Sidretella 20

Package leaflet: information for the user

Sidretella 20, 0.02 mg + 3 mg, film-coated tablets
Ethinylestradiolum + Drospirenonum
Important information regarding 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 following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the user suspects symptoms of blood clot formation (see section 2, "Blood clots").

Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people.
• 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 Sidretella 20 is and what it is used for
2. Important information before taking Sidretella 20
3. How to take Sidretella 20
4. Possible side effects
5. How to store Sidretella 20
6. Contents of the pack and other information

1. What Sidretella 20 is and what it is used for

Sidretella 20 is a contraceptive medicine used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones named drospirenone and ethinylestradiol.
Contraceptive tablets containing two hormones are known as "combined" tablets.

2. Important information before using Sidretella 20

General information
Before starting to take Sidretella 20, you should read the information about blood clots in section 2. It is especially important to be aware of the symptoms of blood clots – see section 2, "Blood clots".
Before a woman starts taking Sidretella 20, her doctor will ask several questions about her current and past health, as well as that of her close relatives. The doctor will measure her blood pressure and, depending on her current health status, may carry out further examinations.
This leaflet describes various situations in which you should stop taking Sidretella 20 or in which the effectiveness of Sidretella 20 may be reduced. In such cases, you should avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other barrier methods.
Do not use fertility awareness-based methods or temperature-based methods. These methods may not be reliable, as Sidretella 20 disrupts the monthly cycle of body temperature changes and cervical mucus secretion.
Sidretella 20, like other hormonal contraceptives, does not protect against infection with the HIV virus (AIDS) or against other sexually transmitted infections.

When not to use Sidretella 20
Do not use Sidretella 20 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 alternative method of contraception may be more suitable.

• 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 a blood clotting disorder – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies.
• If you require surgery or prolonged immobilization (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 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 previously had a type of migraine called "migraine with aura".
• If you currently 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 currently 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 are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). This allergy may cause itching, rash, or swelling. Do not use Sidretella 20 if you have hepatitis C and are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Sidretella 20 and other medicines").

Additional information for special populations
Children and adolescents
Sidretella 20 is not intended for use in girls who have not yet started menstruating.
Elderly women
Sidretella 20 is not intended for use after menopause.
Women with liver function disorders
Do not take Sidretella 20 if you have liver disease. See also sections "When not to use Sidretella 20" and "Warnings and precautions".
Women with kidney function disorders
Do not take Sidretella 20 if you have kidney failure or acute kidney failure. See also sections "When not to use Sidretella 20" and "Warnings and precautions".

Warnings and precautions
When should you contact your doctor?
Seek immediate medical advice if:

• You notice possible symptoms of a blood clot, which may indicate that 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 the symptoms of these serious adverse effects, see "How to recognize a blood clot". When using Sidretella 20 or any other combined hormonal contraceptives, special caution may be required. Regular health checks by your doctor may be necessary.

If you have any of the following conditions, tell your doctor
before starting to take Sidretella 20. If any of the following symptoms appear or worsen during treatment with Sidretella 20, inform your doctor as well.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases).
• If you have systemic lupus erythematosus (a disease affecting the natural immune system).
• If you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure).
• If you have sickle cell anaemia (an inherited disorder of red blood cells).
• If you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
• If you require surgery or prolonged immobilization (see section 2, "Blood clots").
• If you have recently given birth, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Sidretella 20.
• If you have superficial thrombophlebitis (inflammation of veins under the skin).
• If you have varicose veins.
• If any of your close relatives have or have had breast cancer.
• If you have liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have epilepsy (see section "Sidretella 20 and other medicines").
• If you have a condition that first occurred during pregnancy or during 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 involuntary movements (Sydenham's chorea)).
• If you currently have or have previously had chloasma (skin discoloration, especially on the face or neck, also known as "melasma" or "mask of pregnancy"). In such cases, avoid direct sunlight and ultraviolet radiation.
• If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives that may cause breathing difficulties, seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Sidretella 20 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 disorders").
  Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal. It is important to remember that the overall risk of harmful blood clots associated with the use of Sidretella 20 is low.

HOW TO RECOGNIZE A BLOOD CLOT
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). However, 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 highest during the first year of first-time use of combined hormonal contraceptives. The risk may also be increased 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 compared to when combined hormonal contraceptives are not used.
If a woman stops taking Sidretella 20, the risk of developing blood clots returns to normal within a few weeks.

What does the risk of developing blood clots in veins depend on?
The risk depends on the natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism) associated with the use of Sidretella 20 is low.

• In 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 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 one year, about 9–12 out of 10,000 women who are using combined hormonal contraceptives containing drospirenone, such as Sidretella 20, will develop blood clots.
• The risk of developing blood clots may vary depending on an individual woman's 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 Sidretella 20 is low, however,
some factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²).
• if a close family member has had blood clots in the leg, lung, or another organ at a young age (e.g. under 50 years of age). In this case, the patient may have inherited clotting disorders.
• if the patient requires surgery or will be immobilized for a prolonged period due to injury, illness, or having a leg in a cast. It may be necessary to discontinue use of Sidretella 20 for several weeks before surgery or periods of reduced mobility. If the patient needs to

discontinue use of Sidretella 20, ask the doctor when it is safe to resume
taking the medicine.

• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks). The risk of 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, especially 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 use of Sidretella 20. Inform the doctor if any of the above conditions change during treatment with Sidretella 20, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can cause serious
complications, 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 use of
Sidretella 20 is very small, but may increase:

• with age (above approximately 35 years);
• if the patient smokes tobacco. While using a hormonal contraceptive such as Sidretella 20, 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 fats in the blood (cholesterol or triglycerides).
• if the patient suffers from migraines, especially migraines with aura.
• if the patient has heart disease (valvular damage, heart rhythm disorders such as atrial fibrillation).
• if the patient has diabetes. If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be even greater. Inform the doctor if any of the above conditions change during treatment with Sidretella 20, for example, if the patient starts smoking, if a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

CONTRACEPTION AND CANCER
It has been observed that breast cancer occurs slightly more frequently in women using combined
hormonal contraceptives, but it is not known whether this is related to the medication. For example,
it is possible that more cancers are detected in women using hormonal contraceptives because
these women are examined more frequently by doctors. After stopping the use of combined hormonal
contraceptives, the incidence of breast cancer gradually decreases.
It is important to regularly examine the breasts and consult a doctor if any lump is detected.
In women using combined hormonal contraceptives, benign liver tumors have been observed rarely, and malignant liver tumors even more rarely. If the patient experiences an unusual, severe abdominal pain, she should consult a doctor.

INTERMENSTRUAL BLEEDING
During the first few months of using Sidretella 20, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding persists for longer than a few months, or if it appears after several months, the doctor should investigate the cause.
What to do if bleeding does not occur during the pill-free week
If the patient has taken all tablets correctly, has not vomited, has not had severe diarrhea, and has not taken any other medicines, it is very unlikely that she is pregnant.
If expected bleeding does not occur in two consecutive cycles, this may indicate pregnancy. The patient should contact the doctor immediately. The patient should not start the next pack until pregnancy has been ruled out.

PSYCHIATRIC DISORDERS
Some women using hormonal contraceptives, including Sidretella 20, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should contact the doctor as soon as possible for further medical advice.

Sidretella 20 and other medicines
The patient should inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines she plans to take. In addition, the patient should inform any doctor or dentist who prescribes another medicine (or pharmacist) about the use of Sidretella 20. They may advise the need for additional contraceptive methods (e.g. condoms), how long to use them, and whether the use of another medicine the patient is taking needs to be changed.
Some medicines may affect the blood levels of Sidretella 20 and may cause it to be less effective in preventing pregnancy or may cause unexpected bleeding.
These include medicines:

• used to treat epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
• used to treat tuberculosis (e.g. rifampicin),
• used to treat HIV infection and hepatitis C virus (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• used to treat fungal infections (e.g. griseofulvin, ketoconazole),
• used to treat arthritis, osteoarthritis (etoricoxib),
• used to treat pulmonary hypertension (bosentan),
• containing St. John's wort (Hypericum perforatum). Sidretella 20 may also affect other medicines, for example:
• medicines containing cyclosporine,
• the antiepileptic drug lamotrigine (which may lead to increased frequency of seizures),
• theophylline (used for breathing problems),
• tizanidine (used to treat pain and/or muscle spasms). Sidretella 20 should 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, as they may lead to increased liver function test results (elevated levels of the liver enzyme AlAT). The doctor will recommend another type of contraception before starting treatment with these medicines. Approximately 2 weeks after completing such treatment, use of Sidretella 20 may be resumed. See section “When not to use Sidretella 20”.

Sidretella 20 with food and drink
Sidretella 20 may be taken independently of meals. If necessary, it can be taken with a small amount of water.

Laboratory tests
If blood tests are required, inform the doctor or laboratory staff about the use of hormonal contraceptives, as oral contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
Pregnancy
If the patient is pregnant, Sidretella 20 should not be taken. If the patient becomes pregnant while taking Sidretella 20, she should stop taking it immediately and contact her doctor. If the patient wishes to become pregnant, she may discontinue use of Sidretella 20 at any time (see also “Discontinuing use of Sidretella 20”).
Before taking any medicine, consult a doctor or pharmacist.

Breastfeeding
Sidretella 20 is generally not recommended for women who are breastfeeding. If the patient wishes to use a contraceptive during breastfeeding, she should consult her doctor.
Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
There is no information suggesting that Sidretella 20 affects the ability to drive or operate machinery.

Sidretella 20 contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Sidretella 20

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Take one tablet of Sidretella 20 once daily, as needed, with a small amount of water. The tablets may
be taken with or without food. However, they should be taken at approximately the same time each day.
One blister contains 21 tablets. The day of the week on which each tablet should be taken is printed
next to it. For example, if tablet-taking begins on Wednesday, take the tablet marked "śr." (for "środa").
Follow the arrows on the blister until all 21 tablets have been taken.
Then, do not take any tablets for 7 days. During these 7 days of tablet-free interval (the break from taking
the medicine), withdrawal bleeding should occur. This bleeding, also known as withdrawal bleeding,
usually starts on the second or third day of the tablet-free interval.
On the eighth day after taking the last tablet of Sidretella 20 (i.e. after completing the 7-day tablet-free
interval), start a new blister, even if bleeding has not stopped. This means that each new blister should
be started on the same day of the week, and withdrawal bleeding should occur on approximately the
same day each month.
If the patient takes Sidretella 20 exactly as described, she will remain protected against pregnancy
during the 7-day tablet-free interval.

When should the patient start the first pack?

• If the patient has not previously used any hormonal contraceptives. Begin taking Sidretella 20 on the first day of the cycle (i.e. the first day of menstruation). If the patient starts taking Sidretella 20 on the first day of her period, she will be immediately protected against pregnancy. Alternatively, the tablets may be started between the second and fifth day of the cycle, but in this case, additional contraceptive methods (e.g. condoms) must be used for the first 7 days.
• Switching from another combined hormonal contraceptive, vaginal contraceptive system, or transdermal contraceptive system. Begin taking Sidretella 20 the day after taking the last active tablet from the previous pack (i.e. the last tablet containing active ingredients), but no later than the day after the tablet-free interval of the previous contraceptive ends (or after taking the last active tablet of the previous contraceptive). If switching from a vaginal contraceptive system or transdermal contraceptive system containing combined hormonal contraceptives, follow your doctor's advice.
• Switching from a progestogen-only contraceptive (progestogen-only pills, injections, implants, or intrauterine systems releasing progestogen). Switching from progestogen-only pills may be done at any time. (In the case of an implant or intrauterine system releasing progestogen, take the first tablet of the new medicine on the day of removal; in the case of injections, take the first tablet on the day the injection was due.) However, in all cases, additional contraceptive protection (e.g. condoms) is recommended for the first 7 days of tablet-taking.
• After miscarriage. Follow your doctor's advice.
• After childbirth. Sidretella 20 may be started between 21 and 28 days after delivery. If the patient starts taking the medicine later, she should use a barrier method of contraception (e.g. condoms) for the first 7 days of taking Sidretella 20.

If the patient has had sexual intercourse after childbirth but before (re)starting
Sidretella 20, she should ensure she is not pregnant or wait until her next period.

• If the patient is breastfeeding and wishes to (re)start taking Sidretella 20 after childbirth,
  please refer to the section "Breast-feeding."

If the patient is unsure when to start taking the medicine, she should consult her doctor.

Taking more than the recommended dose of Sidretella 20
There are no reports of serious consequences from taking too many Sidretella 20 tablets.
If several tablets are taken at once, the patient may feel unwell, experience nausea or vomiting, or vaginal
bleeding may occur. Even in girls who have not yet started menstruating but accidentally took this
medicine, such bleeding may occur.
If the patient has taken too many Sidretella 20 tablets or if a child has swallowed any tablets, consult a
doctor or pharmacist immediately.

Missed dose of Sidretella 20

• If the delay in taking a tablet is less than 12 hours, contraceptive protection is not reduced. Take the missed tablet as soon as possible, and continue taking the remaining tablets at the usual time.
• If the delay in taking a tablet is more than 12 hours, contraceptive protection may be reduced. The more tablets missed, the greater the risk of pregnancy. The risk of reduced contraceptive protection is greatest if a tablet is missed at the beginning or end of the pack. Follow the instructions below (see also the diagram below):
  • Missing more than one tablet in a pack: Contact your doctor.
  • Missing one tablet in week 1: Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the remaining tablets at the usual time and use additional contraceptive precautions, such as condoms, for the next 7 days. If the patient had sexual intercourse during the week before missing the tablet, there is a risk of pregnancy. In this case, consult your doctor.
  • Missing one tablet in week 2: Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the remaining tablets at the usual time. Contraceptive protection remains effective, and additional precautions are not necessary.
  • Missing one tablet in week 3: Choose one of the following two options:
    1. Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the remaining tablets at the usual time. Instead of taking a 7-day break, immediately start the next blister pack.

Withdrawal bleeding will likely occur after finishing the second blister, but spotting or bleeding may
occur during the intake of tablets from the second blister.

2. Alternatively, stop taking tablets and immediately begin the 7-day tablet-free interval (note the day on which the tablet was missed). If the patient wishes to start the new pack on her usual day of the week, the tablet-free interval should be shorter than 7 days. Following either of these two options ensures continued protection against pregnancy.

If the patient missed any tablet from the blister and did not experience bleeding during the first tablet-free interval, this may indicate pregnancy. In this case, consult your doctor before starting the second pack.

What to do in case of vomiting or severe diarrhoea
If vomiting occurs within 3–4 hours after taking a tablet or if severe diarrhoea develops, there is a risk that the active substances have not been fully absorbed. This situation is similar to missing a tablet. After vomiting or diarrhoea, take a tablet from a spare pack as soon as possible. Ideally, take it within 12 hours of the usual time of tablet intake. If this is not possible or if more than 12 hours have passed, follow the advice given under "Missed dose of Sidretella 20."

Delayed menstruation: what to know
Although not recommended, the patient may delay withdrawal bleeding by skipping the tablet-free interval and immediately starting the second blister of Sidretella 20 tablets, continuing until the end of that blister. Spotting or bleeding may occur during the intake of tablets from the second blister. After the usual 7-day tablet-free interval, start taking tablets from the next blister pack.
Before deciding to delay menstruation, consult your doctor.

Changing the day of menstruation: what to know
If the patient takes the tablets as directed, menstruation will occur during the tablet-free interval. If it is necessary to change this day, it can be done by shortening (but never lengthening – maximum 7 days) the tablet-free interval. For example, if the tablet-free interval starts on Friday, and the patient wishes to shift the start day to Tuesday (3 days earlier), she should start the new pack 3 days earlier than usual. If the tablet-free interval is very short (e.g. 3 days or less), bleeding may not occur during this phase. Spotting or intermenstrual bleeding may occur.
If the patient is unsure what to do, she should consult her doctor.

Stopping treatment with Sidretella 20
Treatment with Sidretella 20 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 contraception. If the patient wishes to become pregnant, she should stop taking Sidretella 20 and wait for menstruation to occur before trying to conceive. This makes it easier to calculate the expected date of delivery.
For any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or any changes
in health that the patient considers related to the use of Sidretella 20, she should
consult a doctor.

Severe adverse effects
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, which may cause difficulty breathing (see also section "Warnings and precautions").

All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on the various risks associated with the use of combined hormonal contraceptives, refer to section 2, "Important information before using Sidretella 20".

The following adverse effects have been associated with the use of Sidretella 20.

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

• mood changes,
• headaches,
• abdominal pain (stomach ache),
• acne,
• breast tenderness, breast enlargement, breast pain, painful or irregular menstruation,
• weight gain.

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

• candidiasis (fungal infections),
• cold sores (herpes simplex),
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disturbances, decreased interest in sex,
• tingling sensation, dizziness (central origin dizziness),
• visual disturbances,
• irregular or abnormally rapid heartbeat,
• pulmonary embolism (blood clot in the lungs), high blood pressure, low blood pressure, migraine, varicose veins,
• sore throat,
• nausea, vomiting, gastritis and/or enteritis, diarrhoea, constipation,
• hair loss (alopecia), eczema (rash), itching, skin rash, dry skin, seborrhoeic skin disorders (seborrhoeic dermatitis),
• neck pain, limb pain, muscle cramps,
• urinary tract infection,
• breast lumps (benign and malignant), galactorrhea (milk discharge in non-pregnant women), ovarian cysts, hot flushes, absence of menstruation, excessively heavy menstrual bleeding, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic pain), abnormal cervical smear test result (Pap test),
• fluid retention, lack of energy, excessive thirst, increased sweating,
• weight loss.

Rare adverse effects (may affect up to 1 in 1000 women):

• asthma,
• hearing impairment,
• erythema nodosum (a condition characterized by red, painful nodules on the skin),
• erythema multiforme (rash presenting as redness or ulceration),
• life-threatening 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 and/or intestine, kidneys or eye. The likelihood of blood clots may be higher if the patient has any other risk factors that increase this risk (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Sidretella 20

Keep this medicine out of the sight and reach of children.
No special storage precautions are required for this medicine.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack
following: "EXP". The expiry date refers to the last day of the stated month.
Medicines should 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 Sidretella 20 contains
The active substances are 0.02 mg ethinylestradiol and 3 mg drospirenone.
The other ingredients are:
Tablet core: monohydrate lactose, maize starch gelatinised, povidone, sodium croscarmellose,
polysorbate 80, magnesium stearate.
Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171),
macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

What Sidretella 20 looks like and contents of the pack
Sidretella 20 is pink, round, smooth film-coated tablets with a diameter of approximately 5.7 mm and a thickness of approximately 3.5 mm.
Sidretella 20 is available in boxes containing 1, 2, 3, 6 or 13 blisters, each blister containing 21 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva k.s.
U Kabelovny 130,
Dolní Měcholupy, 102 37
Prague 10,
Czech Republic

Manufacturer
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera
C/ La Vallina s/n
24193 - Villaquilambre, León
Spain

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Lithuania Sidretella 0.02 mg/3 mg
Latvia Sidretella 0.02 mg/3 mg apvalkotās tabletes
Poland Sidretella 20
Czech Republic, Slovak Republic Sidretella

For more detailed information about the medicine and its names in the European Economic Area countries, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00