Drosfemine mini

Package leaflet: Information for the user

Drosfemine mini, 0.02 mg + 3 mg, coated tablets
Ethinylestradiolum + Drospirenonum
Important information about combined hormonal contraceptives
When used correctly, they are one of the most reliable, reversible methods of
contraception.
They slightly increase the risk of developing blood clots in veins and arteries,
especially during the first year of use or after restarting use following an interval of 4
weeks or longer.
Be vigilant and consult a doctor if you suspect symptoms of blood clot formation (see section 2 "Blood clots").
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Drosfemine mini is and what it is used for
2. What you should know 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 Drosfemine mini is and what it is used for

Drosfemine mini is a contraceptive tablet used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones – ethinylestradiol and
drospirenone.
Contraceptive tablets containing two hormones are known as combined oral contraceptives.

2. Important information before taking Drosfemine mini

General notes
Before starting to take Drosfemine mini, please read the information regarding blood clots in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section 2 "Blood clots"). Before starting Drosfemine mini, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out additional tests.
This leaflet describes several situations in which you should stop using Drosfemine mini and in which the effectiveness of Drosfemine mini may be reduced. In such cases, you should avoid sexual intercourse or use additional non-hormonal contraception, such as condoms or another barrier method. Do not use the calendar method or temperature monitoring method. These methods may be ineffective because Drosfemine mini alters body temperature changes and cervical mucus changes that occur during the menstrual cycle.
Drosfemine mini, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or other sexually transmitted diseases.

When not to use Drosfemine mini
Do not use Drosfemine mini if you have any of the conditions listed below. If any of the following conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative contraceptive method may be more suitable.

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 you have disorders affecting blood clotting—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following diseases that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fats in the blood (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia;
• if you currently have (or have previously had) a type of migraine called "migraine with aura";
• if you have (or have previously had) liver disease and liver function has not returned to normal;
• if you have kidney function disorders (kidney failure);
• if you currently have (or have previously had) liver tumour;
• if you have (or have previously had) breast cancer or cancer of the genital organs, or if such cancer is suspected;
• if you have 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 specific populations
Children and adolescents
Drosfemine mini is not intended for use in women who have not yet started menstruating.
Elderly women
Drosfemine mini is not intended for use after menopause.
Women with liver function disorders
Do 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
Do 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?
Seek immediate medical advice

• if you notice possible symptoms of blood clots, which may indicate you have a blood clot in the leg (deep vein thrombosis), lungs (pulmonary embolism), heart attack, or stroke (see section below "Blood clots"). For a description of symptoms of these serious adverse effects, see "How to recognize blood clots".

Tell your doctor if you have any of the following conditions.
In certain cases, special caution is required when using Drosfemine mini or any other combined oral contraceptive. Regular check-ups by your doctor may also be necessary. If any of these symptoms appear or worsen during treatment with Drosfemine mini, inform your doctor.

• if members of your immediate family have or have previously had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you suffer from depression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you are immediately postpartum, as you are at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Drosfemine mini after delivery;
• if you have phlebitis (inflammation of superficial veins);
• if you have varicose veins;
• if you have epilepsy (see section "Drosfemine mini and other medicines");
• if you have systemic lupus erythematosus (a disease affecting the body's natural defence system);
• if you have experienced conditions that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (pemphigoid gestationis), a nerve disorder causing sudden body movements (Sydenham's chorea));
• if you have developed or have previously developed chloasma (skin pigmentation, especially on the face and neck, also known as "melasma"). If so, 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 with breathing difficulties, you should

seek immediate medical attention. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Psychiatric disorders
Some women using hormonal contraceptives, including Drosfemine mini, have reported depression or mood changes. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor as soon as possible for further medical advice.

BLOOD CLOTS
Using combined hormonal contraceptives such as Drosfemine mini increases the risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious complications.

Blood clots may occur
in veins (referred to as "venous thrombosis" or "venous thromboembolic disease"),
in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").
Full recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.

Remember that the overall risk of harmful blood clots caused by using Drosfemine mini is low.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical attention 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 developing blood clots in veins (venous thrombosis), although these adverse events are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of using
combined hormonal contraceptives for the first time. The risk may also be higher
when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a patient stops taking Drosfemine mini, the risk of blood clots returns to normal within a few weeks.

What does the risk of blood clots in veins depend on?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of
combined hormonal contraceptive being used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Drosfemine mini is low.
In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
In the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
In the course of one year, about 9–12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Drosfemine mini, will develop blood clots.
The risk of developing blood clots depends on the individual's medical history (see "Factors that increase the risk of blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Drosfemine mini is small, however
some factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In this case, the patient may have an inherited clotting disorder;
• if the patient needs to undergo surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue the use of Drosfemine mini several weeks before surgery or due to limited mobility. If the patient must stop taking Drosfemine mini, ask the doctor when it is safe to resume taking the medicine;
• with increasing age (especially over 35 years);
• if the patient has given birth within the last few weeks.

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of venous blood clots, particularly
if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed factors apply to the patient, even
if uncertain. The doctor may decide to discontinue the use of Drosfemine mini.
Inform the doctor if any of the above conditions change during treatment with
Drosfemine mini, for example, if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
Similar to venous blood clots, arterial clots can cause serious
consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Drosfemine
mini is very low, but may increase:

• with age (above approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Drosfemine mini, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, particularly migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them is
particularly severe, the risk of arterial blood clots may be further increased.
Inform the doctor if any of the above conditions change during
treatment with Drosfemine mini, for example, if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Drosfemine mini and cancer
Breast cancer has been observed slightly more frequently in women using combined oral contraceptives,
but it is not known whether this is caused by taking the pills. It is possible that more cancers are
detected in women using combined oral contraceptives because they are examined more frequently by
doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to regularly examine the breasts and
contact the doctor if any lump is detected.
In rare cases, benign liver tumors have been reported in women using oral contraceptives, and even more rarely – malignant liver tumors. If the patient experiences an unusual, severe abdominal pain, contact the doctor.

Intermenstrual bleeding
During the first few months of taking Drosfemine mini, unexpected bleeding (bleeding outside the week of the tablet-free interval) may occur.
If such bleeding persists for longer than a few months or starts after several months of use,
the doctor should investigate the cause.

What to do if no withdrawal bleeding occurs during the tablet-free week
If all tablets have been taken correctly, there has been no vomiting or severe diarrhoea, and no other medicines have been taken, pregnancy is unlikely.
If expected withdrawal bleeding does not occur twice in succession, this may indicate that the patient is pregnant.
Contact the doctor immediately. Do not start the next blister pack until it is confirmed that the patient is not pregnant.

Drosfemine mini and other medicines
Inform the doctor or pharmacist about all medicines and herbal products currently or recently used by the patient, as well as any medicines or herbal products the patient plans to use.
Also inform any other doctor or dentist prescribing another medicine (or pharmacist) that the patient is taking Drosfemine mini. They may advise whether additional contraceptive precautions (e.g. condoms) are needed, for how long, and whether the way other medicines are taken should be changed.
Some medicines:

• may affect the blood concentration of Drosfemine mini;
• may make it 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 (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g. griseofulvin, ketoconazole);
• arthritis, osteoarthritis (etoricoxib);
• pulmonary hypertension (bosentan);
• herbal products containing St. John's wort (Hypericum perforatum).

Drosfemine mini may affect the action of other medicines, for example:

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

Do not use Drosfemine mini if the patient has hepatitis C and is taking medicines
containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or
sofosbuvir with velpatasvir and voxilaprevir, because these medicines may cause abnormal liver function test results (increased levels of liver enzymes AlAT).
The doctor will recommend another type of contraception before starting these medicines.
Drosfemine mini may be restarted approximately 2 weeks after stopping treatment. See section “Do not take Drosfemine mini”.

Laboratory tests
If a blood test is required, inform the doctor or laboratory staff that the patient is taking oral contraceptives, as hormonal contraceptives may affect the results of certain tests.

Drosfemine mini with food and drink
Drosfemine mini may be taken regardless of meals; if needed, it can be taken with a small amount of water.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
If the patient is pregnant, she must not use Drosfemine mini. If the patient becomes pregnant
while taking Drosfemine mini, she should stop taking it immediately and contact
her doctor. If the patient wishes to become pregnant, she may stop taking Drosfemine mini at any time (see section “Discontinuation of Drosfemine mini”).

Breastfeeding
Generally, Drosfemine mini is not recommended for breastfeeding women. If the patient wishes to take oral contraceptives while breastfeeding, she should contact her doctor.

Driving and using machines
There is no information suggesting that Drosfemine mini affects the ability to drive
or operate machinery.

Drosfemine mini contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should contact
her doctor before taking this medicine.

3. How to use Drosfemine mini

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Take one Drosfemine mini tablet daily, with a small amount of water if needed. The tablets may be taken
independently of meals. The tablets should be taken every day at approximately the same time.
The blister pack contains 21 tablets. Next to each tablet is the name of the day of the week on which it
should be taken. For example, if you start taking the tablets on Wednesday, take the tablet marked “Wed”.
Then continue taking the tablets in the direction of the arrows on the blister until all 21 tablets have been
taken.
After this, no tablets should be taken for 7 days. During this 7-day break (called the “tablet-free week”),
withdrawal bleeding usually occurs. This so-called “withdrawal bleeding” typically begins on the 2nd or 3rd
day of the tablet-free week.

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

If you take Drosfemine mini as described above, you are protected against pregnancy also during the 7
days when you do not take tablets.
To help ensure regular daily intake of the contraceptive, pay attention to the arrows on the blister pack.
The arrows indicate the order in which the tablets should be taken.

When can you start the first blister pack?
If you have not used a hormonal contraceptive in the previous month
Start taking Drosfemine mini on the first day of your menstrual cycle (i.e. the first day of your period). If
you start Drosfemine mini on the first day of your period, you are immediately protected against
pregnancy. You may also start between day 2 and day 5 of your menstrual cycle, but in this case, you
should use an additional contraceptive method (e.g. condoms) for the first 7 days.

Switching from a combined hormonal contraceptive, combined vaginal contraceptive ring, or transdermal
contraceptive system (patch)
Start taking Drosfemine mini the day after taking the last active tablet (i.e. the last tablet containing active
substances) of your previous contraceptive, but no later than the day following the tablet-free interval (or
after the last inactive tablet of your previous contraceptive). If switching from a combined vaginal
contraceptive ring or transdermal contraceptive system (patch), follow your doctor’s advice.

Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-
releasing intrauterine device – IUD)
You may switch to Drosfemine mini at any time (from an implant or IUD – on the day of removal; from an
injectable contraceptive – on the day the next injection would have been due). In all these cases, you
should use an additional contraceptive method (e.g. condoms) for the first 7 days of taking Drosfemine mini.

After miscarriage
Follow your doctor’s advice.

After childbirth
You may start taking Drosfemine mini between 21 and 28 days after childbirth. If you start later than 28
days after childbirth, you should use a barrier method (e.g. condoms) for the first 7 days of taking
Drosfemine mini.
If you have had sexual intercourse after giving birth, you should confirm that you are not pregnant before
starting (or restarting) Drosfemine mini, or wait until your next menstrual period.

If you are breastfeeding and wish to start (or restart) taking Drosfemine mini after childbirth
Please read section “Breast-feeding”.

If you are unsure about when to start the first blister pack, consult your doctor.

Taking more Drosfemine mini than recommended
There are no reports of serious harmful effects from taking too many Drosfemine mini tablets. If several
tablets are taken at once, nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur
in girls who have not yet started menstruating but have accidentally taken this medicine.
If you take more Drosfemine mini tablets than recommended, or if a child accidentally swallows any
tablets, contact your doctor or pharmacist immediately.

Missed dose of Drosfemine mini

• If less than 12 hours have passed since you missed a tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as possible, and continue taking the next tablets at your usual time.
• If more than 12 hours have passed since you missed a tablet, protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of pregnancy.

The risk of inadequate protection against pregnancy is greatest if a tablet is missed at the beginning or
end of the blister pack. Therefore, follow the rules below (see also the chart):

Missing more than one tablet from the pack
Contact your doctor.

Missing one tablet in the first week
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Then
continue taking the tablets at your usual time and use additional protection, such as condoms, for the
next 7 days. If you had sexual intercourse in the week before missing the tablet, you may be pregnant. In
this case, contact your doctor.

Missing one tablet in the second week
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Then
continue taking the tablets at your usual time. Protection against pregnancy is not reduced, and no
additional protection is needed.

Missing one tablet in the third week
You have two options:

1. Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Skip the tablet-free interval and start the next blister pack immediately.

   Withdrawal bleeding will most likely occur at the end of the second blister pack, but you may also experience light bleeding or spotting during the second pack.

2. Alternatively, stop taking tablets from the current blister pack and immediately begin the 7-day tablet-free interval (note the day on which you missed the tablet). If you wish to start the new blister pack on the day you usually start, the tablet-free interval may be shortened to less than 7 days.

If you follow either of these two options, you remain protected against pregnancy.

If you have missed any tablets from the pack and do not experience bleeding during the first tablet-free
interval, this may indicate that you are pregnant. Contact your doctor before starting the next blister pack.

More than one
Consult your doctor for advice.
missed tablet from
one blister pack
yes
Did you have sexual intercourse in the
1st week week before missing the tablet?
no

• Take the missed tablet.
• Use a barrier method (condom) for the next 7 days.
• Continue taking tablets from the blister pack. Only one missed tablet (delay in
• Take the missed tablet. 2nd week taking tablet
• Continue taking tablets from the blister pack. exceeds 12 hours)
• Take the missed tablet.
• Continue taking tablets from the blister pack.
• Instead of the usual 7-day tablet-free interval, start the next blister pack immediately.

3rd week or

• Immediately stop taking tablets from the current blister pack.
• Begin the 7-day tablet-free interval (no longer than 7 days, including the day the tablet was missed).
• Then start the next blister pack.

What to do if you vomit or have severe diarrhoea
If you vomit within 3 to 4 hours after taking a tablet or have severe diarrhoea, there is a risk that the active
substances in the tablet may not be fully absorbed. This situation is almost the same as missing a tablet.
After vomiting or diarrhoea, take another tablet from a spare blister pack as soon as possible. If possible,
take it within 12 hours of your usual tablet-taking time. If this is not possible or if more than 12 hours
have passed, follow the advice given under “Missed dose of Drosfemine mini”.

Delaying your period: what you need to know
Although not recommended, it is possible to delay your period by skipping the tablet-free interval and
starting a new Drosfemine mini blister pack immediately, continuing until it is finished. During the second
pack, you may experience light bleeding or spotting. After the usual 7-day tablet-free interval, start the next
blister pack.
You may consult your doctor before deciding to delay your period.

Changing the day your period starts: what you need to know
If you take the tablets as directed, your period will start during the tablet-free week. If you wish to change
this day, you may shorten the number of tablet-free days (but never extend them – the tablet-free interval
must not exceed 7 days!). For example, if your tablet-free interval starts on Friday and you wish to change
it to Tuesday (3 days earlier), start the new blister pack 3 days earlier than usual. If you significantly
shorten the tablet-free interval (e.g. to 3 days or fewer), you may not have a withdrawal bleed during this
time. However, you may later experience light bleeding or spotting.
If you are unsure how to proceed, consult your doctor.

Stopping Drosfemine mini
You may stop taking Drosfemine mini at any time. If you do not wish to become pregnant, consult your
doctor about other effective methods of birth control.
If you wish to become pregnant, stop taking Drosfemine mini and wait for your first natural period before
trying to conceive. This will make it easier to calculate your expected due date.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them. If any adverse reactions occur, especially severe and persistent ones, or any changes in health that the patient considers related to the use of Drosfemine mini, medical advice should be sought from a physician.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Drosfemine mini".

Listed below are adverse reactions associated with the use of Drosfemine mini:

Serious adverse reactions

Seek immediate medical attention if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria potentially associated with breathing difficulties (see also section 2, "Warnings and precautions").

Other adverse reactions

Common adverse reactions (may affect up to 1 in 10 women):

• mood swings,
• headache,
• abdominal pain,
• acne,
• breast pain, breast enlargement, breast tenderness, painful or irregular menstruation,
• weight gain.

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

• candidiasis (fungal infection),
• herpes simplex virus infection,
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disturbances,
• tingling and numbness, dizziness,
• visual disturbances,
• heart rhythm disorders or abnormally rapid heartbeat,
• blood clot (thrombosis) in a blood vessel of the leg or lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins,
• sore throat,
• nausea, vomiting, gastritis and/or enteritis, diarrhoea, constipation,
• sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat) and/or difficulty swallowing, or urticaria with breathing difficulties (angioedema), hair loss (alopecia), eczema (rash), itching, skin rashes, dry skin, seborrhoeic skin disorders,
• neck pain, limb pain, muscle cramps,
• urinary tract infections,
• breast lumps (benign and malignant), milk secretion in non-pregnant women (galactorrhea), ovarian cysts, hot flushes, absence of menstruation, very heavy menstrual bleeding, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic pain), abnormal cervical smear (Papanicolaou test), decreased sexual desire,
• fluid retention, lack of energy, excessive thirst, increased sweating,
• weight loss.

Rare adverse reactions (may affect up to 1 in 1,000 women):

• asthma,
• hearing disorders,
• skin diseases – erythema nodosum (characterized by painful red nodules on the skin) or erythema multiforme (characterized by a rash with red, target-like lesions or ulcerations),
• blood clots in veins or arteries, for example:
• in the leg or foot (e.g. deep vein thrombosis),
• in the lungs (e.g. pulmonary embolism),
• heart attack,
• stroke,
• mini-stroke or transient ischaemic attack, known as transient ischaemic attack (TIA),
• 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 increasing this risk (see section 2 for further information on risk factors for blood clots and symptoms of blood clot formation).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Drosfemine mini

Keep this medicine out of sight and reach of children.
No special storage instructions are required for this 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Drosfemine mini contains

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

What Drosfemine mini looks like and contents of the pack
Each Drosfemine mini blister pack 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 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