveness and/or side effects of the following medicines:

• cyclosporine (a medicine to prevent organ rejection after transplantation);
• theophylline (a medicine for asthma);
• corticosteroids (medicines for inflammation and allergies);
• lamotrigine (a medicine for epilepsy);
• levothyroxine (a medicine for underactive thyroid);
• valproate (a medicine for seizures);
• flunarizine (a medicine used for migraine). Concomitant administration of Harmonet and flunarizine increases the risk of milk discharge from the breasts in women who are not breastfeeding (galactorrhea).

If you are being treated with any of the medicines listed above, you must use a barrier contraceptive method (e.g., condom) in addition to Harmonet, not only during concomitant use but also for an additional 7 days afterward. In the case of treatment with rifampicin, you must use a barrier contraceptive method for up to 28 days after stopping concomitant treatment.
If concomitant treatment must continue after you have finished all tablets in a pack of Harmonet, you must immediately start the next pack of Harmonet without observing the tablet-free interval.
If you are prescribed long-term treatment with any of the medicines listed above, your doctor will advise you to use another type of medicine or a barrier contraceptive method to prevent unintended pregnancies.

Interactions with laboratory tests
The use of Harmonet may affect the results of certain laboratory tests, such as values measuring liver, thyroid, adrenal gland, and kidney function, as well as the levels of certain proteins in the blood, including proteins affecting lipid (fat) metabolism, carbohydrate (sugar) metabolism, blood clotting, and the mechanism of dissolving blood clots (fibrinolysis). In addition, blood levels of folic acid may decrease. However, these values generally remain within the normal range.
Do not use Harmonet if you have hepatitis C and are taking other medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as these products may cause elevated liver function test results (increased ALT liver enzymes).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.
Harmonet may be resumed approximately 2 weeks after completion of this treatment.
See section "Do not use Harmonet."

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take Harmonet if you are pregnant.
If you discover you are pregnant while taking Harmonet, you must stop taking this medicine and consult your doctor.
If you have recently given birth and wish to start/restart treatment with Harmonet, your doctor will consider the risk of blood clot formation in blood vessels.

Breastfeeding
The use of Harmonet during breastfeeding is not recommended because this medicine may alter breast milk and reduce its production. In addition, Harmonet passes into breast milk, although no negative effects of this medicine on the infant's health are currently known.
If you wish to breastfeed, your doctor will recommend another suitable form of contraception.

Driving and operating machinery
The effects of Harmonet on the ability to drive vehicles and operate machinery are unknown.

Harmonet contains lactose and sucrose
Harmonet contains lactose and sucrose, two types of sugars. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Harmonet

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The Harmonet pack contains 21 tablets. You must take one tablet daily for 21 consecutive days, starting with the tablet marked "1" (located next to the word “START”) and continuing to take the tablets in numerical order, as indicated by the arrows, until the pack is finished.
Puncture the blister on the day of the week on which you started taking the tablets (e.g., “Mon”). If you are taking the tablets correctly, this will be the same day of the week on which you will take tablet number 1, 8, and 15 in the following weeks, and on which you must start taking the first tablet of a new pack of Harmonet.
After taking all 21 tablets, you must stop taking the tablets for 7 days.
Your menstrual period usually begins 2 or 3 days after taking the last tablet.
After the 7 tablet-free days, start taking tablets from a new pack of Harmonet the next day, i.e., on day 8, even if bleeding is still occurring.
You must swallow the tablets whole, without chewing, preferably at the same time every day, ideally after the evening meal.

How to start taking Harmonet

• If you have not used any hormonal contraceptive in the previous month: Start taking Harmonet on the first day of your cycle, i.e., the first day of menstruation, by taking the tablet marked with the number 1. If you start taking Harmonet between day 2 and day 5 of your cycle, you must use a barrier contraceptive method (e.g., condom) during the first 7 days of taking this medicine.
• If you were using another combined oral contraceptive (containing two hormones as active ingredients): You may take the first tablet of Harmonet the day after the last tablet of your previous contraceptive, without any break:
  • the day after the last active tablet (the last tablet containing active ingredients) of your previous contraceptive. If in doubt, consult your doctor.
  • You may also start later, but not later than the day after the usual tablet-free interval or the day after the last inactive tablet (the last tablet without active ingredients) of your previous contraceptive.
• If you were using a progestogen-only contraceptive method (the so-called mini-pill, an injectable, an implant, or an intrauterine device):
  • If you were using the mini-pill: you may start taking Harmonet at any time, beginning the day after you stopped taking the mini-pill.
  • If you were using an implant or an intrauterine device: start taking Harmonet on the same day the implant or intrauterine device is removed.
  • If you were using an injectable contraceptive: start taking Harmonet on the day when the next injection would have been due.

In all cases, you must use a barrier contraceptive method (e.g., condom) for the first 7 days of treatment with Harmonet.

• After a miscarriage occurring in the first 3 months of pregnancy: You may start taking Harmonet immediately as prescribed by your doctor, and no additional barrier contraceptive methods (e.g., condom) are required.
• After childbirth or a second-trimester abortion: You must not start Harmonet earlier than 21–28 days after childbirth or abortion, because the risk of blood clots is higher during this period. Your doctor will advise you to use a barrier contraceptive method (e.g., condom) during the first 7 days of taking this medicine. If you have had sexual intercourse before starting Harmonet, make sure you are not pregnant, or wait for the onset of the first menstrual period.

If you take more Harmonet than you should
In case of accidental ingestion/overdose of Harmonet, contact your doctor immediately or go to the nearest hospital.
If you take more tablets than required, you may experience stomach and intestinal problems (nausea and abdominal pain), breast tenderness, confusion, drowsiness/fatigue, and vaginal bleeding.

If you forget to take Harmonet
If you forget to take one or more tablets of Harmonet, there is a risk of unintended pregnancy.

• If you realize you have missed a tablet within 12 hours of your usual time, take the missed tablet immediately and continue taking the following tablets at the usual time.
• If you realize you have missed a tablet more than 12 hours after your usual time, or if you have missed 2 or more tablets, there is a risk of becoming pregnant. The risk of pregnancy is particularly high if you miss tablets at the beginning or end of the pack. In such cases, follow the rules below:

If you missed 1 tablet during the first week of taking Harmonet:
Take the missed tablet as soon as you remember, even if this means taking two tablets on the same day, and continue taking the following tablets at the usual time.
For the next 7 days, you must also use a barrier contraceptive method (e.g., condom). If you had sexual intercourse during the week before missing the tablet, pregnancy may have occurred. Inform your doctor immediately.

If you missed 1 tablet during the second week of taking Harmonet:
Take the missed tablet as soon as you remember, even if this means taking two tablets on the same day, and continue taking the following tablets at the usual time. Harmonet remains effective, provided you have taken the tablets correctly during the 7 days before the missed tablet. Otherwise, or if you missed more than one tablet, you must use additional contraceptive protection for 7 days to prevent pregnancy.

If you missed 1 tablet during the third week of taking Harmonet:
You may choose one of the following two options without needing to use additional contraception (e.g., condom), provided you took the tablets correctly during the 7 days before the missed tablet. Otherwise, follow the first option and use additional precautions to prevent pregnancy for the next 7 days.

1. Take the missed tablet as soon as you remember, even if this means taking two tablets on the same day, and continue taking the following tablets at the usual time. After finishing the first pack, immediately start taking tablets from the next pack without observing the usual tablet-free interval between the two packs. By doing so, your menstrual period will not occur until the end of the second pack. However, you may experience vaginal bleeding during tablet intake.

Or:

2. Do not take any further tablets from the current pack. After a 7-day interval, including the day on which the tablet was missed, resume taking Harmonet by starting a new pack. If you missed tablets and do not have a menstrual period during the first regular tablet-free interval, pregnancy may have occurred. Therefore, consult your doctor before continuing treatment with Harmonet.

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What to do in case of vomiting and diarrhoea
If you vomit or have diarrhoea within 3–4 hours after taking the tablet, the situation is similar to
that which occurs when you forget to take a tablet. You must use tablets from a new pack, as
described above (see section “If you forget to take Harmonet”).

What to do in case of unexpected bleeding
With all oral contraceptives, you may experience vaginal bleeding between periods during the
first few months of use. Irregular bleeding usually stops once your body has adapted to the pill
(usually after about 3 cycles of use). You should always consult your doctor, particularly if this
bleeding persists, becomes heavy, or recurs at intervals.

What to do in case of absence of menstruation
If you have taken all tablets correctly, have not vomited, and have not taken other medicines, it is
very unlikely that you are pregnant. Continue using the product as usual.
If you miss your period twice in succession, you may be pregnant. Consult your doctor immediately.
Do not start a new pack until your doctor has excluded pregnancy.

If you stop treatment with Harmonet
You may stop using Harmonet at any time. If you do not wish to become pregnant, consult your
doctor for advice on other methods of birth control.
After stopping treatment with Harmonet, you may not have periods for several months
(amenorrhoea) or may experience infrequent bleeding (oligomenorrhoea). This is more likely if
you already had irregular cycles before starting treatment with this medicine.
This effect usually resolves spontaneously, but if it does not, you should inform your doctor.
If you stop treatment with Harmonet because you wish to become pregnant, it is advisable to wait
until your periods return to regularity before attempting conception.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to Harmonet, inform your doctor.
There is an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before taking Harmonet”.

STOP taking Harmonet immediately if you experience any of the following side effects, as they are serious:

• swelling of the face, tongue and/or throat causing difficulty in swallowing and breathing (angioedema)
• harmful blood clots in a vein or an artery, for example:
• in a leg or foot (DVT)
• in a lung (PE)
• heart attack
• stroke
• mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys or eye. The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot)
• inflammation of a vein (phlebitis)
• high blood pressure (hypertension)
• coronary artery problems, the blood vessels supplying blood to the heart
• increased levels of fats (cholesterol, triglycerides) in the blood
• development of breast lumps (fibrocystic mastopathy), severe breast pain (mastodynia)
• severe and unusual headache and migraine, as these may be symptoms that could precede a stroke
• dizziness
• changes in vision, as this may be a symptom that precedes a stroke or loss of vision
• worsening of epileptic seizures
• benign or malignant liver tumours (e.g. focal nodular hyperplasia or hepatic adenoma)
• yellow/yellowish discoloration of the skin and mucous membranes (cholestatic jaundice)
• liver diseases (hepatitis, altered liver function)
• appearance of yellowish and/or brown patches on the skin (chloasma)
• inflammation of the optic nerve (optic neuritis)
• malignant cervical tumour of the uterus
• breast cancer

The following side effects have been reported more commonly during use of Harmonet.
Contact your doctor, who may recommend an alternative medicine to Harmonet:

• nausea and feeling unwell
• headache, migraine
• weight gain or weight loss
• irritability
• nervousness
• dizziness
• heavy legs
• breast tenderness, pain on touch, increased sensitivity, swelling or discharge
• bleeding between periods, infrequent bleeding (oligomenorrhoea), absence of bleeding (amenorrhoea), and painful menstrual periods (dysmenorrhoea)
• changes in vaginal discharge
• changes in sexual desire
• eye irritation after using contact lenses
• fluid retention in the body and/or swelling (oedema)
• vaginal infection, including vaginal candidiasis
• increased or decreased appetite
• depressed mood

The following side effects have been reported rarely:

• vomiting, abdominal pain, abdominal cramps
• bloating sensation
• skin disorders: patchy hair loss (alopecia), acne, excessive and abnormal hair growth, oily skin (seborrhoea), skin rash (exanthema), a type of skin reaction called “nodular erythema”, a type of skin reaction called “erythema multiforme”
• inflammation of the pancreas (pancreatitis)
• chronic inflammatory bowel diseases (Crohn’s disease and ulcerative colitis)
• severe abdominal pain which may be a symptom of serious intestinal problems (ischaemic colitis)
• severe allergic reactions, including very rare cases of urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms
• worsening of systemic lupus erythematosus (an autoimmune disease)
• decreased levels of folate (vitamin B) in the blood
• worsening of varicose veins
• gallstones (small stones forming in the gallbladder, a small organ involved in fat digestion)
• worsening of porphyria, a disease affecting haemoglobin production
• depression
• worsening of pre-existing gallbladder diseases

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Harmonet

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Harmonet contains
The active substances are gestodene and ethinylestradiol.
Each coated tablet contains 0.075 mg of gestodene and 0.02 mg of ethinylestradiol.
The other components are: monohydrate lactose, sucrose (see section 2 "Harmonet contains lactose and sucrose"), maize starch, povidone K-25, magnesium stearate, povidone K-90, macrogol 6000, calcium carbonate, talc, wax E.
Description of the appearance of Harmonet and package contents
Harmonet tablets are white coated tablets.
Harmonet is available in packages containing one PVC/Al blister with 21 tablets.
Marketing Authorization Holder and Manufacturer
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Manufacturer
Pfizer Ireland Pharmaceuticals
Little Connell, Newbridge, County Kildare
Ireland