Drosfemine forte

Package leaflet: Information for the user

Drosfemine forte, 0.03 mg + 3 mg, film-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 that you can read it again if necessary.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Contents of the leaflet

1. What Drosfemine forte is and what it is used for
2. What you need to know before taking Drosfemine forte
3. How to take Drosfemine forte
4. Possible side effects
5. How to store Drosfemine forte
6. Contents of the pack and other information

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

Drosfemine forte 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 forte

General notes
Before starting to take Drosfemine forte, you should read the information about blood clots in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section 2 "Blood clots"). Before you start taking Drosfemine forte, 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 forte and when the effectiveness of Drosfemine forte may be reduced. In such cases, you should avoid sexual intercourse or use additional non-hormonal contraceptive protection, such as a condom or another barrier method. Do not use the rhythm method or temperature-based methods. These methods may be ineffective because Drosfemine forte alters body temperature changes and cervical mucus changes that occur during the menstrual cycle.

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

When not to use Drosfemine forte

Do not use Drosfemine forte if any of the following conditions apply to you. If any of the conditions listed below apply to you, inform your doctor. Your doctor will discuss with you which other method of contraception may be more suitable.

Do not take Drosfemine forte

• 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 your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in 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 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 currently 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 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 forte and other medicines").

Additional information for specific populations

Children and adolescents
Drosfemine forte is not intended for patients who have not yet started menstruating.

Older women
Drosfemine forte is not intended for use after menopause.

Women with liver function disorders
Do not take Drosfemine forte if you have liver disease. See also sections "Do not take Drosfemine forte" and "Warnings and precautions".

Women with kidney function disorders
Do not take Drosfemine forte if you have kidney failure or acute kidney failure. See also sections "Do not take Drosfemine forte" and "Warnings and precautions".

Warnings and precautions

When to contact your doctor

Seek immediate medical advice if:

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

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

• if blood clots or cancer have occurred in your immediate family;
• 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 in the immediate postpartum period, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Drosfemine forte;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see section "Drosfemine forte 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 occurred 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 chloasma (skin discoloration, especially on the face and neck, also 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 breathing difficulties, you should

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

Psychiatric disorders
Some women using hormonal contraceptives, including Drosfemine forte, have reported depression or low mood. Depression can be severe and, in some cases, may 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 forte is associated with an increased risk of blood clots compared to not using such therapy. 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 disorder"),
in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic disorder").

Complete 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 forte is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice 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 thromboembolism), although these adverse effects 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 taking
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 longer.
After the first year, the risk decreases, although it remains higher compared to when not using combined hormonal contraceptives.
If a patient stops taking Drosfemine forte, the risk of developing 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 being used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Drosfemine forte 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 forte, will develop blood clots.
The risk of developing blood clots depends on the patient's individual medical history (see
"Factors that increase the risk of developing blood clots in veins" below).

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

• 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, if she 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 forte for several weeks before surgery or immobilization. If the patient must stop taking Drosfemine forte, she should consult her doctor about when she can 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 mentioned risk factor.
It is important to inform the doctor if any of the listed factors apply to the patient, even
if she is uncertain. The doctor may decide to discontinue the use of Drosfemine forte.
The patient should inform her doctor if any of the above conditions change during treatment
with Drosfemine forte, e.g. if a close relative is diagnosed with thrombosis without a known
cause, or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the 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
forte is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Drosfemine forte, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, her doctor may recommend using another type of contraception;
• if the patient has 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 been diagnosed with high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly 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.
The patient should inform her doctor if any of the above conditions change during
treatment with Drosfemine forte, e.g. if she starts smoking, if a close relative is diagnosed
with thrombosis without a known cause, or if she gains significant weight.

Drosfemine forte and cancer
A slightly higher 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 an unusual, severe abdominal pain, she should contact a doctor.

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

What to do if no withdrawal bleeding occurs during the weekly break
If all tablets have been taken correctly, there have been no vomiting or severe diarrhoea, and no
other medications have been taken, pregnancy is unlikely.
If the expected bleeding does not occur twice in succession, this may indicate that the patient is pregnant.
She should contact her doctor immediately. A new blister pack should not be started until
it is confirmed that the patient is not pregnant.

Drosfemine forte and other medicines
The patient should inform her doctor or pharmacist about all medicines and herbal products she is currently or recently using, as well as any medicines or herbal products she plans to use.
She should also inform any other doctor or dentist prescribing another medicine (or a pharmacist) that she is using Drosfemine forte. They may advise whether additional contraceptive precautions (e.g. condoms) are needed, and if so, for how long, and whether the way of taking other medicines should be changed.
Some medicines:

• may affect the blood levels of Drosfemine forte;
• may make it less effective in preventing pregnancy;
• may cause unexpected bleeding.

This applies to medicines used in the treatment of:

• 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 forte may affect the action of other medicines, e.g.:

• 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).

Drosfemine forte must not be used 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 activity of the liver enzyme AlAT).
The doctor will recommend another type of contraception before starting treatment with these medicines.
Drosfemine forte may be restarted approximately 2 weeks after completion of
treatment. See section "Do not take Drosfemine forte".

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

Drosfemine forte with food and drink
Drosfemine forte may be taken independently of meals; if necessary, 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 have a child, she should consult her doctor or pharmacist before using this medicine.

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

Breastfeeding
Drosfemine forte is generally not recommended for women who are breastfeeding. If the patient wishes to take oral contraceptives during breastfeeding, she should contact her doctor.

Driving and operating machinery
There is no information suggesting that Drosfemine forte affects the ability to
drive or operate machinery.

Drosfemine forte 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 forte

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

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

The blister pack contains 21 tablets. Each tablet is marked with the day of the week on which it should be taken. For example, if starting on Wednesday, take the tablet marked "Wed". Then continue taking the tablets in the order indicated by the arrows on the blister until all 21 tablets have been taken.

After completing the pack, do not take any tablets 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 forte 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 pack should be started on the same day of the week, and withdrawal bleeding should occur on the same days in each cycle.

If Drosfemine forte is taken as directed, the patient is protected against pregnancy also during the 7 days when no tablets are taken.

To ensure regular daily intake of the contraceptive, follow the arrows on the blister pack. The arrows indicate the order in which the tablets should be taken.

When to start the first blister pack?

If no hormonal contraceptive has been used in the previous month
Start taking Drosfemine forte on the first day of the menstrual cycle (i.e., the first day of menstruation). If the patient starts taking Drosfemine forte on the first day of her period, she is immediately protected against pregnancy. Alternatively, the tablets may be started between day 2 and day 5 of the menstrual cycle, but in this case, an additional contraceptive method (e.g., condom) should be used for the first 7 days.

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

Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing intrauterine device – IUD)
Switching from progestogen-only pills can be done on any day. When switching from an implant or IUD, do so on the day of removal. When switching from injections, switch 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 forte.

After miscarriage
Follow your doctor's advice.

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

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

If the patient is breastfeeding and wishes to start (or restart) Drosfemine forte after childbirth
Please read section "Breast-feeding".

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

Taking more Drosfemine forte than prescribed

There are no reports of serious harmful effects from taking too many Drosfemine forte tablets. If several tablets are taken at once, symptoms such as 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 forte tablets are taken, or if a child accidentally swallows some tablets, consult a doctor or pharmacist immediately.

Missed dose of Drosfemine forte

• If less than 12 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 12 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 inadequate protection is greatest if a tablet is missed at the beginning or end of the pack. Therefore, follow these rules (see also the chart below):

Missing more than one tablet from the pack
Consult 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 tablets at the usual time and use additional contraception (e.g., condom) for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, pregnancy may be possible. In this case, consult 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 tablets at the usual time. Protection against pregnancy is not reduced, and no additional contraception is needed.

Missing one tablet in the third week
Two options are available:

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. Skip the tablet-free interval and start the next pack immediately.

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

2. Alternatively, stop taking tablets from the current pack and immediately start the 7-day tablet-free interval (note the day the tablet was missed). If the patient wishes to start the new pack on her usual starting day, the tablet-free interval may be shortened to less than 7 days.

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

If any tablet from the pack has been missed and no withdrawal bleeding occurs during the first tablet-free interval, this may indicate pregnancy. Consult your doctor before starting the next pack.

More than one
tablet missed from
one pack
yes

Has sexual intercourse occurred
in the week
preceding the missed
tablet?
no

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

in the 3rd week or

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

What to do in case of vomiting or severe diarrhoea
If vomiting occurs within 3 to 4 hours after taking a tablet, or if severe diarrhoea develops, there is a risk that the active substances may not be fully absorbed. This situation is similar to 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 the usual time for taking the tablet. If this is not possible or if 12 hours have passed, follow the instructions under "Missed dose of Drosfemine forte".

Delayed menstruation: what you should know
Although not recommended, it is possible to delay menstruation by skipping the tablet-free interval and immediately starting a new pack of Drosfemine forte until it is finished. During the second pack, light bleeding or spotting may occur. After the usual 7-day tablet-free interval, start the next pack.

Before deciding to delay menstruation, consult your doctor.

Changing the day of menstruation: what you should know
If tablets are taken as directed, menstruation will occur during the tablet-free week. If a change in the day of menstruation is desired, reduce the number of tablet-free days (but never increase—maximum 7 days). For example, if the tablet-free interval starts on Friday and you wish to change it to Tuesday (3 days earlier), start the new pack 3 days earlier than usual. If the tablet-free interval is significantly shortened (e.g., to 3 days or less), menstruation may not occur during this time, but light bleeding or spotting may occur later.

If in doubt about how to proceed, consult your doctor.

Stopping Drosfemine forte

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

If the patient wishes to become pregnant, she should stop taking Drosfemine forte and wait for the first natural menstrual period before trying to conceive. This will make 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 and persistent ones, or changes in health which the patient considers to be related to the use of Drosfemine forte, medical advice should be sought.

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 the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Drosfemine forte".

Below is a list of adverse reactions associated with the use of Drosfemine forte:

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):

• Menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness,
• Headache, depressed mood,
• Migraine,
• Nausea,
• Thick, white vaginal discharge and candidal vaginitis.

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

• Breast enlargement, changes in sexual desire,
• High blood pressure, low blood pressure,
• Vomiting, diarrhoea,
• Acne, skin rash, severe itching, hair loss (alopecia),
• Vaginal infection,
• Fluid retention and changes in body weight.

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

• Allergic reactions (hypersensitivity), asthma,
• Breast discharge,
• Hearing disorders,
• Skin disorders – nodular erythema (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 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, intestines, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on factors increasing the risk of 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 for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 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 forte

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 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Drosfemine forte contains

• The active substances are ethinylestradiol and drospirenone. Each tablet contains 0.03 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, yellow iron oxide (E172).

What Drosfemine forte looks like and contents of the pack
Each Drosfemine forte blister contains 21 yellow, round, film-coated tablets.
Drosfemine forte 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