SIBILLA DAILY 2 mg/0.03 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sibilla Daily 2 mg / 0.03 mg Film-Coated Tablets EFG

dienogest / ethinylestradiol

Important Things 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 suffering from a blood clot in the veins and arteries, especially in the first year or when restarting the 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 the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.4.

Contents of the Package Leaflet

1. What is Sibilla Daily and what is it used for
2. What you need to know before starting to take Sibilla Daily
3. How to take Sibilla Daily
4. Possible side effects
5. Storage of Sibilla Daily
6. Package contents and additional information

1. What is Sibilla Daily and what is it used for

Sibilla Daily is a medication

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

Sibilla Daily is a combined oral contraceptive that belongs to a group of drugs often referred to as "the pill". Each of the 21 active white tablets contains two types of hormones: an estrogen and a progestogen. The 7 green tablets do not contain active ingredients and are also called placebo tablets.

The combined birth control pill protects against pregnancy in three ways. These hormones:

1. prevent the ovary from releasing an egg each month (ovulation),
2. also make the fluid of the cervix thicker, making it more difficult for sperm to reach the egg,
3. and alter the inner layer of the uterus to make it less likely to accept a fertilized egg.

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

General considerations

Before starting to use Sibilla daily, you should read the information about blood clots (thrombosis) in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 "Blood clots").

In this prospectus, several situations are described in which you should stop taking Sibilla daily, or in which the effectiveness of the contraceptive may be reduced. In these situations, you will have to stop having sexual intercourse or you should take additional non-hormonal contraceptive precautions (such as a condom or another barrier method) during sexual intercourse to ensure effective contraception. Do not use the calendar method or body temperature measurement when getting up, as oral contraceptives can influence body temperature and cyclic changes in cervical mucus composition.

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

Sibilla daily in acne

Acne will 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 three to six months after its initiation and periodically thereafter.

Do not useSibilla daily

You should not use Sibilla daily 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 any of the other components of this medication (including those 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 that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need an operation or spend a lot of time without getting up (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 that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms);
• if you have any of the following diseases that may increase your risk of forming a 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 severe liver disease and your liver function is still not normal; jaundice or itching all over the body may be signs of liver disease;
• if you have or have had liver tumors;

• if you have or have ever had or if it is suspected that you have breast cancer or cancer of the genital 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) inflammation of the pancreas (pancreatitis).

Do not use Sibilla daily if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Other medications and Sibilla daily").

If you experience any of the above situations while taking Sibilla daily, 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 daily.

When should you consult your doctor?

Seek urgent medical attention

• if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in your leg (i.e., deep vein thrombosis), a blood clot in your lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section "Blood clot (thrombosis)" below).

To obtain a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

Tell your doctor if you suffer from any of the following conditions

In some situations, you will need to be particularly careful while taking Sibilla daily or any other combined oral contraceptive, and your doctor may need to perform regular checks. If any of the following conditions apply to you, consult your doctor before starting to take Sibilla daily.

If the condition develops or worsens while you are using Sibilla daily, you should also inform your doctor.

• if a close relative has or has had breast cancer
• if you suffer from 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 hemolytic uremic syndrome (HUS - a blood clotting disorder that causes kidney failure)
• if you have sickle cell anemia (a hereditary disease of red blood cells)
• if you have epilepsy (see "Other medications and Sibilla daily")
• 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 (inflammation of the pancreas)
• if you need an operation or spend a lot of time without getting up (see section 2 "Blood clots")
• if you have recently given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Sibilla daily after childbirth
• if you have inflammation of the veins that are under the skin (superficial thrombophlebitis)
• if you have varicose veins
• if you have a disease that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nerve disease that causes sudden movements of the body (Sydenham's chorea),
• if you have or have ever had chloasma (a skin color disorder mainly on the face and neck known as "pregnancy spots". 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 pharynx and/or difficulty swallowing or urticaria with possible difficulty breathing, you should see your doctor immediately. Medications that contain estrogens can cause or worsen the symptoms of hereditary and acquired angioedema

BLOOD CLOTS

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

Blood clots can form:

• in the veins (which is called "venous thrombosis", "venous thromboembolism" or VTE),
• in the arteries (which is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

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

How to recognize a blood clot

Seek urgent medical attention if 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 combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.

• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can 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 having a blood clot in a vein higher?

The risk of having a blood clot in a vein is higher during the first year that you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medication or a different one) after an interruption 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 daily, your risk of having a blood clot returns to normal within a few weeks.

What is the risk of having a blood clot?

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

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

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 will have a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains dienogest and ethinylestradiol, such as Sibilla daily, approximately 8-11 women will have a blood clot in a year.
• The risk of having a blood clot will depend on your personal 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 having a blood clot with Sibilla daily is small, but some conditions increase the risk. Your risk is higher:

• if you are overweight (body mass index or BMI over 30 kg/m2);
• 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 the age of 50); in this case, you may have a hereditary blood clotting disorder;
• if you need an operation or spend a lot of time without getting up due to an injury or illness, or if you have your leg in a cast. You may need to stop using Sibilla daily several weeks before surgery or while you have reduced mobility. If you need to stop using Sibilla daily, ask your doctor when you can start using it again;
• as you get older (especially above 35 years);
• if you have recently given birth.

The risk of having a blood clot increases with the number of conditions you have.

Long-haul flights (more than 4 hours) can temporarily increase the risk of having a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you need to stop using Sibilla daily.

If any of the above conditions change while you are using Sibilla daily, for example, a close relative experiences a thrombosis 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 stroke.

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

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

• with age (above 35 years);
• if you smoke.When you use a combined hormonal contraceptive like Sibilla daily, 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;

• if any of your close relatives have had a heart attack or stroke at a young age (less than 50 years); in this case, you may also be at higher risk of having a 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 have migraines, especially migraines with aura;
• if you have a heart problem (valve disorder, 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, the risk of having a blood clot may be increased further.

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

Sibilla daily and cancer

It has been observed that breast cancer is slightly more common in women who take combined oral contraceptives, but it is not known if this is caused by the treatment. For example, it may be due to the fact that more tumors are detected in women who take combined contraceptives because they are examined more frequently by their doctor. The occurrence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential that you regularly examine your breasts and should contact your doctor if you notice any lump. In rare cases, benign liver tumors, and in an even smaller number, malignant liver tumors have been reported in users of hormonal oral contraceptives. Contact your doctor if you have unusually severe abdominal pain.

In some epidemiological studies, it has been noted that...

3. How to take Sibilla daily

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

Each blister of Sibilla daily contains 28 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 every day; if necessary with a small amount of liquid, in the order that appears in the blister. You should take one tablet per day, starting with the 21 active white tablets of the blister. The first tablet you should take is the one marked with the text “1 Start”. To keep track, follow the direction of the arrows on the blister. Then you will take 7 green placebo tablets. During the 7 days you take the green placebo tablets, on day 2 or 3 you will have a withdrawal bleed similar to menstruation, i.e., your monthly period.

Start the next blister immediately after the 7 green placebo tablets (so that there is no interruption between the two blisters) - even if the bleeding has not stopped yet. While taking Sibilla daily correctly, you will always start a new blister on the same day of the week, and you will always have your period on the same day of the week.

Preparing the strip

To help you keep track, there are 7 adhesive labels in the form of a strip with the 7 days of the week marked. Choose the label from the row that starts with the day of the week that coincides with the first day you start taking the tablets. For example, if you start on a Wednesday, use the label that starts with “Wed”.

Place the “→” symbol of the label over the same symbol on the blister card and place it inside the area surrounded by a black line. Each day will align with a row of tablets.

Now a day will appear over each tablet, and you can see if you have taken or not taken the tablet on a particular day. Follow the direction of the arrow on the card until you have taken all 28 tablets.

If you use Sibilla daily in this way, you will also be protected against pregnancy during the 7 days you take the placebo 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 first day of your cycle – the day when bleeding starts. Take the first tablet that is marked with the text “1 Start”.

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

Start taking Sibilla daily preferably on the day after the last active tablet (the last tablet that contains active ingredients) of the previous oral contraceptive, and at the latest on the day after the pill-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 to Sibilla daily from a progestin-only method (progestin-only pill, injection, implant, or intrauterine system (IUS) that releases progestin)

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

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

Starting after an abortion

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

If you take more Sibilla daily than you should

We do not have data on overdose with Sibilla daily. 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, mild vaginal bleeding. In general, no special treatment is necessary; if necessary, treatment should be symptomatic.

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.

If you forget to take Sibilla daily

The last seven film-coated tablets of the blister are placebo tablets. If you forget to take one of these film-coated tablets, this will have no effect on the effectiveness of Sibilla daily. You should discard the forgotten placebo tablets to avoid prolonging the placebo week, which would have a negative effect on the reliability of Sibilla daily.

If you forget to take an activewhite tablet from the blister (film-coated tablets 1-21), you should follow the following advice:

If you are late by 12 hours or less in taking a tablet

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

If you are late by more than 12 hours in taking a tablet

If you are late by 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 active white tablets.

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 a tablet in 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 then on, continue taking the tablets at the usual time of day. Also, use a barrier contraceptive method, e.g., a condom, for the next 7 days. If you have had sexual intercourse in the 7 days prior, you should consider the possibility that you are pregnant. Contact your doctor as soon as possible for advice.

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

You should take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. From then on, continue taking the tablets at the usual time of day. As long as the tablets have been taken correctly during 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

As long as you have taken all the tablets correctly during the 7 days prior to 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 then on, continue taking the tablets at the usual time of day. Then you should start the next blister immediately after taking the last tablet of the current blister, i.e., without a placebo tablet phase between blisters. It is unlikely that a withdrawal bleed will occur until the end of the second blister, but you may experience intermenstrual bleeding or spotting during the days you are taking tablets.

1. You can also stop taking the active white tablets and go directly to the green placebo tablets. Before this placebo week, you must note the day you forgot to take the active tablet to remember the first day of the hormone-free period, which can never be longer than 7 days, including the day you forgot to take the tablet. From then on, continue with the next blister. If you want to start the new blister on the usual day of the week, you can make the placebo tablet phase less than 7 days.

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

What to do if you have gastrointestinal upset

If you have vomited or had diarrhea within 3-4 hours after taking an active tablet, the active ingredients of the contraceptive may not have been fully 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 daily”.

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 daily after taking the last active tablet of the current blister, without a placebo tablet phase. You can take all the tablets you want until the end of the second blister. When using the second blister, you may experience intermenstrual bleeding or spotting. After the usual 7-day placebo tablet phase, you should take Sibilla daily normally again.

What to do if you want to change your period

If you take Sibilla daily 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 than usual with the current way of taking the tablets, you can shorten (but never lengthen) the next placebo tablet phase 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., three days earlier), you should start the next blister of Sibilla daily three days earlier. The shorter the placebo tablet phase, the higher the likelihood that you will not have a withdrawal bleed and that you will experience intermenstrual bleeding or spotting during the second blister.

If you do not have your period

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

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

If you stop treatment with Sibilla daily

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

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

4. Possible Adverse Effects

Like all medicines, Sibilla daily may produce adverse effects, although not all people suffer from them.

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

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

All women who take 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 taking Sibilla daily".

In section 2 "Warnings and Precautions" serious adverse 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 adverse effects have been associated with the use of Sibilla daily:

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

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

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 pain in the upper and lower abdomen, discomfort/bloating)
• nausea, vomiting, diarrhea
• acne
• hair loss (alopecia)
• skin rash (including rash with spots)
• itching (in some cases all over the body)
• irregular withdrawal bleeding, including heavy bleeding (menorrhagia), light bleeding (hypomenorrhea), scant bleeding (oligomenorrhea), and absence of withdrawal bleeding (amenorrhea)
• intermenstrual bleeding (vaginal bleeding and metrorrhagia)
• menstrual pain (dysmenorrhea), pelvic pain
• breast enlargement including swelling and edema of the breasts

• vaginal discharge
• ovarian cysts
• exhaustion including weakness, fatigue, and general indisposition
• weight gain

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

• inflammation of the Fallopian tubes or ovary
• cervical inflammation (cervicitis)
• urinary tract inflammation, bladder inflammation (cystitis)
• breast inflammation (mastitis)
• fungal infections (e.g., candida), viral infections, cold sores
• flu, bronchitis, upper respiratory tract infections, paranasal infection (sinusitis)
• benign growth in the uterus (myoma)
• benign growth in the breast fatty tissue (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 (muscle disorder that produces, e.g., an abnormal posture)
• dry or irritated eyes
• vision disorders (oscillopsia, vision deterioration)
• sudden hearing loss (hearing loss), hearing impairment
• tinnitus
• vestibular disorders (dizziness, vertigo)
• rapid heart rate

• increase in diastolic blood pressure (the lowest blood pressure value)
• dizziness or fainting when standing up from a sitting or lying position (orthostatic hypotension)
• hot flashes
• vein inflammation (thrombophlebitis)
• varicose veins (varices), venous disorders, or pain in the veins
• asthma
• increased respiratory rate (hyperventilation)
• gastric mucosa inflammation (gastritis), intestinal inflammation (enteritis)
• stomach discomfort (dyspepsia)
• skin reactions/disorders, including allergic reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis
• excessive sweating

• brownish spots (also called pregnancy spots), especially on the face (chloasma), changes in pigmentation/increased pigmentation
• oily skin (seborrhea)
• dandruff
• excessive body hair (hirsutism)
• orange peel skin (cellulite)
• vascular spider (a red spot with reddish extensions that radiate outward like a spider's web)
• back pain, chest pain
• discomfort in the bones and muscles, muscle pain (myalgia), pain in the 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 growths (fibrocystic mastopathy), swelling of congenital accessory breast glands (supernumerary breast)
• pain during sexual intercourse
• secretion from the breast glands, breast secretion
• menstrual disorders
• peripheral edema (fluid accumulation in the body)
• pseudo-flu syndrome, inflammation, pyrexia (fever)
• increase in triglyceride or cholesterol levels in the blood (hypertriglyceridemia, hypercholesterolemia)
• weight loss or variations (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
• mild stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The possibility 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).

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

• mood changes
• increased or decreased sexual desire (libido)
• irritation of the eyes when wearing contact lenses
• urticaria (itching)
• erythema nodosum (red and painful nodules on the skin)
• erythema multiforme (rash in the form of a red target or blisters)
• breast secretion
• fluid retention

Reporting of adverse effects:

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

5. Storage of Sibilla daily

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

Do not use this medicine after the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Sibilla daily

The active ingredients are dienogest and ethinylestradiol.

Each white (active) film-coated tablet contains 2 mg of dienogest and 0.03 mg of ethinylestradiol.

The green film-coated tablets do not contain active ingredients.

The other components are:

White film-coated tablets

Tablet core:

Lactose monohydrate

Corn starch

Hypromellose type 2910

Talc

Potassium polacrilin

Magnesium stearate

Tablet coating:

Poly(vinyl alcohol)

Titanium dioxide (E171)

Macrogol 3350

Talc

Green film-coated tablets

Tablet core:

Microcrystalline cellulose type 12

Anhydrous lactose

Pregelatinized corn starch

Magnesium stearate

Anhydrous colloidal silica

Tablet coating:

Poly(vinyl alcohol)

Titanium dioxide (E171)

Macrogol 3350

Talc

Aluminum lake, carmine (E132)

Aluminum lake, yellow quinoline (E104)

Black iron oxide (E172)

Aluminum lake, sunset yellow FCF (E110)

Appearance of Sibilla daily and package contents

Active film-coated tablets:

The active tablet is a white or almost white, round, biconvex film-coated tablet, with a diameter of approximately 5.5 mm and "G53" engraved on one side.

Inactive film-coated tablets:

The placebo tablet is a green, round, biconvex film-coated tablet, with a diameter of approximately 6 mm.

Sibilla daily 2 mg/0.03 mg film-coated tablets EFG are packaged in transparent and rigid PVC/PE/PVDC blisters and aluminum. The blisters are packaged in a cardboard box with a leaflet, a blister sleeve, and an adhesive label with the days of the week.

The tablets are marked with numbers from 1 to 28 on the blister. The first tablet is marked with "1 Start" and the last is marked with "28". There are arrows between the numbers on the blister to help follow the order of the numbers.

Package sizes:

1×(21+7) tablets

3×(21+7) tablets

6×(21+7) tablets

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer:

Gedeon Richter Plc.

Gyömroi út 19-21

1103 Budapest

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

Gedeon Richter Ibérica S.A.

Sabino Arana nº 28, 4º 2ª

08028 Barcelona

This medicine is authorized in the member states of the European Economic Area (EEA) under the following names:

Germany: Sibilla

Spain: Sibilla daily

Date of the last revision of this prospectus:December 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/