Sidretella 30

Leaflet accompanying the packaging: information for the user

Sidretella 30, 3 mg + 0.03 mg, coated tablets

Drospirenone + Ethinylestradiol

You should read the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

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").

Table of contents of the leaflet

• 1. What is Sidretella 30 and what is it used for
• 2. Important information before taking Sidretella 30
• 3. How to take Sidretella 30
• 4. Possible side effects
• 5. How to store Sidretella 30
• 6. Contents of the packaging and other information

1. What is Sidretella 30 and what is it used for

Sidretella 30 is a contraceptive, used to prevent pregnancy.
Each coated tablet contains a small amount of two different female hormones called drospirenone and ethinylestradiol.
Contraceptive tablets containing two hormones are called "combined" tablets.

2. Important information before taking Sidretella 30

General information

Before starting to take Sidretella 30, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots - see section 2 "Blood clots".
Before you start taking Sidretella 30, your doctor will ask you a few questions about your health (current and 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 tests.
This leaflet describes various situations in which you should stop taking Sidretella 30 or in which the effect of Sidretella 30 may be reduced.
In such situations, you should abstain 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 30 disrupts the monthly cycle of body temperature changes and cervical mucus secretion.

Sidretella 30, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to take Sidretella 30

You should not take Sidretella 30 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 clotting disorder - such as 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 "Blood clots").
• -If you have had a heart attack or stroke.
• -If you have angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (transient 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) a type of migraine called "migraine with aura".
• -If you have (or have had) liver disease, and liver function has not returned to normal.
• -If you have kidney function disorders (kidney failure).
• -If you have (or have had) liver cancer.
• -If you currently have (or have had) breast cancer or cancer of the genital organs.
• -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. If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Sidretella 30 and other medicines").

Additional information for special patient groups

Children and adolescents
Sidretella 30 is not indicated for use in women who have not yet started menstruating.
Older women
The medicinal product Sidretella 30 is not intended for use after menopause.
Women with liver function disorders
You should not take Sidretella 30 if you have liver disease. See also sections "When not to take Sidretella 30" and "Warnings and precautions".
Women with kidney function disorders
You should not take Sidretella 30 if you have kidney failure or acute kidney failure. See also sections "When not to take Sidretella 30" and "Warnings and precautions".

Warnings and precautions

When should you contact your doctor?

• -If you notice any symptoms that may indicate the formation 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 the symptoms of these serious side effects, see "How to recognize a blood clot".

You should tell your doctor if you have any of the following conditions.

You should discuss with your doctor before starting to take Sidretella 30. In certain situations, you should be particularly careful when taking Sidretella 30 or any other combined hormonal contraceptive, and you may need to be regularly examined by your doctor. If these symptoms occur or worsen while taking Sidretella 30, you should also tell your doctor:

• -If someone in your immediate family has had breast cancer.
• -If you have liver or gallbladder disease.
• -If you have diabetes.
• -If you have depression.
• -If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases).
• -If you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure).
• -If you have sickle cell anemia (a genetic disorder of red blood cells).
• -If you or someone in your immediate family has had high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis (pancreatitis).
• -If you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots").
• -If you have recently given birth, you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Sidretella 30 after giving birth.
• -If you have superficial thrombophlebitis (blood clots in the veins under the skin).
• -If you have varicose veins.
• -If you have epilepsy (see section "Sidretella 30 and other medicines").
• -If you have systemic lupus erythematosus (a disease that affects the body's natural immune system).
• -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 (pemphigoid gestationis), a nerve disease that causes sudden involuntary movements of the body (Sydenham's chorea)).
• -If you have or have had chloasma (skin discoloration, especially on the face or neck, also called "mask of pregnancy"). 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 symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Sidretella 30, 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 form:

• -in veins (also called "venous thromboembolism" or "deep vein thrombosis"),
• -in arteries (also called "arterial thromboembolism" or "arterial thrombosis"). Not all patients who have had a blood clot will fully recover. In rare cases, the effects of a blood clot can be permanent or even fatal.

It is important to remember that the overall risk of having a harmful blood clot due to Sidretella 30 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 veins (venous thromboembolism). However, these side effects are rare. They most often occur in the first year of using combined hormonal contraceptives.

If a blood clot forms in the veins of the leg or foot, it can lead to deep vein thrombosis. If a blood clot breaks loose from the leg and settles 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 veins 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 30, 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 blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism) associated with Sidretella 30 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 30, 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 30 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 30 for a few weeks before surgery or immobilization. If you need to stop taking Sidretella 30, you should ask your doctor when you can resume taking it.
• -With age (especially over 35 years old).

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 serious complications, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is important to note that the risk of a heart attack or stroke associated with Sidretella 30 is very small, but it may increase:

• -With age (over about 35 years old).
• -If you smoke. If you are taking a hormonal contraceptive like Sidretella 30, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using 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 had 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 severe, the risk of blood clots may be even higher. You should inform your doctor if any of the above conditions change while taking Sidretella 30, e.g., if you start smoking, if someone in your immediate family has had a blood clot without a known cause, or if you gain significant weight.

CANCER AND CONTRACEPTION

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 the use of combined hormonal contraceptives, the frequency of breast cancer gradually decreases. It is important to regularly examine your breasts and consult a doctor if you notice 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.

MENTAL DISORDERS

Some women taking hormonal contraceptives, including Sidretella 30, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes and symptoms of depression, you should contact your doctor as soon as possible for further medical advice.

INTERMENSTRUAL BLEEDING

During the first few months of taking Sidretella 30, you may experience unexpected bleeding (bleeding outside of the withdrawal week). 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 bleeding does not occur during the withdrawal week

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 your expected bleeding does not occur twice in a row, it may mean that you are pregnant. You should contact your doctor immediately. You should not start the next blister pack until you are sure you are not pregnant (see also "Stopping Sidretella 30").

Sidretella 30 and other medicines

You should tell your doctor or pharmacist about all medicines and herbal products 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 any other medicine (or pharmacist) that you are taking Sidretella 30. They may inform you that you need to use additional contraceptive methods (e.g., condoms) and how long or whether you need to change the use of another necessary medicine. Some medicines may affect the level of Sidretella 30 in your blood and may make it less effective in preventing pregnancy or may cause unexpected bleeding. These include:

• -Medicines used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
• tuberculosis (e.g., rifampicin),
• HIV infection and hepatitis C virus (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• fungal infections (e.g., griseofulvin, ketoconazole),
• arthritis, degenerative joint disease (etoricoxib),
• pulmonary hypertension (bosentan),
• -Herbal products containing St. John's wort (Hypericum perforatum).

Sidretella 30 may affect the action of other medicines, such as:

• -Medicines containing cyclosporin,
• -Antiepileptic drugs - lamotrigine (may lead to an increased frequency of seizures),
• -Theophylline (used for breathing problems),
• -Tizanidine (used to treat pain and/or muscle spasms). You should not take Sidretella 30 if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause elevated liver function test results (elevated liver enzyme ALT). Your doctor will recommend a different type of contraception before starting treatment with these medicines. About 2 weeks after stopping such treatment, you can resume taking Sidretella 30. See section "When not to take Sidretella 30".

Sidretella 30 with food and drink

Sidretella 30 can be taken with or without food, and if necessary, it can be taken with a small amount of water.

Lab tests

If lab tests are necessary, you should tell your doctor or lab staff that you are taking a contraceptive, as oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant, you should not take Sidretella 30. If you become pregnant while taking Sidretella 30, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Sidretella 30 at any time (see also "Stopping Sidretella 30").
Before taking any medicine, you should consult your doctor or pharmacist.
Breastfeeding
It is not recommended to take Sidretella 30 while breastfeeding. If you want to use a contraceptive while breastfeeding, you should consult your doctor.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

There is no information suggesting that Sidretella 30 affects the ability to drive or use machines.

Sidretella 30 contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking Sidretella 30.

3. How to take Sidretella 30

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 30 tablet every day, at the same time, if necessary, with a small amount of water. The tablets can be taken with or without food. However, you should take them at about the same time every day.
One blister pack contains 21 coated tablets. The day of the week on which 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 of not taking the tablets (during the break in taking the medicine), you should experience bleeding. This bleeding, also called 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 30 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 30 as described, you will also be protected from pregnancy during the 7-day break in taking the tablets.

When can you start the first pack?

• -If you did not take any hormonal contraceptives in the previous monthYou should start taking Sidretella 30 on the first day of your cycle (i.e., on the first day of your period). If you start taking Sidretella 30 on the first day of your period, you will have immediate protection against pregnancy. You can also start taking Sidretella 30 from the second to the fifth day of your cycle, but then you should use additional contraceptive methods (e.g., condoms) for the first 7 days.
• -Switching from another combined hormonal contraceptive, vaginal ring, or transdermal patch containing combined hormonal contraceptivesYou can start taking Sidretella 30 the next day after taking the last active tablet from the previous pack (the last active tablet), but no later than the day after the end of the previous contraceptive break (or after taking the last inactive tablet from the previous pack). When switching from a vaginal ring or transdermal patch containing combined hormonal contraceptives, you should follow your doctor's instructions.
• -Switching from a progestogen-only product (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen)You can switch from taking progestogen-only pills at any time (in the case of an implant or intrauterine system releasing progestogen, you should take the tablet on the day the implant or intrauterine system is removed; in the case of injections, you should take the tablet on the day the next injection is scheduled), but it is recommended to use additional contraception (e.g., condoms) for the first 7 days.
• -After a miscarriageYou should follow your doctor's instructions.
• -After childbirth

You can start taking Sidretella 30 between the 21st and 28th day after giving birth. If you start taking Sidretella 30 later, you should use a barrier method of contraception (e.g., condoms) for the first 7 days of taking Sidretella 30.
If you have had sexual intercourse after giving birth and before resuming Sidretella 30, you should make sure you are not pregnant or wait for your next period.

• -If you are breastfeeding and want to resume taking Sidretella 30 after childbirthYou should read the section "Breastfeeding".

If you are unsure when to start taking Sidretella 30, you should consult your doctor.

What to do if you take more Sidretella 30 than you should

There are no reports of serious consequences of taking too many Sidretella 30 tablets at once. Taking several tablets at once may cause nausea and vomiting or vaginal bleeding. Even girls who have not yet started menstruating but have taken this medicine by mistake may experience such bleeding. If you have taken too many Sidretella 30 tablets or noticed that a child has taken them, you should consult your doctor or pharmacist.

What to do if you miss a dose of Sidretella 30

• -If the delay in taking a tablet is less than 12 hours, the protection against pregnancy is not reduced. You should take the tablet as soon as you remember and take the next tablets at the usual time.
• -If the delay in taking a tablet is more than 12 hours, the protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of becoming pregnant. The risk of reduced protection against pregnancy is highest if you miss a tablet at the beginning or end of the blister 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 rest of the tablets at the usual time and use additional contraceptive methods, such as condoms, for the next 7 days. If you 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 rest of the tablets at the usual time. The contraceptive effect 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 rest of the tablets at the usual time. Then, instead of the 7-day break in taking the medicine, start the next blister pack. Withdrawal bleeding will probably occur after finishing the second blister pack, or

spotting/bleeding may occur while taking the tablets from the second blister pack.

• 2. You can also stop taking the tablets and start the 7-day break in taking the medicine immediately (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, your break in taking the medicine should be less than 7 days. Following one of these two instructions will provide protection against pregnancy. If you miss a tablet from the blister pack and do not experience withdrawal bleeding during the first break in taking the medicine, you may be pregnant. In this case, you should consult your doctor before starting the second 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 identical to missing a tablet. After vomiting or diarrhea, you should take a tablet from a spare pack as soon as possible. If possible, 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 "Missing a dose of Sidretella 30".

4. Possible Adverse Reactions

Like all medications, this medication can cause adverse reactions, although they do not occur in everyone.
If any adverse reactions occur, especially severe and persistent ones or changes in health status that the patient considers related to the use of Sidretella 30, it is recommended to consult a doctor.
In all women taking combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disease). For detailed information on the various types of risks associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before taking Sidretella 30".

Severe Adverse Reactions

The patient should immediately contact her doctor if she 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 the "Warnings and Precautions" section).
The following adverse reactions have been associated with the use of Sidretella 30.
Common Adverse Reactions(may affect up to 1 in 10 women):

• -Menstrual disorders, intermenstrual bleeding, breast tenderness, breast pain
• -Headache, depressive mood
• -Abdominal pain (abdominal pain)
• -Migraine
• -Nausea
• -Vaginal thickening, white vaginal discharge, and vaginal fungal infections

Uncommon Adverse Reactions(may affect up to 1 in 100 women):

• -Breast enlargement, decreased libido
• -High blood pressure, low blood pressure
• -Vomiting, diarrhea
• -Acne, rash, itching, hair loss (alopecia)
• -Vaginal infection
• -Fluid retention and weight changes

Rare Adverse Reactions(may affect up to 1 in 1000 women):

• -Allergic reactions (hypersensitivity), asthma
• -Breast discharge
• -Hearing impairment
• -Erythema nodosum (a condition characterized by red, painful nodules on the skin) or erythema multiforme (a rash in the form of redness or ulceration)
• -Life-threatening blood clots in a vein or artery, such as:
• 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 blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Reporting Adverse Reactions

If any adverse reactions occur, including any adverse reactions not listed in the leaflet, the patient should inform her doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder or its representative in Poland.
Reporting adverse reactions can help gather more information on the safety of the medication.

5. How to Store Sidretella 30

The medication should be stored in a place that is out of sight and reach of children.
There are no special recommendations for storing the medication.
The medication should not be used after the expiration date stated on the carton and blister pack after: "EXP". The expiration date refers to the last day of the specified month.
Medications should not be disposed of in the sewage system or household waste containers. The patient should ask her pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Sidretella 30 Contains

The active substances of the medication are 3 mg drospirenone and 0.03 mg ethinylestradiol.
The other ingredients are:

• -Tablet core: lactose monohydrate, corn starch, corn starch paste, crospovidone, povidone, polysorbate 80, magnesium stearate.
• -Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

What Sidretella 30 Looks Like and What the Package Contains

Sidretella 30 is a yellow, round, smooth film-coated tablet with a diameter of approximately 5.7 mm and a thickness of approximately 3.5 mm.
Sidretella 30 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 for Sale in the Member States of the European

Economic Area Under the Following Names:

To Obtain More Detailed Information on the Medication, 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