Sibillette

Package leaflet: Information for the user

Sibillette

2 mg/0.03 mg film-coated tablets
dienogest/ethinylestradiol
Important information about combined hormonal contraceptives (CHCs):

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

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, as it may be harmful to them.
• If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Sibillette is and what it is used for

Sibillette is a medicine used:

• to prevent pregnancy ("contraceptive pill")
• for the treatment of moderate acne in women who are willing to use a contraceptive pill after failure of appropriate topical or oral antibiotic treatments.

Sibillette is a combined oral contraceptive, belonging to a group of medicines commonly known as "the pill". Each of the 21 white active tablets contains two types of hormones: an oestrogen and a progestogen. The 7 green tablets contain no active substances and are also called placebo tablets.
The combined oral contraceptive pill protects you from pregnancy in three ways. These hormones:

1. prevent the ovary from releasing an egg each month (ovulation)
2. make the fluid (in the cervix) thicker, thereby preventing sperm from reaching the egg
3. alter the lining of the uterus to reduce the likelihood of it accepting a fertilized egg.

2. What you should know before taking Sibillette

General information
Before starting to use Sibillette, you must read the information about blood clots in
paragraph 2. It is particularly important that you read the symptoms of a blood clot (see
paragraph 2 “Blood clots”).
This patient leaflet describes certain situations in which you must stop taking Sibillette
or in which the effectiveness of the pill may be reduced. In these cases, you must not have
sexual intercourse or must use additional non-hormonal contraceptive precautions (such
as condoms or another barrier method) during intercourse to ensure effective
contraception. Do not use the calendar method or the basal body temperature method, as
oral contraceptives can affect body temperature and the cyclic changes in cervical mucus
composition.
Remember that combined oral contraceptive pills such as Sibillette do not protect you against
sexually transmitted diseases (such as AIDS). Only condoms can help protect you in this regard.

Sibillette in the treatment of acne
Acne usually improves after three to six months and may continue to improve even after six
months of treatment. Discuss with your doctor the need to continue treatment three to six months
after starting therapy, and subsequently at regular intervals.

Do not take Sibillette
Do not take Sibillette if you have any of the conditions listed below. If you have any of the
conditions listed below, consult your doctor. Your doctor will discuss with you other methods of
birth control that might be more suitable for your case.

• 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 vein of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to undergo surgery or if you will be bedridden for a prolonged period (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 which may be an early sign of heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have one of the following conditions, which could increase the risk of developing clots in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
• a condition known as hyperhomocysteinaemia;
  • if you currently suffer or have previously suffered from severe liver disease and your liver function has not yet returned to normal; jaundice or itching all over the body may be signs of liver disease;
  • if you have or have had a liver tumour;
  • if you have or have had, or if there is suspicion that you may have, breast or genital organ cancer, such as ovarian cancer, cervical cancer, or uterine cancer;
  • if you experience unexplained vaginal bleeding;
  • if you have (or have ever had) a type of migraine called “migraine with aura”;
  • if you have (or have had in the past) inflammation of the pancreas (pancreatitis).

Do not take Sibillette if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir (also see section “Other medicines and Sibillette”).
If you develop any of these conditions while taking Sibillette, stop taking the pill immediately
and contact your doctor. In the meantime, use another non-hormonal method of contraception.

Warnings and precautions
Talk to your doctor or pharmacist before taking Sibillette.

When should you contact a doctor?
Contact a doctor urgently

• if you notice possible signs of a blood clot which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clot (thrombosis)”). For a description of the symptoms of these serious side effects, refer to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
In certain situations, you need to be particularly careful when using Sibillette or any other combined pill, and regular medical monitoring may be necessary. If any of the following conditions apply to you, inform your doctor before starting Sibillette. If your condition worsens while taking Sibillette, inform your doctor:

• if a close relative has or has previously had breast cancer;
• if you have liver or gallbladder disease;
• if you suffer from diabetes;
• if you suffer from depression or mood changes;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you suffer from epilepsy (see “Other medicines and Sibillette”);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are due to undergo surgery or if you will be bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Sibillette;
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins;
• if you have or have previously had a condition that first occurred during pregnancy or a previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nervous system disorder causing sudden involuntary movements (Sydenham’s chorea));
• if you have or have previously had chloasma (a skin pigmentation disorder, especially on the face or neck, also known as “melasma” or “pregnancy mask”). If so, avoid direct exposure to sunlight or ultraviolet rays;
• if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives possibly accompanied by breathing difficulties, contact a doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Sibillette increases the risk of developing
a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels
and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE);
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or TEA).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with
Sibillette is low.

How to recognize a blood clot
Contact a doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What might you have?

• swelling in one leg or along a vein in the leg or in the foot, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;

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 developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, a clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher when restarting a combined hormonal contraceptive (the same or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Sibillette, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Sibillette is low.

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

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Sibillette is low, but certain conditions can increase this risk. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you are due to undergo surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Sibillette several weeks before surgery or during periods of reduced mobility. If you need to stop taking Sibillette, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• if you gave birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have any of the other listed risk factors.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to have you stop taking Sibillette.
If any of the above conditions change while you are using Sibillette—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they may lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Sibillette is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Sibillette, it is advisable 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 (under 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 fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using Sibillette—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Sibillette and cancer
Breast cancer has been detected slightly more frequently in women using combined pills, but it has not been established whether this is due to the treatment. For example, a higher number of tumors may be diagnosed in women taking combined pills because they undergo medical examinations more frequently. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly check your breasts and contact your doctor if you notice any lumps.

Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported in women taking the pill. Consult your doctor if you experience unusual, severe abdominal pain.

In some epidemiological studies, an increased risk of cervical cancer has been reported in women using combined pills long-term, but there is no consensus on how much this may instead be attributable to confounding effects of sexual behavior and other factors, such as human papillomavirus.

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

Unexpected bleeding between menstrual periods
During the first few months of using Sibillette, you may experience unexpected bleeding (bleeding not coinciding with the pill-free interval). If this bleeding persists for more than a few months, or if it starts after several months, your doctor should investigate the cause.

Regular check-ups
Once you start taking the pill, your doctor will schedule regular check-ups. The frequency and nature of these visits will be determined by your doctor and tailored to your individual needs and health status.

Children and adolescents
The use of Sibillette is not indicated before the first menstrual period (menarche).

Elderly women
Sibillette is not indicated after menopause.

Other medicines and Sibillette
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Also, inform your doctor or dentist who is prescribing another medicine that you are using Sibillette. They will advise you whether you need to take additional contraceptive precautions (e.g., condoms), and if so, for how long, or whether the use of another medicine needs to be adjusted.
Do not take Sibillette if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in liver function blood tests (elevated liver enzymes ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Sibillette can be resumed approximately 2 weeks after completion of this treatment.
See section “Do not take Sibillette”.

Some medicines may affect Sibillette blood levels and may make it less effective in preventing pregnancy, or may cause unexpected bleeding. These include medicines used to treat:

• epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate);
• tuberculosis (e.g., rifampicin);
• HIV or hepatitis C infections (so-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 remedy used for depression) while using Sibillette, you must consult your doctor first.

Interactions between Sibillette and other medicines may also lead to an increased or pronounced occurrence of adverse effects.
The following medicines may impair the tolerability of Sibillette:

• etoricoxib (used to treat arthritis, osteoarthritis).

Sibillette may affect the efficacy of other medicines, such as:

• cyclosporine (a medicine used to suppress tissue rejection);
• lamotrigine (a medicine used to treat epilepsy);
• theophylline (used to treat respiratory problems);
• tizanidine (used to treat muscle pain and/or muscle spasms).

In diabetic women, it may be necessary to adjust the dose of blood sugar-lowering medicines (e.g., insulin).
Consult your doctor or pharmacist before taking any medicine.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, you must not take Sibillette. If you become pregnant or think you might be pregnant, stop taking Sibillette immediately and contact your doctor.
If you take Sibillette 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 have effects on the infant. Therefore, Sibillette must not be taken during breastfeeding.

Driving and using machines
Sibillette has no effect on the ability to drive vehicles or operate machinery.

Sibillette contains lactose and Sunset Yellow FCF aluminium lake
The white film-coated active tablets contain monohydrate lactose, and the green film-coated inactive tablets contain anhydrous lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
The green film-coated inactive tablets contain Sunset Yellow FCF aluminium lake (E110), which may cause allergic reactions.

3. How to take Sibillette

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Each Sibillette blister pack contains 28 film-coated tablets. The blister pack is designed to help you remember to take your pill.
You should try to take the pill at approximately the same time every day; if necessary, with a little liquid, in the order shown on the blister pack. Take one tablet daily until you have taken all 21 white active tablets in the pack. The first tablet is marked “Start”. To maintain the correct order, follow the direction of the arrows on the blister. Then you will take 7 green placebo tablets. During the intake of these 7 green placebo tablets, on the second or third day, you will experience a withdrawal bleed similar to menstruation, i.e., your monthly cycle.
Start the next pack immediately after the 7 green placebo tablets (so that there is no gap between the two packs), even if bleeding has not yet stopped. As long as you continue taking Sibillette correctly, each new pack will always begin on the same day of the week, and your monthly bleed will occur on the same day of the week.

Preparing the blister pack
To help you keep track, there are 7 weekly adhesive strips with the 7 days of the week. Choose the strip that starts with the day you begin taking the pills. For example, if you start on Wednesday, use the weekly strip starting with “Wed”.
Align the symbol “  ” on the strip with the same symbol on the blister and place the strip over the area bounded by the black line. Each day will then align with a row of tablets. Now, each tablet has a day marked above it, so you can see whether you have taken the pill on a particular day. Follow the direction of the arrow until you have taken all 28 tablets.
If you use Sibillette in this way, you will be protected against pregnancy even during the 7 days when you are taking the placebo tablets.

When to start the first pack
If no hormonal contraception was used in the previous cycle
Take the first pill on the first day of your cycle, i.e., the first day of menstrual bleeding. Take the first tablet marked “Start”.
Switching from another combined hormonal contraceptive (combined oral contraceptive, vaginal ring, transdermal patch)
Start taking Sibillette preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous pill, but no later than the day after the tablet-free days of your previous pill end (or after the last inactive tablet of your previous pill).
If switching from a vaginal ring or transdermal patch, follow your doctor’s advice.
Switching from a progestogen-only method (progestogen-only pill, injection, implant, intrauterine system releasing progestogen (IUS))
Switching from a progestogen-only pill can occur on any day (from an implant or IUS on the day of removal, from an injectable contraceptive on the day the next injection would have been administered), but in all these cases you must use additional protective measures (e.g., a condom) for the first 7 days of tablet intake.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
Starting after childbirth
If you have recently given birth, you may start taking Sibillette between 21 and 28 days after delivery. If you start later than 28 days after delivery, you must use an additional barrier method (e.g., condom) during the first 7 days of using Sibillette. If you have had sexual intercourse after childbirth before starting (or restarting) Sibillette, you must first ensure you are not pregnant or wait for your next menstrual period.
If you are breastfeeding, read the section “Pregnancy and breastfeeding”.
Starting after a miscarriage or abortion
After a miscarriage or abortion, your doctor will advise you on when to start taking the pill.

If you take more Sibillette than you should
There are no available data on overdose with Sibillette. Acute oral toxicity due to overdose with other oral contraceptives in adults and children is low. Symptoms that may occur in such cases include nausea, vomiting, and, in young girls, slight vaginal bleeding. In general, no specific treatment is required; if necessary, treatment should be symptomatic.
If you realize a child has taken more than one tablet, consult a doctor.

If you forget to take Sibillette
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 not affect the effectiveness of Sibillette. You should discard the forgotten film-coated tablet to avoid prolonging the placebo week, which could negatively affect the reliability of Sibillette.
If you forget to take a white active tablet from the blister (tablets 1 to 21), follow the instructions below:
If the delay is 12 hours or less
Take the missed pill as soon as you remember, and you will still be protected against pregnancy. Continue taking the following pills at your usual time. This may mean taking two pills on the same day.
If the delay is more than 12 hours
If the delay in taking the pill exceeds 12 hours, protection against pregnancy may be reduced. The risk of pregnancy is higher if you miss a pill at the beginning of a pack or before finishing the 21 active white tablets.
In this case, follow the rules below.
If you have missed more than one pill
If you have missed more than one pill, consult your doctor. Remember that your contraceptive protection is not effective.
What to do if you miss a pill in week 1
Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. You must also use a barrier method, e.g., a condom, for the next 7 days. If you had sexual intercourse during the previous 7 days, consider the possibility of pregnancy. Consult your doctor as soon as possible.
What to do if you miss a pill in week 2
Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. No additional contraceptive measures are necessary, provided you have taken the tablets correctly in the 7 days prior to the missed pill.
What to do if you miss a pill in week 3
No additional contraceptive measures are necessary, provided you have taken the tablets correctly in the 7 days prior to the first missed tablet and you follow one of the two options below:

1. Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. You must then start the next pack immediately after taking the last active white tablet of the current pack, i.e., without the placebo tablet phase between packs. Withdrawal bleeding is unlikely to occur until the end of the second pack, but you may experience spotting or breakthrough bleeding during tablet intake.
2. You may also stop taking the active white tablets of the current pack and go directly to the green placebo tablets. Before this placebo week, note the day you missed the active tablet to remember the first day of the hormone-free interval, which must not exceed 7 days, including the day you missed the tablet. Then continue with the next pack. If you wish to start a new pack on the same day of the week, you may shorten the placebo tablet interval to less than 7 days.

If you have missed tablets and do not have withdrawal bleeding during the normal placebo tablet interval, pregnancy must be considered. In this case, you must consult your doctor before starting the next pack.

What to do if you have stomach problems
If you vomit or have diarrhoea within 3–4 hours of taking the pill, the active ingredients may not have been completely absorbed by your body. In this case, follow the advice for missed pills described above. Take another pill as soon as possible, within and no later than 12 hours. If more than 12 hours have passed, follow the instructions in the section “If you forget to take Sibillette”.

What to do if you wish to delay your period
If you wish to delay your period, continue with the next pack of Sibillette after taking the last active tablet of the current pack, without observing the placebo tablet interval. From this second pack, you may take as many tablets as desired, up to the end of the second blister pack. During use of the second pack, you may experience breakthrough bleeding or spotting. Regular intake of Sibillette should resume after the usual 7-day interval with placebo tablets.

What to do if you wish to shift your period
If you take Sibillette correctly, your period will occur every 4 weeks on the same day of the week. If you wish to shift your period to another day of the week instead of the one you are used to with your current pill regimen, you may shorten (but not extend) the next tablet-free interval by the number of days desired. For example, if your period usually starts on Friday and you wish it to start on Tuesday (i.e., three days earlier), start the next pack of Sibillette three days earlier. The shorter the placebo tablet interval, the greater the chance that withdrawal bleeding will not occur and that you may experience breakthrough bleeding or spotting during the second pack.

If you miss a period
If you have taken all tablets correctly, without stomach problems or use of other medicines, it is unlikely that you are pregnant. Continue taking Sibillette as usual.
If you miss two consecutive periods, you may be pregnant and should consult your doctor immediately. You may continue taking the pill only after a pregnancy test and on the advice of your doctor.

If you wish to stop treatment with Sibillette
You may stop treatment with Sibillette at any time. If you do not wish to become pregnant, ask your doctor to recommend other reliable contraceptive methods.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sibillette can cause side effects, although not everyone experiences them.
If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to Sibillette, inform your doctor.
Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, potentially with breathing difficulties (see also section “Warnings and precautions”).
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “Warnings and precautions”.
Serious side effects associated with the use of the pill are described in section 2 “Warnings and precautions”, where you will find more detailed information. Consult your doctor immediately if necessary.
The following is a list of side effects that have been associated with the use of Sibillette:

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

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

Uncommon side 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
• low or high blood pressure
• abdominal pain (including pain in the upper and lower abdomen, discomfort/bloating)
• nausea, vomiting or diarrhoea
• acne
• hair loss (alopecia)
• skin rash (including macular skin rash)
• itching (in some cases affecting the entire body)
• irregular breakthrough bleeding, including heavy bleeding (menorrhagia), light bleeding (hypomenorrhoea), infrequent bleeding (oligomenorrhoea), and absence of breakthrough bleeding (amenorrhoea)
• bleeding between periods (vaginal haemorrhage and metrorrhagia)
• menstrual pain (dysmenorrhoea), pelvic pain
• breast enlargement, including breast swelling, breast oedema
• vaginal discharge
• ovarian cysts
• extreme fatigue, including weakness, tiredness, and general malaise
• weight gain.

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

• inflammation of the uterine or ovarian tube
• inflammation of the cervix (cervicitis)
• urinary tract infection, bladder inflammation (cystitis)
• breast inflammation (mastitis)
• fungal infections (e.g. candida), viral infections, cold sores (herpes labialis)
• fever (influenza), bronchitis, upper respiratory tract infections, paranasal infection (sinusitis)
• benign growth in the uterus (fibroid)
• benign growth in the fatty tissue of the breast (breast lipoma)
• anaemia
• allergic reactions (hypersensitivity)
• masculinization (virilism)
• loss of appetite (anorexia)
• depression, irritability, mental disorders, aggression
• drowsiness, sleep disorders
• circulatory disorders of the brain or heart, stroke
• dystonia (muscle disorder causing, for example, abnormal posture)
• dry or irritated eyes
• visual disturbances (oscillopsia, deterioration of vision)
• sudden deafness (hearing loss), impaired sense of hearing
• tinnitus
• vestibular disorders (sensation of dizziness, vertigo)
• increased heart rate
• increased diastolic blood pressure (elevated value of minimum blood pressure)
• dizziness or fainting when rising from a sitting or lying position (orthostatic dysregulation)
• hot flushes
• inflammation of veins (thrombophlebitis)
• varicose veins (varicosities), venous disorders and vein pain
• asthma
• increased respiratory rate (hyperventilation)
• inflammation of the gastric mucosa (gastritis), intestinal inflammation (enteritis)
• stomach discomfort (dyspepsia)
• skin reactions/disorders, including allergic reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis
• excessive sweating
• brown or golden pigmented spots (called chloasma), particularly on the face (melasma), pigmentary disorders/increased pigmentation
• oily skin (seborrhoea)
• dandruff
• excessive body hair (hirsutism)
• orange-peel skin (cellulite)
• spider nevus (a central red spot with reddish extensions radiating outward like a spider’s web)
• back pain, chest pain
• discomfort in bones and muscles, 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 and ovaries
• breast cysts, benign breast growths (fibrocystic mastopathy), additional congenital mammary gland tissue outside the breast (accessory breast)
• pain during intercourse
• secretion from mammary glands, breast discharge
• menstrual disorders
• peripheral oedema (fluid accumulation in the body)
• flu-like illness, inflammations, pyrexia (fever)
• increased levels of triglycerides or cholesterol in the blood (hypertriglyceridaemia, hypercholesterolaemia)
• weight loss or weight changes (increase, decrease or fluctuations)
• harmful blood clots in a vein or an artery, for example:

o in a leg or foot (DVT)
o in a lung (PE)
o heart attack
o stroke
o mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
o blood clots in the liver, stomach/intestine, kidneys or eye.
The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

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 (painful, red skin nodules)
• erythema multiforme (target-shaped rash or blisters)
• breast discharge
• fluid retention.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sibillette

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 that month.
Store below 25 °C. Keep in the outer carton or packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sibillette contains

• 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
Maize starch
Hypromellose type 2910
Talc
Polyacrylic acid potassium salt
Magnesium stearate
Coating:
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc
Green film-coated tablets
Tablet core:
Microcrystalline cellulose type 12
Anhydrous lactose
Pregelatinized maize starch
Magnesium stearate
Anhydrous colloidal silica
Coating:
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc
Indigo carmine aluminium lake (E132)
Quinoline yellow aluminium lake (E104)
Iron oxide black (E172)
Sunset yellow FCF aluminium lake (E110)
Description of the appearance of Sibillette and contents of the pack
Active film-coated tablets:
The active tablets are white or almost white, round, biconvex, film-coated tablets with a diameter of approximately 5.5 mm, marked with "G53" on one side.
Inactive film-coated tablets:
The placebo tablets are green, round, biconvex, film-coated tablets with a diameter of approximately 6 mm.
The tablets are packaged in transparent rigid PVC/PE/PVDC-aluminum blisters. The blisters are packed in cardboard boxes containing the package leaflet, a carton sleeve, and adhesive labels with the days of the week included in each box.
The tablets are marked with numbers from 1 to 28 on the blister. The first tablet is marked "1 Start", the last tablet is marked "28". Arrows between the numbers on the blister will help you follow the correct order.
Pack sizes:
1x28 tablets
3x28 tablets
6x28 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary