Sibilla

Package leaflet: Information for the user

Sibilla, 2 mg + 0,03 mg, film-coated tablets
Dienogest + Ethinylestradiol
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 a woman suspects symptoms of blood clot formation (see section 2 "Blood clots").

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm others, even if their symptoms are similar.
• If any adverse effects occur in the patient, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Sibilla is and what it is 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 package and other information

1. What Sibilla is and what it is used for

Sibilla is a medicinal product

• used to prevent pregnancy (contraceptive tablet),
• for the treatment of women with moderate acne who have decided to use oral contraceptives and in whom adequate topical treatment or oral antibiotic therapy has failed.

Sibilla is a combined oral contraceptive, one of a group of medicines commonly referred to as "the pill".
Each tablet contains two types of female hormones: an oestrogen – ethinylestradiol, and a progestagen –
dienogest.
The combined oral contraceptive prevents pregnancy through three mechanisms:

1. Inhibition of ovulation (preventing the release of an egg from the ovaries).
2. Preventing fertilisation of a released egg.
3. Preventing implantation of a fertilised egg into the lining of the uterus.

Sibilla belongs to a group of medicines often referred to as "micro-pills" due to their low hormone content. It is also described as a combined oral contraceptive because it contains two types of hormones, and as a monophasic oral contraceptive because each tablet has the same composition.
Sibilla improves acne in women in whom this condition may be caused by an excess of male sex hormones called "androgens", which are naturally present in all women.

2. Information to know before taking Sibilla

General notes
Before starting to take Sibilla, you should read the information about blood clots in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section 2 “Blood clots”).
This leaflet describes several situations in which you should stop taking Sibilla or when the effectiveness of Sibilla may be reduced. In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive methods (such as condoms or other barrier methods) to ensure effective contraception.
Do not use the calendar method or the basal body temperature method, as oral contraceptives may affect body temperature and the cyclic changes in cervical mucus.
Remember that combined oral contraceptive tablets such as Sibilla do not protect against sexually transmitted infections (such as AIDS). Only the use of condoms provides such 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. You should discuss with your doctor the need to continue treatment after three to six months, and then at regular intervals thereafter.

When not to use Sibilla
Do not take Sibilla if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you are allergic to dienogest or ethinylestradiol or any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have ever had) a blood clot in the blood vessels of your legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have blood clotting disorders — for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a prolonged period (see section “Blood clots”);
• if you have had a heart attack or stroke;
• if you currently have (or have had in the past) 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 currently have (or have had in the past) any of the following diseases 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 pancreatitis;
• if you currently have or have previously had severe liver disease or jaundice (yellowing of the skin). Jaundice or generalized itching may be symptoms of liver disease;
• if you currently have or have previously had liver tumours;
• if you currently have or may have breast cancer or another cancer, such as ovarian cancer, cervical cancer, or cancer of the uterus;
• if you have vaginal bleeding of unknown cause;
• if you currently have (or have had in the past) a type of migraine called “migraine with aura”.

Do not use Sibilla in patients with hepatitis C who are taking medicinal products containing ombitasvir with 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 while taking Sibilla, stop taking the contraceptive tablets immediately and contact your doctor without delay. During this time, use other non-hormonal contraceptive methods. See also section “Warnings and precautions”.
If you have any of the conditions listed above, inform your doctor before starting Sibilla. Your doctor may recommend using alternative contraceptive methods.

Warnings and precautions
Before starting Sibilla, discuss this with your doctor or pharmacist.

When to contact your doctor
Seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below “Blood clots (thrombosis)”).

For a description of the symptoms of these serious adverse effects, see “How to recognize the occurrence of blood clots”.

Tell your doctor if you have any of the following conditions.
In some cases, combined oral contraceptives should be used under strict medical supervision. If you have any of the conditions listed below, inform your doctor before taking Sibilla. If any of these symptoms develop or worsen during treatment with Sibilla, inform your doctor immediately:

• if you have diabetes;
• if you are significantly overweight (obesity);
• if you have high blood pressure;
• if you have heart valve disorders or certain heart rhythm abnormalities;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you or your close relatives have any condition that may increase the risk of developing blood clots;
• if you have migraines;
• if you have Sydenham's chorea (a movement disorder);
• if you or your close relatives have lipid metabolism disorders (lipid disorders) in the blood or other very rare blood disorders;
• if you have liver disease and/or gallbladder disease (jaundice, gallstones);
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have jaundice or generalized itching;
• if you have systemic lupus erythematosus (SLE; a disease affecting the body’s natural immune system);
• if you have haemolytic uraemic syndrome (HUS; a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”);
• if you are in the immediate postpartum period, as you are at increased risk of blood clots. Consult your doctor to determine how soon after delivery you can start taking Sibilla;
• if you have a hereditary condition called porphyria;
• if you have had a skin rash called pemphigoid gestationis;
• if you have a hereditary hearing loss called otosclerosis;
• if you have brown patches on your face and body (melasma), which can be minimized by avoiding direct sun exposure or not using sunbeds or tanning lamps;
• if you smoke. In women who smoke, taking combined hormonal contraceptives increases the risk of serious cardiovascular disorders (such as myocardial infarction and stroke). This risk increases with age and the number of cigarettes smoked;
• if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria, possibly causing breathing difficulties, contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.
• if you have depression or mood changes.

Women over 35 years of age should stop smoking if they wish to use combined oral contraceptives. If you do not wish to stop smoking, you should use alternative contraceptive methods, especially if other risk factors are present.
If any of the above conditions occur for the first time or worsen during treatment with Sibilla, consult your doctor as soon as possible.

BLOOD CLOTS
The use of combined hormonal contraceptives such as Sibilla is associated with an increased risk of blood clots compared to not using such therapy. 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”).

Recovery after a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots associated with taking Sibilla is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.

Do you experience any of these symptoms? What is the likely reason?

• swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:

  • pain or tenderness in the leg, which may occur only when standing or walking;
  • increased warmth in the affected leg;
  • change in skin colour of the leg, such as pallor, redness, or bluish discoloration.

• sudden unexplained shortness of breath or rapid breathing;

• sudden cough without obvious cause, possibly accompanied by coughing up blood;

• sharp chest pain, which may worsen on deep breathing;

• severe dizziness or vertigo;

• rapid or irregular heartbeat;

• severe abdominal pain.

If you are unsure, contact your doctor, as some of these symptoms, such as cough or rapid breathing, may be mistaken for milder conditions such as respiratory tract infection (e.g. cold).

Symptoms usually affect one eye:

• sudden loss of vision; or

• painless visual disturbances, which may progress to vision loss.
  (Retinal vein thrombosis — blood clot in the eye)

• chest pain, discomfort, pressure, or heaviness;

• sensation of tightness or fullness in the chest, arm, or below the breastbone;

• feeling of fullness, indigestion, or choking;

• discomfort in the lower chest radiating to the back, jaw, throat, arm, or stomach;

• sweating, nausea, vomiting, or dizziness;

• 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 visual disturbances in one or both eyes;

• sudden difficulty walking, dizziness, loss of balance, or coordination.
  (Stroke)

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). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher 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 than in women who do not use combined hormonal contraceptives.
If a woman stops taking Sibilla, the risk of developing 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 used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Sibilla is low.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 8 to 11 out of 10,000 women who use combined hormonal contraceptives containing dienogest and ethinylestradiol, such as Sibilla, will develop blood clots.
• The risk of developing blood clots depends on the individual's medical history (see "Factors that increase the risk of blood clots", below).

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Sibilla is low, but certain factors may increase this risk. The risk is higher:

• if the patient is overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In such cases, the patient may have an inherited blood clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue Sibilla several weeks before surgery or periods of reduced mobility. If the patient must stop taking Sibilla, ask the doctor when it is safe to resume taking the medicine;
• with increasing age (particularly over 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has any other risk factor listed above.
It is important to inform the doctor if any of these risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue Sibilla.
Inform the doctor if any of the above conditions change during treatment with Sibilla, 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 lead to serious consequences, 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 Sibilla is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Sibilla, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has uncontrolled high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In such cases, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, heart rhythm disorder 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 further increased.
Inform the doctor if any of the above conditions change during treatment with Sibilla, for example, if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

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

Psychiatric disorders:
Some women using hormonal contraceptives, including Sibilla, 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 for further medical advice.

Children and adolescents
Sibilla is not indicated for use before the onset of first menstruation (menarche).

Older women
Sibilla is not indicated for use in postmenopausal women.

Sibilla and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
The patient should also inform other doctors or dentists prescribing other medicines about the use of Sibilla. The doctor will advise whether additional contraception (e.g. condoms) is needed, for how long, and whether any changes in the use of certain medicines are required.
Do not use Sibilla in patients with hepatitis C who are taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these products may cause abnormal liver function test results (increased activity of liver enzymes ALT).
Before starting these medicines, the doctor will prescribe another type of contraception.
Sibilla may be restarted approximately 2 weeks after completing the above-mentioned treatment. See section "When not to use Sibilla".
Some medicines may affect blood levels and cause reduced effectiveness of Sibilla 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 virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g. griseofulvin).

If the patient wishes to use herbal products containing St. John's wort (an herbal remedy used to treat depression) while taking Sibilla, she should consult the doctor.
Interactions between Sibilla and other medicines may also lead to a higher frequency of adverse effects.
The following medicines may affect the tolerability of Sibilla:

• etoricoxib (used to treat arthritis, osteoarthritis).

Sibilla may affect the effectiveness of other medicines, for example:

• cyclosporine (a medicine used to prevent 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).

In women with diabetes, a change in blood sugar-lowering medicines (e.g. insulin) may be necessary.
Before taking any medicine, consult a doctor or pharmacist.

Before laboratory tests
Inform the doctor or laboratory staff that you are taking oral contraceptives, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take Sibilla if the patient is pregnant. If pregnancy is confirmed or suspected, stop taking Sibilla and contact the doctor immediately.

Breastfeeding
If the patient takes Sibilla while breastfeeding, tablet use may lead to reduced milk production and changes in its composition. Small amounts of contraceptive steroids and/or their metabolites may pass into breast milk. These amounts may affect the infant. Therefore, Sibilla should not be used during breastfeeding.

Driving and operating machinery
Sibilla has no effect on the ability to drive or operate machinery.

Sibilla contains 47.66 mg of monohydrate lactose per tablet
Sibilla contains 47.66 mg of monohydrate lactose in one coated tablet. If the patient has previously been diagnosed with intolerance to certain sugars, she should consult the doctor before taking this medicine.

3. How to take Sibilla

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.
The blister pack has been designed to help you remember to take the tablets.
One blister contains 21 tablets. Next to each tablet, the day of the week on which the tablet should
be taken is printed. For example, if treatment is started on Wednesday, take the tablet marked "Wed".
Tablets should be taken in the direction of the arrow on the blister until all tablets have been used.
The patient should take one tablet daily at approximately the same time each day, swallowing it
with a small amount of liquid if necessary, following the order indicated on the packaging. One
tablet should be taken every day until all 21 tablets in the pack have been consumed. After this,
a 7-day tablet-free interval follows. During this 7-day break, withdrawal bleeding, similar to
menstruation, usually occurs 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 bleeding
has not yet stopped. If Sibilla has been taken correctly, each subsequent pack should always be
started on the same day of the week, and menstrual bleeding will occur regularly on the same day
of the month.
If the patient takes the contraceptive tablets correctly, contraceptive protection is ensured from
the very beginning of tablet intake.

Starting the first pack
If no oral hormonal contraception was used in the previous cycle
The first contraceptive tablet should be taken on the first day of menstruation. This is the first
day of the cycle—the day when bleeding begins. Take the tablet marked with the appropriate
day of the week.

Switching from another combined hormonal contraceptive (combined oral contraceptive,
vaginal contraceptive system, or transdermal contraceptive patch)
Start taking Sibilla the day after taking the last active tablet from the previous contraceptive pack,
but no later than the day after the tablet-free interval of the previous contraceptive ends.
If the previous contraceptive blister pack also contains placebo tablets, start taking Sibilla the
day after the last active (hormone-containing) tablet, but no later than the day after the last inactive
tablet of the previous contraceptive.
When switching from a vaginal contraceptive system or transdermal patch, follow your doctor's
instructions.
If in doubt or for further questions, consult your doctor or pharmacist.

Switching from a progestogen-only method (progestogen-only pill, mini-pill, injection, implant,
or intrauterine system releasing progestogen - IUS)
You may switch at any time from a progestogen-only pill and start taking Sibilla the next day at
the usual time. You may switch from an implant or intrauterine system on the day of its removal,
and from an injectable form on the day the next injection would have been due. In all these cases,
additional contraceptive methods (e.g., condoms) should be used for the first 7 days of taking
Sibilla tablets.

Starting Sibilla after a first-trimester miscarriage
Follow your doctor's instructions.

Starting Sibilla after childbirth or second-trimester miscarriage
After childbirth or a second-trimester miscarriage, Sibilla may be started between 21 and 28 days
post-event. If treatment is started later than on day 28, a mechanical contraceptive method (e.g.,
condoms) should be used for the first 7 days of taking Sibilla.
If the patient has had sexual intercourse after childbirth and before restarting Sibilla, pregnancy
should first be ruled out, or the patient should wait until the next menstrual bleeding occurs.
If the patient is unsure when to start taking the medicine, she should consult her doctor.
If the patient is breastfeeding, she should take Sibilla only as directed by her doctor.
If the patient feels that the effect of Sibilla is too weak or too strong, she should contact her doctor.

Taking more than the recommended dose of Sibilla
There are no available data on overdose with Sibilla. Acute toxicity after oral overdose of other
combined hormonal contraceptives in adults and children is low.
In such cases, symptoms such as nausea, vomiting, and slight vaginal bleeding in young girls may
occur. Usually, no specific treatment is required. If necessary, treatment should be symptomatic.
If a child has taken more than one tablet, consult a doctor immediately.

Missed dose of Sibilla
If less than 12 hours have passed since the last tablet was taken
The patient remains protected against pregnancy if she takes the missed tablet immediately as
soon as she remembers. Subsequent tablets should be taken at the usual time. This may mean taking
two tablets within one day.

If more than 12 hours have passed since the last tablet was taken
If more than 12 hours have passed since the last tablet was taken, contraceptive protection may
be reduced. The risk of pregnancy is higher if the patient missed a tablet at the beginning or end
of the pack.
In such cases, follow the instructions below:

If the patient missed more than one tablet
If the patient missed more than one tablet, consult a doctor. Remember that contraceptive
protection is reduced.

What to do if a tablet is missed in the first week
Take the last missed tablet as soon as remembered, even if this means taking two tablets at the same
time. Continue taking the remaining tablets at the usual time.
For the next 7 days, use mechanical contraceptive methods (e.g., condoms). If sexual intercourse
occurred in the week before the missed tablet, consider the possibility of pregnancy. Contact your
doctor as soon as possible for advice.

What to do if a tablet is missed in the second week
Take the last missed tablet as soon as remembered, even if this means taking two tablets at the
same time. Continue taking the remaining tablets at the usual time.
If tablets were taken correctly in the 7 days before the missed tablet, additional (mechanical)
contraceptive methods are not required.

What to do if a tablet is missed in the third week
If the patient took tablets correctly in the 7 days before the missed tablet and follows one of the
two options below, additional contraceptive methods are not required.

1. Take the last missed tablet immediately upon remembering, even if this means taking two tablets at the same time. Continue taking tablets at the usual time. Start the next pack immediately after finishing the last tablet of the current pack—i.e., without a break between packs. Withdrawal bleeding will most likely not occur until after finishing the second pack, but spotting or breakthrough bleeding may occur during the intake of tablets from the second pack.
2. Alternatively, stop taking tablets from the current pack. In this case, skip the 7-day tablet-free interval, including the days when tablets were missed, and immediately start taking tablets from the next pack. If the patient wishes to start the new pack on a previously established day, she may take a shorter-than-7-day break from the medication.

If tablets are missed and no withdrawal bleeding occurs during the next tablet-free interval,
consider the possibility of pregnancy. In such cases, consult a doctor before starting the next pack.

What to do in case of gastrointestinal disturbances
If vomiting or diarrhoea occurs within 3 to 4 hours after taking the contraceptive tablet, the active
substances may not have been completely absorbed. In such cases, follow the above instructions
for missed tablets. Take another tablet as soon as possible, but no later than within 12 hours.
If more than 12 hours have passed, follow the instructions under "Missed dose of Sibilla".

What to do if the patient wishes to delay withdrawal bleeding
If the patient wishes to delay withdrawal bleeding, she should start taking tablets from the next
pack of Sibilla immediately after the last tablet of the current pack, without a break in taking
contraceptive tablets. The patient may take any number of tablets from the next pack up to the end
of the second blister pack. Spotting or breakthrough bleeding may occur during the intake of tablets
from the second pack. Regular intake of Sibilla should be resumed after the usual 7-day tablet-free
interval.

What to do if the patient wishes to change the day of withdrawal bleeding
If the patient takes Sibilla as directed, withdrawal bleeding occurs on the same day each month.
If the patient wishes to change the day of bleeding to another day of the week than the one it
currently occurs on, she may shorten (but never extend) the tablet-free interval by any number of
days before starting the current pack. For example, if menstrual bleeding usually starts on Friday
and the patient wants it to start on Tuesday (i.e., 3 days earlier), she should start taking tablets from
the next pack of Sibilla 3 days earlier. The shorter the tablet-free interval, the higher the likelihood
that withdrawal bleeding will not occur, and spotting or breakthrough bleeding may occur during
the intake of tablets from the second pack.

If the patient experiences breakthrough bleeding
Some women may experience light breakthrough bleeding or spotting during the intake of
contraceptive tablets, especially during the first few months. Usually, such bleeding is not a cause
for concern and resolves within 1–2 days. A sanitary pad or tampon may be needed, but contraceptive
tablets should be taken at the usual time, as these issues typically resolve after taking a few packs.
If bleeding recurs, is bothersome, or persists for a longer time, consult a doctor.

If withdrawal bleeding does not occur
If tablets were taken correctly, no gastrointestinal disturbances occurred, and no other medicines
were taken, the likelihood of pregnancy is low. Continue taking Sibilla as usual.
If withdrawal bleeding does not occur for two consecutive cycles, pregnancy may be possible,
and the patient should contact her doctor immediately. Sibilla may be continued only after a
negative pregnancy test and consultation with a doctor.

Discontinuing Sibilla
Sibilla may be discontinued at any time. If the patient does not wish to become pregnant, she should
consult her doctor about other suitable contraceptive methods.
For any further questions or uncertainties regarding the use of this medicine, consult your doctor
or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If any adverse effects occur, especially severe and persistent ones, or changes in health status which the patient considers to be related to the use of Sibilla, medical advice should be sought.
Immediate medical attention must be sought 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").

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

The following adverse effects have been reported during clinical trials with the combination of dienogest and ethinylestradiol:

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

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

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

• genital infections (vaginitis and/or vulvitis and vaginitis), fungal infections of the vagina (candidiasis, vaginal and vulval infections),
• increased appetite,
• depression,
• dizziness,
• migraine,
• high or low blood pressure,
• abdominal pain (including upper and lower abdominal pain, discomfort and/or bloating),
• nausea, vomiting, diarrhoea,
• acne,
• hair loss (alopecia),
• skin rash (including maculopapular rash),
• itching (in some cases generalized),
• irregular withdrawal bleeding, including heavy bleeding (menorrhagia), scanty bleeding (hypomenorrhea), infrequent bleeding (oligomenorrhea), or absence of withdrawal bleeding (amenorrhea),
• intermenstrual bleeding (vaginal bleeding or uterine haemorrhage),
• menstrual pain (dysmenorrhoea), pelvic pain,
• breast enlargement, including breast swelling, breast fullness,
• vaginal discharge,
• ovarian cysts,
• fatigue, including weakness, tiredness and general malaise,
• weight gain.

Rare adverse effects (may affect up to 1 in 1,000 users):

• inflammation of the ovaries or fallopian tubes,
• cervical inflammation,
• urinary tract infection, cystitis,
• mastitis,
• fungal infections (e.g. caused by Candida species), viral infections such as herpes labialis,
• influenza, bronchitis, upper respiratory tract infections, sinus infection (sinusitis),
• benign proliferation in the uterus (leiomyomas),
• benign proliferation in breast fatty tissue (fibroadenoma of the breast),
• anaemia,
• allergic reactions (hypersensitivity),
• masculinization (virilization),
• loss of appetite (anorexia),
• depression, irritability, mood disorders, aggression,
• insomnia, sleep disorders,
• circulatory disorders in the brain or heart, stroke,
• dystonia (muscle disorders which may, for example, cause abnormal body posture),
• dry eyes or eye irritation,
• visual disturbances (oscillopsia [objects appear to jump, vibrate or oscillate], blurred vision),
• sudden deafness (hearing loss), hearing impairment,
• tinnitus (ringing in the ears),
• sensation of spinning, dizziness,
• rapid heartbeat,
• increased diastolic blood pressure (reduction in arterial blood pressure),
• dizziness or fainting upon changing position from sitting or lying to standing (orthostatic disturbances),
• hot flushes,
• inflammation of veins (thrombophlebitis),
• varicose veins, venous disorders or pain in veins,
• asthma,
• increased breathing rate (hyperventilation),
• inflammation of the stomach lining (gastritis), enteritis,
• indigestion (dyspepsia),
• skin reactions/skin disorders, including allergic skin reaction, neurodermatitis (thickened, irritated, intensely itchy skin)/atopic dermatitis (itchy, red, swollen and cracked skin), eczema, psoriasis,
• excessive sweating,
• golden-brown pigmentation spots on the skin (so-called chloasma), particularly on the face (melasma), skin discoloration/increased pigmentation,
• oily skin (seborrhoea),
• dandruff,
• excessive body hair growth (hirsutism),
• cellulite,
• spider angioma (visible network of blood vessels with a centrally located red spot on the skin),
• back pain, chest pain,
• bone and muscle discomfort, muscle pain (myalgia), pain in arms and legs,
• cervical dysplasia (abnormal cell growth on the surface of the cervix),
• pain or cyst of the adnexa (fallopian tubes and ovaries),
• breast cysts, benign changes in the breast (fibrocystic mastopathy), development of additional mammary glands outside the breast (supernumerary nipples),
• pain during sexual intercourse,
• nipple discharge (abnormal milk production),
• menstrual disorders,
• oedema (fluid retention),
• influenza-like symptoms, inflammation, fever,
• increased blood levels of triglycerides and cholesterol (hypertriglyceridaemia, hypercholesterolaemia),
• weight loss or weight fluctuations (increase, decrease or fluctuation in weight),
• 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 ischaemic attack (TIA),
  • 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 section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Unknown frequency (cannot be estimated from available data):

• mood changes,
• increased or decreased sexual desire (libido),
• eye irritation when wearing contact lenses,
• urticaria (itching),
• erythema nodosum (painful red nodules on the skin),
• erythema multiforme (rash with red, target-shaped lesions or blisters),
• breast discharge,
• fluid retention.

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

5. How to store the medicine Sibilla

Keep this medicine 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 stated month.
Store below 25°C. Keep in the original packaging to protect from light.
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 Sibilla contains

• The active substances are: dienogest and ethinylestradiol. Each coated tablet contains 2 mg of dienogest and 0.03 mg of ethinylestradiol.

• Other ingredients are:
  Core: Lactose monohydrate, Corn starch, Hypromellose type 2910, Talc, Potassium polacrilin, Magnesium stearate

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

What Sibilla looks like and contents of the pack
White or almost white, round, biconvex coated tablets, approximately 5.5 mm in diameter. On one side of the tablet is embossed the code "G53", the other side is smooth.
The coated tablets of the medicinal product Sibilla are packed in white PVC/PE/PVDC/Aluminium foil blisters. The blisters are placed in a cardboard box containing the patient leaflet and a holder for storing the blister packs.
Pack sizes:
1 x 21 coated tablets
3 x 21 coated tablets
6 x 21 coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

Manufacturer:
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

For further information about this medicinal product and its trade names in other European Economic Area countries, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Tel. +48 (22) 755 96 48
[email protected]

This medicinal product is authorised in the European Economic Area countries under the following trade names:
Hungary Mistral
Czech Republic Mistra
Poland Sibilla
Slovakia Mistra

Date of the latest revision of the leaflet: