Prospect: Information for the User

Sibilla 2 mg /0.03 mg film-coated tablets EFG

dienogest/ etinilestradiol

Important things you should 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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause 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 this prospect thoroughly before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to others, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

Sibilla is a medication:

• for preventing pregnancy (“birth control pill"),
• for the treatment of women with moderate acne who accept receiving a birth control pill after the failure of local treatments or oral antibiotics.

Sibilla is a combined oral contraceptive that belongs to a group of drugs that are often referred to as “the pill”. It contains two types of hormones: an estrogen 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 make the fluid (from the cervix) thicker, making it more difficult for sperm to reach the egg,
3. and alter the inner lining of the uterus to make it less likely to accept a fertilized egg.

General Considerations

Before starting to use Sibilla, you should read the information about blood clots in section 2. It is particularly important that you read 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 effectiveness of the contraceptive may be reduced. In these situations, you will need to stop having sex or take additional non-hormonal contraceptive precautions (such as a condom or other barrier method) during sex to ensure effective contraception. Do not use the rhythm method or basal body temperature method as hormonal contraceptives can affect body temperature and cervical mucus composition.

Remember that combined oral contraceptives like Sibilla do not protect against sexually transmitted infections (such as HIV). Only a condom can help you achieve this.

Sibilla and Acne

Acne should normally improve 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 for three to six months after starting and periodically thereafter.

Do Not Use Sibilla

You should 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 what other form of contraception would be more suitable.

• If you are allergic to dienogest or ethinylestradiol or to any of the other components of this medication (listed in section 6);
• If you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs;
• If you know that 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 need surgery or if you cannot stand for long periods (see section “Blood Clots”);
• If you have ever had a heart attack or a stroke;
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke);
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • Severe diabetes with vascular 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 severe liver disease and your liver function is not yet normal; jaundice or itching all over the body may be signs of liver disease;
• If you have liver tumors or if you have ever had them;
• If you have or have ever had or if you suspect you have cancer of the breast or cancer of the reproductive organs, for example, ovarian cancer, cervical cancer, or uterine cancer (womb);
• If you have any 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) pancreatitis (inflammation of the pancreas).

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

If you experience any of the above situations while 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.

Inform Your Doctor If You Suffer Any of the Following Conditions.

In some situations, you will need to take special care while taking Sibilla or any other combined oral contraceptive, and you may need to have regular check-ups. If any of the following situations apply to you, consult your doctor before starting to use Sibilla. If any of the following conditions develop or worsen while you are using Sibilla, you should also inform your doctor:

• If a close relative has had breast cancer;
• If you have liver disease or gallstones;
• If you have diabetes;
• If you have depression or mood changes;
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• If you have sickle cell anemia(a hereditary disorder of red blood cells);
• If you have epilepsy (see “Use of Sibilla with other medications”);
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system);

• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis;
• If you need surgery or if you cannot stand for long periods (see section 2 “Blood Clots”);
• If you are at greater risk of blood clots after childbirth. You should ask your doctor when you can start taking Sibilla after childbirth;
• If you have superficial thrombophlebitis (inflammation of the veins under the skin);
• If you have varicose veins;
• If you have a disease that first appeared during pregnancy or previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationis), a nervous disorder that causes sudden body movements (Sydenham's chorea);
• If you have or have ever had melasma (a skin discoloration mainly on the face and neck known as “pregnancy mask”. If so, avoid direct exposure to sunlight or ultraviolet light;
• If you experience symptoms of angioedema such as facial swelling, tongue swelling, and/or throat swelling and/or difficulty swallowing or urticaria with possible difficulty breathing, you should seek immediate medical attention. Medications containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined oral contraceptive like Sibilla increases your risk of suffering a blood clot compared with not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• in veins (known as “deep vein thrombosis”, “venous thromboembolism” or VTE),
• in arteries (known as “arterial thrombosis”, “arterial thromboembolism” or TEA).

The recovery from blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

It is essential to remember that the overall risk of a blood clot causing harm due to Sibilla is small.

How to Recognize a Blood Clot

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

BLOOD CLOTS IN A VEIN

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

• The use of a combined oral contraceptive has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of use of a combined oral contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

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

The risk of a blood clot in a vein is higher during the first year of taking a combined oral contraceptive for the first time. The risk may be higher if you start taking a combined oral contraceptive again (the same medication or a different one) 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 oral contraceptive.

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

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined oral contraceptive you are taking.

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

• Of every 10,000 women who are not using a combined oral contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000 women using a combined oral contraceptive containing levonorgestrel or norethisterone or norgestimate, about 5-7 will develop a blood clot in a year.
• Of every 10,000 women using a combined oral contraceptive containing dienogest and ethinylestradiol like Sibilla, approximately 8-11 women will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

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

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

• If you are overweight (body mass index (BMI) of 30 kg/m2or higher);
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years old). In this case, you may have a hereditary disorder of blood clotting;
• If you need surgery or spend a lot of time immobile due to an injury or illness, or if you have your leg plastered. You may need to stop taking Sibilla for several weeks before the operation or while you have less mobility. If you need to stop taking Sibilla, ask your doctor when you can start taking it again;
• With increasing age (especially over about 35 years);
• If you have given birth recently.

The risk of a blood clot in a vein 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.

It is essential to inform your doctor if you have any of the above conditions, 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 blood clot without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

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

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

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

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

• With age (over about 35 years);
• If you smoke.When using a combined oral contraceptive like 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 high blood pressure that is not controlled with treatment;
• If any close relative has had a heart attack or stroke at a young age (less than 50 years old). In this case, you may also be at higher risk of a heart attack or stroke;
• If you have high levels of fat in the blood (cholesterol or triglycerides);
• If you have migraines, especially migraines with aura;
• If you have a heart condition (heart valve disorders, abnormal heart rhythm 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 a blood clot may be increased even further.

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

Sibilla and Cancer

Breast cancer has been observed at a slightly higher frequency in women taking combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, it may be due to the fact that women taking combined oral contraceptives are examined more frequently by their doctor. The appearance of breast tumors decreases gradually after stopping combined oral contraceptives. It is essential to regularly examine your breasts and to contact your doctor if you notice any lump. In rare cases, benign liver tumors and, less frequently, malignant liver tumors have been reported in users of combined oral contraceptives. Contact your doctor if you have severe abdominal pain that is not usual.

In some epidemiological studies, an increased risk of cervical cancer has been found in long-term users of combined oral contraceptives, but there is still controversy about how much this finding is due to the confounding effect of sexual behavior and other factors such as the human papillomavirus.

Mental Disorders

Some women who use combined oral contraceptives like Sibilla have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional 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 of the menstrual period). If this bleeding lasts longer than a few months or starts after a few months, your doctor will need to investigate the cause.

Regular Check-Ups

Once you have started taking the contraceptive, your doctor will see you for regular check-ups. The frequency and characteristics of the check-ups will be determined by your doctor and will be adapted to your individual needs and health status.

Children and Adolescents

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

Older Women

Sibilla is not indicated after menopause.

Use of Sibilla with Other Medications

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication.

You should also inform any doctor or dentist who prescribes another medication that you are taking Sibilla. They may tell you if you need to take additional contraceptive precautions (e.g., condoms) and for how long, or if you should change the use of another medication.

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

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

You can start taking Sibilla again approximately 2 weeks after this treatment.See the section “Do Not Use Sibilla”.

Some medications may have a certain influence on the levels of Sibilla in the blood and make it less effective for preventing pregnancy, or may cause unexpected bleeding. This includes medications used to treat:

• Epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate);
• Tuberculosis (e.g., rifampicin);
• Infections caused by the HIV and hepatitis C viruses (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
• Fungal infections (e.g., griseofulvin).

If you want to take herbal medications containing St. John's Wort (a plant preparation used for depression), while taking Sibilla, you should first consult your doctor.

Interactions of Sibilla with other medications that may cause an increase in side effects or an aggravation of the same.

The following medications may decrease the tolerability of Sibilla:

• Etoricoxib (for the treatment of arthritis, osteoarthritis)

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

-Ciclosporin (a medication used to prevent tissue rejection)

-Lamotrigine (a medication 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, you may need to change your medication to reduce blood sugar levels (e.g., insulin).

Consult your doctor or pharmacist before taking any medication.

Before Blood Tests

Inform your doctor or the laboratory team that you are taking the pill, as oral contraceptives can affect the results of some blood tests.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should not use Sibilla when pregnant. If you become pregnant or think you may be pregnant, stop taking Sibilla and contact your doctor immediately.

If you take Sibilla while breastfeeding, the pill 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 baby. Therefore, you should not take Sibilla during breastfeeding.

Driving and Operating Machines

Sibilladoes not affect your ability to drive and operate machines.

Sibilla Contains Lactose

If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Each blister of Sibilla 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 approximately at the same time each day; if necessary with a small amount of liquid, in the order that appears in the blister.You should take one tablet a day until you have finished the 21 tablets in the blister. After that, there are 7 days when you will not take the tablets. During the 7 days without tablets, on the 2nd or 3rd day, you will have a withdrawal bleeding similar to menstruation, that is, your period.

Start the next blister on the 8th day (after the 7 days without tablets), even if the bleeding has not stopped yet. While taking Sibilla correctly, you will always start each new blister on the same day of the week, and you will always have your period on the same day of 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 the tablets.

How to start taking the first blister

If you have not taken oral contraceptives during the previous cycle

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

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

Start taking Sibilla preferably on the day after the last active tablet (the last tablet containing active ingredients) of the previous oral contraceptive, and at the latest on the day after the tablet-free period of your previous oral contraceptive (or after the last inactive tablet of the previous oral contraceptive).

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

If you switch from a method that only has progestogen (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen)
You can switch on any day from the progestogen-only pill (from an implant or an IUS on the day of its removal, from an injectable when the next injection is due), but in all these cases, use additional protective measures (e.g., a condom) during the first 7 days you take the tablets.

In case of doubt, ask your doctor or pharmacist.

Starting after having a baby

If you have had a baby, you can start taking Sibilla between 21 and 28 days after giving birth. If you start after the 28th day, you must use an additional barrier method (e.g., a condom) during the first 7 days you take Sibilla. If, after giving birth, you have had sexual intercourse before taking Sibilla (again), make sure you are not pregnant or wait until your next menstrual period.

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

Starting after an abortion

After an abortion, your doctor will advise you on how to take the tablets.

What to do if you take more Sibilla than you should

We do not have data on overdose with Sibilla. The acute oral toxicity of an overdose with other combined oral contraceptives in adults and children is low. The symptoms that may appear in this case are: nausea, vomiting, and, in young girls, light vaginal bleeding. In general, no special treatment is necessary; if necessary, symptomatic treatment should be provided.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915620420, indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

What to do if you forget to takeSibilla

If you delay 12 hours or less in taking a tablet

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

If you delay more than 12 hours in taking a tablet

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

In this case, you should follow the following rules:

If you have forgotten to take more than one tablet

If you have forgotten to take more than one tablet, ask your doctor for advice. Remember that you have lost your contraceptive protection.

What to do if you forget the tablet the first week

You should take the last forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time. From that moment on, continue taking the tablets at the usual time of the day. In addition, use a barrier contraceptive method, e.g., a condom, during the next 7 days. If you have had sexual intercourse in the 7 days before forgetting the tablet, you should consider the possibility of pregnancy. Contact your doctor as soon as possible for advice.

What to do if you forget the tablet the second week

You should take the last forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time.From that moment on, continue taking the tablets at the usual time of the day. As long as the tablets have been taken correctly during the 7 days before the forgotten tablet, no additional contraceptive precautions are necessary.

What to do if you forget the tablet the third week

As long as you have taken all the tablets correctly during the 7 days before the forgotten tablet and follow one of the two alternatives below, no additional contraceptive precautions are necessary.

1. You should take the last forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time. From that moment on, you should continue taking the tablets at the usual time of the day. After that, you should start the next blister immediately after taking the last tablet of the current blister, that is, without leaving a tablet-free period between blisters. It is unlikely that withdrawal bleeding will occur until the end of the second blister, but you may experience spotting or bleeding during the days you are taking tablets.
2. You can also stop taking tablets from the current blister. In this case, you should leave a 7-day tablet-free period, including the day you forgot to take the tablet, and then continue with the next blister. If you want to start the new blister on the usual day of the week, you can have a tablet-free period of less than 7 days.

If you have forgotten a tablet and then do not have withdrawal bleeding in the first normal tablet-free period, you should consider the possibility of pregnancy. In this case, you should inform your doctor before starting the next blister.

What to do if you have digestive problems

If you have vomited or had diarrhea in the 3-4 hours after taking a tablet, the active ingredients of the contraceptive may not have been completely absorbed by your body. In this case, you should follow the advice described above for forgotten tablets. Take another tablet as soon as possible,without more than 12 hours passing. 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 want to delay your period, you should continue taking the next blister of Sibilla, after taking the last tablet of the current blister, without a tablet-free period. You can take all the tablets you want until the end of the second blister. When using the second blister, you may experience spotting or bleeding. After the usual 7-day tablet-free period, you should take Sibilla normally again.

What to do if you want to change your period

If you take Sibilla correctly, you will always have your menstrual period every 4 weeks on the same day of the week. If you want to change your period to a different day of the week, other than the usual one with the current method of taking tablets, you can shorten (but never lengthen) the next tablet-free period by as many days as you want. For example, if your menstrual period usually starts on Friday and you want it to start on Tuesday (i.e., 3 days earlier), you should start the next blister of Sibilla 3 days earlier. The shorter the tablet-free period, the greater the likelihood that you will not have withdrawal bleeding and will experience spotting or bleeding during the second blister.

If you do not have a period

If you have taken all the tablets correctly and have not had any stomach problems or taken other medications, it is very unlikely that you are pregnant. Continue taking Sibilla as usual.

If you have not had a period twice in a row, you may be pregnant and should consult your doctor immediately. You can only continue taking the tablets after doing a pregnancy test and following your doctor's advice.

What to do if you interrupt treatment with Sibilla

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related to Sibilla, consult your doctor.

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

All women taking combined hormonal contraceptives are at a higher 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 of taking combined hormonal contraceptives, see section 2“What you need to know before starting to take Sibilla”.

In section 2 "Warnings and precautions" severe side effects associated with the use of oral contraceptives are described. You will find more detailed information there. If necessary, contact your doctor immediately.

The following side effects have been associated with the use of Sibilla:

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

• headache
• breast pain, including discomfort and sensitivity in the breasts

Less frequent side effects(may affect up to 1 in 100 people):

• inflammation of the genitals (vaginitis/vulvovaginitis)
• yeast infections of the vagina (candidiasis, vaginal infections)
• increased appetite
• depressed mood
• dizziness
• migraine
• high or low blood pressure
• abdominal pain (including upper and lower abdominal pain, discomfort, and feeling bloated)
• nausea, vomiting, diarrhea
• acne
• hair loss (alopecia)
• hives (including the appearance of skin patches)
• itching (in some cases, all over the body)
• irregular menstrual bleeding, including heavy bleeding (menorrhagia), light bleeding (hypomenorrhea), infrequent bleeding (oligomenorrhea), and amenorrhea (absence of menstrual bleeding)
• intermenstrual bleeding (vaginal and metrorrhagia)
• menstrual cramps (dysmenorrhea), pelvic pain
• breast enlargement, including swelling and edema of the breasts
• vaginal discharge
• ovarian cysts
• fatigue, including weakness, tiredness, and general malaise
• weight gain

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

• inflammation of the Fallopian tubes or ovaries

• cervicitis (inflammation of the cervix)
• urinary tract inflammation, bladder inflammation (cystitis)
• mastitis (inflammation of the breast)
• fungal infections (e.g., candida), viral infections, herpes labialis
• influenza, bronchitis, upper respiratory tract infections, sinusitis
• benign uterine proliferation (myoma)
• benign breast tissue proliferation (breast lipoma)
• anemia
• 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
• distonia (muscular alteration that produces, e.g., an abnormal posture)
• dry or irritated eyes
• vision disorders (oscillopsia, visual deterioration)
• sudden hearing loss (hearing loss), visual deterioration
• tinnitus
• vestibular disorders (feeling of dizziness, vertigo)
• rapid heart rate
• increased diastolic blood pressure (increase in the minimum value of blood pressure)
• dizziness or fainting after getting up while sitting or lying down (orthostatic hypotension)
• seizures
• inflammation of the veins (thrombophlebitis)
• varicose veins (varices), venous disorders, or pain in the veins
• 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
• intense sweating
• brownish-yellow skin patches (also known as pregnancy patches), especially on the face (melasma), changes in skin pigmentation/increased pigmentation.
• oily skin (seborrhea)
• dandruff
• excessive body hair (hirsutism)
• orange peel skin (cellulitis)
• spider veins (a red patch with reddish extensions that radiate outward like a spider web)
• back pain, chest pain
• joint and muscle pain, muscle pain (myalgia), pain in the arms and legs
• cervical dysplasia (abnormal growth of cells on the surface of the cervix)
• ovarian cysts, breast cysts, benign breast tissue proliferation (mastopathy fibrocystic), additional congenital breast glands (accessory breasts)
• pain during sex
• breast secretion, breast discharge
• menstrual disorders
• peripheral edema (accumulation of fluid in the body)
• pseudogripal syndrome, inflammation, pyrexia (fever)
• increased triglycerides or cholesterol levels in the blood (hypertriglyceridemia, hypercholesterolemia)
• weight loss or fluctuations (gain, loss, 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 ischemic attack (TIA) or symptoms similar to a stroke
• blood clots in the liver, stomach/intestine, kidneys, or eye.

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

Unknown frequency(cannot be estimated from available data)

• mood changes
• increased or decreased libido (sex drive)
• irritation of the eyes when wearing contact lenses
• itching (pruritus)
• erythema nodosum (red, painful nodules on the skin)
• erythema multiforme (red, target-shaped rash or blisters)
• breast discharge
• fluid retention.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date indicated on the box, after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sibilla

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

The other components are:

Tablet core:

Lactose monohydrate, cornstarch, hypromellose type 2910, talc, potassium polacrilinate, magnesium stearate

Film coating:

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

Appearance of the product and contents of the package

Film-coated tablets of white or almost white color, round, biconvex, and approximately 5.5 mm in diameter.

“G53” engraved on one face; the other face unengraved.

Sibilla 2 mg/0.03 mg film-coated tablets EFG are packaged in white PVC/PE/PVDC//Aluminum blisters.The blisters are packaged in a cardboard box with the leaflet and a blister pack cover included in each box.

Package sizes:

21 tablets

3×21 tablets

6×21 tablets

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer:

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

For more information about this medication, please contact the local representative of the marketing authorization holder.

Gedeon Richter Ibérica, S.A.

Sabino Arana, 28 - 4th 2nd

08028 Barcelona

Spain

This medication is authorized in the European Economic Area (EEA) member states with 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 film-coated tablets EFG

Italy:Sibilla

Portugal:Sibilla

Last review date of this leaflet:December 2022

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/