Sibilla

Leaflet accompanying the packaging: information for the user

Sibilla, 2 mg + 0.03 mg, film-coated tablets

Dienogest + Ethinylestradiol

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.
• Caution should be exercised and a doctor should be consulted if the patient suspects that blood clot symptoms have occurred (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.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Sibilla and what is it used for

Sibilla is a medicinal product

• used to prevent pregnancy (contraceptive pill),
• to treat women with moderate acne who have decided to use contraceptive pills and have not responded to appropriate local treatment or oral antibiotic treatment.

Sibilla is a combined oral contraceptive, one of a group of medicines often referred to as the pill.
Each tablet contains two types of female hormones: estrogen - ethinylestradiol and progestogen -
dienogest.
The combined pill prevents pregnancy based on three mechanisms:

• 1. Inhibiting the release of an egg from the ovaries.
• 2. Preventing fertilization of an already released egg.
• 3. Preventing the implantation of a fertilized egg in the uterine lining.

Sibilla belongs to a group of medicines often referred to as "mini-pills" due to their low hormone content.
It is also referred to as a combined contraceptive pill because it contains both types of hormones and as a monophasic oral contraceptive due to the same composition of each tablet.
Sibilla alleviates acne (acne) in women whose condition may be caused by an excess of male sex hormones called "androgens" that occur in every woman.

2. Important information before taking Sibilla

General notes

Before starting to take Sibilla, 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").
The leaflet describes several situations in which you should stop taking Sibilla or in which the effectiveness of Sibilla may be reduced.
In such situations, you should not have intercourse or use additional non-hormonal contraceptive methods (such as condoms or other mechanical methods) to ensure effective contraception.
You should not use the calendar method or the temperature measurement method after waking up, as oral contraceptives may affect body temperature and cyclical changes in cervical mucus.
Remember that combined oral contraceptive pills like Sibilla do not protect against sexually transmitted diseases (such as AIDS). Only the use of condoms has this protective effect.
Sibilla in the treatment of acne:
Improvement in acne symptoms usually occurs after three to six months of treatment, but skin condition may continue to improve even after six months of treatment.
The patient should discuss with the doctor the need to continue treatment after three to six months of treatment, and then at regular intervals.

When not to use Sibilla

Sibilla should not be used if the patient has any of the following conditions.
If the patient has any of the following conditions, they should inform their doctor.
The doctor will discuss with the patient which other contraceptive method will be more suitable.

• if the patient is allergic to dienogest or ethinylestradiol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has (or has ever had) a blood clot in the blood vessels of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows they have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has had in the past) 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 the patient has any of the following diseases, which may increase the risk of developing a blood clot in an artery:
• 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 the patient has or has had pancreatitis;
• if the patient has or has had severe liver disease, jaundice. Jaundice or itching all over the body may be symptoms of liver disease;
• if the patient has or has had a liver tumor;
• if the patient has or may have breast cancer or other cancer, such as ovarian cancer, cervical cancer, or uterine cancer;
• if the patient has unexplained vaginal bleeding;
• if the patient has (or has had in the past) a type of migraine called "migraine with aura".

Sibilla should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Sibilla and other medicines").
If any of these conditions occur during the use of Sibilla, the tablets should not be taken anymore and a doctor should be consulted immediately.
In this case, other non-hormonal contraceptive methods should be used. See also section "Warnings and precautions".
If the patient has any of the above conditions, they should inform their doctor before starting to take Sibilla.
The doctor may recommend that the patient use other contraceptive methods.

Warnings and precautions

Before starting to take Sibilla, the patient should discuss it with their doctor or pharmacist.
When should the patient contact their doctor?
The patient should contact their doctor immediately

• if they notice any symptoms of a blood clot, which may indicate that they have a blood clot in their leg (deep vein thrombosis), blood clot in their lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots (thrombosis)").

To find a description of the serious side effects listed, see "How to recognize a blood clot".

The patient should tell their doctor if they have any of the following conditions.

In some cases, combined oral contraceptives should be used under close medical supervision.
If the patient has any of the conditions listed below, they should inform their doctor before taking Sibilla.
If these symptoms occur or worsen during the use of Sibilla, the patient should also tell their doctor:

• if the patient has diabetes;
• if the patient is significantly overweight (obese);
• if the patient has high blood pressure;
• if the patient has heart valve problems or certain heart rhythm disorders;
• if the patient has superficial thrombophlebitis (inflammation of the veins under the skin);
• if the patient has varicose veins;
• if the patient or their close relatives have a condition that may increase the risk of developing blood clots;
• if the patient has migraines;
• if the patient has movement disorders called Sydenham's chorea;
• if the patient or their close relatives have lipid metabolism disorders (blood lipid disorders) or other very rare blood disorders;
• if the patient has liver or biliary disease (jaundice, gallstones);
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has jaundice or itching all over the body;
• if the patient has systemic lupus erythematosus (SLE; a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (HUS; a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a hereditary disease of red blood cells);
• if the patient has been found to have high levels of triglycerides in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has recently given birth, as they are at increased risk of blood clots. The patient should consult their doctor about how soon they can start taking Sibilla after giving birth;
• if the patient has a hereditary disease called porphyria;
• if the patient has had a rash called pregnancy impetigo;
• if the patient has a congenital hearing loss called otosclerosis;
• if the patient has brown spots on the face and body (chloasma), which can be limited by avoiding direct sun exposure or not using tanning beds or lamps;
• if the patient smokes. Women who smoke and use combined hormonal contraceptives like Sibilla are at increased risk of serious heart and blood vessel disorders (such as heart attack and stroke). This risk increases with age and the number of cigarettes smoked;
• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing, they should contact their doctor immediately. Products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.
• if the patient has depression or mood changes.

Women over 35 years old should stop smoking if they want to use combined oral contraceptives.
If the patient does not want to stop smoking, they should use other contraceptive methods, especially if they have other risk factors.
If any of the above conditions occur for the first time or worsen during the use of Sibilla, the patient should consult their doctor as soon as possible.

Blood Clots

The use of combined hormonal contraceptives like Sibilla is associated with an increased risk of blood clots compared to not using them.
Blood clots can form:

• in veins (also called "venous thromboembolism" or "venous thrombosis");
• in arteries (also called "arterial thromboembolism" or "arterial thrombosis").

Not everyone who has a blood clot will recover completely.
In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

Remember that the overall risk of developing harmful blood clots due to Sibilla is small.

How to Recognize a Blood Clot

The patient should contact their doctor immediately if they notice any of the following symptoms.
Is the patient experiencing any of these symptoms?
Why is the patient likely to be suffering

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color of the leg, such as pallor, redness, or discoloration. Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe stomach pain.

If the patient is unsure, they should contact their doctor,
as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).
Pulmonary embolism
Symptoms usually occur in one eye:

• sudden loss of vision or;
• painless vision disturbances, which may lead to loss of vision. Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, tightness;
• a feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• a feeling of fullness, indigestion, or choking;
• discomfort in the upper body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or fainting;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat. Heart attack
• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
• sudden confusion, speech disturbances, or difficulty understanding;
• sudden vision disturbances in one or both eyes;
• sudden disturbances of gait, dizziness, loss of balance, or coordination; Stroke

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). Although these side effects are rare, they can occur. 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 moves 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 the patient stops taking Sibilla, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

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

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's close family has had blood clots in their legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to have surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to stop taking Sibilla for a few weeks before surgery or immobilization. If the patient needs to stop taking Sibilla, they should ask their doctor when they can resume taking it;
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Traveling by air (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors are present, even if the patient is unsure. The doctor may decide to stop Sibilla.
If any of the above conditions change during the use of Sibilla, e.g., someone in the patient's close family is diagnosed with a blood clot without a known cause or the patient gains significant weight, the patient should inform their doctor.

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 have serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of heart attack or stroke associated with Sibilla is very small, but it may increase:

• with age (over approximately 35 years old);
• if the patient smokes. During the use of a hormonal contraceptive like Sibilla, it is recommended to stop smoking. If the patient cannot stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure that is not controlled with treatment;
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or their close relatives have high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
The patient should inform their doctor if any of the above conditions change during the use of Sibilla, e.g., they start smoking, someone in their close family is diagnosed with a blood clot without a known cause, or the patient gains significant weight.

Sibilla and Cancer

Breast cancer occurs slightly more often in women who use combined oral contraceptives, but it is not known if this is caused by their use. For example, it may be that more tumors are detected in women who use combined oral contraceptives because they are examined by doctors more often. The risk of breast cancer decreases gradually after stopping the use of combined hormonal contraceptives. It is essential to regularly examine the breasts and contact a doctor if any lump is found.
Rarely, benign liver tumors, and even more rarely, malignant liver tumors have been reported in women who use oral contraceptives. If the patient experiences unusual, severe stomach pain, they should contact their doctor.

Psychiatric Disorders:

Some women who use hormonal contraceptives, including Sibilla, have reported depression or mood swings. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should contact their doctor as soon as possible for further medical advice.
Children and Adolescents
Sibilla is not intended for use before the first menstrual period (menarche).
Older Women
Sibilla is not intended for use in postmenopausal women.

Sibilla and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should also inform other doctors or their dentist who prescribe other medicines about the use of Sibilla.
The doctor will inform the patient whether there is a need to use additional contraception (e.g., condoms) and if so, for how long, and whether there is a need to change the use of certain medicines.
Sibilla should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these products may cause abnormal liver function test results (increased liver enzyme activity).
Before starting to take these medicines, the doctor will prescribe a different type of contraception.
The patient can start taking Sibilla again after about 2 weeks after finishing the above treatment. See section "When not to use Sibilla".
Certain medicines may affect the level of Sibilla in the blood and reduce its effectiveness in preventing pregnancy or cause unexpected bleeding. These include medicines used to treat:

• epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate),
• tuberculosis (e.g., rifampicin),
• HIV and hepatitis C infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• fungal infections (e.g., griseofulvin),

If the patient wants to use herbal products containing St. John's Wort (a herbal medicine used to treat depression) while taking Sibilla, they should consult their doctor.
Interactions between Sibilla and other medicines can also lead to more frequent side effects.
The following medicines may affect the tolerance of Sibilla:

• etoricoxib (used to treat arthritis, osteoarthritis).

Sibilla may affect the effectiveness of other medicines, such as:

• cyclosporin (a medicine used to prevent the rejection of transplanted tissue),
• lamotrigine (a medicine used to treat epilepsy),
• tizanidine (a medicine used to treat muscle spasticity),
• theophylline (a medicine used to treat asthma).

Women with diabetes may need to adjust their blood sugar-lowering medicines (e.g., insulin).
Before taking any medicine, the patient should consult their doctor or pharmacist.

Before Laboratory Tests

The patient should tell their doctor or laboratory staff that they are taking contraceptive pills, as oral contraceptives may affect the results of some laboratory tests.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Sibilla should not be taken if the patient is pregnant. If the patient becomes pregnant or thinks they may be pregnant, they should stop taking Sibilla and contact their doctor immediately.
Breastfeeding
Sibilla should not be used during breastfeeding. If the patient is taking Sibilla while breastfeeding, it may reduce the amount of milk produced and change its composition. Small amounts of contraceptive steroids and/or their metabolites may pass into the breast milk. These amounts may affect the baby. Therefore, Sibilla should not be used during breastfeeding.

Driving and Using Machines

Sibilla does not affect the ability to drive or use machines.

Sibilla contains 47.66 mg of lactose monohydrate

Sibilla contains 47.66 mg of lactose monohydrate in one film-coated tablet .If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to Take Sibilla

This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
The blister pack has been designed to help remember to take the tablets.
One blister pack contains 21 tablets. The day of the week is printed next to each tablet. If, for example, the patient starts taking the medicine on a Wednesday, they should take the tablet marked "Wed".
The tablets should be taken in the direction of the arrow on the blister pack until all the tablets have been taken.
The patient should take one tablet every day at about the same time; with a little water if necessary, in the order indicated on the packaging. The patient should take one tablet each day for 21 days, then have a 7-day break from taking tablets. During this 7-day break, the patient will usually have a withdrawal bleed, similar to a period, on the 2nd or 3rd day of the break.
The next pack should be started on the 8th day (the day after the 7-day break) - even if the patient is still bleeding. If the patient has taken Sibilla correctly, they will start each new pack on the same day of the week and have their period on the same day of the month.
If the patient takes the tablets correctly, they will be protected against pregnancy from the start of the tablets.

Starting the First Pack If the patient did not use contraception in the previous cycle

The first contraceptive tablet should be taken on the first day of the menstrual period. This is the first day of the cycle - the day when bleeding begins. The patient should take the tablet marked with the corresponding day of the week.
Switching from another combined hormonal contraceptive (combined oral contraceptive, vaginal ring, or transdermal patch)
The patient should start taking Sibilla the next day after taking the last tablet from the previous contraceptive pack, but no later than the day after the last tablet-free day of the previous contraceptive method.
If the previous contraceptive pack contains placebo tablets, the patient should start taking Sibilla the next day after taking the last active tablet (i.e., the last tablet containing hormones) from the previous pack, but no later than the day after taking the last inactive tablet from the previous pack.
When switching from a vaginal ring or transdermal patch, the patient should follow the doctor's advice.
In case of doubt or further questions, the patient should consult their doctor or pharmacist.
Switching from a progestogen-only method (progestogen-only pill, mini-pill, injection, implant, or intrauterine system releasing progestogen - IUS)
The patient can switch from a progestogen-only pill at any time and start taking Sibilla the next day at the usual time. From an implant or intrauterine system, the patient can switch on the day of its removal, and from injections when the next injection is due. In all these cases, the patient should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Sibilla.
Starting Sibilla after a Miscarriage in the First Trimester
The patient should follow the doctor's advice.
Starting Sibilla after Childbirth or Miscarriage in the Second Trimester
After childbirth or miscarriage in the second trimester, the patient can start taking Sibilla between 21 and 28 days after the event. If the patient starts taking Sibilla more than 28 days after the event, they should use a barrier method (e.g., condoms) for the first 7 days of taking Sibilla.
If the patient has had intercourse after childbirth before taking Sibilla again, they should first make sure they are not pregnant or wait for their next menstrual period.
If the patient is unsure when to start taking Sibilla, they should consult their doctor.
If the patient is breastfeeding, they should take Sibilla as advised by their doctor.
If the patient thinks that the effect of Sibilla is too weak or too strong, they should contact their doctor.

What to Do if the Patient Takes More Sibilla Than They Should

There are no available data on overdosing with Sibilla. The acute toxicity of combined oral contraceptives in adults and children is low.
In such a case, symptoms may occur, such as nausea, vomiting, and in young girls, slight vaginal bleeding. Usually, no special treatment is needed. If necessary, treatment should be symptomatic.
If a child has taken more than one tablet, the patient should consult their doctor.

What to Do if the Patient Forgets to Take Sibilla

If it has been less than 12 hours since the last tablet was taken
The patient is still protected against pregnancy if they take the missed tablet as soon as they remember. The next tablets should be taken at the usual time. This may mean taking two tablets in one day.
If it has been more than 12 hours since the last tablet was taken
If more than 12 hours have passed since the last tablet was taken, the contraceptive protection may be reduced. The risk of pregnancy is higher if the patient misses a tablet at the beginning or end of the pack.
In such a case, the patient should follow these instructions:

• 1. If the patient has missed one tablet, they should take the missed tablet as soon as they remember, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time.
• 2. If the patient has missed more than one tablet, they should consult their doctor for advice. The patient should remember that the contraceptive protection is reduced.

What to Do if the Patient Misses a Tablet in the First Week
The patient should take the last missed tablet as soon as they remember, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time of day.
For the next 7 days, the patient should use a barrier method, such as condoms. If the patient had intercourse in the week before missing the tablet, they should consider the possibility of pregnancy. The patient should contact their doctor as soon as possible for advice.
What to Do if the Patient Misses a Tablet in the Second Week
The patient should take the last missed tablet as soon as they remember, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time of day. If the patient took the tablets correctly in the 7 days before missing the tablet, they do not need to use additional barrier methods of contraception.
What to Do if the Patient Misses a Tablet in the Third Week
If the patient took the tablets correctly in the 7 days before missing the tablet and follows one of the two instructions below, they do not need to use additional barrier methods of contraception.

• 1. The patient should take the last missed tablet as soon as they remember, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time of day. The patient should start the next pack immediately after taking the last tablet from the current pack, i.e., without a break between packs. It is likely that the patient will not have a withdrawal bleed until they finish the second pack, but they may experience spotting or breakthrough bleeding during the second pack.
• 2. The patient can also stop taking the tablets from the current pack. In this case, the patient should not take the 7-day break and should start taking the tablets from the next pack. If the patient wants to start the new pack on the scheduled day, they can have a shorter break (less than 7 days) from taking the tablets.

If the patient misses tablets and does not have a withdrawal bleed during the next break from taking tablets, they should consider the possibility of pregnancy. Before starting the next pack, the patient should contact their doctor for advice.

What to Do in Case of Gastrointestinal Disorders

If the patient vomits or has diarrhea within 3-4 hours after taking a contraceptive tablet, the active substances in the tablet may not be fully absorbed. In such a case, the patient should follow the instructions for missing tablets. The patient should take another tablet as soon as possible, but no later than 12 hoursafter the original tablet. If more than 12 hours have passed, the patient should follow the instructions in the section "If the patient forgets to take Sibilla".

4. Possible side effects

Like any medicine, this medicine can cause side effects, although not everybody gets them. If side effects occur, especially severe and persistent or changes in health that the patient considers related to the use of Sibilla, you should consult a doctor. You should immediately contact your doctor if the patient experiences any of the following symptoms of angioedema: facial swelling, tongue and/or pharynx swelling, and/or difficulty swallowing or urticaria, which may cause breathing difficulties (see also "Warnings and precautions"). In all women using combined hormonal contraceptives, there is an increased risk of developing blood clots in veins (venous thromboembolism) or blood clots in arteries (arterial thrombosis). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, you should refer to point 2 "Important information before using Sibilla". The following side effects were reported during the combined use of dienogest and ethinylestradiol in clinical trials:

• headaches,
• breast pain, including discomfort and breast tenderness.

Uncommon side effects(may occur in up to 1 in 100 patients):

• vaginal and/or vulvovaginal infection, fungal infections in the vagina (candidiasis, vulvovaginal infection),
• increased appetite,
• depression,
• dizziness,
• migraines,
• high or low blood pressure,
• abdominal pain (including upper and lower abdominal pain, discomfort, and/or bloating),
• nausea, vomiting, diarrhea,
• acne,
• hair loss (alopecia),
• skin rash (including patchy skin rash),
• itching (in some cases, all over the body),
• irregular withdrawal bleeding, including heavy bleeding (menstrual bleeding), scant bleeding (hypomenorrhea), infrequent bleeding (oligomenorrhea), or absence of withdrawal bleeding (amenorrhea),
• intermenstrual bleeding (vaginal bleeding or metrorrhagia),
• dysmenorrhea (painful menstruation), pelvic pain,
• breast enlargement, including breast swelling, breast tenderness,
• vaginal discharge,
• ovarian cysts,
• fatigue, including weakness, tiredness, and general malaise,
• weight gain.

Rare side effects(may occur in up to 1 in 1000 patients):

• ovarian and/or fallopian tube infection,
• cervicitis,
• urinary tract infection, cystitis,
• breast infection,
• fungal infections (e.g., caused by Candida fungi), viral infections (e.g., herpes simplex),
• influenza, bronchitis, upper respiratory tract infections, sinusitis,
• benign liver tumor (hepatic adenoma),
• benign breast tumor (breast lipoma),
• anemia,
• allergic reactions (hypersensitivity),
• virilization (hirsutism),
• loss of appetite (anorexia),
• depression, irritability, mood swings, aggression,
• insomnia, sleep disorders,
• cerebral or cardiac circulation disorders, stroke,
• dystonia (muscle disorders that can cause abnormal body posture),
• dry eyes or eye irritation,
• vision disorders (oscillopsia [objects appear to jump, vibrate, or oscillate], vision impairment),
• sudden hearing loss (hearing loss), hearing impairment,
• tinnitus (ringing in the ears),
• feeling of spinning, dizziness,
• rapid heart rate,
• increased diastolic blood pressure (decreased arterial blood pressure),
• orthostatic disorders (dizziness or fainting when changing position from sitting or lying to standing),
• hot flashes,
• phlebitis (thrombophlebitis),
• varicose veins or vein disorders, or vein pain,
• asthma,
• increased respiratory rate (hyperventilation),
• gastritis, enteritis,
• indigestion (dyspepsia),
• skin reactions/skin disorders, including allergic skin reaction, neurodermatitis (thick, irritated, very itchy skin)/atopic dermatitis (itchy, red, swollen, and cracked skin), eczema, psoriasis,
• excessive sweating,
• golden-brown pigment spots on the skin (chloasma), especially on the face (melasma), skin discoloration/increased pigmentation,
• oily skin (seborrhea),
• dandruff,
• excessive body hair growth (hirsutism),
• cellulite,
• spider veins (visible network of blood vessels with a localized central red spot on the skin),
• back pain, chest pain,
• musculoskeletal discomfort, muscle pain (myalgia), pain in arms and legs,
• cervical dysplasia (abnormal cell growth on the surface of the cervix),
• adnexal pain or adnexal cyst (fallopian tubes and ovaries),
• breast cysts, benign breast changes (fibrocystic mastopathy), appearance of additional breast tissue outside the breast (supernumerary nipples),
• pain during sexual intercourse,
• breast discharge (abnormal milk production),
• menstrual disorders,
• edema (fluid retention in the body),
• flu-like symptoms, inflammation, fever,
• increased triglyceride and cholesterol levels in the blood (hypertriglyceridemia, hypercholesterolemia),
• weight loss or weight fluctuations (weight gain, weight loss, or weight fluctuations)
• harmful 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 a transient ischemic attack,
• blood clots in the liver, stomach/intestine, kidneys, or eye. The likelihood of developing blood clots may be higher if the patient has any other risk factors (see point 2 for more information on risk factors for developing blood clots and symptoms of blood clots).

Unknown (cannot be estimated from available data)

• mood changes,
• increased or decreased libido (sexual desire),
• eye irritation when wearing contact lenses,
• urticaria (itching),
• erythema nodosum (painful red nodules on the skin),
• erythema multiforme (rash with red patches in the shape of a target or blister),
• breast discharge,
• fluid retention in the body.

Reporting side effects

If any side effects occur, 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 Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sibilla

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
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 Sibilla contains

• The active substances of Sibilla are dienogest and ethinylestradiol. Each film-coated tablet contains 2 mg of dienogest and 0.03 mg of ethinylestradiol.
• Other ingredients are: Core:Lactose monohydrate Cornstarch Hypromellose type 2910 Talc Potassium polacrilin Magnesium stearate

Coating:
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc

What Sibilla looks like and what the package contains

White or almost white, round, biconvex film-coated tablets, approximately 5.5 mm in diameter. On one side, the inscription "G53" is embossed, and the other side is smooth.
Sibilla film-coated tablets are packaged in white PVC/PE/PVDC/Aluminum blisters. The blisters are packaged in a cardboard box containing a patient leaflet and a case for storing blisters.
Package sizes:
1 x 21 film-coated tablets
3 x 21 film-coated tablets
6 x 21 film-coated tablets
Not all package sizes may be marketed.

Marketing authorization holder:

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki

Manufacturer:

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
To obtain more detailed information about the medicine and its names in other European Economic Area member states, you should contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel. +48 (22)755 96 48
lekalert@grodzisk.rgnet.org
This medicine is authorized for marketing in European Economic Area member states under the following names:
Hungary Mistral
Czech Republic Mistra
Poland Sibilla
Slovakia Mistra

Date of last revision of the leaflet: