Drosfemine mini

Leaflet accompanying the packaging: information for the user

Drosfemine mini, 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 longer. 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.
• In case of 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 mini and what is it used for
• 2. Important information before taking Drosfemine mini
• 3. How to take Drosfemine mini
• 4. Possible side effects
• 5. How to store Drosfemine mini
• 6. Contents of the pack and other information

1. What is Drosfemine mini and what is it used for

Drosfemine mini is a contraceptive pill used to prevent pregnancy. Each tablet contains a small amount of two different female hormones - ethinylestradiol and drospirenone. Contraceptive pills that contain two hormones are called combined contraceptive pills.

2. Important information before taking Drosfemine mini

General notes

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

When not to take Drosfemine mini

You should not take Drosfemine mini 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 mini

• 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 clotting disorders - for example, deficiency of protein C, protein S, antithrombin III, presence of factor V Leiden mutation or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see section "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 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) liver disease, and liver function has not returned to normal;
• if you have kidney function disorders (kidney failure);
• if you have (or have had) liver cancer;
• if you have (or have had) breast cancer or cancer of the genital organs, 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 mini and other medicines").

Additional information for special populations

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

Warnings and precautions

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

• if you notice any symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), blood clot in your lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots"). To get a description of these serious side effects, see "How to recognize a blood clot".

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

In some cases, you should be particularly careful when taking Drosfemine mini 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 mini, 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 genetic disorder of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a family history of this 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 have just given birth, as you are at increased risk of blood clots. You should consult your doctor for advice on how soon you can start taking Drosfemine mini after giving birth;
• 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 mini 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 (pregnancy pemphigoid), 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, you should

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

Psychiatric disorders

Some women taking hormonal contraceptives, including Drosfemine mini, 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 Drosfemine mini, is associated with an increased risk of blood clots, compared to not taking them. 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"). Not everyone who has a blood clot will fully recover, and in rare cases, the effects of a blood clot can be permanent or even fatal.

Remember that the overall risk of having a harmful blood clot due to Drosfemine mini is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

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 the development of 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 Drosfemine mini, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

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

• if you are significantly overweight (body mass index (BMI) over 30 kg/m2);
• if someone in your close 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 genetic 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. You may need to stop taking Drosfemine mini for a few weeks before surgery or immobilization. If you need to stop taking Drosfemine mini, you should ask your doctor when you can resume taking it;
• 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. 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 risk factors apply to you, even if you are not sure. Your doctor may decide to stop Drosfemine mini. You should inform your doctor if any of the above conditions change while taking Drosfemine mini, e.g., if someone in your close 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 a blood clot forms in an artery?

Similarly to blood clots in veins, blood clots in an artery 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 mini is very small, but it may increase:

• with age (over approximately 35 years old);
• if you smoke. While taking a hormonal contraceptive, it is recommended to quit smoking. If you cannot quit smoking and are over 35 years old, your doctor may recommend a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your close 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 close 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, heart rhythm disturbance 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 inform your doctor if any of the above conditions change while taking Drosfemine mini, e.g., if you start smoking, someone in your close family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

Drosfemine mini 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 more frequently examined by doctors. The incidence of breast tumors decreases gradually 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 stomach pain, you should contact your doctor.

Irregular bleeding

During the first few months of taking Drosfemine mini, you may experience unexpected bleeding (bleeding outside of the withdrawal bleeding week). If such bleeding persists for more than a few months or starts after a few months, your doctor should investigate the cause.

What to do if withdrawal bleeding does not occur

If you have taken all the tablets correctly, have not vomited, or had severe diarrhea, and have not taken any other medicines, it is unlikely that you are pregnant. If the expected withdrawal 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 blister pack until you are sure you are not pregnant.

Drosfemine mini 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 mini. 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 mini in your blood
• may make Drosfemine mini 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),
• high blood pressure in the blood vessels of the lungs (bosentan);
• herbal products containing St. John's Wort.

Drosfemine mini may affect the actionof other medicines, such as:

• medicines containing cyclosporin,
• 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 mini 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 (increased liver enzyme activity). Your doctor will recommend a different contraceptive method before starting these medicines. You can start taking Drosfemine mini again about 2 weeks after finishing the treatment. See section "Do not take Drosfemine mini".

Lab tests

If you need to have a blood test, 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 mini with food and drink

Drosfemine mini 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 baby, you should ask your doctor or pharmacist for advice before taking this medicine. Pregnancy If you are pregnant, you should not take Drosfemine mini. If you become pregnant while taking Drosfemine mini, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Drosfemine mini at any time (see section "Stopping Drosfemine mini"). Breastfeeding Generally, Drosfemine mini is not recommended for use in breastfeeding women. 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 mini affects your ability to drive or use machines.

Drosfemine mini contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking Drosfemine mini.

3. How to take Drosfemine mini

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist. You should take one Drosfemine mini tablet every 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. The blister pack contains 21 tablets. Next to each tablet, the day of the week is printed. If you start taking the tablets on a Wednesday, you should take the tablet with "Wed" on it. Then, you should take the tablets according to the direction of the arrows on the blister pack until all 21 tablets have been taken.

• On the 8th day after taking the last tablet of Drosfemine mini (i.e., after the 7-day break), you should start taking the next blister pack, regardless of whether the withdrawal bleeding has stopped or not. This means that you will start each blister pack on the same day of the week, and the withdrawal bleeding should occur on the same days of each cycle.

If you take Drosfemine mini in this way, you are also protected against pregnancy during the 7 days when you are not taking tablets. 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.

When can you start the first blister pack?

If you have not taken a hormonal contraceptive in the previous month You should start taking Drosfemine mini on the first day of your menstrual cycle (i.e., the first day of your period). If you start taking Drosfemine mini 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 then you should use additional contraceptive methods (e.g., condoms) for the first 7 days.

What to do if you take more than the recommended dose of Drosfemine mini

There are no reports of serious harmful effects from taking too many Drosfemine mini tablets at once. If you take several tablets at once, you may experience nausea, vomiting, or vaginal bleeding. This type of bleeding may 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 mini tablets or if a child swallows some tablets, you should contact your doctor or pharmacist immediately.

What to do if you miss a dose of Drosfemine mini

• If it has been less than 12 hourssince you missed a 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 12 hourssince you missed a tablet, your protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

The risk of reduced protection against pregnancy is highest if you miss a 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 in the first week You should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Then, you should take the tablets at the usual time and use additional contraceptive methods(e.g., condoms) for the next 7 days. If you had sex in the week before missing the tablet, it is possible that you are pregnant. You should contact your doctor.

What to do if you vomit or have severe diarrhea

If you vomit within 3 to 4 hours after taking a tablet or 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 tablet from the reserve blister pack as soon as possible. If possible, you should take it within 12 hoursof the usual time of taking the tablet. If this is not possible or more than 12 hours have passed, you should follow the instructions described in the section "Missing a dose of Drosfemine mini".

Delayed menstruation: what you need to know

Although it is not recommended, you can delay your menstruation by skipping the break in taking the tablets and starting a new blister pack of Drosfemine mini right away, until it is finished. While taking the tablets from the second blister pack, you may experience spotting or breakthrough bleeding. After the usual 7-day break in taking the tablets, you should start a new blister pack. Before deciding to delay your menstruation, you can consult your doctor for advice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Drosfemine mini, they should consult their doctor.
All women using combined hormonal contraceptives have an increased risk of 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, please refer to section 2 "Important information before taking Drosfemine mini".
Below is a list of side effects associated with the use of Drosfemine mini:

Severe side effects

The doctor should be contacted immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives 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,
• abdominal pain,
• acne,
• breast pain, breast enlargement, breast tenderness, painful or irregular menstruation,
• weight gain.

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

• candidiasis (fungal infection),
• herpes simplex virus infection,
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disorders,
• tingling and numbness, dizziness,
• vision disturbances,
• heart rhythm disorders or extremely rapid heart rate,
• blood clots (thrombosis) in a blood vessel in the leg or lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins,
• sore throat,
• nausea, vomiting, gastritis and/or enteritis, diarrhea, constipation,
• sudden swelling of the skin and/or mucous membranes (e.g., tongue or throat) and/or difficulty swallowing or hives with accompanying difficulty breathing (angioedema), hair loss (alopecia), eczema (dermatitis), itching, rash, dry skin, seborrheic dermatitis,
• neck pain, limb pain, muscle cramps,
• urinary tract infections,
• breast lump (benign and malignant), milk secretion in non-pregnant women (galactorrhea), ovarian cysts, hot flashes, absence of menstruation, very heavy menstruation, discharge, vaginal dryness, pain in the lower abdomen (pelvic area), abnormal Pap smear, decreased libido,
• fluid retention, lack of energy, excessive thirst, increased sweating,
• weight loss.

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

• asthma,
• hearing disorders,
• skin disease - erythema nodosum (characterized by painful red nodules on the skin) or erythema multiforme (characterized by a rash with redness resembling a target or ulcers),
• 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 the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their 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
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Drosfemine mini

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
The medicine should not be used after the expiry date stated on the blister and carton. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 mini contains

• The active substances of the medicine are ethinylestradiol and drospirenone. Each tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
• The other ingredients are: lactose monohydrate, corn starch, maltodextrin, magnesium stearate, hypromellose 3cP, talc, titanium dioxide (E171), polysorbate 80, iron oxide red (E172).

What Drosfemine mini looks like and what the pack contains

Each blister of Drosfemine mini contains 21 pink, round, film-coated tablets.
Drosfemine mini is available in packs containing 1, 3, or 6 blisters, each with 21 tablets.
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:04.2023