Sibilla 2 mg/0.03 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Sibilla 2 mg /0.03 mg film-coated tablets EFG

dienogest / ethinylestradiol

Important things you need to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of developing a blood clot in the veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Sibilla is and what it is used for

Sibilla is a medicine:

• to prevent pregnancy (a "birth control pill"),
• for the treatment of women with moderate acne who agree to use a birth control pill after failure of appropriate topical treatments or oral antibiotics.

Sibilla is a combined oral contraceptive belonging to a group of medicines commonly referred to as "the pill". It contains two types of hormones: an oestrogen and a progestogen.

Combined oral contraceptives prevent pregnancy in three ways. These hormones

1. prevent the ovary from releasing an egg each month (ovulation),
2. also thicken the cervical mucus, making it more difficult for sperm to reach the egg,
3. and alter the lining of the uterus, making it less likely to accept a fertilized egg.

2. What you need to know before starting to take Sibilla

General considerations

Before starting to use Sibilla, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot – see section 2 (“Blood clots”).

This leaflet describes several situations in which you should stop taking Sibilla, or in which the contraceptive may become less effective. In these situations, you must either avoid sexual intercourse or use additional non-hormonal contraceptive precautions (such as a condom or another barrier method) during sexual intercourse to ensure effective contraception. Do not use calendar-based methods or body temperature measurement upon waking, as oral contraceptives may affect body temperature and cyclic changes in cervical mucus composition.

Remember that combined oral contraceptives such as Sibilla do not protect you against sexually transmitted infections (such as AIDS). Only condoms can help protect you from these.

Sibilla for acne

Acne usually improves within three to six months of treatment and may continue to improve even after six months. You should discuss with your doctor the need to continue treatment three to six months after starting and periodically thereafter.

Do not use Sibilla

Do not use Sibilla if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you which other form of contraception would be more suitable.

• if you are allergic to dienogest or ethinylestradiol or to any of the other ingredients of this medicine (listed in section 6);

• if you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs;

• if you know you have a disorder affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;

• if you require surgery or are unable to walk for long periods (see section “Blood clots”);

• if you have ever had a heart attack or stroke;

• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (TIA, temporary stroke-like symptoms);

• if you have any of the following conditions that may increase your risk of developing a blood clot in the arteries:

  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fat in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia;

• if you have or have had a serious liver disease and liver function is still abnormal; jaundice or itching all over the body may be signs of liver disease;

• if you have liver tumours or have ever had them;

• if you have or have ever had or are suspected of having breast cancer or cancer of the genital organs, for example ovarian cancer, cervical cancer, or uterine (womb) cancer;

• if you have unexplained vaginal bleeding;

• if you have (or have ever had) a type of migraine called “migraine with aura”;

• if you have (or have ever had) inflammation of the pancreas (pancreatitis).

Do not use Sibilla if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, or glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Use of Sibilla with other medicines”).

If any of the above conditions occur while you are taking Sibilla, do not take any more tablets and contact your doctor immediately. In the meantime, use another non-hormonal contraceptive method.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sibilla.

When should you consult your doctor?

Seek urgent medical help:

• if you notice possible signs of a blood clot which may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clot” below).

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

Inform your doctor if you have any of the following conditions.

In some situations, you need to be especially careful while taking Sibilla or any other combined contraceptive, and your doctor may need to perform regular check-ups. If any of the following situations apply to you, consult your doctor before starting to use Sibilla. If the condition develops or worsens while using Sibilla, you must also inform your doctor:

• if a close relative has or has had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression or mood changes;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have epilepsy (see “Use of Sibilla with other medicines”);
• if you have systemic lupus erythematosus (SLE, a disease affecting your body’s natural defence system);
• if you have high levels of fat in the blood (hypertriglyceridaemia) or a known family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas);
• if you require surgery or are unable to walk for long periods (see section 2 “Blood clots”);
• if you have recently given birth, you are at higher risk of blood clots. Ask your doctor when you can start taking Sibilla after childbirth;
• if you have inflammation of veins beneath the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have a condition that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nerve disorder causing sudden jerky movements (Sydenham’s chorea));
• if you have or have ever had chloasma (a skin pigmentation disorder mainly affecting the face and neck, also known as “pregnancy mask”). If so, avoid direct exposure to sunlight or ultraviolet light;
• if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible breathing difficulties, you should seek immediate medical attention. Medicines containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Sibilla increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• in veins (called “venous thrombosis”, “venous thromboembolism” or VTE),
• in arteries (called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Sibilla is small.

How to recognize a blood clot

Seek urgent medical help if you notice any of the following signs or symptoms:

Are you experiencing any of these signs?	What could you be suffering from?
swelling in one leg or along a vein in the leg or foot, especially when accompanied by: pain or tenderness in the leg, which may only be noticed when standing or walking. increased warmth in the affected leg. change in skin color of the leg, e.g., if it becomes pale, red, or blue.	Deep vein thrombosis
sudden shortness of breath without known cause or rapid breathing; sudden cough without clear cause, possibly bringing up blood; sharp chest pain that may worsen on deep breathing; severe dizziness or lightheadedness; rapid or irregular heartbeat. severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: sudden loss of vision, or painless blurred vision that may progress to vision loss	Retinal vein thrombosis (blood clot in the eye).
chest pain, discomfort, pressure, heaviness; feeling of tightness or fullness in the chest, arm, or below the sternum; feeling of fullness, indigestion, or suffocation; discomfort in the upper body spreading 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, arm, or leg, especially on one side of the body; sudden confusion, difficulty speaking or understanding speech; sudden vision problems in one or both eyes; sudden difficulty walking, dizziness, loss of balance or coordination; sudden, severe, or prolonged headache without known cause; loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
swelling and slight bluish discoloration of a limb. severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels.

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse effects are rare. They occur more frequently during the first year of using a combined hormonal contraceptive.

• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).

• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).

• Very rarely, a blood clot may form in a vein of another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein higher?

The risk of developing a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be increased if you restart taking a combined hormonal contraceptive (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 slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Sibilla, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Sibilla is small.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing dienogest and ethinylestradiol, such as Sibilla, approximately 8 to 11 women will develop a blood clot in one year.
• Your risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	Approximately 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	Approximately 5–7 out of 10,000 women
Women who use Sibilla	Approximately 8–11 out of 10,000 women

Factors that increase your risk of a blood clot in a vein

The risk of having a blood clot with Sibilla is small, but certain conditions increase the risk. Your risk is higher:

• if you are overweight (body mass index or BMI above 30 kg/m²);
• if any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you may have an inherited blood clotting disorder;
• if you need surgery or will be immobile for a long time due to injury or illness, or if you have a plaster cast on your leg. You may need to stop taking Sibilla several weeks before surgery or while you are less mobile. If you need to stop taking Sibilla, ask your doctor when you can start taking it again;
• as you get older (especially above approximately 35 years of age);
• if you have given birth within the last few weeks.

The risk of developing a blood clot increases the more conditions you have.

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

It is important to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you need to stop taking Sibilla.

If any of the above conditions change while you are using Sibilla—for example, a close relative experiences a thrombosis without a known cause or you gain significant weight—inform your doctor.

BLOOD CLOTS IN AN ARTERY

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

Just like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it may cause a heart attack or stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of a heart attack or stroke while using Sibilla is very small, but it may increase:

• with age (especially above approximately 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Sibilla, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive;
• if you are overweight;
• if you have uncontrolled high blood pressure despite treatment;
• if any of your close relatives have had a heart attack or stroke at a young age (approximately under 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides);
• if you suffer from migraines, especially migraines with aura;
• if you have a heart condition (valve disorders, heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have one or more of these conditions, or if any of them are particularly severe, your risk of developing a blood clot may be further increased.

If any of the above conditions change while you are using Sibilla—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

Sibilla and cancer

A slightly higher frequency of breast cancer has been observed in women taking combined contraceptives, but it is not known whether this is caused by the treatment. For example, it may be due to more tumors being detected in women taking combined contraceptives because they are examined more frequently by their doctor. The occurrence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly examine your breasts and contact your doctor if you notice any lumps. Rare cases of benign liver tumors and even rarer cases of malignant liver tumors have been reported in users of hormonal contraceptives. Contact your doctor if you experience severe, unusual abdominal pain.

Some epidemiological studies have found an increased risk of cervical cancer in long-term users of combined contraceptives, but there is still controversy about how much this finding is attributable to confounding effects of sexual behavior and other factors such as human papillomavirus.

Psychiatric disorders

Some women using hormonal contraceptives such as Sibilla have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for medical advice as soon as possible.

Unexpected bleeding between periods

During the first few months of taking Sibilla, you may experience unexpected bleeding (bleeding outside the rest period). If this bleeding lasts longer than a few months, or if it starts after several months, your doctor should investigate the cause.

Periodic check-ups

After you start taking the contraceptive, your doctor will schedule periodic check-ups for you. The frequency and nature of these check-ups will be determined by your doctor and tailored to your individual needs and health status.

Children and adolescents

Sibilla is not indicated for use before the first menstrual bleeding (menarche).

Older women

Sibilla is not indicated after menopause.

Use of Sibilla with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Also inform any doctor or dentist who prescribes another medicine that you are taking Sibilla. They can advise you whether you need to take additional contraceptive precautions (e.g., condoms), and if so, for how long, or whether you should change the use of any other medicine.

Do not use Sibilla if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause an increase in blood test results for liver function (elevated liver enzyme ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Sibilla may be resumed approximately 2 weeks after completing this treatment. See section “Do not use Sibilla”.

Some medicines may affect the blood levels of Sibilla and make it less effective in preventing pregnancy, or may 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 (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g., griseofulvin).

If you wish to take herbal remedies containing St. John’s wort (a herbal preparation used for depression) while taking Sibilla, you must first consult your doctor.

Interactions of Sibilla with other medicines that may increase adverse effects or worsen them.

The following medicines may reduce the tolerability of Sibilla:

• etoricoxib (for the treatment of arthritis, osteoarthritis)

Sibilla may influence the effectiveness of other medicines, e.g.:

• cyclosporine (a medicine used to prevent tissue rejection)
• lamotrigine (a medicine for the treatment of epilepsy)
• theophylline (used for the treatment of respiratory problems)
• tizanidine (used for the treatment of muscle pain or cramps)

In women with diabetes, it may be necessary to adjust medication to reduce blood sugar levels (e.g., insulin).

Ask your doctor or pharmacist before taking any medicine.

Before having a blood test

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not use Sibilla during pregnancy. If you become pregnant or suspect you may be pregnant, stop taking Sibilla and contact your doctor immediately.

If you take Sibilla while breastfeeding, the tablet may reduce the amount and alter the composition of breast milk. Small amounts of contraceptive steroids and/or their metabolites may be excreted in breast milk. These amounts may affect the infant. Therefore, you must not take Sibilla while breastfeeding.

Driving and using machines

Sibilla has no influence on the ability to drive or use machines.

Sibilla contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Sibilla

Follow exactly the instructions for taking this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Each Sibilla blister pack contains 21 film-coated tablets. The blister has been designed to help you remember to take the tablets.

You should try to take the tablets at approximately the same time each day; if necessary, with a small amount of liquid, in the order shown on the blister. Take one tablet daily until you have finished the 21 tablets in the blister. After this, there will be 7 days when you do not take any tablets. During these 7 tablet-free days, on day 2 or 3, you will experience a withdrawal bleed similar to menstruation, i.e., your period.

Start the next blister on the 8th day (after the 7 tablet-free days), even if the bleeding has not yet stopped. As long as you take Sibilla correctly, you will always start each new blister on the same day of the week, and your period will always occur on the same day each month.

If you use Sibilla in this way, you will also be protected against pregnancy during the 7 days when you do not take tablets.

How to start the first blister

If you have not used hormonal contraceptives in the previous cycle

Take the first tablet on the first day of your period, which is the day bleeding starts. Take the tablet marked for that day of the week.

If switching from another combined hormonal contraceptive (combined oral contraceptive, vaginal ring, or transdermal patch)

Start taking Sibilla preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous oral contraceptive, and no later than the day after the tablet-free interval of your previous oral contraceptive (or after the last inactive tablet of your previous oral contraceptive).

When switching from a vaginal ring or a combined transdermal patch, follow your doctor's recommendations.

If switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen)

You may switch on any day from the progestogen-only pill (from an implant or IUS on the day of removal, from an injectable when the next injection is due), but in all these cases, use additional barrier methods (e.g., a condom) during the first 7 days of taking the tablets.

If in doubt, ask your doctor or pharmacist.

Starting after childbirth

If you have given birth, you may start taking Sibilla between 21 and 28 days after delivery. If you start after day 28, you must use an additional barrier method (e.g., a condom) during the first seven days of taking Sibilla. If, after childbirth, you have had sexual intercourse before starting Sibilla (again), ensure that you are not pregnant or wait until your next menstrual period.

If you are breastfeeding, read the section on “Pregnancy and breastfeeding”.

Starting after a miscarriage or abortion

After a miscarriage or abortion, your doctor will advise you on how to take the tablets.

If you take more Sibilla than you should

There are no data available on overdose with Sibilla. The acute oral toxicity of an overdose with other combined oral contraceptives in adults and children is low. Symptoms that may occur in such cases are: nausea, vomiting, and in young girls, slight vaginal bleeding. Generally, no specific treatment is required; if necessary, treatment should be symptomatic.

If you notice that a child has taken more than one tablet, consult a doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 915620420, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Sibilla

If you are 12 hours or less late taking a tablet

If you take the tablet as soon as you remember and continue taking the following tablets at your usual time, you will remain protected against pregnancy. This may mean taking two tablets in one day.

If you are more than 12 hours late taking a tablet

If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The risk of pregnancy is higher if you forgot to take the tablet at the beginning of the blister or near the end of the blister.

In this case, follow these rules:

If you have forgotten more than one tablet

If you have forgotten more than one tablet, seek advice from your doctor. Remember that you have lost your contraceptive protection.

What to do if you forget a tablet in the first week

Take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual daily time. Additionally, use a barrier contraceptive method, e.g., a condom, for the next 7 days. If you had sexual intercourse in the previous 7 days, consider the possibility that you may be pregnant. Contact your doctor as soon as possible for advice.

What to do if you forget a tablet in the second week

Take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual daily time. If you have taken all tablets correctly in the 7 days prior to the forgotten tablet, no additional contraceptive precautions are necessary.

What to do if you forget a tablet in the third week

If you have taken all tablets correctly during the 7 days prior to the forgotten tablet and you follow one of the two following alternatives, no additional contraceptive precautions are necessary.

1. Take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual daily time. After this, start the next blister immediately after finishing the last tablet of the current blister, i.e., without a tablet-free interval between blisters. Withdrawal bleeding is unlikely to occur until the end of the second blister, but breakthrough bleeding or spotting may occur during the days you are taking tablets.
2. Alternatively, you may stop taking tablets from the current pack. In this case, have a 7-day tablet-free interval, including the day you forgot the tablet, and then continue with the next blister. If you wish to start the new blister on your usual day of the week, you may have a tablet-free interval of less than 7 days.

If you have forgotten a tablet and do not have a withdrawal bleed during the first normal tablet-free interval, consider the possibility of pregnancy. In this case, consult your doctor before starting the next blister.

What to do if you have gastrointestinal disturbances

If you vomit or have diarrhoea within 3–4 hours of taking a tablet, the active ingredients of the contraceptive may not have been completely absorbed by your body. In this case, follow the advice given above for missed tablets. Take another tablet as soon as possible, within no more than 12 hours. If more than 12 hours have passed, follow the instructions in the section “If you forget to take Sibilla”.

What to do if you want to delay your period

If you wish to delay your period, continue taking the next blister of Sibilla immediately after finishing the last tablet of the current blister, without a tablet-free interval. You may take as many tablets as desired up to the end of the second blister. While using the second blister, breakthrough bleeding or spotting may occur. After the usual 7-day tablet-free interval, resume taking Sibilla normally.

What to do if you want to change your period

If you take Sibilla correctly, your menstrual period will occur every 4 weeks on the same day of the week. If you wish to change your period to a different day of the week than your current schedule, you may shorten (but never extend) the next tablet-free interval by as many days as desired. For example, if your period usually starts on Friday and you want it to start on Tuesday (i.e., three days earlier), you should start the next blister of Sibilla three days earlier. The shorter the tablet-free interval, the higher the likelihood that you will not experience a withdrawal bleed and that breakthrough bleeding or spotting may occur during the second blister.

If you do not have a period

If you have taken all tablets correctly, without gastrointestinal problems or taking other medications, it is very unlikely that you are pregnant. Continue taking Sibilla as usual.

If you miss two consecutive periods, you may be pregnant and should consult your doctor immediately. You may only continue taking the tablets after a pregnancy test and following your doctor's advice.

If you stop taking Sibilla

You may stop taking Sibilla at any time. If you do not wish to become pregnant immediately, ask your doctor for another reliable contraceptive method.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in health that you think may be due to Sibilla, consult your doctor.

Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also section “Warnings and precautions”).

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take Sibilla”.

Serious adverse effects associated with the use of the oral contraceptive are described in section 2 “Warnings and precautions”. More detailed information can be found there. If necessary, contact your doctor immediately.

The following are adverse effects that have been associated with the use of Sibilla:

Frequent adverse effects (may affect up to 1 in 10 people):

• headache
• breast pain, including discomfort and breast tenderness

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

• genital inflammation (vaginitis/vulvovaginitis)
• fungal infections of the vagina (candidiasis, vulvovaginal infections)
• increased appetite
• depressed mood
• dizziness
• migraine
• high or low blood pressure
• abdominal pain (including upper and lower abdominal pain, discomfort/feeling bloated)
• nausea, vomiting, diarrhoea
• acne
• hair loss (alopecia)
• rash (including skin spots)
• itching (in some cases generalized over the body)
• irregular withdrawal bleeding, including heavy bleeding (menorrhagia), scanty bleeding (hypomenorrhoea), infrequent bleeding (oligomenorrhoea), and absence of withdrawal bleeding (amenorrhoea)
• intermenstrual bleeding (vaginal haemorrhage and metrorrhagia)
• menstrual pain (dysmenorrhoea), pelvic pain
• breast enlargement, including breast swelling and oedema
• vaginal discharge
• ovarian cysts
• fatigue, including weakness, tiredness, and general malaise
• weight gain

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

• inflammation of the fallopian tubes or ovary
• inflammation of the cervix (cervicitis)
• urinary tract infection, bladder inflammation (cystitis)
• breast inflammation (mastitis)
• fungal infections (e.g., candida), viral infections, cold sores (herpes labialis)
• flu (influenza), bronchitis, upper respiratory tract infections, paranasal infection (sinusitis)
• benign proliferation in the uterus (myoma)
• benign proliferation in the fatty tissue of the breast (breast lipoma)
• anaemia
• allergic reactions (hypersensitivity)
• masculinization (virilization)
• loss of appetite (anorexia)
• depression, irritability, mental disorders, aggression
• insomnia, sleep disorders
• circulatory disorders in the brain or heart, stroke
• dystonia (muscle disorder causing, for example, abnormal posture)
• dry or irritated eyes
• vision disorders (oscillopsia, visual deterioration)
• sudden deafness (hearing loss), deterioration of hearing
• tinnitus
• vestibular disorders (dizziness, vertigo)
• rapid heartbeat
• increased diastolic blood pressure (increase in the lower blood pressure value)
• dizziness or fainting after standing up from a sitting or lying position (orthostatic hypotension)
• hot flushes
• inflammation of the veins (thrombophlebitis)
• varicose veins (varices), venous disorders or vein pain
• asthma
• increased respiratory rate (hyperventilation)
• inflammation of the gastric mucosa (gastritis), intestinal inflammation (enteritis)
• stomach discomfort (dyspepsia)
• skin reactions/disorders, including allergic reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis
• excessive sweating
• golden-brown pigmented spots (also known as pregnancy spots), especially on the face (chloasma), pigmentary changes/increased pigmentation
• oily skin (seborrhoea)
• dandruff
• excessive body hair (hirsutism)
• orange peel skin (cellulitis)
• spider angioma (a red spot with reddish extensions radiating outward like a spider's web)
• back pain, chest pain
• bone and muscle discomfort, muscle pain (myalgia), pain in arms and legs
• cervical dysplasia (abnormal growth of cells on the surface of the cervix)
• pain or cysts in the fallopian tubes or ovaries
• breast cysts, benign breast proliferations (fibrocystic mastopathy), swelling of congenital accessory mammary glands (accessory breasts)
• pain during sexual intercourse
• secretion from mammary glands, breast discharge
• menstrual disorders
• peripheral oedema (fluid accumulation in the body)
• pseudo-influenza syndrome, inflammations, pyrexia (fever)
• increased blood levels of triglycerides or cholesterol (hypertriglyceridaemia, hypercholesterolaemia)
• weight loss or changes (increase, decrease, or fluctuation)
• harmful blood clots in a vein or artery, for example:
• in a leg or foot (i.e., DVT)
• in a lung (i.e., PE)
• heart attack
• stroke
• transient ischaemic attack (TIA), or mild stroke or temporary stroke-like symptoms
• blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about conditions that increase the risk of blood clots and symptoms of a blood clot).

Frequency not known (cannot be estimated from available data):

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sibilla

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, after EXP. The expiry date is the last day of the month indicated.

Store in the original container to protect from light. Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly discard unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sibilla

The active substances are 2 mg of dienogest and 0.03 mg of ethinylestradiol in each film-coated tablet.

The other components are:

Tablet core:

Lactose monohydrate, maize starch, hypromellose type 2910, talc, potassium polacrylate, magnesium stearate

Tablet coating:

Polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc

Appearance of the product and contents of the pack

Film-coated tablets, white or almost white, round, biconvex, with a diameter of approximately 5.5 mm.

“G53” engraved on one side; the other side unmarked.

Sibilla 2 mg/0.03 mg film-coated tablets EFG are packed in white PVC/PE/PVDC//aluminum blisters. The blisters are packed in a cardboard box with the package leaflet and a blister holder included in each box.

Pack sizes:

21 tablets

3×21 tablets

6×21 tablets

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

You can request further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder.

Gedeon Richter Ibérica, S.A.

Sabino Arana, 28 - 4º 2ª

08028 Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

Germany: Sibilla 2 mg/0.03 mg Filmtabletten

Austria: Sibilla 0.03 mg/2 mg 21 Filmtabletten

Spain: Sibilla 2 mg/0.03 mg comprimidos recubiertos con película EFG

Italy: Sibilla

Portugal: Sibilla

Date of the most recent review of this leaflet: December 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/