Sibilla Diario 2 mg/0.03 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Sibilla diario 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 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 taking 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 you should not give it to others, 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 4.4.

Contents of the leaflet

What Sibilla diario is and what it is used for
What you need to know before taking Sibilla diario
How to take Sibilla diario
Possible adverse effects
How to store Sibilla diario
Contents of the pack and other information

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

Sibilla diario is a medicine

for preventing pregnancy (“birth control pill”).
for the treatment of women with moderate acne who are willing to use a birth control pill after failure of appropriate topical treatments or oral antibiotics.

Sibilla diario is a combined oral contraceptive that belongs to a group of medicines commonly referred to as “the pill”. Each of the 21 white active tablets contains two types of hormones: an oestrogen and a progestogen. The 7 green tablets do not contain active ingredients and are also called placebo tablets.

The combined oral contraceptive pill prevents pregnancy in three ways. These hormones:

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

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

General considerations

Before starting to use Sibilla daily, you must read the information about blood clots (thrombosis) 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 daily, or when the contraceptive may become less effective. In these situations, you must either abstain from 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 can affect body temperature and cyclic changes in cervical mucus composition.

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

Sibilla daily for acne

Acne usually improves after three to six months of treatment and may continue to improve even beyond 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 daily

Do 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 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 will be immobile 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 severe liver disease and liver function has not returned to normal; jaundice or itching all over the body may be signs of liver disease;
if you have liver tumors or have ever had them;
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 cancer of the uterus (womb);
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 daily if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Sibilla daily”).

If any of the above conditions occur while you are 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, 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 (thrombosis)” 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 certain situations, you must take special care when taking Sibilla daily or any other combined oral contraceptive, and your doctor may need to perform regular check-ups. If any of the following conditions apply to you, consult your doctor before starting Sibilla daily.

If the condition develops or worsens while you are using Sibilla daily, 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 anemia (a hereditary red blood cell disorder)
if you have epilepsy (see “Other medicines and Sibilla daily”)
if you have systemic lupus erythematosus (SLE – a disease affecting your body’s 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 require surgery or will be immobile 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 daily after childbirth
if you have inflammation of veins beneath the skin (superficial thrombophlebitis)
if you have varicose veins
if you have ever developed a condition 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 must see your doctor immediately. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Sibilla daily 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 daily is small.

How to recognize a blood clot

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

Are you experiencing any of these signs?	What might you be suffering from?
swelling in one leg or foot along a vein in the leg or foot, especially when accompanied by: pain or tenderness in the leg, which may only be noticeable 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 a clear cause, possibly bringing up blood; sudden sharp chest pain that may worsen when breathing deeply; 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 such as 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, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye)
pain, discomfort, pressure, heaviness; feeling of tightness or fullness in the chest, arm, or beneath the breastbone; sensation of fullness, indigestion, or suffocation; discomfort in the upper body radiating to the back, jaw, throat, arm, or stomach; sweating, nausea, vomiting, or dizziness; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeat.	Heart attack
sudden weakness or numbness of the face, 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.
Very rarely, a 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 you take a combined hormonal contraceptive for the first time. The risk may also be increased if you restart 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 diario, 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 on 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 diario 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 to 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 diario, 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	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5 - 7 out of 10,000 women
Women who use Sibilla daily	About 8 – 11 out of 10,000 women

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

The risk of developing a blood clot with Sibilla daily is small, but certain conditions may increase this risk. Your risk is higher:

if you are overweight (body mass index or BMI above 30 kg/m²);
if any of your close relatives has 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 might 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 your leg is in a cast. You may need to stop taking Sibilla daily several weeks before surgery or while you are less mobile. If you need to stop taking Sibilla daily, 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 of these conditions you have.

Air travel (more than 4 hours) may temporarily increase the risk of developing 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 should stop taking Sibilla daily.

If any of the above conditions change while you are using Sibilla daily—for example, if a close relative experiences a thrombosis without a known cause or if 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 lead to 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 heart attack or stroke while using Sibilla daily is very small, but it may increase:

with age (above approximately 35 years);
if you smoke. When using 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 recommend using a different type of contraceptive;
if you are overweight;
if you have uncontrolled high blood pressure despite treatment;
if a close relative has had a heart attack or stroke at a young age (less than approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
if you or a close relative 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 is 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 daily—for example, if you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

Sibilla daily and cancer

A slightly higher frequency of breast cancer has been observed 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 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 lump. In rare cases, benign liver tumors have been reported in users of oral hormonal contraceptives, and even more rarely, malignant liver tumors. Contact your doctor if you experience unusually severe abdominal pain.

In some epidemiological studies, an increased risk of cervical cancer has been reported in long-term users of combined oral contraceptives, but there remains controversy regarding 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 daily have reported depression or a depressed mood. Depression can be severe and, in some cases, may lead to suicidal thoughts. If you experience mood changes or 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 daily, you may experience unexpected bleeding (bleeding outside the week when you are taking the green placebo tablets). If this bleeding lasts for more than a few months, or if it starts after several months, your doctor should investigate the cause.

Periodic check-ups

Once you have started taking the pill, your doctor will schedule periodic check-ups. Your doctor will determine the frequency and nature of these check-ups based on your individual needs and health status.

Children and adolescents

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

Older women

Sibilla daily is not indicated after menopause.

Other medicines and Sibilla daily

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

Also inform any other doctor or dentist who prescribes you another medicine that you are taking Sibilla daily. 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 another medicine you need.

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

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

Sibilla daily can be restarted approximately 2 weeks after completing this treatment. See section “Do not use Sibilla daily.”

Some medicines may affect the blood levels of Sibilla daily and may make it less effective in preventing pregnancy, or may cause unexpected bleeding. This includes medicines used to treat:

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

If you wish to use herbal products containing St. John's wort (a herbal preparation used for depression) while taking Sibilla daily, you should first consult your doctor.

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

The following medicines may reduce the tolerability of Sibilla daily:

etoricoxib (for the treatment of arthritis, osteoarthritis).

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

ciclosporin (a medicine used to prevent tissue rejection),
lamotrigine (a medicine for the treatment of epilepsy),
theophylline (for the treatment of respiratory problems),
tizanidine (to treat muscle pain and/or muscle spasms).

In women with diabetes, the dose of medicines that lower blood sugar levels (e.g., insulin) may need to be adjusted.

Consult 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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

If you are taking Sibilla daily while breastfeeding, the tablet may reduce the quantity 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 child. Therefore, you must not take Sibilla daily while breastfeeding.

Driving and using machines

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

Sibilla daily contains lactose and sunset yellow FCF aluminum lake

The active white film-coated tablets contain monohydrate lactose, and the inactive green film-coated tablets contain anhydrous lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

The inactive green film-coated tablets also contain sunset yellow FCF aluminum lake (E110), which may cause allergic-type reactions.

3. How to take Sibilla diario

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

Each Sibilla diario blister 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 each day; if necessary, with a small amount of liquid, in the order shown on the blister. One tablet must be taken daily, starting with the 21 white active tablets in the blister. The first tablet you take is the one marked with the text “1 Start”. To keep track, follow the direction of the arrows on the blister. After that, you will take 7 green placebo tablets. During the 7 days you take the green placebo tablets, on day 2 or 3 you will experience 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 break between the two blisters)—even if the bleeding has not yet stopped. While taking Sibilla diario 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 the week.

Preparing the strip

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

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

Now a day of the week will appear over each tablet, and you will be able to see whether or not you have 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 diario 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 in the previous cycle

Take the first tablet on the first day of your period, which is the first day of your cycle—the day bleeding starts. Take the first tablet marked with the text “1 Start”.

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

Start taking Sibilla diario preferably the day after the last active tablet (the last tablet containing active ingredients) of the 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 the previous oral contraceptive).

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

If switching to Sibilla diario from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system (IUS) 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 protective measures (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 diario 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 diario. If, after childbirth, you have had sexual intercourse before starting Sibilla diario (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.

If you take more Sibilla diario than you should

There are no data available on overdose with Sibilla diario. The acute oral toxicity of 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. In general, 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 packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Sibilla diario

The last seven film-coated tablets in 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 diario. You should discard the forgotten placebo tablets to avoid prolonging the placebo week, which would negatively affect the reliability of Sibilla diario.

If you forget to take an active white tablet from the blister (tablets 1–21 coated), follow the advice below:

If you are 12 hours or less late 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 taking two tablets in one day.

If you are more than 12 hours late in 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 just before the end of the white active tablets.

In this case, follow the rules below.

If you have forgotten more than one tablet

If you have forgotten 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

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 your usual daily time. In addition, use a barrier contraceptive method, e.g., a condom, for the next 7 days. If you had sexual intercourse in the 7 days before forgetting the tablet, 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. From then on, continue taking the tablets at your usual daily time. If 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

Provided you have taken all 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.

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 your usual daily time. Then start the next blister immediately after taking the last tablet of the current blister, i.e., without a placebo tablet phase between blisters. A withdrawal bleed is unlikely to occur until the end of the second blister, but spotting or intermenstrual bleeding may occur during the days you are taking tablets.
You may also stop taking the white active 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 interval, which must never exceed 7 days, including the day you forgot the tablet. From then on, continue with the next blister. If you wish to start the new blister on your usual day of the week, you may make the placebo tablet period less than 7 days.

If you have forgotten a tablet and do not have a withdrawal bleed during the first normal tablet-free interval, pregnancy should be considered. 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 after taking an active tablet, the active ingredients of the contraceptive may not have been completely absorbed by your body. In this case, follow the advice given above regarding missed tablets. Take another tablet as soon as possible, without exceeding 12 hours. If more than 12 hours have passed, follow the instructions in the section “If you forget to take Sibilla diario”.

What to do if you want to delay your period

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

What to do if you want to change your period

If you take Sibilla diario correctly, you will always have your menstrual period 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 allows, you may shorten (but never lengthen) the next placebo tablet phase by as many days as desired. 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 diario three days earlier. The shorter the placebo tablet phase, the higher the likelihood that you will not have a withdrawal bleed and that you may experience intermenstrual bleeding or spotting during the second blister.

If you do not have your period

If you have taken all tablets correctly, and have had no stomach problems or taken other medicines, it is very unlikely that you are pregnant. Continue taking Sibilla diario as usual.

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

If you stop taking Sibilla diario

You may stop taking Sibilla diario 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, Sibilla daily may cause adverse effects, although not everyone experiences them.

If you experience any adverse effect, especially if it is severe and persistent, or if you notice any change in your health that you think 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 hives with possible breathing difficulties (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 daily”.

Serious adverse effects associated with the use of oral contraceptives are described in section 2 “Warnings and precautions”. You will find more detailed information there. If necessary, contact your doctor immediately.

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

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

headache
breast pain, including discomfort and tenderness 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 upper and lower abdominal pain, discomfort/bloating)
nausea, vomiting, diarrhoea
acne
hair loss (alopecia)
skin rash (including rash with spots)
itching (in some cases affecting the whole body)
irregular withdrawal bleeding, including heavy bleeding (menorrhagia), light bleeding (hypomenorrhoea), scanty bleeding (oligomenorrhoea), and absence of withdrawal bleeding (amenorrhoea)
intermenstrual bleeding (vaginal bleeding and metrorrhagia)
menstrual pain (dysmenorrhoea), pelvic pain
breast enlargement, including swelling and oedema of the breasts
vaginal discharge
ovarian cysts
exhaustion, including weakness, fatigue, and general malaise
weight gain

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

inflammation of the fallopian tubes or ovary
inflammation of the cervix (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 proliferation in the uterus (fibroid)
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
visual disturbances (oscillopsia, impaired vision)
sudden deafness (hearing loss), deterioration of hearing
tinnitus
vestibular disorders (sensation of dizziness, vertigo)
rapid heartbeat
increased diastolic blood pressure (the lower value of blood pressure)
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 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
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 (cellulite)
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
cysts in the breasts, benign proliferations in the breasts (fibrocystic mastopathy), swelling of congenital additional mammary glands distinct from the breasts (supernumerary breast)
pain during sexual intercourse
discharge from mammary glands, breast discharge
menstrual disorders
peripheral oedema (fluid accumulation in the body)
pseudo-flu syndrome, inflammations, pyrexia (fever)
increased levels of triglycerides or cholesterol in the blood (hypertriglyceridaemia, hypercholesterolaemia)
weight changes (increase, decrease, or fluctuation)
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
mini-stroke or transient stroke-like symptoms, known as transient ischaemic attack (TIA)
blood clots in the liver, stomach/intestines, 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 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)
eye irritation when wearing contact lenses
urticaria (itching)
erythema nodosum (red, painful nodules on the skin)
erythema multiforme (target-shaped red rash or blisters)
breast discharge
fluid retention

Reporting of adverse effects:

If you experience any type of 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 daily

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

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Sibilla diario

The active substances are dienogest and ethinylestradiol.

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

The green film-coated tablets do not contain any active substances.

Other components are:

White film-coated tablets

Tablet core:

Lactose monohydrate
Corn starch
Hypromellose type 2910
Talc
Potassium polacrylate
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
Aluminium lake of indigo carmine (E132)
Quinoline yellow aluminium lake (E104)
Black iron oxide (E172)
Sunset yellow FCF aluminium lake (E110)

Appearance of Sibilla diario and package contents

Film-coated active tablets:

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

Film-coated inactive tablets:

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

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

The tablets are numbered from 1 to 28 on the blister. The first tablet is marked "1 Start" and the last is marked "28". Arrows between the numbers on the blister help guide the correct order.

Pack sizes:

1×(21+7) tablets
3×(21+7) tablets
6×(21+7) tablets

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer:

Gedeon Richter Plc.
Gyömroi út 19-21
1103 Budapest
Hungary

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder.

Gedeon Richter Ibérica S.A.
Sabino Arana nº 28, 4º 2ª
08028 Barcelona
Spain

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

Germany: Sibilla
Spain: Sibilla diario

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

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