Drosfemine

Leaflet accompanying the packaging: information for the user

Drosfemine, 0.02 mg + 3 mg, film-coated tablets

Ethinylestradiol + Drospirenone

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 more. You should be vigilant and consult a doctor if you suspect that blood clot symptoms have occurred (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, even if their symptoms are the same.
• 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 Drosfemine and what is it used for
• 2. Important information before taking Drosfemine
• 3. How to take Drosfemine
• 4. Possible side effects
• 5. How to store Drosfemine
• 6. Contents of the pack and other information

1. What is Drosfemine and what is it used for

Drosfemine is a contraceptive pill used to prevent pregnancy. Each of the 24 pink tablets contains a small amount of two different female hormones - ethinylestradiol and drospirenone. The 4 white tablets do not contain any active substance and are called placebo tablets. Contraceptive pills that contain two hormones are called combined contraceptive pills.

2. Important information before taking Drosfemine

General notes

Before starting to take Drosfemine, 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 Drosfemine, your doctor will ask you a few questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may also perform additional tests.

Drosfemine, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to take Drosfemine

You should not take Drosfemine 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 for you.

Do not take Drosfemine

• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). Symptoms of hypersensitivity may include itching, rash, or swelling;
• 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 that you have blood coagulation disorders - such as 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 due to injury or illness or have a leg in a cast. It may be necessary to stop taking Drosfemine for a few weeks before surgery or immobilization. If you need to stop taking Drosfemine, you should ask your doctor when you can resume taking the medicine;
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (reversible 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 in the past) a type of migraine called "migraine with aura";
• if you have (or have had in the past) liver disease, and liver function has not returned to normal;
• if you have kidney function disorders (renal failure);
• if you have (or have had in the past) liver cancer;
• if you have (or have had in the past) breast cancer or genital cancer or if it is suspected;
• if you have had vaginal bleeding of unknown cause;
• if you have hepatitis C and are taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see section "Drosfemine and other medicines").

Additional information for special populations

Children and adolescents
Drosfemine is not intended for use in women who have not yet started their menstrual cycles.
Women of advanced age
Drosfemine is not intended for use after menopause.
Women with liver function disorders
You should not take Drosfemine if you have liver disease. See also sections "Do not take Drosfemine" and "Warnings and precautions".
Women with kidney function disorders
You should not take Drosfemine if you have renal failure or acute renal failure. See also sections "Do not take Drosfemine" and "Warnings and precautions".

Warnings and precautions

When should you contact your doctor?
You should contact your doctor immediately

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

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

In some cases, you should be particularly careful when taking Drosfemine or any other combined contraceptive pill. You may also need to be regularly examined by your doctor. If these symptoms occur or worsen while taking Drosfemine, you should also tell your doctor.

• if any of your close relatives have had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• 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 been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history for 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 section 2 "Blood clots");
• if you are immediately after childbirth, in which case you are at increased risk of blood clots. You should consult your doctor for information on how soon you can start taking Drosfemine after childbirth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see section "Drosfemine and other medicines");
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have had conditions that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy (pemphigoid gestationis), a nerve disease that causes sudden movements of the body (Sydenham's chorea));
• if you have had chloasma (skin discoloration, especially on the face and neck, so-called pregnancy spots). If so, you should avoid direct exposure to sunlight or ultraviolet radiation;
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria potentially with breathing difficulties, you should

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

Psychiatric disorders

Some women taking hormonal contraceptives, including Drosfemine, 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

The use of combined hormonal contraceptives, such as Drosfemine, 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 "deep vein thrombosis") or in the arteries (called "arterial thromboembolism" or "arterial occlusive disease"). 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 Drosfemine is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS

You should contact your doctor immediately if you notice any of the following symptoms.

BLOOD CLOTS IN VEINS

What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism), although these side effects are rare. They most often occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and lodges 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 veins highest?

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

What factors increase the risk of blood clots in veins?

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 Drosfemine is small. In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots. In a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots. In a year, about 9-12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Drosfemine, 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 Drosfemine is small, but some factors can increase this risk. The risk is higher:

• if you are overweight (body mass index (BMI) over 30 kg/m);
• if someone in your immediate family has 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 due to injury or illness or have a leg in a cast. It may be necessary to stop taking Drosfemine for a few weeks before surgery or immobilization. If you need to stop taking Drosfemine, you should ask your doctor when you can resume taking the medicine;
• with age (especially over 35 years old);
• if you have given birth in the last few weeks.

The risk of blood clots increases with the number of risk factors present in the patient. Air travel (more than 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 not sure. Your doctor may decide to stop Drosfemine. You should inform your doctor if any of the above conditions change while taking Drosfemine, e.g., if someone in your immediate family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in arteries?

Similarly to blood clots in veins, blood clots in arteries can cause severe 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 Drosfemine is very small, but it may increase:

• with age (over about 35 years old);
• if you smoke. While taking a hormonal contraceptive like Drosfemine, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your immediate family has 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 someone in your immediate family has 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, arrhythmia called atrial fibrillation);
• if you have diabetes.

If you have more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be even higher. You should inform your doctor if any of the above conditions change while taking Drosfemine, e.g., if you start smoking, if someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

Drosfemine and cancer

Women taking combined contraceptive pills have been found to have a slightly higher incidence of breast cancer, but it is not known whether this is caused by the pills. It is possible that more tumors are detected in women taking combined contraceptive pills because they are examined by doctors more frequently. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is essential to regularly examine your breasts and contact your doctor if you feel any lump. In rare cases, women taking contraceptive pills have been reported to have benign liver tumors, and even more rarely, malignant liver tumors. If you experience unusual, severe abdominal pain, you should contact your doctor.

Intermenstrual bleeding

During the first few months of taking Drosfemine, unexpected bleeding (bleeding outside the period of taking placebo tablets) may occur. If such bleeding persists for longer than a few months or starts after a few months, your doctor should investigate the cause.

What to do if bleeding does not occur during the placebo period

If you have taken all the active tablets correctly, have not vomited, or have not had severe diarrhea, and have not taken any other medicines, it is unlikely that you are pregnant. If the expected bleeding does not occur twice in a row, it may mean that you are pregnant. You should contact your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Drosfemine and other medicines

You should tell your doctor or pharmacist about all the medicines and herbal products you are currently taking or have recently taken, as well as any medicines and herbal products you plan to take. You should also tell any other doctor or dentist prescribing another medicine (or pharmacist) that you are taking Drosfemine. They may advise you to use additional contraceptive precautions (e.g., condoms) and for how long, and whether you should change the way you take other medicines. Some medicines

• may affect the level of Drosfemine in your blood
• may make Drosfemine less effective in preventing pregnancy
• may cause unexpected bleeding.

This applies to medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
• tuberculosis (e.g., rifampicin),
• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• fungal infections (e.g., griseofulvin, ketoconazole),
• arthritis, degenerative joint disease (etoricoxib),
• pulmonary hypertension (bosentan),
• herbal products containing St. John's Wort.

Drosfemine may affect the actionof other medicines, such as:

• cyclosporine-containing medicines,
• the antiepileptic medicine lamotrigine (may lead to an increased frequency of seizures),
• theophylline (used to treat respiratory disorders),
• tizanidine (used to treat muscle pain and/or muscle spasms).

You should not take Drosfemine if you have hepatitis C and are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these medicines may cause abnormal liver function test results (elevated liver enzyme ALT). Your doctor will recommend a different contraceptive method before starting these medicines. You can start taking Drosfemine again about 2 weeks after finishing the treatment. See section "Do not take Drosfemine".

Lab tests

If a blood test is necessary, you should tell your doctor or laboratory staff that you are taking contraceptive pills, as hormonal contraceptives may affect the results of some tests.

Drosfemine with food and drink

Drosfemine can be taken with or without food, and if necessary, it can be taken with a small amount of water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. Pregnancy If you are pregnant, you should not take Drosfemine. If you become pregnant while taking Drosfemine, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Drosfemine at any time (see section "Stopping Drosfemine"). Breastfeeding Generally, Drosfemine is not recommended for women who are breastfeeding. If you want to take contraceptive pills while breastfeeding, you should contact your doctor.

Driving and using machines

There is no information suggesting that taking Drosfemine affects the ability to drive or operate machines.

Drosfemine contains lactose and sodium

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

3. How to take Drosfemine

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. Each blister pack contains 24 pink active tablets and 4 white placebo tablets. The two different colored tablets are arranged in sequence. One blister pack contains 28 tablets. You should take one Drosfemine tablet per day, and if necessary, you can take it with a small amount of water. The tablets can be taken with or without food. You should take the tablets every day at about the same time. Do not confuse the tablets:you should take the pink active tablets for the first 24 days, followed by the white placebo tablets for the last 4 days. Then, you should start a new blister pack (24 pink active tablets, followed by 4 white placebo tablets) immediately. There is no break between the two blister packs. Due to the differences in tablet composition, you should start taking the tablets from the first tablet marked "START" and take the tablets every day. To maintain the correct order, you should take the tablets in the direction of the arrows on the blister pack.

Preparing the blister pack

To have control over the regular intake of the contraceptive every day, you should pay attention to the arrows on the blister pack. The arrows show the order in which you should take the tablets. You should remember which day of the week you take the first tablet. (The day of the week when you take the first tablet can be marked in the field next to the start of the blister pack.) During the 4 days when you take the white placebo tablets (placebo days), you should have bleeding (so-called withdrawal bleeding). It usually starts on the 2nd or 3rd day after taking the last pink active tablet, and you should start the next blister pack as soon as you finish the placebo tablets, regardless of whether the bleeding has stopped or not. This means that you should start each blister pack on the same day of the week, and the withdrawal bleeding should occur on the same days of each cycle.

When can you start the first blister pack?

If you have not used a hormonal contraceptive in the previous month You should start taking Drosfemine on the first day of your menstrual cycle (i.e., the first day of your period). If you start taking Drosfemine on the first day of your period, you are immediately protected against pregnancy. You can also start taking the tablets between the 2nd and 5th day of your menstrual cycle, but in this case, you should use additional contraceptive methods (e.g., condoms) for the first 7 days. Changing from a combined hormonal contraceptive or a combined contraceptive vaginal ring or patch If you want to start taking Drosfemine, it is best to start the day after you take the last active tablet (the last tablet containing active substances) from your previous contraceptive pills, but no later than the day after the break in taking your previous contraceptive pills (or after taking the last inactive tablet from your previous contraceptive pills). When changing from a combined contraceptive vaginal ring or patch, you should follow your doctor's advice. Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine device (IUD) releasing progestogen) You can change from a progestogen-only pill at any time (from an implant or IUD on the day it is removed, from injections when the next injection would be due). In all these cases, it is recommended to use additional contraceptive methods (e.g., condoms) for the first 7 days. After a miscarriage You should follow your doctor's advice. After childbirth You can start taking Drosfemine between the 21st and 28th day after childbirth. If you start taking Drosfemine more than 28 days after childbirth, you should use a barrier method (e.g., condoms) for the first 7 days of taking Drosfemine. If you have had sexual intercourse after giving birth, before starting Drosfemine (again), you should make sure you are not pregnant or wait for your next menstrual period. If you are breastfeeding and want to start taking Drosfemine (again) after giving birth You should read the section "Breastfeeding". If you are unsure when to start the first blister pack, you should consult your doctor.

What to do if you take more Drosfemine than you should

There are no reports of serious harmful effects from taking too many Drosfemine tablets at once. If you take several tablets at once, you may experience nausea, vomiting, or vaginal bleeding. This type of bleeding can occur even in girls who have not yet started their menstrual cycles but have taken the medicine by mistake. If you take too many Drosfemine tablets or if a child has taken some tablets, you should contact your doctor or pharmacist immediately.

What to do if you forget to take Drosfemine

The last 4 tablets in the blister pack (tablets 25-28) are placebo tablets. If you miss one of these tablets, it does not affect the efficacy of Drosfemine. You should discard the missed placebo tablet. If you miss a pink active tablet (tablets 1-24 in the blister pack), you should:

• if it has been less than 24 hourssince you missed the tablet, your protection against pregnancy is not reduced. You should take the tablet as soon as possible and take the next tablets at the usual time.
• if it has been more than 24 hourssince you missed the tablet, your protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of pregnancy.

The risk of reduced protection against pregnancy is highest if you miss a pink active tablet at the beginning or end of the blister pack. Therefore, you should follow these rules (see also the diagram): Missing more than one tablet from the blister pack You should contact your doctor. Missing one tablet between days 1 and 7 You should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Then, take the tablets at the usual time, and for the next 7 days, use additional contraceptive methods, such as condoms. If you had sexual intercourse in the week before missing the tablet, it is possible that you are pregnant. In this case, you should contact your doctor. Missing one tablet between days 8 and 14 You should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Then, take the tablets at the usual time. Your protection against pregnancy is not reduced, and you do not need to use additional contraceptive methods. Missing one tablet between days 15 and 24 There are two options to choose from:

• 1. You should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Then, take the tablets at the usual time. Instead of taking the white placebo tablets from the blister pack, you should discard them and start a new blister pack (the start day will be different from before).

Most likely, your period will occur at the end of the second blister pack - during the white placebo tablets, but you may also experience spotting or bleeding similar to a period during the second blister pack.

• 2. You can also stop taking the pink active tablets and immediately start taking the 4 white placebo tablets (before taking the placebo tablets, you should note the day you missed the tablet). If you want to start a new blister pack on the day you usually start taking the tablets, you can take the placebo tablets for less than4 days.

If you follow one of these two recommendations, you will still be protected against pregnancy. If you miss any of the tablets in the blister pack and do not have bleeding during the placebo days, it may mean that you are pregnant. Before starting the next blister pack, you should contact your doctor. More than one missed pink tablet from one blister pack You should consult your doctor for advice. Yes Did you have sexual intercourse in the week before missing the tablet? Day 1 - 7 No

• You should take the missed tablet.
• You should use a barrier method (condom) for the next 7 days.
• You should continue taking the tablets from the blister pack. Only one missed tablet (delay in taking the tablet exceeded 24 hours) Day 8 - 14
• You should take the missed tablet.
• You should continue taking the tablets from the blister pack.
• You should take the missed tablet.
• You should continue taking the tablets from the blister pack.
• You should discard the 4 white placebo tablets.
• You should start a new blister pack.

or Day 15 - 24

• You should stop taking the tablets from the blister pack immediately.
• You should start taking the 4 white placebo tablets.
• Then, you should start a new blister pack.

What to do if you vomit or have severe diarrhea

If you vomit within 3-4 hours of taking a pink active tablet, or if you have severe diarrhea, there is a risk that the active substances from the tablet will not be fully absorbed into your body. This situation is almost the same as missing a tablet. After vomiting or diarrhea, you should take another pink active tablet from a spare blister pack as soon as possible. If possible, you should take it within 24 hoursof the usual time you take the tablet. If this is not possible or more than 24 hours have passed, you should follow the instructions in the section "If you forget to take Drosfemine".

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any side effects, especially serious and persistent ones, or changes in your health that you think are related to the use of Drosfemine, you should consult a doctor.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before taking Drosfemine".
Below is a list of side effects associated with the use of Drosfemine:

Severe side effects

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

Other side effects

Common side effects (may affect up to 1 in 10 patients):

• mood swings,
• headache,
• nausea,
• breast pain, menstrual disorders, such as irregular menstruation, absence of menstruation.

Uncommon side effects (may affect up to 1 in 100 patients):

• depression, nervousness, drowsiness,
• dizziness, tingling, and numbness,
• migraine, varicose veins, increased blood pressure,
• abdominal pain, vomiting, indigestion, bloating, gastritis, diarrhea,
• acne, itching, rash,
• painful conditions, e.g., back pain, limb pain, muscle cramps,
• vaginal fungal infections, pelvic pain, breast enlargement, benign breast tumors, uterine and/or vaginal bleeding (which usually subsides during continued treatment), vaginal discharge, hot flashes, vaginal inflammation, menstrual disorders, painful menstruation, scanty menstruation, heavy menstruation, vaginal dryness, abnormal cervical smear, decreased libido,
• lack of energy, increased sweating, fluid retention,
• weight gain.

Rare side effects (may affect up to 1 in 1,000 patients):

• candidiasis (fungal infection),
• anemia, increased platelet count,
• allergic reaction,
• hormonal disorders (endocrine),
• increased appetite, loss of appetite, abnormal high potassium levels in the blood, abnormal low sodium levels in the blood,
• orgasm disorders, insomnia,
• dizziness, tremors,
• eye disorders, e.g., conjunctivitis, dry eye syndrome,
• abnormal rapid heart rhythm,
• phlebitis, nosebleeds, fainting,
• abdominal circumference enlargement, gastrointestinal disorders, feeling of bloating, abdominal hernia, oral fungal infection, constipation, dry mouth,
• painful conditions related to the bile ducts or gallbladder, cholecystitis,
• brown spots on the skin, eczema (rash), hair loss, acne-like skin inflammation, dry skin, nodular skin inflammation, excessive hair growth, skin diseases, skin stretch marks, skin inflammation, sun allergy, skin tumors,
• difficult or painful intercourse, vaginal inflammation (vaginitis and vulvitis), post-coital bleeding, withdrawal bleeding, breast cyst, increased number of breast gland cells (hyperplasia), malignant breast tumors, abnormal growth of the cervical mucosa, shrinkage or atrophy of the uterine mucosa, ovarian cysts, uterine enlargement,
• general malaise,
• weight loss,
• 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 developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for developing blood clots and symptoms of blood clots).
Based on available data, it is not possible to determine the frequency of the following reported side effects:

• hypersensitivity,
• erythema multiforme (rash with redness resembling a target or ulcers).

Reporting side effects

If you experience any side effects, including any side effects 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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 the medicine.

5. How to store Drosfemine

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater. 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 Drosfemine contains

• The active substances of Drosfemine are ethinylestradiol and drospirenone. Each pink film-coated tablet containing active substances contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.

The white film-coated tablets do not contain active substances.

• The other ingredients are: lactose monohydrate, maize starch, maltodextrin, magnesium stearate, hypromellose 3cP, talc, titanium dioxide (E171), polysorbate 80, iron oxide red (E172).

White film-coated placebo tablets:

• The other ingredients are: lactose monohydrate, maize starch, maltodextrin, magnesium stearate, hypromellose 15cP, titanium dioxide (E171), macrogol 4000, sodium citrate.

What Drosfemine looks like and what the pack contains

Each Drosfemine blister pack contains 24 pink film-coated tablets containing active substances and 4 white film-coated placebo tablets.
The active substance tablets are pink. The placebo tablets are white. Both types of film-coated tablets are round.
Drosfemine is available in packs containing 1, 3, or 6 blister packs, each with 24+4 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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:04.2023