Drosfemine

Package leaflet: Information for the user

Drosfemine, 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 a break of 4
weeks or longer.
Be vigilant and consult a doctor if a woman suspects symptoms of blood clot formation (see section 2 "Blood clots").
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Drosfemine is and what it is used for
2. What you need to know 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 Drosfemine is and what it is used for

Drosfemine is a contraceptive tablet 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 contain no active substance and are called placebo tablets.
Contraceptive tablets containing two hormones are called combined oral contraceptives.

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 become familiar with the symptoms of blood clots
(see section 2 "Blood clots"). Before starting Drosfemine, 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 examinations.
This leaflet describes several situations in which you should stop taking
Drosfemine and in which the effectiveness of Drosfemine may be reduced. In such situations,
you should not have sexual intercourse or should use an additional non-hormonal
contraceptive method, such as a condom or another barrier method. Do not use the
calendar method or temperature monitoring. These methods may be ineffective because Drosfemine
alters body temperature changes and cervical mucus changes that occur during the
menstrual cycle.
Drosfemine, like other hormonal contraceptives, does not protect against infection
with HIV (AIDS) or other sexually transmitted diseases.

When not to take Drosfemine
Do not take Drosfemine if you have any of the conditions listed below.
If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you
which alternative contraceptive method would be more suitable.
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), in the lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders — 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 had in the past) 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 conditions 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 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 (kidney failure);
• if you have (or have had in the past) liver tumour;
• if you have (or have had in the past) breast cancer or reproductive organ cancer, 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 with other medicines").

Additional information for specific populations
Children and adolescents
Drosfemine is not intended for use in women who have not yet started menstruating.
Older women
Drosfemine is not intended for use after menopause.
Women with liver function disorders
Do not take Drosfemine if you have liver disease. See also sections "Do not take Drosfemine" and "Warnings and precautions".
Women with kidney function disorders
Do not take Drosfemine if you have kidney failure or acute kidney 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 possible symptoms of blood clots, which may indicate that you have blood clots in the leg (deep vein thrombosis), in the 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 or any other combined oral contraceptive. Regular check-ups by your doctor may also be necessary. If any of these conditions appear or worsen during treatment with Drosfemine, you should also inform your doctor.

• if close family members have or have ever 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 blood fat levels (hypertriglyceridaemia) or have a 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 have recently given birth, as you are then at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Drosfemine;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see section "Drosfemine with 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 or have ever had chloasma (skin pigmentation, especially on the face and neck, known as "pregnancy mask"). 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 hives potentially with difficulty breathing, you should

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

Psychiatric disorders
Some women using hormonal contraceptives, including Drosfemine, have reported depression or
low mood. Depression can be severe and 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 is associated with an
increased risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can 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 from a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, lead to death.
Remember that the overall risk of harmful blood clots caused by taking Drosfemine is low.

HOW TO RECOGNIZE BLOOD CLOTS
Contact your doctor immediately if you notice any of the following symptoms.

BLOOD CLOTS IN VEINS
What can happen if blood clots form in a vein?

• Use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thromboembolism), 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 developing 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 an interval 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, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Drosfemine is low.
In the course of one year, about 2 out of 10,000 women who are not using 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 are using 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 are using combined hormonal contraceptives containing drospirenone, such as Drosfemine, 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 is small, however,
some factors may increase this risk. The risk is higher:

• if the patient has a high body weight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years of age). In this case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue Drosfemine for several weeks before surgery or immobilization. If the patient must stop taking Drosfemine, consult the doctor about 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 blood clots, particularly
if the patient has another risk factor listed above.
It is important to inform the doctor if any of these factors apply to the patient, even
if uncertain. The doctor may decide to discontinue Drosfemine.
Inform the doctor if any of the above conditions change during treatment with
Drosfemine, for example, if a close family member is diagnosed with unexplained thrombosis or
if the patient gains significant weight.
ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the arteries?
As with 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 is
very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Drosfemine, 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 a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member 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 family member has high levels of lipids in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder called 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 blood clots may be further increased.
Inform the doctor if any of the above conditions change during
treatment with Drosfemine, for example, if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.
Drosfemine and cancer
A slightly increased incidence of breast cancer has been observed in women using combined oral contraceptives,
but it is not known whether this is caused by taking the pills. It is possible that more tumours 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 a doctor if any lump is detected.
In rare cases, benign liver tumours have been reported in women using oral contraceptives, and even more rarely, malignant liver tumours. If the patient experiences unusual, severe abdominal pain, contact a doctor.
Intermenstrual bleeding
During the first few months of taking Drosfemine, unexpected bleeding (bleeding outside the placebo tablet period) may occur.
If such bleeding persists for longer than a few months or begins after several months,
the doctor should investigate the cause.
What to do if no withdrawal bleeding occurs during the placebo tablet period
If all pink active tablets have been taken correctly, there has been no vomiting or severe diarrhoea, and no other medicines have been taken, pregnancy is unlikely.
If the expected withdrawal bleeding does not occur twice in succession, this may indicate that the patient is pregnant.
Contact the doctor immediately. Do not start a new blister pack until it is confirmed that the patient is not pregnant.
Drosfemine 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 Drosfemine is being used. 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,
• 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 (so-called 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 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 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, as these medicines may cause abnormal liver function test results (increased activity of the liver enzyme AlAT).
The doctor will recommend another type of contraception before starting these medicines.
Drosfemine may be restarted approximately 2 weeks after stopping treatment.
See section "Do not take Drosfemine".
Laboratory tests
If a blood test is required, inform the doctor or laboratory staff that oral contraceptives are being taken, as hormonal contraceptives may affect the results of certain tests.
Drosfemine with food and drink
Drosfemine may be taken independently 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 a doctor or pharmacist before using this medicine.
Pregnancy
If the patient is pregnant, Drosfemine must not be used. If the patient becomes pregnant
while taking Drosfemine, she should stop taking it immediately and contact her
doctor. If the patient wishes to become pregnant, she may stop taking Drosfemine at any time
(see section "Stopping Drosfemine").
Breastfeeding
Generally, Drosfemine is not recommended for women who are breastfeeding. 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 affects the ability to drive
or operate machinery.
Drosfemine contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, she should contact
her doctor before taking this medicine.
The placebo coated tablets contain less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine
is considered "sodium-free".

3. How to take Drosfemine

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Each blister contains 24 pink tablets containing active substances and 4 white placebo tablets. The two differently coloured tablets are arranged in sequence. One blister contains 28 tablets.

Take one tablet of Drosfemine daily, which may be taken with a small amount of water. The tablets may be taken regardless of meals. Tablets should be taken every day at approximately the same time.

Do not confuse the tablets: take the pink tablets for the first 24 days, followed by the white tablets for the last 4 days. Then immediately start taking tablets from a new blister (24 pink, then 4 white tablets). Therefore, there is no break between blisters.

Due to the differing composition of the tablets, treatment should always begin with the first tablet marked “START”, and tablets should be taken daily. To maintain the correct order, follow the direction of the arrows on the blister.

Preparing the blister

To help ensure regular daily intake of the contraceptive, pay attention to the arrows printed on the blister.

The arrows indicate the order in which the tablets should be taken.

Remember the day of the week on which you take the first tablet. (You may mark the day of the week you started in the box next to the starting point on the blister.)

During the 4 days when the patient takes the white placebo tablets (placebo days), withdrawal bleeding should begin. This usually starts on the 2nd or 3rd day after taking the last active pink tablet of Drosfemine. After taking the last white placebo tablet, start the next blister immediately, regardless of whether bleeding has stopped or not. This means each blister should be started on the same day of the week, and withdrawal bleeding should occur on the same days in each cycle.

If Drosfemine is taken as directed, protection against pregnancy is maintained even during the 4 days when placebo tablets are taken.

When to start the first blister?

If no hormonal contraceptive has been used in the previous month

Start taking Drosfemine on the first day of the menstrual cycle (i.e. the first day of menstruation). If the patient starts taking Drosfemine on the first day of menstruation, immediate protection against pregnancy is provided. The patient may also start taking the tablets between day 2 and day 5 of the cycle, but in this case, an additional contraceptive method (e.g. a condom) should be used for the first 7 days.

Switching from a combined hormonal contraceptive, combined contraceptive vaginal ring system, or transdermal contraceptive patch system

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

Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine device releasing progestogen – IUD)

Switching from progestogen-only pills can be done on any day. (From an implant or intrauterine device – on the day of removal; from injectable forms – on the day the next injection would have been due.) In all these cases, an additional contraceptive method (e.g. condom) should be used for the first 7 days of taking Drosfemine tablets.

After miscarriage

Follow your doctor’s instructions.

After childbirth

Drosfemine may be started between day 21 and day 28 after childbirth. If starting later than day 28 after childbirth, a barrier method (e.g. condoms) should be used for the first 7 days of taking Drosfemine.

If sexual intercourse has occurred after childbirth, before starting (or restarting) Drosfemine, ensure the patient is not pregnant, or wait until the next menstrual bleeding.

If the patient is breastfeeding and wishes to start (or restart) taking Drosfemine after childbirth

Read section “Breast-feeding”.

If the patient is unsure when to start the first blister, she should contact her doctor.

Taking more Drosfemine than recommended

There are no reports of serious harmful effects from taking too many Drosfemine 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 too many Drosfemine tablets are taken, or if a child swallows several tablets, consult a doctor or pharmacist immediately.

Missed dose of Drosfemine

The last 4 tablets in the blister (tablets 25–28) are placebo tablets. If one of these is missed, contraceptive effectiveness is not affected. Discard the missed placebo tablet.

If a pink tablet containing active substances is missed (tablets 1–24 of the blister), take the following steps:

• If less than 24 hours have passed since the missed tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as possible, and continue taking the following tablets at the usual time.
• If more than 24 hours have passed since the missed tablet, protection against pregnancy may be reduced. The greater the number of missed tablets, the higher the risk of pregnancy.

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

Missing more than one tablet from a blister

Contact your doctor.

Missing one tablet between days 1 and 7

Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Then continue taking tablets at the usual time and use additional contraception (e.g. condoms) for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, pregnancy may have occurred. In this case, contact your doctor.

Missing one tablet between days 8 and 14

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

Missing one tablet between days 15 and 24

There are 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 tablets at the usual time. Instead of taking the white placebo tablets from the blister, discard them and start the next blister immediately (the starting day will be different from usual).

Menstruation will most likely occur at the end of the second blister – during the intake of white placebo tablets – but light bleeding or breakthrough bleeding resembling menstruation may also occur during the second blister.

2. Alternatively, stop taking the active pink tablets and immediately start taking the 4 white placebo tablets (before taking the placebo tablets, note the day on which the tablet was missed). If the patient wishes to start the new blister on the usual starting day, the placebo tablets may be taken for fewer than 4 days.

If either of these two options is followed, the patient remains protected against pregnancy.

If the patient has missed any tablet from the blister and no bleeding occurs during the placebo days, this may indicate pregnancy. Contact your doctor before starting the next blister.

More than one active pink tablet missed from one blister

Yes
Has sexual intercourse occurred in the
1–7 days preceding the missed tablet?
No

• Take the missed tablet.
• Use barrier method (condom) for the next 7 days.
• Continue taking tablets from the blister.
  Only one missed tablet (delay in tablet intake
  exceeds 24 hours)
• Take the missed tablet.
• Continue taking tablets from the blister.
• Take the missed tablet.
• Continue taking tablets from the blister.
• Discard the 4 white placebo tablets.
• Start the next blister.

Day 15–24 or

• Immediately stop taking tablets from the blister.
• Start taking the 4 white placebo tablets.
• Then start the next blister.

What to do if vomiting or severe diarrhoea occurs

If vomiting occurs within 3 to 4 hours after taking a pink active tablet, or if severe diarrhoea occurs, there is a risk that the active substances may not be completely absorbed. This situation is almost equivalent to missing a tablet. After vomiting or diarrhoea, take another pink active tablet from a spare blister as soon as possible. If possible, take it within 24 hours of the usual tablet-taking time. If this is not possible or if 24 hours have passed, follow the advice given in the section “Missed dose of Drosfemine”.

Delayed menstruation: what you should know

Although not recommended, it is possible to delay the onset of menstruation by skipping the white placebo tablets (tablets 25–28) and immediately starting a new blister of Drosfemine until it is finished. During intake of the second blister, light bleeding or breakthrough bleeding resembling menstruation may occur. After completing 4 white placebo tablets (tablets 25–28) from the second blister, start the next blister.

Before deciding to delay menstruation, consult your doctor for advice.

Changing the day of menstruation: what you should know

If the patient takes the tablets as directed, menstruation will begin during the placebo days. If a change in this day is required, reduce the number of placebo days – the days when white placebo tablets are taken (but never increase – maximum 4 days!). For example, if the patient usually starts placebo tablets on Friday but wishes to change to Tuesday (3 days earlier), she must start the new blister 3 days earlier than usual. Bleeding may not occur at this time, but light bleeding or breakthrough bleeding resembling menstruation may occur later.

If the patient is unsure how to proceed, she should contact her doctor.

Stopping Drosfemine

Drosfemine may be stopped at any time. If the patient does not wish to become pregnant, she should consult her doctor about other effective methods of birth control.

If the patient wishes to become pregnant, she should stop taking Drosfemine and wait for the first natural menstrual period before trying to conceive. This makes it easier to calculate the expected date of delivery.

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 experiences them. If any adverse reactions occur, especially severe or persistent ones, or any changes in health that the patient considers related to the use of Drosfemine, medical advice should be sought from a physician.

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

The following is a list of adverse reactions associated with the use of Drosfemine:

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 users):

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

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

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

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

• candidiasis (fungal infection),
• anaemia, increased platelet count,
• allergic reaction,
• endocrine (hormonal) disorders,
• increased appetite, loss of appetite, abnormally high blood potassium levels, abnormally low blood sodium levels,
• anorgasmia, insomnia,
• dizziness, tremor,
• eye disorders, e.g. eyelid inflammation, dry eye syndrome,
• abnormally rapid heart rhythm,
• phlebitis, nosebleeds, fainting,
• increased abdominal girth, intestinal disorders, bloating sensation, abdominal hernia, oral fungal infection, constipation, dry mouth,
• biliary tract or gallbladder-related pain, gallbladder inflammation,
• yellowish-brown skin patches, eczema (rash), hair loss, acneiform dermatitis, dry skin, nodular dermatitis, hirsutism, skin disorders, striae, dermatitis, photosensitivity dermatitis, skin nodules,
• painful or difficult intercourse, vulvovaginitis (inflammation of the vagina and vulva), post-coital bleeding, withdrawal bleeding, breast cysts, increased number of breast gland cells (hyperplasia), malignant breast tumours, abnormal cervical endometrial hyperplasia, endometrial atrophy or shrinkage, 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 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 conditions that increase this risk (see section 2 for further information on risk factors for blood clots and symptoms of blood clot formation).

Based on available data, the frequency of the following reported adverse reactions cannot be determined:

• hypersensitivity,
• erythema multiforme (rash with red, target-shaped lesions or ulceration).

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 provide more information on the safety of this medicine.

5. How to store the medicine Drosfemine

Keep the medicine out of sight and reach of children.
No special storage instructions are required for this medicine.
Do not use the medicine after the expiry date stated on the blister and the 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 contains

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

The white coated placebo tablets do not contain any active substances.

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

White coated placebo tablets:

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

What Drosfemine looks like and contents of the pack
Each Drosfemine blister pack contains 24 pink coated tablets with active substances and 4 white coated placebo tablets.
The tablets containing active substances are pink. The placebo tablets are white. Both types of coated tablets are round.
Drosfemine is available in packs containing 1, 3 or 6 blisters, 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