Prospect: Information for the usera

Sibilla diario 2 mg / 0.03 mg film-coated tablets

dienogest/ etinilestradiol

Important things you should know about combined hormonal contraceptives (CHCs):

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

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.4.

Sibilla diariois a medication

-to prevent pregnancy (“birth control pill").

-for the treatment of women with moderate acne who accept receiving a birth control pill after the failure of local treatments or oral antibiotics.

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

The combined oral contraceptive protects against pregnancy in three ways. These hormones:

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

General Considerations

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

This leaflet describes several situations in which you should stop taking Sibilla diario, or in which the effectiveness of the contraceptive may be reduced. In these situations, you will have to stop having sexual intercourse or take additional non-hormonal contraceptive precautions (such as a condom or other barrier method) during sexual intercourse to ensure effective contraception. Do not use the calendar method or basal body temperature measurement, as hormonal contraceptives can affect body temperature and cyclic changes in cervical mucus composition.

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

Sibilla diario in Acne

Acne will usually improve within three to six months of treatment and may continue to improve even after six months. You should discuss with your doctor the need to continue treatment three to six months after starting and periodically thereafter.

Do Not Use

You should not use Sibilla diario if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

• If you are allergic to dienogest or etinilestradiol or any of the other components of this medication (listed in section 6);
• If you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs;
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• If you need surgery or spend a lot of time without standing up (see section “Blood Clots”);
• If you have ever had a heart attack or stroke;
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke);
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • Severe diabetes with vascular damage
  • Very high blood pressure
  • Very high levels of fat in the blood (cholesterol or triglycerides)
  • A condition called hyperhomocysteinemia;
• If you have or have had severe liver disease and your liver function is not yet normal; jaundice or itching all over the body may be signs of liver disease;
• If you have liver tumors or have ever had them;

• If you have or have ever had or if you suspect you have breast cancer or genital organ cancer, for example, ovarian cancer, cervical cancer, or uterine cancer (womb);
• If you have any unexplained vaginal bleeding;
• If you have (or have ever had) a type of migraine called “migraine with aura”
• If you have (or have ever had) pancreatitis (inflammation of the pancreas).

You should not use Sibilla diario if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Other Medications and Sibilla diario”).

If you experience any of the above situations while taking Sibilla diario, do not take any more pills and contact your doctor immediately. In the meantime, use another non-hormonal contraceptive method.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Sibilla diario.

Inform your doctor if you experience any of the following conditions

In some situations, you will need to be particularly careful while taking Sibilla diario or any other combined oral contraceptive, and you may need to have regular check-ups.If any of the following situations apply to you, consult your doctor before starting to take Sibilla diario.

If any of the following situations develop or worsen while you are using Sibilla diario, you should also inform your doctor.

• If a close relative has had breast cancer
• If you have liver disease or gallbladder disease
• If you have diabetes
• If you have depression or mood changes
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• If you have hemolytic uremic syndrome (HUS - a blood clotting disorder that causes kidney failure)
• If you have sickle cell anemia (a hereditary disorder of red blood cells)
• If you have epilepsy (see “Other Medications and Sibilla diario”)
• If you have systemic lupus erythematosus (SLE - a disease that affects your natural defense system)
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas)
• If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”)
• If you are at increased risk of blood clots after childbirth. You should ask your doctor when you can start taking Sibilla diario after childbirth
• If you have superficial thrombophlebitis (inflammation of veins under the skin)
• If you have varicose veins
• If you have a disease that first appeared during pregnancy or previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder that causes sudden body movements (Sydenham's chorea),
• If you have or have ever had melasma (a skin discoloration, mainly on the face and neck, known as “pregnancy mask”. If so, avoid direct exposure to sunlight or ultraviolet light,
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, you should contact your doctor immediately. Medications containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema

BLOOD CLOTS

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

Blood clots can form:

• In veins (known as “deep vein thrombosis”, “venous thromboembolism”, or VTE),
• In arteries (known as “arterial thrombosis”, “arterial thromboembolism”, or ATE).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

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

How to Recognize a Blood Clot

Seek immediate medical attentionif you notice any of the following signs or symptoms:

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thromboembolism, VTE). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.

• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).
• In very rare cases, a blood clot can form in a vein of another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Sibilla diario, your risk of a blood clot returns to normal within a few weeks.

What is the risk of 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 a blood clot in the leg or lung (DVT or PE) with Sibilla diario is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or noretisterone or norgestimato, about 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing dienogest and etinilestradiol like Sibilla diario, approximately 8-11 women will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below)

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

Your risk of a blood clot with Sibilla diario is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) of 30 kg/m2or higher);
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years old). You may have an inherited blood clotting disorder;
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have your leg immobilized. You may need to stop taking Sibilla diario for several weeks before surgery or while you have limited mobility. If you need to stop taking Sibilla diario, ask your doctor when you can start taking it again;
• With increasing age (especially above 35 years old);
• If you have given birth recently.

Your risk of a blood clot increases the more conditions you have.

Long flights (over 4 hours) may temporarily increase your risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you experience any of the above conditions, even if you are unsure. Your doctor may decide that you should stop taking Sibilla diario.

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

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

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

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

• With age (above 35 years old);
• If you smoke.You should quit smoking when using a combined hormonal contraceptive like Sibilla diario. If you cannot quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive;
• If you are overweight;
• If you have high blood pressure that is not controlled with treatment;

• If any close relatives have had a heart attack or stroke at a young age (less than 50 years old). You may also be at higher risk of a heart attack or stroke;
• If you or any close relatives have high levels of fat in the blood (cholesterol or triglycerides);
• If you have migraines, especially migraines with aura;
• If you have a heart problem (valve disorder, arrhythmia called atrial fibrillation);
• If you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, your risk of a blood clot may be increased even further.

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

Sibilla diario and Cancer

There has been an observed increase in breast cancer in women taking combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, it may be due to more tumors being detected in women taking combined oral contraceptives because they are examined more frequently by their doctor. The appearance of breast tumors decreases gradually after stopping combined oral contraceptives. It is essential to regularly examine your breasts and to contact your doctor if you notice any lumps. In rare cases, benign liver tumors and, in a smaller number of cases, malignant liver tumors have been reported in users of oral contraceptives. Contact your doctor if you have unusual abdominal pain.

In some epidemiological studies, there has been a reported increase in the risk of cervical cancer in long-term users of combined oral contraceptives, but there is still controversy over how much this finding is due to the confounding effect of sexual behavior and other factors such as the human papillomavirus.

Mental Health Disorders

Some women who use combined hormonal contraceptives like Sibilla diario have reported depression or a depressed mood. Depression can be severe and, in some cases, may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Unexpected Bleeding Between Periods

During the first few months of taking Sibilla diario, you may experience unexpected bleeding (bleeding outside the week in which you take the green active pills). If this bleeding lasts more than a few months or starts after some months, your doctor should investigate the cause.

Regular Check-Ups

Once you have started taking the pill, your doctor will see you for regular check-ups. Your doctor will determine the frequency and nature of the check-ups and adapt them to your individual needs and health status.

Children and Adolescents

Sibilla diario is not indicated for use before the first menstrual period (menarche).

Women of Advanced Age

Sibilla diario is not indicated after menopause.

Other Medications and Sibilla diario

Inform your doctor or pharmacist. If you are taking or have recently taken or may need to take any other medication.

Also, inform any other doctor or dentist who prescribes another medication that you are taking Sibilla diario. They may tell you if you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or if you need to change another medication that you need.

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

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

You can restart taking Sibilla diario approximately 2 weeks after completing this treatment. See the section “Do Not Use Sibilla diario”.

Some medications may affect the blood levels of Sibilla diario and may make it less effective for preventing pregnancy or may cause unexpected bleeding. This includes medications used to treat:

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

If you want to use herbal products containing St. John's Wort (a plant-based preparation used for depression) while taking Sibilla diario, you should first consult your doctor.

Interactions of Sibilla diario with other medications that may produce an increase in side effects or an aggravation of the same.

The following medications may decrease the tolerability of Sibilla diario:

• Etoricoxib (for the treatment of arthritis, artrosis).

Sibilla diario may affect the efficacy of other medications, for example:

-Ciclosporin (a medication used to prevent tissue rejection),

-Lamotrigine (a medication for the treatment of epilepsy),

-Theophylline (for the treatment of respiratory problems),

-Tizanidine (for the treatment of muscle pain and/or muscle cramps).

In women with diabetes, you may need to change the dose of medications that reduce blood sugar levels (e.g., insulin).

Consult your doctor or pharmacist before taking any medication.

Before Blood Tests

Inform your doctor or laboratory personnel that you are taking the pill, as hormonal contraceptives can affect the results of some blood tests.

Pregnancy and Lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should not use Sibilla diario when pregnant.If you become pregnant or think you may be pregnant, stop taking Sibilla diario and contact your doctor immediately.

If you are taking Sibilla diario during breastfeeding, the pill may reduce the amount and alter the composition of breast milk. Small amounts of contraceptive steroids and/or their metabolites may be excreted with breast milk. These amounts may affect the baby. Therefore, you should not take Sibilla diario during breastfeeding.

Driving and Operating Machines

Sibilla diariohas no influence on the ability to drive and operate machines.

Sibilla diario contains lactose and sunset yellow FCF aluminum lake

The white-coated active pills contain lactose monohydrate, and the green-coated inactive pills contain lactose anhydrous. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

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

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

Each blister pack of Sibilla daily contains 28 film-coated tablets. The blister pack has been designed to help you remember to take the tablets.

You should try to take the tablets approximately at the same time each day; if necessary with a small amount of liquid, in the order that appears in the blister pack.You should take one tablet a day, starting with the 21 active white tablets in the blister pack. The first tablet you should takeis the one marked with the text “1 Start”. To keep track, follow the direction of the arrows on the blister pack.After that, you will take 7 green placebo tablets. During the 7 days you take the green placebo tablets, on day 2 or 3 you will have a withdrawal bleeding similar to menstruation, that is, your monthly period.

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

Preparation of the strip

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

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

Now you will see a day over each tablet, and you will be able to see if you have taken or not the tablet on a particular day. Follow the directionof the arrow on the card until you have taken the 28 tablets.

If you use Sibilla daily in this way, you will also be protected against pregnancy during the 7 days you take the placebo tablets.

How to start taking the first blister pack

If you have not taken oral contraceptives during the previous cycle

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

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

Start taking Sibilla daily preferably on the day after the last active tablet (the last tablet containing active ingredients)of the previous oral contraceptive, and at the latest on the day after the pill-free period of your previous oral contraceptive (or after the last inactive tablet of the previous oral contraceptive).

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

If you switch to Sibilla daily from a method that only has progestin (progestin-only pill, injection, implant or intrauterine system (IUS) that releases progestin)
You can switch any day from the progestin-only pill (from an implant or anIUSon the day of its removal, from an injectable when it is due for the next injection), but in all these cases use additional contraceptive protection (e.g. a condom) during the first 7 days you take the tablets.

Consult your doctor or pharmacist if you are unsure.

Starting after having a baby

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

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

Starting after an abortion

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

If you take more Sibilla daily than you should

We do not have data on overdose with Sibilla daily. The acute oral toxicity of an overdose with other combined oral contraceptives in adults and children is low. The symptoms that may appear in this case are: nausea, vomiting, and in young girls, light vaginal bleeding. In general, no special treatment is necessary; if necessary, symptomatic treatment will be required.

Consult a doctor if you detect that a child has taken more than one tablet.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915620420 indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to takeSibilla daily

The last 7 film-coated tablets in the blister pack are placebo tablets. If you forget to take one of these film-coated tablets, this will have no effect on the efficacy of Sibilla daily. You should discard the forgotten placebo tablets to avoid prolonging the placebo week, which would have a negative effect on the reliability of Sibilla daily.

If you forget to take anactivewhite tablet from the blister pack (tablets 1-21), you should follow the following advice:

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

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

If you are delayed more than 12 hours in taking a tablet

If you are delayed more than 12 hours in taking a tablet, the protection against pregnancy may be reduced. The risk of pregnancy is higher if you have forgotten to take the tablet at the beginning of the blister pack or before the end of the active white tablets.

You should follow the following rules.

If you have forgotten to take more than one tablet

If you have forgotten to take more than one tablet, consult your doctor. Remember that you have lost your contraceptive protection.

What to do if you forget the tablet the first week

You should take the last forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time. From that moment on, continue taking the tablets at the usual time of the day. Use additional contraceptive protection, e.g. a condom, during the next 7 days. If you have had sex in the 7 days before forgetting the tablet, you should consider the possibility of pregnancy. Contact your doctor as soon as possible for advice.

What to do if you forget the tablet the second week

You should take the last forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time. From that moment on, continue taking the tablets at the usual time of the day. As long as the tablets have been taken correctly during the 7 days before the forgotten tablet, no additional contraceptive protection is necessary.

What to do if you forget the tablet the third week

As long as you have taken all the tablets correctly during the 7 days before the forgotten tablet and follow one of the two alternatives below, no additional contraceptive protection is necessary.

1. You should take the last forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time. From that moment on, continue taking the tablets at the usual time of the day. Then you should start the next blister pack immediately after taking the last tablet from the current blister pack, i.e. without a placebo tablet phase between blister packs. It is unlikely that withdrawal bleeding will occur until the end of the second blister pack, but you may experience spotting or intermenstrual bleeding during the days you are taking tablets.

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

If you have forgotten a tablet and then do not have withdrawal bleeding in the first normal interval without tablets, you should consider the possibility of pregnancy. In this case, you should tell your doctor before starting the next blister pack.

What to do if you have digestive problems

If you have vomited or had diarrhea in the 3-4 hours after taking an active tablet, the active ingredients of the contraceptive may not have been fully absorbed by your body. In this case, you should follow the advice described above for forgotten tablets. Take another tablet as soon as possible,without more than 12 hours passing. If more than 12 hours have passed, follow the instructions in the section “If you forget to take Sibilla daily”.

What to do if you want to delay your period

If you want to delay your period, you should continue taking the next blister pack of Sibilla daily, after taking the last active tablet from the current blister pack, without a placebo tablet phase. You can take all the tablets you want until the end of the second blister pack. When using the second blister pack, you may experience spotting or intermenstrual bleeding. After the usual 7-day placebo tablet phase, you should return to taking Sibilla daily normally.

What to do if you want to change your period

If you take Sibilla daily correctly, you will always have your menstrual period every 4 weeks on the same day of the week. If you want to change your period to a different day of the week from the usual one with the current method of taking the tablets, you can shorten (but never lengthen) the next placebo tablet phase by as many days as you want. For example, if your menstrual period usually starts on Friday and you want it to start on Tuesday (i.e. 3 days earlier), you should start the next blister pack of Sibilla daily 3 days earlier. The more you shorten the placebo tablet phase, the higher the probability that you will not have withdrawal bleeding and that you will experience spotting or intermenstrual bleeding during the second blister pack.

If you do not have your period

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

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

If you interrupt treatment with Sibilla daily

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

Consult your doctor or pharmacist if you have any doubts about the use of this medication.

Like all medicines, Sibilla diario may cause side effects, although not everyone will experience them.

If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related to Sibilla diario, consult your doctor.

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

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before starting to take Sibilla diario".

In section 2 "Warnings and precautions", severe side effects associated with the use of oral contraceptives are described. You will find more detailed information there. If necessary, contact your doctor immediately.

The following side effects have been associated with the use of Sibilla diario:

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

• headache
• breast pain, including discomfort and breast tenderness

Less frequent side effects (may affect up to 1 in 100 people)):

• inflammation of the genitals (vaginitis/vulvovaginitis)
• genital fungal infections (candidiasis, vulvovaginal infections)
• increased appetite
• depressed mood
• dizziness
• migraine
• high or low blood pressure
• abdominal pain (including upper and lower abdominal pain, discomfort/distension)
• nausea, vomiting, diarrhea
• acne
• hair loss (alopecia)
• skin rash (including skin rash with spots)
• itching (in some cases, all over the body)
• irregular menstrual bleeding, including heavy bleeding (menorrhagia), light bleeding (hypomenorrhea), infrequent bleeding (oligomenorrhea), and amenorrhea (absence of bleeding)
• intermenstrual bleeding (vaginal and metrorrhagia)
• menstrual pain (dysmenorrhea), pelvic pain
• breast enlargement, including swelling and edema of the breasts

• vaginal discharge
• ovarian cysts
• fatigue, including weakness, tiredness, and general malaise
• weight gain

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

• inflammation of the fallopian tubes or ovary
• inflammation of the cervix (cervicitis)
• inflammation of the urinary tract, inflammation of the bladder (cystitis)
• inflammation of the breast (mastitis)
• genital fungal infections (e.g., candida), viral infections, herpes labialis
• flu, bronchitis, upper respiratory tract infections, sinusitis
• benign proliferation in the uterus (myoma)
• benign proliferation in the fatty tissue of the breast (breast lipoma)
• anemia
• allergic reactions (hypersensitivity)
• masculinization (virilization)
• loss of appetite (anorexia)
• depression, irritability, mental disorders, aggression
• insomnia, sleep disorders
• cerebral or cardiac circulatory disorders, stroke
• dystonia (muscular alteration that produces, e.g., an abnormal posture)
• dry or irritated eyes
• vision disorders (oscillopsia, visual deterioration)
• sudden hearing loss (loss of hearing), visual deterioration
• tinnitus
• vestibular disorders (sensation of dizziness, vertigo)
• rapid heart rate

• aortic diastolic hypertension (the lowest value of blood pressure)
• dizziness or fainting after getting up while sitting or lying down (orthostatic hypotension)
• cluster headaches
• inflammation of the veins (thrombophlebitis)
• varicose veins (varices), venous disorders or pain in the veins
• asthma
• increased respiratory rate (hyperventilation)
• inflammation of the gastric mucosa (gastritis), intestinal inflammation (enteritis)
• stomach discomfort (dyspepsia)
• skin reactions/disorders, including allergic reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis
• intense sweating

• brownish-yellow skin spots (also known as pregnancy spots), skin pigmentation changes
• oily skin (seborrhea)
• dandruff
• excessive body hair (hirsutism)
• orange skin (cellulitis)
• spider veins (a red spot with radiating red extensions like a spider web)
• back pain, chest pain
• joint and muscle pain, muscle pain (myalgia), arm and leg pain
• cervical dysplasia (abnormal growth of cells on the surface of the cervix)
• ovarian cysts, ovarian pain
• breast cysts, benign breast proliferations (fibrocystic breast disease), additional congenital breast glands (supernumerary breast)
• pain during sexual intercourse
• breast secretion, nipple discharge
• menstrual disorders
• peripheral edema (accumulation of fluid in the body)
• pseudogripal syndrome, inflammation, pyrexia (fever)
• increased triglycerides or cholesterol levels in the blood (hypertriglyceridemia, hypercholesterolemia)
• weight loss or fluctuations (gain, loss, or fluctuation)

• harmful blood clots in a vein or artery, for example:
• in a leg or foot (i.e., DVT)
• in a lung (i.e., PE)
• heart attack
• stroke
• transient ischemic attack (TIA), which is a temporary stroke-like symptom
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk 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).

Unknown frequency (cannot be estimated from available data):

• mood changes
• increased or decreased libido (sex drive)
• irritation of the eyes when wearingcontact lenses
• urticaria (itching)
• erythema nodosum (red, painful nodules on the skin)
• erythema multiforme (red, target-like rash or blisters)
• breast secretion
• fluid retention

Reporting of side effects:

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

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

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

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

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Sibilla daily

The active principles are dienogest and ethinylestradiol.

Each film-coated tablet contains 2 mg of dienogest and 0.03 mg of ethinylestradiol.

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

The other components are:

Film-coated white tablets

Tablet core:

Lactose monohydrate

Maize starch

Hypromellose type 2910

Talc

Potassium polacrile sulfate

Magnesium stearate

Tablet coating:

Poly(vinyl alcohol)

Titanium dioxide (E171)

Macrogol 3350

Talc

Film-coated green tablets

Tablet core:

Microcrystalline cellulose type 12

Anhydrous lactose

Pregelatinized maize starch

Magnesium stearate

Anhydrous colloidal silica

Tablet coating:

Poly(vinyl alcohol)

Titanium dioxide (E171)

Macrogol 3350

Talc

Aluminum lake, indigo carmine (E132)

Yellow aluminum lake of quinoline yellow (E104)

Iron oxide black (E172)

Yellow aluminum lake sunset FCF (E110)

Appearance of Sibilla daily and packaging content

Film-coated active tablets:

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

Film-coated inactive tablets:

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

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

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

Packaging sizes:

1 × (21 + 7) tablets

3 × (21 + 7) tablets

6 × (21 + 7) tablets

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer:

Gedeon Richter Plc.

Gyömroi út 19-21

1103 Budapest

Hungary

For more information about this medicinal product, please contact the local representative of the marketing authorization holder.

Gedeon Richter Ibérica S.A.

Sabino Arana nº 28, 4º 2ª

08028 Barcelona

This medicinal product is authorized in the member states of the European Economic Area (EEA) with the following names:

Germany: Sibilla

Spain: Sibilla daily

Last review date of this leaflet: December 2022

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/