Dessette

Leaflet attached to the packaging: information for the user

Dessette

20 micrograms + 150 micrograms, film-coated tablets

Ethinylestradiol + Desogestrel

Important information about combined hormonal contraceptives

If used correctly, they are one of the most reliable, reversible methods of contraception. They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or longer. You should be vigilant and consult a doctor if you suspect that you have symptoms of blood clots (see section 2 "Blood clots").

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dessette and what is it used for
• 2. Important information before using Dessette
• 3. How to use Dessette
• 4. Possible side effects
• 5. How to store Dessette
• 6. Contents of the pack and other information

1. What is Dessette and what is it used for

Composition and type of tablet

Dessette is a combined oral contraceptive used orally (oral contraceptive - "combined tablet"). Each tablet contains a small amount of two different female hormones. These are desogestrel (progestogen) and ethinylestradiol (estrogen). Due to the low hormone content, Dessette is called a low-dose oral contraceptive. Dessette belongs to monophasic, combined oral contraceptives, as each tablet in the blister contains the same hormones in the same doses.

What is Dessette used for

Dessette is used to prevent pregnancy. The chance of becoming pregnant during proper use of oral contraceptives (provided that the patient does not forget to take the tablets) is very low.

2. Important information before using Dessette

General notes

Before starting to take Dessette, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots"). Before starting to take Dessette, your doctor will ask you a few questions about your medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your condition, may also perform other tests. The leaflet describes various situations in which you should stop taking the medicine or in which its effectiveness may be reduced. In these situations, you should refrain from sexual intercourse or use additional non-hormonal methods of contraception, such as a condom or another barrier method. You should notuse the calendar or temperature measurement methods. These methods may be ineffective because taking oral contraceptives affects changes in body temperature and cervical mucus that occur during the menstrual cycle.

Dessette, like other hormonal contraceptives, does not prevent HIV (AIDS) or other sexually transmitted diseases.

Dessette is prescribed by a doctor individually for each patient. Do not give this medicine to others. Dessette should not be used to delay the start of bleeding. In exceptional cases, when there is a need to delay the day of bleeding, you should consult a doctor.

When not to use Dessette

You should not use Dessette if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you which other contraceptive method will be more suitable. See also "Warnings and precautions". You should not use Dessette:

• If you are allergic to ethinylestradiol, desogestrel, or any of the other ingredients of this medicine (listed in section 6).
• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs.
• if you know you have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, presence of factor V Leiden mutation, or antiphospholipid antibodies.
• if you need to have surgery or will be immobilized for a long time (see "Blood clots").
• if you have had a heart attack or stroke.
• if you have (or have had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (transient stroke symptoms).
• if you have any of the following diseases that may increase the risk of a blood clot in an artery: severe diabetes with blood vessel damage, very high blood pressure, very high levels of fats in the blood (cholesterol or triglycerides), a disease called hyperhomocysteinemia.
• if you have (or have had) a type of migraine called "migraine with aura".
• if you have (or have had) pancreatitis associated with high levels of fats in the blood.
• if you have jaundice (yellowing of the skin) or severe liver disease and liver function has not returned to normal.
• if you have (or have had) a hormone-dependent tumor (e.g., breast cancer or genital cancer).
• if you have (or have had) a liver tumor.
• if you have had vaginal bleeding of unknown cause.
• if you have abnormal growth of the endometrium (endometrial hyperplasia).
• if you are pregnant or think you may be pregnant.
• if you have hepatitis C and are taking antiviral medicines containing ombitasvir, paritaprevir, and ritonavir, and dasabuvir, or glecaprevir and pibrentasvir (see "Dessette and other medicines").

If any of the above conditions occur for the first time while using Dessette, you should stop taking the medicine immediately and consult a doctor. Until the situation is clarified, you should use a non-hormonal method of contraception (see also "General notes").

Warnings and precautions

Before starting to take Dessette, you should discuss it with your doctor or pharmacist. When should you contact your doctor? You should contact your doctor immediately if you notice any symptoms that may indicate a blood clot, such as a blood clot in the leg (deep vein thrombosis), blood clot in the lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots").

• if you notice any symptoms that may indicate a blood clot, such as a blood clot in the leg (deep vein thrombosis), blood clot in the lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots").

To find a description of the serious side effects listed above, see "How to recognize a blood clot".

You should tell your doctor if you have any of the following conditions.

If these symptoms occur or worsen while taking Dessette, you should also tell your doctor.

• If you smoke;
• if you have diabetes;
• if you are overweight;
• if you have high blood pressure;
• if you have a heart valve disorder or heart rhythm disorder;
• if you have superficial thrombophlebitis (inflammation of the veins under the skin);
• if you have varicose veins;
• if any of your close relatives have had blood clotting disorders, heart attack, or stroke;
• if you have migraines;
• if you have epilepsy;
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. You should consult your doctor for information on how soon you can start taking Dessette after giving birth;
• if any of your close relatives have had breast cancer;
• if you have liver or gallbladder disease;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you have had conditions that first occurred or worsened during pregnancy or previous use of hormonal contraception (e.g., loss of hearing, metabolic disease - porphyria, skin disease - herpes during pregnancy, Sydenham's chorea);
• if you have chloasma (yellow-brown pigmented spots on the skin, especially on the face); in these cases, you should avoid sun exposure or ultraviolet radiation;
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with difficulty breathing, you should contact your doctor immediately. Estrogen-containing medicines may cause or worsen symptoms of hereditary or acquired angioedema.

Psychiatric disorders

Some women taking hormonal contraceptives, including Dessette, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Dessette, is associated with an increased risk of blood clots, compared to not using the therapy. In rare cases, a blood clot can block a blood vessel and cause serious complications. Blood clots can occur in the veins (called "venous thromboembolism" or "venous thrombotic events") or in the arteries (called "arterial thromboembolism" or "arterial thrombotic events"). Not all patients recover fully after a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

Remember that the overall risk of harmful blood clots caused by taking Dessette is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms. Do you experience any of these symptoms? Why might the patient be suffering from this condition?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color in the affected leg, such as pallor, redness, or discoloration. Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

If you are unsure, you should contact your doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold). Pulmonary embolism The symptoms usually occur in one eye:

• sudden loss of vision or
• painless vision disturbances, which may lead to loss of vision.

Arterial thrombosis Chest pain, discomfort, or pressure; feeling of tightness or fullness in the chest, arm, or below the breastbone; feeling of fullness, indigestion, or choking; discomfort in the upper body radiating to the back, jaw, throat, arm, and stomach; sweating, nausea, vomiting, or fainting; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeat.

• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
• sudden confusion, speech disorders, or difficulty understanding;
• sudden vision disturbances in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance, or coordination;
• sudden severe or prolonged headaches without a known cause;
• loss of consciousness or fainting with or without seizures.

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism), although these side effects are rare. They most often occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of forming a blood clot in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or longer. After the first year, the risk decreases, but it is always higher compared to not taking combined hormonal contraceptives. If you stop taking Dessette, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used. The overall risk of blood clots in the legs or lungs associated with taking Dessette is small. In a year, about 2 out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots. In a year, about 5-7 out of 10,000 women taking combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots. In a year, about 9-12 out of 10,000 women taking combined hormonal contraceptives containing desogestrel, such as Dessette, will develop blood clots. The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots" below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with taking Dessette is small, but some factors can increase this risk. The risk is higher:

• if you are severely overweight (body mass index (BMI) over 30 kg/m2);
• if any of your close relatives have had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time (you may need to stop taking Dessette for a few weeks before surgery or immobilization. If you need to stop taking Dessette, you should ask your doctor when you can resume taking the medicine);
• with age (especially over 35 years old);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient. Traveling by air (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor. It is essential to tell your doctor if any of these factors apply to you, even if you are unsure. Your doctor may decide to stop you from taking Dessette. You should tell your doctor if any of the above conditions change while taking Dessette, e.g., if you start smoking, if any of your close relatives are diagnosed with a blood clot without a known cause, or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of heart attack or stroke associated with taking Dessette is very small, but it may increase:

• with age (over about 35 years old);
• if you smoke.While taking a hormonal contraceptive like Dessette, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if any of your close relatives have had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or any of your close relatives have been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher. You should tell your doctor if any of the above conditions change while taking Dessette, e.g., if you start smoking, if any of your close relatives are diagnosed with a blood clot without a known cause, or if you gain weight significantly.

DESSette AND CANCER

In women taking oral contraceptives, breast cancer is diagnosed slightly more often than in women of the same age who do not take them. The small increase in the frequency of breast cancer diagnosis gradually decreases over 10 years after stopping oral contraceptives. It is not known whether this difference is caused by taking oral contraceptives. It may be related to the fact that women taking oral contraceptives are more often examined by doctors and therefore breast cancer is diagnosed earlier. In rare cases, benign liver tumors, and even more rarely, malignant liver tumors, have been observed in women taking oral contraceptives. These tumors can lead to bleeding into the abdominal cavity. If you experience severe abdominal pain, you should contact your doctor immediately. Cervical cancer may be caused by the presence of human papillomavirus. It has been noted that cervical cancer occurs more frequently in women taking oral contraceptives for a long time. However, it is not known whether this is due to taking oral contraceptives, or whether it is related to sexual behavior or other factors (e.g., more frequent cervical screening).

Children and adolescents

The efficacy and safety of desogestrel in adolescents under 18 years of age have not been established. There are no available data.

Dessette and other medicines

You should tell your doctor or pharmacist about all medicines or herbal products you are taking. You should also inform your doctor or pharmacist about taking Dessette if you are prescribed other medicines by another doctor or dentist. They may inform you about the need to use additional contraceptive methods and determine the duration of their use or whether the use of other medicines should be changed. Some medicines may affect the efficacy of Dessette or increase the risk of side effects. These include:

• medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• medicines used to treat tuberculosis (e.g., rifampicin);
• medicines used to treat HIV infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz);
• medicines used to treat hepatitis C virus infection (e.g., boceprevir, telaprevir);
• medicines used to treat other infectious diseases (e.g., griseofulvin);
• medicines used to treat high blood pressure in the blood vessels of the lungs (bosentan);
• medicines used to treat depression (herbal products containing St. John's Wort [Hypericum perforatum]).

If you are taking medicines or herbal products that may reduce the efficacy of Dessette, it is recommended to use additional barrier methods of contraception. The effect of other medicines on Dessette may last for up to 28 days, so you should use additional barrier methods for the entire period. Dessette may affect the efficacy of other medicines, such as:

• medicines containing cyclosporin;
• lamotrigine used to treat epilepsy (which may lead to an increased frequency of seizures).

Effect on laboratory tests

If you need to have blood tests, you should tell your doctor or laboratory staff that you are taking Dessette, as oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy Dessette should not be taken by women who are pregnant or think they may be pregnant. If you suspect you are pregnant while taking Dessette, you should contact your doctor immediately. Breastfeeding It is not recommended to take Dessette while breastfeeding. If you want to take Dessette while breastfeeding, you should consult your doctor.

Driving and using machines

No effects on driving or using machines have been reported.

When to consult a doctor

Regular check-ups

A woman taking oral contraceptives should be informed by her doctor about the need for regular medical check-ups. These check-ups are usually performed once a year.

You should contact your doctor immediately in the following cases:

• if you notice any symptoms that may indicate a blood clot, such as a blood clot in the leg (deep vein thrombosis), blood clot in the lungs (pulmonary embolism), heart attack, or stroke (see above "Blood clots"). To find a description of the serious side effects listed above, see "How to recognize a blood clot";
• if you experience any changes in your health, especially the conditions listed in this leaflet (see also "When not to use Dessette" and "Warnings and precautions"); do not forget about diseases that occur in your close relatives;
• if you feel lumps in your breasts;
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with difficulty breathing;
• if you plan to take other medicines (see also "Dessette and other medicines");
• if you are going to have surgery or be immobilized (you should consult your doctor at least 4 weeks in advance);
• if you experience irregular, heavy vaginal bleeding;
• if you forgot to take a tablet in the first week of taking the blister pack and had sexual intercourse in the previous 7 days;
• if you experience severe diarrhea;
• if you do not have your period twice in a row or suspect you may be pregnant (continue taking the medicine only after consulting your doctor).

Dessette contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking Dessette. The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Dessette

When and how to take Dessette

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. One blister pack of Dessette contains 21 tablets. On the blister pack, each tablet has a symbol of the day of the week on which it should be taken. You should take the tablets at the same time every day, with water if necessary. You should continue taking the tablets for 21 days, following the direction of the arrows on the blister pack. Then, you should wait for 7 days, during which you will not take any tablets. Menstrual bleeding (withdrawal bleeding) should occur during these 7 days. It usually occurs 2-3 days after taking the last tablet of Dessette. You should take the first tablet from the next blister pack on the 8th day, even if you are still bleeding. This means that you will always start a new blister pack on the same day of the week, and your withdrawal bleeding will occur at about the same time every month.

Starting to take Dessette for the first time

˗ If you did not use any hormonal contraceptive method in the previous month, you should start taking Dessette on the first day of your menstrual cycle, i.e., the first day of your period. On the packaging, each tablet is marked with the day of the week on which it should be taken. If you start taking the medicine on a Friday, you should take the tablet marked "Fri". Then, you should continue taking the tablets following the direction of the arrows on the blister pack. Dessette starts working immediately. You do not need to use any additional contraceptive method. You can also start taking the tablets between the 2nd and 5th day of your menstrual cycle, but in this case, you should use an additional barrier method of contraception (e.g., a condom) for the first 7 days of taking the tablets in the first menstrual cycle. ˗ If you are switching from another combined hormonal contraceptive (combined oral contraceptive, vaginal ring, or transdermal patch), you can start taking Dessette the next day after taking the last tablet of your previous contraceptive (or after taking the last active tablet if your previous contraceptive contained inactive tablets). If your previous contraceptive contained inactive tablets, you can start taking Dessette the next day after taking the last active tablet (if you are unsure which tablet is the last active one, you should ask your doctor or pharmacist). You can also start taking Dessette on the day you would normally start a new vaginal ring or transdermal patch. If you follow these instructions, you do not need to use any additional contraceptive method. ˗ If you are switching from a progestogen-only tablet (minipill), you can stop taking the minipill and start taking Dessette the next day at the same time. You should also use an additional barrier method of contraception (e.g., a condom) for the first 7 days of taking Dessette. ˗ If you are switching from a progestogen-only injection, implant, or intrauterine system, you should start taking Dessette on the day you would normally have your next injection or on the day the implant or intrauterine system is removed. You should also use an additional barrier method of contraception (e.g., a condom) for the first 7 days of taking Dessette. ˗ After childbirth, your doctor will advise you to wait until your first menstrual period before starting to take Dessette. Your doctor may also advise you to start taking the tablets earlier. If you are breastfeeding, you should discuss taking Dessette with your doctor first. ˗ After a miscarriage or abortion, you should follow your doctor's advice.

Taking more than the recommended dose of Dessette

No serious side effects have been reported after taking a large dose of Dessette tablets. If you take several tablets at the same time, you may experience nausea, vomiting, or vaginal bleeding. If a child accidentally takes Dessette, you should contact your doctor.

Missing a dose of Dessette

˗ If the delay in taking a tablet is less than 12 hours, the efficacy of the tablet is maintained. You should take the missed tablet as soon as possible and continue taking the tablets as usual. ˗ If the delay in taking a tablet is more than 12 hours, the efficacy of the tablet may be reduced. The more tablets you miss, the higher the risk of reduced contraceptive efficacy. The risk of pregnancy is especially high if you miss a tablet at the beginning or end of the blister pack. You should refer to the instructions below (see also the scheme of action below).

If you miss more than one tablet from the blister pack

You should consult your doctor.

If you miss one tablet in the first week of taking

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the tablets at the usual time. For the next 7 days, you should use an additional barrier method of contraception (e.g., a condom). If you had sexual intercourse in the week before missing the tablet, you may be at risk of pregnancy. You should contact your doctor immediately.

If you miss one tablet in the second week of taking

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the tablets at the usual time. The efficacy of the tablet is maintained, and you do not need to use any additional contraceptive methods.

If you miss one tablet in the third week of taking

There are two possible ways to proceed without the need for additional contraceptive methods:

• 1. You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the tablets at the usual time. After taking the last tablet from the blister pack, you should start taking the tablets from the next blister pack the next day, without a break. Withdrawal bleeding may occur only after finishing the tablets from the second blister pack. However, you may experience spotting or breakthrough bleeding while taking the tablets.

Or

• 2. You can stop taking the remaining tablets from the current blister pack and take a break in taking the tablets, not longer than 7 days (including the day you missed the tablet). Then, you should start taking the tablets from the next blister pack. By doing so, you can start the next blister packs on the same day of the week as usual.

If you miss a tablet and do not have withdrawal bleeding during the first break in taking the tablets, you may be pregnant. In this situation, you should consult your doctor before starting to take the tablets from the next blister pack. Missing a dose of more than one tablet from the blister pack You should consult your doctor.

• Do you have sexual intercourse in the week before missing the tablet?
• in the 1st week
• no
• You should take the missed tablet.
• You should use a barrier method of contraception (e.g., a condom) for the next 7 days.
• You should continue taking the tablets from the blister pack.
• Missing a dose of only one tablet (delay of more than 12 hours)
• You should take the missed tablet.
• You should continue taking the tablets from the blister pack.
• in the 2nd week
• You should take the missed tablet.
• You should continue taking the tablets from the blister pack.
• in the 3rd week or
• You should take the missed tablet immediately.
• You should stop taking the remaining tablets from the current blister pack.
• You should take a break in taking the tablets, not longer than 7 days (including the day you missed the tablet).
• You should start taking the tablets from the next blister pack.

4. Possible side effects

Like all medicines, Dessette can cause side effects, although not everybody gets them. If you experience any side effects, especially severe and persistent ones, or changes in your health that you think are related to taking Dessette, you should consult your doctor. All women taking combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, you should read section 2 "Important information before taking Dessette". Other serious side effects related to the use of Dessette and their symptoms are described in the sections "Blood clots" and "Dessette and cancer".

Frequent (may affect up to 1 in 10 women):

• depressive mood, mood changes,
• headache,
• nausea, abdominal pain,
• breast pain, breast tenderness,
• weight gain.

Uncommon (may affect up to 1 in 100 women):

• fluid retention,
• decreased libido,
• migraine,
• vomiting, diarrhea,
• rash, hives,
• breast enlargement.

Rare (may affect up to 1 in 1000 women):

• hypersensitivity reactions,
• increased libido,
• intolerance to contact lenses,
• erythema nodosum, erythema multiforme (these are skin diseases),
• breast discharge,
• vaginal discharge,
• weight loss,
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g. deep vein thrombosis)
• in the lungs (e.g. pulmonary embolism)
• heart attack
• stroke
• mini-stroke or transient stroke symptoms, known as a transient ischemic attack
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood of blood clots may be higher if you have any other risk factors (see section 2 for more information on risk factors and symptoms of blood clots).

Severe side effects

You should contact your doctor immediately if you experience any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives potentially with difficulty breathing (see also section 2 "Warnings and precautions").

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Dessette

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated. PVC/Aluminum blister (without sachet): Do not store above 30°C. PVC/Aluminum blister in PET/Aluminum/PE sachet: No special precautions. Do not use this medicine if you notice, for example, discoloration, crumbling, or other visible signs of tablet damage. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Dessette contains

• The active substances of Dessette are ethinylestradiol and desogestrel. Each Dessette film-coated tablet contains 20 micrograms of ethinylestradiol and 150 micrograms of desogestrel.
• Other ingredients of Dessette are: Core: lactose monohydrate, corn starch, maltodextrin, sodium carboxymethyl starch (type A), hypromellose, stearic acid, microcrystalline cellulose, all-rac-α-tocopherol.

Coating: hypromellose, lactose monohydrate, titanium dioxide (E 171), stearic acid, macrogol 4000, microcrystalline cellulose, sodium citrate.

What Dessette looks like and what the pack contains

Dessette is a white, biconvex, round film-coated tablet with an embossing. Dessette is available in packs of: 1, 3, or 6 blisters of 21 film-coated tablets in a cardboard box. 1, 3, or 6 blisters of 21 film-coated tablets, each in a sachet, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o., ul. Dolna 21, 05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel, Münchener Straße 15, 06796 Brehna, Germany, SUN-FARM Sp. z o.o., ul. Dolna 21, 05-092 Łomianki, Date of last revision of the leaflet:12.2021