Sidretella 20

Leaflet accompanying the packaging: information for the user

Sidretella 20, 0.02 mg + 3 mg, film-coated tablets

Ethinylestradiol + Drospirenone

Important information about combined hormonal contraceptives

• -If used correctly, they are one of the most reliable, reversible methods of contraception.
• -They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• -You should be vigilant and consult a doctor if you suspect that you have symptoms of a blood clot (see section 2 "Blood clots").

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• -You should keep this leaflet so that you can read it again if necessary.
• -If you have any doubts, you should consult a doctor or pharmacist.
• -This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them.
• -If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sidretella 20 and what is it used for
• 2. Important information before using 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 is Sidretella 20 and what is it used for

Sidretella 20 is a contraceptive, used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones called drospirenone and ethinylestradiol.
Contraceptive tablets that contain two hormones are called "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 read about the symptoms of a blood clot - see section 2 "Blood clots".
Before you start taking Sidretella 20, your doctor will ask you some questions about your health (current and in the past) and that of your close relatives. Your doctor will measure your blood pressure and, depending on your current state of health, may perform other examinations.
This leaflet describes different situations in which you should stop taking Sidretella 20 or in which the effect of Sidretella 20 may be reduced.
In such situations, you should refrain from sexual intercourse or use additional, non-hormonal contraceptive methods, such as a condom or another barrier method.
You should not use the rhythm method or the basal body temperature method. 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 HIV infection (AIDS) or other sexually transmitted diseases.

When not to use Sidretella 20

You should not use Sidretella 20 if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you which other contraceptive method will be more suitable for you.

• -If you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs.
• -If you know you have a blood coagulation disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• -If you need to have surgery or be immobilized for a long time (see section "Blood clots").
• -If you have had a heart attack or stroke.
• -If you have had angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms).
• -If you have any of the following diseases, which may increase the risk of a blood clot in the arteries.
• severe diabetes with blood vessel damage.
• very high blood pressure.
• very high levels of fats in the blood (cholesterol or triglycerides).
• a disease called hyperhomocysteinemia.
• -If you have (or have had in the past) a type of migraine called "migraine with aura".
• -If you currently have (or have had in the past) liver disease, and liver function has not returned to normal.
• -If you have kidney problems (kidney failure).
• -If you currently have (or have had in the past) a liver tumor.
• -If you currently have (or have had in the past) a suspicion of or confirmed breast cancer or cancer of the genital organs.
• -If you have vaginal bleeding of unknown cause.
• -If you have been diagnosed with hypersensitivity to ethinylestradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). This hypersensitivity may be the cause of itching, rash, or swelling. You should not use Sidretella 20 if you have liver disease 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 their menstrual cycle.
Women of advanced age
Sidretella 20 is not intended for use after menopause.
Women with liver function disorders
You should 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
You should 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?

• -If you notice any of the possible symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see below "Blood clots"). To find a description of these serious side effects, see "How to recognize a blood clot". In certain situations, when using Sidretella 20 or any other combined hormonal contraceptive, you should be particularly careful. It may be necessary for your doctor to regularly check your health.

If you have any of the following conditions, you should tell your doctor

before starting to take Sidretella 20. If any of the following conditions occur or worsen while taking Sidretella 20, you should also tell your doctor.

• -If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases).
• -If you have systemic lupus erythematosus (a disease that affects the body's natural defense system).
• -If you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure).
• -If you have sickle cell anemia (a hereditary disease of red blood cells).
• -If you have hypertriglyceridemia (elevated levels of triglycerides in the blood) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
• -If you need to have surgery or be immobilized for a long time (see section 2 "Blood clots").
• -If you are immediately after childbirth, you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Sidretella 20 after childbirth.
• -If you have superficial thrombophlebitis (blood clots in the veins under the skin).
• -If you have varicose veins.
• -If any of your close relatives have had breast cancer.
• -If you have liver or gallbladder disease.
• -If you have diabetes.
• -If you have depression.
• -If you have epilepsy (see section "Sidretella 20 and other medicines").
• -If you have a disease that first occurred during pregnancy or while taking sex hormones (e.g., hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy (pregnancy pemphigoid), a disease that affects the nerves, leading to involuntary movements (Sydenham's chorea)).
• -If you have had chloasma (skin discoloration, especially on the face or neck, also known as "pregnancy mask"). In this case, you should 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 difficulty breathing, you should contact your doctor immediately. Products containing estrogens may cause or worsen the symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Sidretella 20, increases the risk of blood clots compared to not using them. In rare cases, a blood clot can block a blood vessel and cause serious complications. Blood clots can occur:

• -in the veins (also known as "venous thromboembolism" or "deep vein thrombosis"),
• -in the arteries (also known as "arterial thromboembolism"). Not all blood clots are completely resolved after treatment, and in rare cases, the consequences of a blood clot can be permanent or even fatal.

It is essential to remember that the overall risk of developing harmful blood clots associated with Sidretella 20 is small.

HOW TO RECOGNIZE A BLOOD CLOT
You should contact your doctor immediately if you notice any of the following symptoms.

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• -The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). However, these side effects are rare. They most often occur in the first year of using combined hormonal contraceptives.
• -If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• -If a blood clot breaks loose from the leg and lodges in the lungs, it can cause a pulmonary embolism.
• -In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein the highest?

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not using combined hormonal contraceptives.
If you stop taking Sidretella 20, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of developing a blood clot in the leg (deep vein thrombosis) or lung (pulmonary embolism) associated with Sidretella 20 is small.

• -In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• -In a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• -In a year, about 9-12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Sidretella 20, will develop blood clots.
• -The risk of blood clots may vary depending on the patient's individual medical history (see "Factors that increase the risk of blood clots in veins" below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Sidretella 20 is small, but some factors can increase this risk. The risk is higher:

• -if you are significantly overweight (body mass index (BMI) over 30 kg/m²).
• -if someone in your immediate family has had a blood clot in the leg, lung, or other organ at a young age (e.g., under 50 years old). In this case, you may have a hereditary blood clotting disorder.
• -if you need to have surgery or be immobilized for a long time due to injury, illness, or having a leg in a cast. You may need to stop taking Sidretella 20 for a few weeks before surgery or immobilization. If you need to stop taking Sidretella 20, you should ask your doctor when you can resume taking it.
• -with age (especially over 35 years old);
• -if you have given birth in the last few weeks. The risk of blood clots increases with the number of risk factors present in the patient. Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor. It is essential to tell your doctor if any of these risk factors are present, even if you are not sure. Your doctor may decide to stop Sidretella 20. You should inform your doctor if any of the above conditions change while taking Sidretella 20, e.g., if someone in your immediate family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

Similarly to blood clots in veins, blood clots in arteries can cause severe complications, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to emphasize that the risk of a heart attack or stroke associated with Sidretella 20 is very small, but it may increase:

• -with age (over about 35 years old);
• -if you smoke. While taking a hormonal contraceptive like Sidretella 20, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend a different type of contraception.
• -if you are overweight.
• -if you have high blood pressure.
• -if someone in your immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of having a heart attack or stroke.
• -if you or someone in your immediate family has high levels of fats in the blood (cholesterol or triglycerides).
• -if you have migraines, especially migraines with aura.
• -if you have heart disease (valve damage, arrhythmias called atrial fibrillation).
• -if you have diabetes. If you have more than one of the above conditions or if any of them are particularly severe, the risk of a blood clot may be even higher. You should inform your doctor if any of the above conditions change while taking Sidretella 20, e.g., if you start smoking, if someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

CONTRACEPTION AND CANCER

It has been observed that breast cancer occurs slightly more often in women taking combined contraceptives, but it is not known if this is related to the medicine being taken. For example, it is possible that more tumors are detected in women taking contraceptives because they are examined by a doctor more often. After stopping combined hormonal contraceptives, the frequency of breast cancer gradually decreases.
It is essential to regularly examine your breasts and consult a doctor if you find any lump.
In women taking combined contraceptives, rare cases of benign liver tumors and even rarer cases of malignant liver tumors have been reported. If you experience unusual, severe abdominal pain, you should consult a doctor.

INTERMENSTRUAL BLEEDING

During the first few months of taking Sidretella 20, you may experience unexpected bleeding (bleeding outside of the withdrawal bleeding period). If such bleeding persists for more than a few months or appears after a few months, your doctor should investigate the cause.

What to do if withdrawal bleeding does not occur

If you have taken all the tablets correctly, have not vomited, have not had severe diarrhea, and have not taken any other medicines, it is very unlikely that you are pregnant.
If the expected withdrawal bleeding does not occur, you may be pregnant. You should contact your doctor immediately. You should not start the next pack until you are sure you are not pregnant.

PSYCHIATRIC DISORDERS

Some women taking hormonal contraceptives, including Sidretella 20, 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, you should contact your doctor as soon as possible for further medical advice.

Sidretella 20 and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should also tell any doctor or dentist who prescribes you another medicine (or pharmacist) that you are taking Sidretella 20. They may inform you about the need to use additional contraceptive methods (e.g., condoms) and how long to use them, and whether the use of another medicine you are taking needs to be changed.
Some medicines may affect the level of Sidretella 20 in your blood and make it less effective in preventing pregnancyor may cause unexpected bleeding. These include:

• -medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
• -medicines used to treat tuberculosis (e.g., rifampicin),
• -medicines used to treat HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• -medicines used to treat fungal infections (e.g., griseofulvin, ketoconazole),
• -medicines used to treat arthritis, degenerative joint disease (etoricoxib),
• -medicines used to treat pulmonary hypertension (bosentan),
• -products containing St. John's Wort, Sidretella 20 may affect other medicines, such as:
• -medicines containing cyclosporin,
• -the antiepileptic medicine lamotrigine (which may increase the frequency of seizures),
• -theophylline (used for breathing problems),
• -tizanidine (used to treat pain and/or muscle spasms). You should not take 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, as they may lead to increased liver enzyme test results (elevated ALT levels). Your doctor will recommend a different type of contraception before starting treatment with these medicines. About 2 weeks after finishing such treatment, you can resume taking Sidretella 20. See section "When not to use Sidretella 20".

Sidretella 20 with food and drink

Sidretella 20 can be taken with or without food, and if necessary, it can be taken with a small amount of water.

Laboratory tests

If you need to have blood tests, you should tell your doctor or laboratory staff that you are taking a contraceptive. Oral contraceptives may affect the results of some laboratory tests.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant, you should not take Sidretella 20. If you become pregnant while taking Sidretella 20, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Sidretella 20 at any time (see also "Stopping Sidretella 20").
Before taking any medicine, you should consult your doctor or pharmacist.
Breastfeeding
It is not recommended to use Sidretella 20 during breastfeeding. If you want to use a contraceptive during breastfeeding, you should consult your doctor.

Driving and using machines

There is no information suggesting that Sidretella 20 affects the ability to drive or use machines.

Sidretella 20 contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking Sidretella 20.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Sidretella 20

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
You should take one Sidretella 20 tablet every day, at the same time, with a small amount of water if necessary. The tablets can be taken with or without food, but you should take them at the same time every day.
One blister pack contains 21 tablets. The day of the week when you should take a tablet is printed next to each tablet. For example, if you start taking the tablets on a Wednesday, you should take the tablet marked "Wed". You should follow the arrows on the blister pack until all 21 tablets have been taken.
Then, you should not take any tablets for 7 days. During these 7 days when you are not taking tablets (during the break in taking the medicine), you should experience withdrawal bleeding. This bleeding, also known as withdrawal bleeding, usually starts on the second or third day of the break in taking the medicine.
On the eighth day after taking the last Sidretella 20 tablet (i.e., after the 7-day break in taking the medicine), you should start the next blister pack, even if the bleeding has not stopped. This means that you should start each blister pack on the same day of the week, and the withdrawal bleeding should occur on the same day every month.
If you take Sidretella 20 as described, you will also be protected against pregnancy during the 7-day break in taking the tablets.

When can you start the first pack?

• -If you did not use any hormonal contraceptives in the previous month.You should start taking Sidretella 20 on the first day of your cycle (i.e., on the first day of your period). If you start taking Sidretella 20 on the first day of your period, you will have immediate protection against pregnancy. You can also start taking it from the second to the fifth day of your cycle, but in this case, you should use additional contraceptive methods (e.g., condoms) for the first 7 days.
• -Switching from another combined hormonal contraceptive, a vaginal ring, or a transdermal patch.You can start taking Sidretella 20 the next day after taking the last active tablet from the previous pack (the last active tablet from the previous pack), but no later than the day after the usual break in taking the previous contraceptive. In the case of switching from a vaginal ring or transdermal patch, you should follow your doctor's instructions.
• -Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system).You can switch from a progestogen-only pill at any time (in the case of an implant or intrauterine system, you should take the tablet on the day the implant or system is removed; in the case of injections, you should take the tablet on the day the next injection is due), but in all cases, it is recommended to use additional contraceptive methods (e.g., condoms) for the first 7 days.
• -After a miscarriage.You should follow your doctor's instructions.
• -After childbirth.You can start taking Sidretella 20 between the 21st and 28th day after childbirth. If you start taking it later, you should use a barrier method of contraception (e.g., condoms) for the first 7 days of taking Sidretella 20.

If you have had sexual intercourse after childbirth and before restarting Sidretella 20, you should make sure you are not pregnant or wait for your next period.

• -If you are breastfeeding and want to restart Sidretella 20 after childbirth,you should read the section "Breastfeeding".

If you are unsure when to start taking Sidretella 20, you should consult your doctor.

What to do if you take more Sidretella 20 than you should

There are no reports of serious consequences after taking too many Sidretella 20 tablets. If you take several tablets at once, you may feel unwell or vomit, or you may experience bleeding from the vagina. Even in girls who have not yet started their menstrual cycle, taking this medicine by mistake may cause such bleeding.
If you take too many Sidretella 20 tablets or discover that a child has taken them, you should consult your doctor or pharmacist.

What to do if you forget to take Sidretella 20

• -If the delay in taking a tablet is less than 12 hours, the contraceptive protection is not reduced. You should take the tablet as soon as you remember, and then take the next tablets at the usual time.
• -If the delay in taking a tablet is more than 12 hours, the contraceptive protection may be reduced. The more tablets you miss, the higher the risk of becoming pregnant. The risk of reduced contraceptive protection is highest if you miss a tablet at the beginning or end of the pack. You should therefore follow these instructions (see also the diagram below).
• Missing more than one tablet in a packYou should contact your doctor.
• Missing one tablet in week 1You should take the missed tablet as soon as you remember, even if it means taking two tablets at once. You should continue taking the remaining tablets at the usual time and use additional contraceptive methods, such as condoms, for the next 7 days. If you have had sexual intercourse in the week before missing the tablet, there is a risk that you may have become pregnant. In this case, you should consult your doctor.
• Missing one tablet in week 2You should take the missed tablet as soon as you remember, even if it means taking two tablets at once. You should continue taking the remaining tablets at the usual time. The contraceptive protection is not reduced, and additional contraceptive methods are not necessary.
• Missing one tablet in week 3You can choose one of two options:
• 1. Take the missed tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the remaining tablets at the usual time. Then, instead of the usual 7-day break in taking the medicine, start taking the tablets from the next pack.

Withdrawal bleeding will probably occur after finishing the second pack, but spotting or bleeding may also occur while taking the tablets from the second pack.

• 2. You can also stop taking the tablets and have a 7-day break in taking the medicine ( make a note of the day you missed the tablet). If you want to start the next pack on your usual day of the week, the break in taking the medicine should be less than 7 days. Following one of these two instructions will provide contraceptive protection.

If you miss a tablet and do not have withdrawal bleeding during the break in taking the medicine, you may be pregnant. In this case, you should consult your doctor before starting the next pack.

What to do if you vomit or have severe diarrhea

If you vomit within 3-4 hours of taking a tablet or have severe diarrhea, there is a risk that the active substances will not be fully absorbed by your body. The situation is almost the same as if you had missed a tablet. After vomiting or diarrhea, you should take another tablet from a spare pack as soon as possible. Ideally, you should take it within 12 hoursof the usual time of taking the tablet. If this is not possible or if more than 12 hours have passed, you should follow the instructions given in the section "If you forget to take Sidretella 20".

Delayed menstruation: what you need to know

Although it is not recommended, you can delay your withdrawal bleeding if you do not take the 7-day break in taking the medicine and immediately start taking the tablets from the next pack of Sidretella 20 until you finish it. While taking the tablets from the second pack, you may experience spotting or bleeding. After the usual 7-day break in taking the medicine, you should start taking the tabletsfrom the next pack.
Before deciding to delay your menstruation, you should consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any side effects, especially severe and persistent ones, or changes in your health that you think are related to taking Sidretella 20, you should consult a doctor.

Severe side effects

You should immediately contact a doctor if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria, which can cause difficulty breathing (see also the section "Warnings and precautions"). In all women taking combined hormonal contraceptives, there is an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). To get detailed information about the different types of risk associated with the use of combined hormonal contraceptives, you should read section 2 "Important information before taking Sidretella 20". The following side effects have been associated with the use of Sidretella 20. Common side effects(may affect up to 1 in 10 women):

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

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

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

Rare side 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 (a rash in the form of 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 stroke-like symptoms, known as a transient ischemic attack,
• blood clots in the liver, stomach, and/or intestine, kidneys, or eye. The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Sidretella 20

The medicine should be stored out of sight and reach of children. There are no special precautions for storing the medicine. Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Sidretella 20 contains

The active substances of the medicine are 0.02 mg of ethinylestradiol and 3 mg of drospirenone. The other ingredients are: Core of the tablet: lactose monohydrate, corn starch, povidone, croscarmellose sodium, polysorbate 80, magnesium stearate. Tablet coating: partially hydrolyzed 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 what the pack contains

Sidretella 20 is pink, round, smooth, film-coated tablets with a diameter of about 5.7 mm and a thickness of about 3.5 mm. Sidretella 20 is available in packs of 1, 2, 3, 6, and 13 blisters, each containing 21 tablets. Not all pack sizes may be marketed.

Marketing authorization 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 authorized in the Member States of the European Economic Area 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

To obtain more detailed information on the medicinal product and its names in the Member States of the European Economic Area, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o. ul. Bonifraterska 17 00-203 Warsaw tel.: +48 22 375 92 00 Date of last revision of the leaflet:November 2024