Sidretella 30

Package leaflet: Information for the user

Sidretella 30, 3 mg + 0,03 mg, coated tablets
Drospirenonum + Ethinylestradiolum
Please read the entire leaflet before starting to take the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives:

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the patient suspects symptoms of blood clots (see section 2 “Blood clots”).

Leaflet contents

1. What Sidretella 30 is and what it is 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 pack and other information

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

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

2. Important information before using Sidretella 30

General information
Before starting treatment with Sidretella 30, you should read the information concerning blood clots in section 2. It is particularly important to be aware of the symptoms of blood clots – see section 2, "Blood clots".
Before you start taking Sidretella 30, your doctor will ask you several questions about your current and past health, as well as that of your close relatives. Your doctor will measure your blood pressure and, depending on your current health status, may carry out additional tests.
This leaflet describes various situations in which you should stop taking Sidretella 30 or in which the effectiveness of Sidretella 30 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 because 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 infections.

When not to use Sidretella 30
Do not take Sidretella 30 if you have any of the conditions listed below. If you have any of the following conditions, 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 clotting disorder – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies.
• If you require surgical intervention 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 dysfunction (renal failure).
• If you currently have or have previously had liver tumours.
• If you currently have or have previously had, or are suspected of having, breast cancer or cancer of the reproductive 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 with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and 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.
Elderly women
Sidretella 30 is not intended for use after menopause.
Women with liver function disorders
Do not take Sidretella 30 if you suffer from liver disease. See also section "When not to use Sidretella 30" and "Warnings and precautions".
Women with kidney function disorders
Do not take Sidretella 30 if you suffer from renal failure or acute kidney failure. See also section "When not to use Sidretella 30".

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

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

Tell your doctor if you have any of the following conditions.
Talk to your doctor before starting Sidretella 30. In certain situations, special caution is required when using Sidretella 30 or any other combined hormonal contraceptive, and regular medical check-ups may be necessary. If any of these conditions appear or worsen during treatment with Sidretella 30, inform your doctor:

• If breast cancer is present or has occurred in your close family.
• 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 haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure).
• If you have sickle cell anaemia (a hereditary red blood cell disorder).
• If you have high levels of fats in the blood (hypertriglyceridaemia) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots").
• If you have recently given birth, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Sidretella 30.
• If you have superficial thrombophlebitis (inflammation of 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 affecting the natural immune system).
• 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 sudden involuntary movements (Sydenham's chorea)).
• If you currently have or have previously had chloasma (skin pigmentation, 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 30 increases the risk of blood clots compared to not using 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 events").
  Full recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal. It is important to remember that the overall risk of developing harmful blood clots associated with the use of Sidretella 30 is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical attention if you experience 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 thrombosis). However, these adverse reactions 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 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 taking combined hormonal contraceptives for the first time. 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 not using combined hormonal contraceptives.
If a woman stops taking Sidretella 30, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive being used.
The overall risk of developing blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism) associated with using Sidretella 30 is low.

• 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 developing blood clots may vary depending on the individual's medical history (see "Factors increasing the risk of venous blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Sidretella 30 is low, however,
some factors may increase this risk. The risk is higher:

• If the patient has significant overweight (body mass index (BMI) above 30 kg/m²).
• If a close relative of the patient has been diagnosed with blood clots in the leg, lung, or another organ at a young age (e.g., under 50 years). In this case, the patient may have inherited clotting disorders.
• If the patient needs to undergo 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 the use of Sidretella 30 several weeks before surgery or reduced mobility. If the patient must stop taking Sidretella 30, 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, particularly if the patient has another risk factor listed above. It is important to inform the doctor if any of these factors apply to the patient, even if uncertain. The doctor may decide to discontinue the use of Sidretella 30. Inform the doctor if any of the above conditions change during treatment with Sidretella 30, for example, if a close relative 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 the use of
Sidretella 30 is very small, but may increase:

• With age (over approximately 35 years).
• If the patient smokes tobacco. While using a hormonal contraceptive such as Sidretella 30, it is recommended to stop smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend using another type of contraception.
• If the patient has overweight.
• If the patient has high blood pressure.
• If a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke.
• If the patient or a close relative has been diagnosed with high blood lipid levels (cholesterol or triglycerides).
• If the patient suffers from migraines, especially migraines with aura.
• If the patient has heart disease (valve damage, heart rhythm disorders known 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 30, for example, if the patient starts smoking, a close relative 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 report any lumps to a doctor.
In rare cases, benign liver tumors have been observed in women using combined hormonal
contraceptives, and even more rarely, malignant liver tumors. If the patient experiences an unusual,
severe abdominal pain, she should consult a doctor.

PSYCHIATRIC DISORDERS
Some women using hormonal contraceptives, including Sidretella 30, have reported depression
or low mood. Depression can be severe and sometimes lead to suicidal thoughts.
If mood changes or symptoms of depression occur, contact the doctor as soon as possible
to obtain further medical advice.

INTERMENSTRUAL BLEEDING
During the first few months of using Sidretella 30, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding persists for longer than a few months, or if it reappears 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 medications, it is very unlikely that she is pregnant.
If expected bleeding does not occur for 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.

Sidretella 30 and other medicines
Inform the doctor or pharmacist about all medicines and herbal products the patient is currently taking or has recently taken, as well as any medicines the patient plans to use. Additionally, inform any doctor or dentist who prescribes another medicine (or pharmacist) about the use of Sidretella 30. They may advise the patient to use additional contraceptive methods (e.g., condoms) and inform her how long or whether to adjust the use of the other medicine.

Some medicines may affect the blood levels of Sidretella 30 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),
• 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, osteoarthritis (etoricoxib),
• Pulmonary hypertension (bosentan),
• Herbal products containing St. John's wort ( Hypericum perforatum ).

Sidretella 30 may affect the action of other medicines, for example:

• Those containing cyclosporine,
• Antiepileptic drugs – lamotrigine (may lead to increased frequency of seizures),
• Theophylline (used for breathing problems),
• Tizanidine (used to treat pain and/or muscle spasms).

Do not use Sidretella 30 if the patient has hepatitis C and is taking medications containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these products may cause elevated liver function test results (increased levels of the liver enzyme AlAT). The doctor will recommend another type of contraception before starting treatment with these drugs. Sidretella 30 may be restarted approximately 2 weeks after completing such treatment. See section "When not to use Sidretella 30".

Sidretella 30 with food and drink
Sidretella 30 may be taken regardless 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, do not take Sidretella 30. If the patient becomes pregnant
while taking Sidretella 30, stop taking the medicine immediately and contact
the doctor. If the patient wishes to become pregnant, she may stop taking Sidretella 30 at any time (see also "Discontinuation of Sidretella 30").

Before taking any medicine, consult a doctor or pharmacist.
Breastfeeding
Sidretella 30 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 30 affects the ability to drive
or operate machinery.

Sidretella 30 contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should
consult her doctor before taking this medicine.

3. How to take Sidretella 30

This medicine should always be taken according to the instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Take one tablet of Sidretella 30 every day 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 pack contains 21 coated 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 “Wed” (or “W”). Follow the arrows on the blister until all 21 tablets have been taken.
After that, do not take any tablets for 7 days. During these 7 days of non-intake (the tablet-free interval), 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 30 (that is, after completing the 7-day tablet-free interval), start a new blister pack, even if bleeding has not yet stopped.
This means that each new blister pack 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 30 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 used any hormonal contraceptives in the previous month
  Start taking Sidretella 30 on the first day of the cycle (i.e., the first day of menstruation). If the patient starts taking Sidretella 30 on the first day of her period, she will be protected against pregnancy immediately. Alternatively, the tablets may be started between the second and fifth day of the cycle; however, in this case, additional contraceptive methods (e.g., condoms) must be used for the first 7 days of tablet-taking.

• Switching from another combined hormonal contraceptive, a vaginal contraceptive system, or a transdermal system containing a combined hormonal contraceptive
  You may start taking Sidretella 30 the day after taking the last active tablet (i.e., the last tablet containing active ingredients) from the previous pack, but no later than the day after the end of the tablet-free interval of the previous contraceptive (or after taking the last inactive tablet of the previous contraceptive). When switching from a vaginal contraceptive system or a transdermal contraceptive system, 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 can be done at any time. In the case of an implant or an intrauterine system releasing progestogen, take the first tablet of the new medicine on the day of removal. For injections, take the first tablet on the day the next injection would have been due. In all cases, it is recommended to use additional contraception (e.g., condoms) for the first 7 days of taking Sidretella 30.

• After miscarriage
  Follow your doctor’s advice.

• After childbirth
  Sidretella 30 may be started between days 21 and 28 after delivery. If the patient starts taking the medicine later than this, she should use a barrier method of contraception (e.g., condoms) for the first 7 days of taking Sidretella 30.
  If the patient has already had sexual intercourse after childbirth, before (re)starting Sidretella 30, she should ensure she is not pregnant or wait until her next menstrual period.

• If the patient is breastfeeding and wishes to (re)start taking Sidretella 30 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.

Accidental overdose of Sidretella 30
There are no reports of serious consequences following an overdose of Sidretella 30. Taking several tablets at once may cause nausea, vomiting, or vaginal bleeding. Even girls who have not yet started menstruating may experience such bleeding if they accidentally take this medicine.
If the patient has taken more tablets than recommended or if a child has swallowed any tablets, consult a doctor or pharmacist immediately.

Missed dose of Sidretella 30

• If a tablet is taken less than 12 hours late, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and continue taking the remaining tablets at the usual time.
• If a tablet is taken more than 12 hours late, protection against pregnancy may be reduced. The more tablets missed, the higher the risk of becoming pregnant. 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 you remember, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time and use additional precautions, such as condoms, for the next 7 days. If you had sexual intercourse in 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 you remember, even if this means taking two tablets at the same time. 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
    You have two options:
    1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. 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 pack, or spotting/bleeding may occur during the intake of tablets from the second pack.
    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 any tablet from the pack was missed and no withdrawal bleeding occurs 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 the tablet or if severe diarrhoea develops, there is a risk that the active substances have not been fully absorbed by the patient's body. This situation is almost equivalent to missing a tablet. After vomiting or diarrhoea occurs, take a tablet from a spare pack as soon as possible. Ideally, it should be taken within 12 hours of the usual time for taking the tablet. If this is not possible or if more than 12 hours have passed, follow the instructions given under the section "Missed dose of Sidretella 30".

Delayed withdrawal bleeding: what you need to know
Although not recommended, a patient may delay withdrawal bleeding by not taking a break from treatment and immediately starting tablets from a second blister pack of Sidretella 30, continuing until the pack is finished. During this time, spotting or breakthrough bleeding may occur. After the usual 7-day break from taking the tablets, start taking tablets from the next blister pack.

Before deciding to delay withdrawal bleeding, consult your doctor.

Changing the first day of withdrawal bleeding: what you need to know
If the patient takes the tablets as directed, bleeding will occur during the tablet-free interval. If it is necessary to change this day, it can be done by shortening ( but never extending – 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 cycle phase. Spotting or intermenstrual bleeding may occur.

If the patient is unsure about what to do, she should contact her doctor or pharmacist.

Stopping treatment with Sidretella 30
Treatment with Sidretella 30 can be stopped at any time. If the patient does not wish to become pregnant, she should consult her doctor regarding other effective methods of contraception. If the patient wishes to become pregnant, she should stop taking Sidretella 30 and wait for a menstrual period before trying to conceive. This makes it easier to calculate the expected date of delivery.

If there are any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers to be related to the use of Sidretella 30, medical advice should be sought.
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, please refer to section 2, "Important information before using Sidretella 30".
Serious adverse effects
Seek immediate medical advice 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 breathing difficulties (see also section "Warnings and precautions").
The following adverse effects have been associated with the use of Sidretella 30.
Common adverse effects (may affect up to 1 in 10 women):

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

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

• Breast enlargement, decreased interest in sex
• High blood pressure, low blood pressure
• Vomiting, diarrhoea
• Acne, rash, skin itching, hair loss (alopecia)
• Vaginal infection
• Fluid loss and changes in body weight

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

• Allergic reactions (hypersensitivity), asthma
• Breast discharge
• Hearing impairment
• Nodular erythema (a condition characterized by red, painful skin nodules) or erythema multiforme (a 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 stroke symptoms, known as transient ischaemic 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 of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your 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, Tel: + 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 authorization 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 30

Keep the medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack
following "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sidretella 30 contains
The active substances are 3 mg drospirenone and 0.03 mg ethinylestradiol.
The other ingredients are:

• Tablet core: monohydrate lactose, maize starch, pregelatinized maize starch, 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 contents of the pack
Sidretella 30 is yellow, round, smooth film-coated tablets with a diameter of approximately 5.7 mm and a thickness of approximately 3.5 mm.
Sidretella 30 is available in boxes containing 1, 2, 3, 6 and 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 marketing in the European Economic Area Member States under the following names:

For more detailed information about the medicinal product, please contact the
local representative of the marketing authorisation holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warszawa
tel.: +48 22 375 92 00