SIBILLETTE 2 mg /0,03 Mg Film-Coated Tablets

Содержание инструкции

1. Sibillette
   1. What Sibillette is and what it is used for
   2. Cosa deve sapere prima di prendere Sibillette
   3. How to take Sibillette
   4. Possible side effects
   5. How to store Sibillette
   6. Contents of the pack and other information

Sibillette

2 mg/0.03 mg film-coated tablets
Dienogest/ ethinylestradiol

Important things to know 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 blood clots forming 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.
• Pay attention and see a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Read this leaflet carefully before taking this medicine as 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.
• If you get any side effects, even those 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 you take 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 (“pill” contraceptive)
• for the treatment of moderate acne in women who agree to take a contraceptive pill after the failure of suitable topical treatments or oral antibiotics.

Sibillette is a combined oral contraceptive, belonging to a group of medicines often
called the pill. Each of the 21 white active tablets contains two types of hormones: an estrogen
and a progestin. The 7 green tablets do not contain active ingredients and are also called
placebo tablets.
The combined contraceptive pill protects you from pregnancy in three ways. These hormones:

• 1. prevent the ovary from releasing an egg each month (ovulation)

• 2. also make the fluid (in the cervix) thicker, preventing sperm from reaching the egg
• 3. alter the lining of the uterus to reduce the likelihood that it will accept a fertilised egg.

2. Cosa deve sapere prima di prendere Sibillette

Note generali
Before starting to use Sibillette, read the information on blood clots in paragraph 2. It is
particularly important that you read the symptoms of a blood clot (see paragraph 2 “Blood
clots”).

stop taking Sibillette or when the effectiveness of the pill may be reduced. In these
cases, you should not have sexual intercourse or you should 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 cyclical change in
cervical mucus composition.
Remember that combined oral contraceptive pills like Sibillette do not protect you against
sexually transmitted diseases (such as AIDS). Only condoms can help with this.

Sibillettein the treatment of acne
Acne usually improves after three to six months and may continue to improve after six months of
treatment. Discuss with your doctor the need to continue treatment three to six months after starting
therapy and subsequently at periodic 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. The doctor will discuss with you other methods of
birth control that may 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 paragraph 6);
• if you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE) or in other organs;
• if you know you have a disorder that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
• if you are going to have surgery or if you will be bedridden for a long period (see paragraph “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or a transient ischemic attack (TIA - symptoms of a temporary stroke);
• if you have any of the following conditions, which may increase the risk of blood clots forming in the arteries:
• severe diabetes with damage to blood vessels
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a condition known as hyperhomocysteinemia;
• if you suffer from or have suffered from a severe liver disease and your liver function has not yet returned to normal; jaundice or itching all over the body may be signs of a liver disease;
• if you have or have had a liver tumor;
• if you have or have had, or if there is a suspicion that you may have, breast or genital 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 and dasabuvir (see also the paragraph Other medicines and Sibillette).
If you develop any of these conditions while taking Sibillette, stop taking the pill and
contact your doctor immediately. In the meantime, use another method of non-
hormonal contraception.

Warnings and precautions
Talk to your doctor or pharmacist before taking Sibillette.
When should you see a doctor?
Seek urgent medical attention if

• you observe possible signs of a blood clot that may indicate 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 paragraph “Blood clot (thrombosis)”). For a description of the symptoms of these serious side effects, see the paragraph “How to recognize a blood clot”.

Tell your doctor if any of the following conditions apply to you.
In some situations, you need to be particularly careful while using Sibillette or
any other combined pill, and regular medical check-ups may be necessary. If any
of the following conditions apply to you, tell your doctor before starting to take
Sibillette. Also, if any of the following conditions apply to you or if any of these conditions
appear or worsen while you are taking Sibillette, you should tell your doctor:

• if a close relative has or has had breast cancer;
• if you have a liver or gallbladder disease;
• if you suffer from diabetes;
• if you suffer from depression or mood swings;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disease);
• if you suffer from epilepsy (see “Other medicines and Sibillette”);
• if you have systemic lupus erythematosus (SLE, a disease that affects the body's defense system);
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history positive for this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are going to have surgery or if you will be bedridden for a long period (see paragraph 2 “Blood clots”);
• if you have just given birth, your risk of developing blood clots is higher. Ask your doctor how long after childbirth you can start taking Sibillette;
• if you have inflammation of the veins in the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have a disease that first appeared during pregnancy or a previous use of sex hormones (for example, hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (herpes gravidicum), a nervous system disease that causes sudden movements of the body (Sydenham's chorea));
• if you have or have had chloasma (a change in skin color, especially on the face or neck, also called “pregnancy spots”). If so, avoid direct exposure to sunlight or ultraviolet rays;
• if you suffer from hereditary angioedema, products containing estrogens may induce or worsen your symptoms. You should seek immediate medical attention if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, all accompanied by difficulty breathing.

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

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

Recovery from blood clots is not always complete. Rarely, long-term effects can occur, or, very rarely, these effects can 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
See your doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What are you likely to be suffering from?

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been linked to an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur in the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, the clot can 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 you
take a combined hormonal contraceptive for the first time. The risk may also be
higher if you restart a combined hormonal contraceptive (the same medicine or
a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but is still 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 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.
In 10,000 women who do not use any combined hormonal contraceptive and who are not
pregnant, about 2 will develop a blood clot in a year.

In 10,000 women who use a combined hormonal contraceptive containing
levonorgestrel, noretisterone or norgestimate, about 5-7 will develop a blood clot
in a year.
In 10,000 women who use a combined hormonal contraceptive containing
dienogest and ethinylestradiol like Sibillette, about 8-11 will develop a blood
clot in a year.

• The risk of a blood clot forming depends on your medical history (see “Factors that increase the risk of a blood clot forming”).

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 some conditions increase it.
Your risk is higher:

• if you are strongly overweight (body mass index or BMI greater than 30 kg/m²);
• if a close relative has had a blood clot in the leg, lung, or another organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you are going to have surgery or if you have to lie down for a long period due to an injury or illness or if you have a leg in a cast. You may need to stop taking Sibillette a few weeks before surgery or during the time when you are less mobile. 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);
• 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) can temporarily increase the risk of a blood clot forming, especially if you have some of the other risk factors listed.
It is important that you tell your doctor if any of these conditions apply to you, even if you are not sure. The doctor may decide to stop you from taking Sibillette.
If any of the above conditions change while you are using Sibillette, for example if a close relative develops thrombosis for no known reason or if you gain a lot of 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 cause 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 can increase:

• as you get older (over 35 years);
• if you smoke.When using a combined hormonal contraceptive like Sibillette it is advisable to quit smoking. If you cannot quit smoking and you are over 35 years old, your doctor may advise you to use a different type of contraception;
• if you are overweight;
• if you have high blood pressure that is not controlled with therapy;
• if a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high 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 (valve 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 serious, 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 for no known reason or if you gain a lot of weight, contact your doctor.

Sibillette and tumors
Breast cancer has been detected with slightly greater frequency in women who use combined pills, but it has not been established whether this is due to the treatment. For example, it may be that a greater number of tumors are diagnosed in women undergoing treatment with combined pills as they are more frequently subjected to medical examinations. The incidence of breast cancer gradually decreases when the use of combined hormonal contraceptives is stopped. It is important that you regularly check your breasts and contact your doctor if you notice any lumps.
Rarely, benign liver tumors have been reported in women taking the pill and even more rarely malignant liver tumors. See your doctor if you experience unusual severe abdominal pain.
In some epidemiological studies, an increased risk of cervical tumors has been reported in women who used combined pills for a long time, but there is no agreement as to whether this data can instead be attributed to the confounding effects of sexual behavior and other factors, such as the human papillomavirus.

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

Unexpected bleeding between periods
During the first few months of using Sibillette, you may experience unexpected bleeding (bleeding not coinciding with the interval period). If these bleedings persist for more than a few months, or if they start after a few months, the doctor must investigate the cause.

Regular checks
Once you have started taking the pill, your doctor will review you for regular check-ups. The frequency and nature of the visits will be determined by the doctor and will be adapted 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Also tell your doctor or dentist if they prescribe another medicine that you are using Sibillette.
They can tell you if you need to take additional contraceptive precautions (e.g. condoms) and if so, for how long, or if the use of another medicine needs to be changed.
Do not take Sibillette if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this can cause increases in blood test results for liver function (increased liver enzymes ALT).
Your doctor will prescribe you another type of contraception before starting treatment with these medicines.
Sibillette can be resumed about 2 weeks after the end of this treatment. See section “Do not take Sibillette”.
Some medicines can affect the levels of Sibillette 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);
• infections due to HIV or hepatitis C virus (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• fungal infection (e.g. griseofulvin);

If you want to use herbal products containing St. John's Wort (a herbal remedy used for depression) during the use of Sibillette, you must consult your doctor first.

Interactions of Sibillette with other medicines can also cause the onset increased or pronounced side effects.
The following medicines can compromise the tolerability of Sibillette:

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

Sibillette can affect the effectiveness of other medicines, such as:

• cyclosporine (a medicine used to suppress tissue rejection);
• lamotrigine (a medicine for the treatment of epilepsy);
• theophylline (used to treat breathing problems);
• tizanidine (used to treat muscle pain and/or muscle cramps).

Ask your doctor or pharmacist before taking any medicine.
Before having blood tests
Tell your doctor or laboratory personnel that you are taking the pill, as oral contraceptives can affect the results of some tests.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You must not take Sibillette if you are pregnant. If you become pregnant or think you may be pregnant, stop taking Sibillette immediately and see your doctor.
If you are taking Sibillette while breastfeeding, the tablet may reduce the amount and change the composition of the milk. Small amounts of contraceptive steroids and/or their metabolites may be excreted in breast milk. These amounts may have effects on the baby. Therefore Sibillette should not be taken during breastfeeding.

Driving and using machines
Sibillette has no effects on the ability to drive and use machines.

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

3. How to take Sibillette

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

Preparing the blister
To help you keep track, there are 7 adhesive strips with the 7 days of the week.
Choose the adhesive strip that starts with the day you start taking the pills. For example, if
you start on Wednesday, use the weekly strip that starts with “Wed”.
Match the “  ” symbol on the strip with the same symbol on the blister and place the strip
on the area bounded by the black line. Each day will align with a row of pills.
Now there is a day indicated above each tablet and you can see if 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 from pregnancy even during the 7 days when you take
the placebo tablet.

When to start the first pack
If you have not used any oral contraception during the previous cycle
Take the first pill on the first day of your cycle, i.e. the first day of your period, the day on
which your bleeding starts. Take the first tablet marked with “Start”.

Switching from another combined hormonal contraceptive (combined oral contraceptive,
vaginal ring, transdermal patch)
Start taking Sibillette preferably the day after you have taken the last active tablet (the last
tablet containing the active ingredients) of your previous pill, but at the latest the day after
the pill-free days of your previous pill have ended (or after the last
inactive tablet of your previous pill).
If switching from a vaginal ring or patch, follow your doctor's advice.

Switching from a progestin-only method (progestin-only pill,
injection, implant, progestin-releasing intrauterine device (IUS))
Switching from a progestin-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 due) but in all these cases you should use
additional protective measures (e.g. a condom) for the first 7 days of taking the
tablets.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

Starting after childbirth
If you have just given birth, you can start taking Sibillette at a time between 21 and 28
days after delivery. If you start after 28 days, you must use an additional barrier method (e.g. a
condom) during the first 7 days of using Sibillette. If, after delivery, you have had
sexual intercourse before starting (or restarting) Sibillette, you must first make sure you are not
pregnant or wait for your next period.
If you are breastfeeding, read the paragraph “Pregnancy and breastfeeding”.

Starting after a spontaneous abortion or abortion
After a spontaneous abortion or abortion, your doctor should advise you on taking the pill.

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

If you forget to takeSibillette
The last seven film-coated tablets in the blister are placebo film-coated 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 extending the
placebo week, which could have a negative effect on the reliability of Sibillette.
If you forget a white activetablet from the blister (the film-coated tablets from 1 to 21)
you should follow the following advice:

If the delay is 12 hours or less
If you take the pill as soon as you remember you will still be protected from pregnancy. Continue to
take the pills at the 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 is more than 12 hours, protection against pregnancy
may be reduced. The risk of pregnancy is higher if you forget to take the pill
at the beginning of a pack or before the end of the white active tablets.
In this case you must follow the following rules.

If you have forgotten to take more than one pill
If you have forgotten more than one pill, ask your doctor for advice. Remember that your protective
contraception is not effective.

What to do if you forget to take the pill in week 1
You should take the forgotten tablet as soon as you remember, even if this
means taking two tablets at the same time. Then continue to take the
pills at the usual time. You should also use a barrier method, e.g. a condom, for the 7
days following. If you have had sexual intercourse during the 7 days before, you should consider the possibility of
pregnancy. Ask your doctor for advice as soon as possible.

What to do if you forget to take the pill in week 2
You should take the forgotten tablet as soon as you remember, even if this
means taking two tablets at the same time. Then continue to take the
pills at the usual time. You do not need to take any further contraceptive measures, provided
you have taken the pills correctly for the 7 days before the forgotten pill.

What to do if you forget to take the pill in week 3
You do not need to take any further contraceptive measures, provided you have taken
the pills correctly for the 7 days before the first forgotten pill and follow one of the two following options:

• 1. You should take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue to take the
  pills at the usual time. You should then start the next pack immediately after taking the last active tablet of the pack, i.e. without the placebo tablet phase between the two packs. It is likely that the withdrawal bleed will not occur until the end of the second pack, but there may be spotting or breakthrough bleeding during the days you take the tablets.
• 2. You can also stop taking the white active tablets of the current pack and go directly to the green placebo tablets. Before this week of placebo, you should note the day you forgot to take the active tablet to remember the first day of the hormone-free period, which can never last more than 7 days, including the day you forgot the pill. Then continue with the next pack. If you want to start a new pack on the same day of the week, you can shorten the placebo tablet period to less than 7 days.

If you have forgotten to take the tablets, and you do not have a withdrawal bleed during the normal
placebo interval, the possibility of pregnancy should be considered. In this
case, you should talk to your doctor before starting the next pack.

What to do if you have stomach problems
If you have vomited or had diarrhea within 3-4 hours of taking the pill, the active ingredients of the
pill may not have been fully absorbed by your body. In this case
you must follow the advice regarding forgotten pills, as described above. Take another pill
as soon as possible, within no more than 12 hours.If more than 12 hours have passed, follow the instructions in the
paragraph “If you forget to take Sibillette”.

What to do if you want to delay your period
If you want to delay your period, continue with the next pack of Sibillette, after
taking the last active tablet of the current pack, without respecting the interval with the placebo
tablets. From this second pack you can take all the pills you want, until the end
of the second blister pack. During the use of the second pack, you may have breakthrough bleeding
or spotting. Regular pill taking should be resumed after the usual 7-day interval with the placebo tablets.

What to do if you want to move your period
If you take Sibillette correctly, you will have your monthly period every 4 weeks on the same
day of the week. If you want to move your period to another day of the week, instead of
the one you are used to with the current pill taking, you can shorten (but not lengthen) the
next pill-free interval by the number of days you want. For example, if your
monthly period usually starts on Friday, and you want it to start on Tuesday (i.e. three days earlier), you must
start the next pack of Sibillette three days earlier. The shorter the placebo tablet interval, the greater the possibility that you will not have a withdrawal bleed and may
have breakthrough bleeding or spotting during the second pack.

If you miss a period
If you have taken all the pills correctly, and you have not had stomach problems, or used other
medicines, then it is unlikely that you are pregnant. Continue to take Sibillette as usual.
If you have missed two periods in a row, then you may be pregnant and should consult your
doctor immediately. You are allowed to continue taking the pill only after taking a pregnancy test and on
medical advice.

If you want to stop treatment with Sibillette
You can stop treatment with Sibillette at any time. If you do not want to become
pregnant, ask your doctor to advise you on other reliable methods of contraception.
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 everybody gets them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think might be due to Sibillette, tell your
doctor.
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or
blood clots in the arteries (arterial thromboembolism (ATE)) is present in all women who
take 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 linked to the use of Sibillette:

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):

• inflammation of the genitals (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 skin rash with spots)
• itching (sometimes all over the body)
• irregular withdrawal bleeding including heavy bleeding (menorrhagia), light bleeding (hypomenorrhoea), infrequent bleeding (oligomenorrhoea) and absence of withdrawal 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 exhaustion including weakness, fatigue and general malaise
• weight increase.

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

• inflammation of the fallopian tube or ovary
• inflammation of the cervix (cervicitis)
• inflammation of the urinary tract, bladder inflammation (cystitis)
• breast inflammation (mastitis)
• fungal infections (e.g. candida), viral infections, herpes labialis
• fever (influenza), bronchitis, upper respiratory tract infections, sinus infection (sinusitis)
• asthma
• increased breathing rate (hyperventilation)
• benign proliferation in the uterus (fibroids)
• benign proliferation in breast fatty tissue (breast lipoma)
• anaemia
• allergic reactions (hypersensitivity)
• masculinization (virilism)
• loss of appetite (anorexia)
• depression, mood swings, irritability, aggression
• sleepiness, sleep disorders
• circulatory disorders of the brain or heart, stroke
• dystonia (muscle disorder, causing e.g. abnormal posture)
• dry or irritated eyes
• vision disorders
• sudden hearing loss, impaired hearing
• tinnitus
• vestibular disorders
• fast heart rate
• increased diastolic blood pressure (lower blood pressure value)
• dizziness or fainting when getting up from a sitting or lying position (orthostatic dysregulation)
• hot flushes
• inflammation of the stomach lining (gastritis), inflammation of the intestine (enteritis)
• stomach discomfort (dyspepsia)
• skin reactions/disorders, including allergic reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis
• excessive sweating
• brown and golden pigment spots (called chloasma, especially on the face), pigment disorders/increased pigmentation
• oily skin (seborrhoea)
• dandruff
• excess hair on the body (hirsutism)
• orange peel skin (cellulite)
• spider nevus (a red central spot and reddish extensions radiating outwards 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 and ovaries
• cysts in the breasts, benign proliferations in the breasts (fibrocystic breast disease), additional congenital breast glands outside the breast (accessory breast)
• pain during intercourse
• nipple discharge, breast milk discharge
• menstrual disorders
• peripheral oedema (fluid retention in the body)
• flu-like illness, inflammation, 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: in a leg or foot (DVT) or in the lung (PE) or heart attack or stroke or mini-stroke or temporary symptoms similar to those of a stroke, known as a transient ischaemic attack (TIA) or blood clots in the liver, stomach/intestine, kidneys or eye.

The possibility 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 the symptoms of a blood clot).

Not known (frequency cannot be estimated from the available data):

• mood alterations
• increased or decreased sexual desire (libido)
• eye irritation when wearing contact lenses
• urticaria (itching)
• erythema nodosum (red and painful skin nodules)
• erythema multiforme (target-shaped or blistering rash)
• nipple discharge
• fluid retention.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
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 which is stated on the blister and the carton after
Exp.
The expiry date refers to the last day of that month.
Store at a temperature below 25°C. Store in the outer carton or in the packaging to
protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sibillette contains

• The active ingredients are dienogest and ethinylestradiol. Each white film-coated tablet (active) contains 2 mg of dienogest and 0.03 mg of ethinylestradiol. The green film-coated tablets do not contain any active ingredients.

The other ingredients are:

White film-coated tablets
Tablet core:
Lactose monohydrate
Corn starch
Hypromellose type 2910
Talc
Potassium polyacrylate
Magnesium stearate

Coating:
Polyvinyl 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 silicon dioxide

Coating:
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc
Indigotine aluminum lake (E132)
Quinoline Yellow aluminum lake (E104)
Black iron oxide (E172)
Sunset Yellow FCF aluminum lake (E110)

Description of the appearance of Sibillette and contents of the pack
Active film-coated tablets:
The active tablets are white to off-white, round, biconvex, film-coated tablets with a diameter of approximately 5.5 mm and imprinted 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 and aluminum blisters. The weekly blisters are included in each box.
The tablets are marked with a number from 1 to 28 on the blister. The first tablet is marked with “Start”, the last tablet is marked with “28”. There are arrows between the numbers on the blister to help you follow the order of the numbers.
Pack sizes:
1x28 tablets
3x28 tablets
6x28 tablets
Not all pack sizes may be marketed.

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