Sibilla

Package leaflet: Information for the user

SIBILLA

2 mg/0.03 mg film-coated tablets
dienogest and ethinylestradiol
Generic medicine

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception when used correctly.
• They slightly increase the risk of developing blood clots in 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 pass it on to others, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Sibilla is and what it is used for

Sibilla is a medicine used:

• to prevent pregnancy (a "birth control pill")
• to treat moderate acne in women who choose to use a birth control pill after failure of suitable topical treatments or oral antibiotics.

Sibilla is a combined oral contraceptive, belonging to a group of medicines commonly called "the pill". It contains two types of hormones: an oestrogen and a progestogen.
The combined oral contraceptive 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, reducing the likelihood that it will accept a fertilized egg.

2. What you should know before taking Sibilla

General information
Before starting to use Sibilla, 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 Sibilla 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 method of measuring basal body temperature upon waking, as oral contraceptives can influence body temperature and the cyclic changes in cervical mucus composition.
Remember that combined oral contraceptive pills such as Sibilla do not protect you
against sexually transmitted diseases (such as AIDS). Only condoms can help protect you
in this regard.

Sibilla 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 use Sibilla
Do not use Sibilla 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 components of this medicine (listed in section 6);
• if you have (or have ever had) a blood clot in a blood vessel 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 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 transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following diseases, which could increase the risk of developing clots in the arteries:
  o severe diabetes with blood vessel damage
  o very high blood pressure
  o very high levels of fats (cholesterol or triglycerides) in the blood
  o a condition known as hyperhomocysteinemia;
• if you currently suffer or have previously suffered from severe liver disease and 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 cancer or genital organ cancers, 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 previously had) inflammation of the pancreas (pancreatitis).

Do not use Sibilla if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Sibilla”).
If you develop any of these conditions while taking Sibilla, stop taking the pill
immediately and contact your doctor without delay. In the meantime, use another non-hormonal
contraceptive method.

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

When should you contact a doctor?
Seek urgent medical advice

• 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 clots”).

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 especially careful when using Sibilla or any other combined oral contraceptive pill, and regular medical monitoring may be necessary. If any of the following conditions apply to you, inform your doctor before starting Sibilla. If any of these conditions develop or worsen while you are using Sibilla, you must inform your doctor:

• if a close relative has or has previously had breast cancer;
• if you have liver or gallbladder disease;
• if you have 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 (a hereditary red blood cell disorder);
• if you suffer from epilepsy (see “Other medicines and Sibilla”);
• 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 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 childbirth you can start taking Sibilla;
• 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 during 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 (skin pigmentation, 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 potentially accompanied by breathing difficulties, contact a doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Sibilla 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 ATE).

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 Sibilla is low.

How to recognize a blood clot
Seek immediate medical attention if you notice any of the following signs or symptoms.
Do you have one of these signs? What might you
be suffering from?

• swelling in one leg or along a vein in the leg, or
• deep pain or tenderness in the leg, which may only be felt when standing or walking;
  especially in the foot or calf – Deep vein thrombosis

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 breaks loose from the leg and travels to 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
that a combined hormonal contraceptive is used for the first time. The risk may also
be higher when restarting a combined hormonal contraceptive (the same
product or a different one) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than in women who are not
using a combined hormonal contraceptive.
When Sibilla is discontinued, 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 VTE (venous thromboembolism) and on the type of combined hormonal
contraceptive you are using. The overall risk of developing a blood clot in the
leg or lung (DVT or PE) with Sibilla 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 within 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 within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing dienogest and ethinylestradiol, about 8–11 will develop a blood clot within one year.
• The likelihood of developing a blood clot also 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 Sibilla 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 scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in plaster. You may need to stop taking Sibilla several weeks before surgery or during periods of reduced mobility. If you need to stop taking Sibilla, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• if you have given 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 clots, especially if you
have any of the other risk factors listed above.
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 stop your treatment with Sibilla.
If any of the conditions listed above change while you are using Sibilla—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 can
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 Sibilla is
very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Sibilla, it is advisable to stop smoking. If you cannot 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 high blood pressure;
• 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 fat 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 conditions listed above change while you are using Sibilla—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.
Sibilla and cancer
Breast cancer has been detected slightly more frequently in women using combined oral
contraceptives, but it has not been established whether this is due to the treatment. For
example, more cancers 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 tumours and even more rarely malignant liver tumours have been reported
in women taking oral contraceptives. Contact your doctor if you experience unusual, severe
abdominal pain.
Some epidemiological studies have reported an increased risk of cervical cancer in women
using combined oral contraceptives long-term, but controversy remains as to how much this
finding may instead be related to confounding effects of sexual behaviour and other factors,
such as human papillomavirus.
Psychiatric disorders
Some women using hormonal contraceptives, including Sibilla, have reported depression or
depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you
experience mood changes or depressive symptoms, contact your doctor as soon as possible for
further medical advice.
Unexpected bleeding between periods
During the first months of using Sibilla, you may experience unexpected bleeding (bleeding not
coinciding with the interval period). 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
After starting the pill, your doctor will want to see you again for 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 Sibilla is not indicated before the first menstrual period (menarche).
Elderly women
Sibilla is not indicated after menopause.
Other medicines and Sibilla
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Also inform the doctor or dentist prescribing another medicine that you are using Sibilla. 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 use Sibilla 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 test results (elevated liver enzymes ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with
these medicines.
Sibilla can be restarted approximately 2 weeks after completing this treatment. See section
“Do not use Sibilla”.
Some medicines may affect Sibilla levels in the blood and may make it less effective in
preventing pregnancy, or may cause unexpected bleeding. These include medicines for the
treatment of:

• 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 remedies containing St. John’s wort (a herbal remedy used for
depression) while using Sibilla, you must consult your doctor first.
Interactions between Sibilla and other medicines may also lead to an increased or pronounced
occurrence of side effects.
The following medicines may impair the tolerability of Sibilla:

• etoricoxib (used for the treatment of arthritis, osteoarthritis).

Sibilla may affect the effectiveness of other medicines, such as:

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

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,
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, you must not take Sibilla. If you become pregnant or think you might be
pregnant, stop taking Sibilla immediately and contact your doctor.
If you are taking Sibilla 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 milk. These amounts may affect the infant. Therefore, Sibilla must not be
taken during breastfeeding.
Driving and using machines
Sibilla has no effect on the ability to drive vehicles or operate machinery.
Sibilla contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.

3. How to take Sibilla

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Each Sibilla blister pack contains 21 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, with some liquid if necessary, in the order shown on the blister pack. Take one tablet daily until you have taken all 21 tablets in the pack. Then you will have 7 days during which you do not take any tablets. During these 7 tablet-free days, you will usually experience a withdrawal bleed similar to menstruation—this is your monthly period.
Start the next pack on the eighth day (the day after the seventh day of the tablet-free interval), even if bleeding has not yet stopped. As long as you continue taking Sibilla correctly, each new pack will always begin on the same day of the week, and your monthly period will occur on the same days each month.
If you take Sibilla as instructed, you will be protected against pregnancy even during the 7 tablet-free days.

When to start the first pack
If you have not used any hormonal contraception in the previous cycle
Take the first tablet on the first day of your cycle—that is, the first day of your menstrual bleeding. Take the tablet marked with that day of the week.

Switching from another combined hormonal contraceptive (combined oral contraceptive, vaginal ring, transdermal patch)
Start taking Sibilla 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 interval of your previous pill ends (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))
You may switch to Sibilla 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 due). However, in all these cases, you must use additional contraceptive protection (e.g., a condom) for the first 7 days of tablet intake.

If you have any doubts or further questions, ask your doctor or pharmacist.

After childbirth
If you have recently given birth, you may start taking Sibilla 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) for the first 7 days of taking Sibilla. If you have had sexual intercourse after childbirth but before starting (or restarting) Sibilla, 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”.

After miscarriage or abortion
After a miscarriage or abortion, your doctor will advise you on when to start taking the pill.

If you take more Sibilla than you should
There are no data available on overdose with Sibilla. Acute oral toxicity due to overdose with other oral contraceptives in adults and children is low. Symptoms that may possibly occur 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 immediately.

If you forget to take Sibilla
If the delay is less than 12 hours
If you take the missed tablet as soon as you remember, you are still protected against pregnancy. Continue taking the following tablets at your usual time. This may mean taking two tablets on the same day.

If the delay is more than 12 hours
If the delay in taking the tablet exceeds 12 hours, protection against pregnancy may be reduced. The risk of pregnancy is higher if you miss a tablet at the beginning or end of a pack.
In this case, follow the instructions below.

If you have missed more than one tablet
If you have missed more than one tablet, consult your doctor. Remember that your contraceptive protection is not reliable.

What to do if you miss a tablet 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., condom) for the next 7 days. If you had sexual intercourse during the previous 7 days, consider the possibility of pregnancy. In this case, consult your doctor as soon as possible.

What to do if you miss a tablet 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 before the missed tablet.

What to do if you miss a tablet in Week 3
No additional contraceptive measures are necessary, provided you have taken the tablets correctly in the 7 days before 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. Start the next pack immediately after finishing the current pack—i.e., skip the tablet-free interval between packs. Withdrawal bleeding is unlikely until the end of the second pack, but you may experience spotting or breakthrough bleeding during tablet intake.
2. Alternatively, you may stop taking tablets from the current pack. In this case, proceed directly to a tablet-free interval of up to 7 days (including the days when you missed tablets), and then start the next pack. If you wish to start the next pack on your usual day of the week, you may choose a tablet-free interval of less than 7 days. If you missed tablets and do not experience withdrawal bleeding during the normal tablet-free interval, pregnancy should be considered. In this case, 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 tablet, the active ingredients may not be completely absorbed. In this case, follow the advice for missed tablets described above. Take another tablet 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 Sibilla”.

What to do if you wish to delay your period
If you wish to delay your period, continue with the next pack of Sibilla immediately after taking the last tablet of the current pack, skipping the tablet-free interval. From this second pack, take as many tablets as desired, up to the end of the second blister pack. During use of the second pack, you may experience withdrawal bleeding or spotting. Regular intake of Sibilla resumes after the usual 7-day tablet-free interval.

What to do if you wish to shift your period
If you take Sibilla 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, 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 (three days earlier), begin the next pack of Sibilla three days earlier. The shorter the tablet-free interval, the greater the chance that you will not have withdrawal bleeding and may instead experience breakthrough bleeding or spotting during the second pack.

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

If you wish to stop taking Sibilla
You may stop taking Sibilla 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 how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 Sibilla, 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 accompanied by 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 “What you should know before using Sibilla”.
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 Sibilla:
Common side effects (may affect up to 1 in 10 people):

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

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, diarrhoea
• acne
• hair loss (alopecia)
• skin rash (including skin rash with spots)
• itching (in some cases affecting the entire body)
• irregular withdrawal bleeding, including heavy bleeding (menorrhagia)
• light bleeding (hypomenorrhea), infrequent bleeding (oligomenorrhea), and absence of withdrawal bleeding (amenorrhea)
• 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 tube or ovary
• inflammation of the cervix (cervicitis)
• urinary tract inflammation, bladder inflammation (cystitis)
• breast inflammation (mastitis)
• fungal infections (e.g. candidiasis), viral infections, cold sores
• fever (influenza), bronchitis, upper respiratory tract infections, paranasal infection (sinusitis)
• benign growth in the uterus (myoma)
• benign growth in the fatty tissue of the breast (lipoma of the breast)
• 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 (higher value of the 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 disorder or vein pain
• asthma
• increased respiratory rate (hyperventilation)
• inflammation of the gastric mucosa (gastritis), intestinal inflammation (enteritis)
• stomach discomfort (dyspepsia)
• skin reactions/disorders, including allergic reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis
• excessive sweating
• brown or golden pigmented spots (known as chloasma), particularly on the face (melasma), pigmentary disorders/increased pigmentation
• oily skin (seborrhoea)
• dandruff
• excessive body hair (hirsutism)
• orange peel skin (cellulite)
• spider angioma (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 uterine tube and ovaries
• breast cysts, benign breast proliferations (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 fluctuation)
• harmful blood clots in a vein or artery, for example:
• in a leg or foot (DVT)
• in a lung (PE)
• heart attack
• stroke
• mini-stroke or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA)
• 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 (frequency cannot be estimated from the available data):

• mood changes
• increased or decreased sexual desire (libido)
• eye irritation when wearing contact lenses
• urticaria (itching)
• erythema nodosum (red, painful skin nodules)
• erythema multiforme (target-shaped red 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 the following website: 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 Sibilla

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light. Store below 25°C.
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 Sibilla contains
The active substances are 2 mg dienogest and 0.03 mg ethinylestradiol in each film-coated tablet.
The other components are:
Tablet core:
Monohydrate lactose
Maize starch
Hypromellose type 2910
Talc
Potassium polyacrylate
Magnesium stearate
Coating:
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc

Description of the appearance of Sibilla and package contents
White or almost white, round, biconvex, film-coated tablets with a diameter of approximately 5.5 mm.
Engraving on one side: "G53"; the other side: no engraving.
Sibilla 2 mg/0.03 mg film-coated tablets are packaged in white PVC/PE/PVDC/Aluminium blisters. The blisters are contained in folding cartons with the package leaflet, and a carton is included in each box.
Pack sizes:
21 tablets
3x21 tablets
6x21 tablets
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary