SIBILLA 2 MG/0.03 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sibilla 2 mg /0.03mg film-coated tablets EFG

dienogest / ethinylestradiol

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 having a blood clot in the veins and arteries, especially in the first year or when restarting the use of a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 "Blood clots").

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What Sibilla is and what it is used for
2. What you need to know before starting to take Sibilla
3. How to take Sibilla
4. Possible side effects
5. Storage of Sibilla
6. Package contents and additional information

1. What Sibilla is and what it is used for

Sibilla is 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 adequate local treatments or oral antibiotics.

Sibilla is a combined oral contraceptive that belongs to a group of drugs often referred to as "the pill". It contains two types of hormones: an estrogen and a progestogen.

Combined oral contraceptives prevent pregnancy in three ways. These hormones

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

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

General considerations

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

In this prospectus, several situations are described in which you should stop taking Sibilla, or in which the effectiveness of the contraceptive may be reduced. In these situations, you will have to stop having sexual intercourse or you should take additional non-hormonal contraceptive precautions (such as a condom or another barrier method) during sexual intercourse to ensure effective contraception. Do not use the calendar method or body temperature measurement when getting up, as oral contraceptives can influence body temperature and cyclic changes in the composition of cervical mucus.

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

Sibilla in acne

Acne will normally 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 its initiation and periodically thereafter.

Do not use Sibilla

You should not use Sibilla 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.

• • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fat in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia;

Do not use Sibilla if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Use of Sibilla with other medications”).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sibilla.

When should you consult your doctor?

Seek urgent medical attention:

To obtain a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

Tell your doctor if you suffer from any of the following conditions.

In some situations, you will need to be particularly careful while taking Sibilla or any other combined contraceptive, and it may be necessary for your doctor to perform regular check-ups. If any of the following conditions apply to you, consult your doctor before starting to use Sibilla. If the condition develops or worsens while you are using Sibilla, you should also inform your doctor:

BLOOD CLOTS

The use of a combined hormonal contraceptive like Sibilla increases your risk of having 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:

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

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

How to recognize a blood clot

Seek urgent medical attention if 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 the veins (venous thrombosis). However, these side 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 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.
• In very rare cases, a clot can form in a vein of another organ, such as the eye (retinal vein thrombosis)

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

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

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

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

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

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains dienogest and ethinylestradiol, such as Sibilla, approximately 8-11 women will have a blood clot in a year.
• The risk of having a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

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

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

• as you get older (especially above 35 years of age);

The risk of having a blood clot increases with the number of conditions you have.

Long-distance flights (more than 4 hours) may temporarily increase the 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 suffer from any of the above conditions, even if you are unsure. Your doctor may decide that you should stop using Sibilla.

If any of the above conditions change while you are using Sibilla, for example, you start smoking, a close relative experiences a thrombosis 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 clot in an artery can cause serious problems. For example, it can cause a heart attack or 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 is very small, but it can increase:

• with age (above 35 years of age);
• When using a combined hormonal contraceptive like Sibilla, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive;

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

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

Sibilla and cancer

Breast cancer has been observed with a slightly higher frequency in women who take combined contraceptives, but it is not known if this is caused by the treatment. For example, it may be due to the fact that more tumors are detected in women who take combined contraceptives because they are examined more frequently by their doctor. The occurrence of breast tumors becomes gradually lower after stopping combined hormonal contraceptives. It is essential that you regularly examine your breasts and should contact your doctor if you notice any lump. In rare cases, benign liver tumors, and even more rarely, malignant liver tumors have been reported in users of hormonal contraceptives. Contact your doctor if you have severe abdominal pain that is not usual.

In some epidemiological studies, an increased risk of cervical cancer has been found in long-term users of combined contraceptives, but it is still not clear if this is due to the treatment or other factors.

3. How to take Sibilla

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

Each blister of Sibilla contains 21 film-coated tablets. The blister is designed to help you remember to take the tablets.

You should try to take the tablets approximately at the same time every day; if necessary with a small amount of liquid, in the order that appears in the blister. You should take one tablet a day until you have finished the 21 tablets of the blister. Then there are 7 days when you will not take the tablets. During the 7 days without tablets, on the 2nd or 3rd day, you will have a withdrawal bleed similar to menstruation, i.e., your period.

Start the next blister on the 8th day (after the 7 days without tablets), even if the bleeding has not stopped yet. While taking Sibilla correctly, you will always start a new blister on the same day of the week, and you will always have your period on the same day of each month.

If you use Sibilla in this way, you will also be protected against pregnancy during the 7 days you do not take the tablets.

How to start taking the first blister

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 day when bleeding starts. Take the tablet marked for that day of the week.

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

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

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

If you are switching from a progestin-only method (progestin-only pill, injection, implant, or intrauterine system)

You can switch any day from the progestin-only pill (from an implant or an IUS on the day of its removal, from an injectable when the next injection is due), but in all these cases, use additional barrier methods (e.g., a condom) for the first 7 days you take the tablets.

In case of doubt, ask your doctor or pharmacist.

Starting after having a baby

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

If you are breastfeeding, read the section on "Pregnancy and lactation".

Starting after an abortion

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

If you take more Sibilla than you should

We do not have data on overdose with Sibilla. 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, mild vaginal bleeding. In general, no special treatment is necessary; if necessary, treatment should be symptomatic.

If you notice that a child has taken more than one tablet, consult a doctor.

In case of overdose or accidental ingestion, 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 take the medication package and leaflet to the healthcare professional.

If you forget to take Sibilla

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

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

If you are late by more than 12 hours in taking a tablet

If you are late by 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 or before the end of the blister.

In this case, 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, ask your doctor for advice. Remember that you have lost your contraceptive protection.

What to do if you forget a tablet in the first week

You should take the last forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time. From then on, continue taking the tablets at the usual time of the day. Also, use a barrier contraceptive method, e.g., a condom, for the next 7 days. If you have had sexual intercourse in the previous 7 days, you should consider the possibility that you are pregnant. Contact your doctor as soon as possible for advice.

What to do if you forget a tablet in the second week

You should take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. From then on, continue taking the tablets at the usual time of the day. As long as the tablets have been taken correctly during the 7 days prior to the forgotten tablet, there is no need to take additional contraceptive precautions.

What to do if you forget a tablet in the third week

As long as you have taken all the tablets correctly during the 7 days prior to the forgotten tablet and follow one of the two following alternatives, there is no need to take additional contraceptive precautions.

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 then on, continue taking the tablets at the usual time of the day. Then, you should start the next blister immediately after taking the last tablet of the current blister, i.e., without leaving a tablet-free period between blisters. It is unlikely that you will have a withdrawal bleed until the end of the second blister, but you may experience spotting or breakthrough bleeding during the second blister.
2. You can also stop taking tablets from the current pack. In this case, you should leave a tablet-free period of 7 days, including the day you forgot to take the tablet, and then continue with the next blister. If you want to start the new blister on the usual day of the week, you can have a tablet-free period of less than 7 days.

If you have forgotten a tablet and then do not have a withdrawal bleed during the first normal tablet-free period, you should consider the possibility of pregnancy. In this case, you should consult your doctor before starting the next blister.

What to do if you have gastrointestinal disorders

If you have vomited or had diarrhea within 3-4 hours after taking a 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".

What to do if you want to delay your period

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

What to do if you want to change your period

If you take Sibilla 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 another day of the week, different from the usual one with the current way of taking the tablets, you can shorten (but never lengthen) the next tablet-free period by as many days as you want. For example, if your menstrual period usually starts on a Friday and you want it to start on a Tuesday (i.e., three days earlier), you should start the next blister of Sibilla three days earlier. The shorter the tablet-free period, the higher the likelihood that you will not have a withdrawal bleed and will experience breakthrough bleeding or spotting during the second blister.

If you do not have a 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 as usual.

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

If you interrupt treatment with Sibilla

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

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to Sibilla, consult your doctor.

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

All women who take 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 taking Sibilla".

In section 2 "Warnings and Precautions" serious adverse effects associated with the use of the oral contraceptive are described. You will find more detailed information there. If necessary, contact your doctor immediately.

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

Frequent Adverse Effects(may affect up to 1 in 10 people):

• headache
• breast pain including discomfort and sensitivity in the breasts

Uncommon Adverse 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
• high or low blood pressure
• abdominal pain (including upper and lower abdominal pain, discomfort/feeling bloated)
• nausea, vomiting, diarrhea
• acne
• hair loss (alopecia)
• rash (including the appearance of spots on the skin)
• itching (in some cases all over the body)
• irregular withdrawal bleeding including heavy bleeding (menorrhagia), scarce (hypomenorrhea), infrequent (oligomenorrhea), and absence of withdrawal bleeding (amenorrhea)
• intermenstrual bleeding (vaginal hemorrhage and metrorrhagia)
• menstrual pain (dysmenorrhea), pelvic pain
• increase in breast size including swelling and edema of the breasts
• vaginal discharge
• ovarian cysts
• exhaustion including weakness, fatigue, and general indisposition
• weight gain

Rare Adverse Effects(may affect up to 1 in 1000 people):

• inflammation in the Fallopian tubes or ovaries

• inflammation of the cervix (cervicitis)
• inflammation of the urinary tract, inflammation of the bladder (cystitis)
• inflammation of the breast (mastitis)
• fungal infections (e.g., candida), viral infections, herpes labialis
• flu (influenza), bronchitis, upper respiratory tract infections, paranasal infection (sinusitis)
• benign growth in the uterus (myoma)
• benign growth in the breast tissue (breast lipoma)
• anemia
• allergic reactions (hypersensitivity)
• masculinization (virilization)
• loss of appetite (anorexia)
• depression, irritability, mental disorders, aggression
• insomnia, sleep disorders
• circulatory disorders in the brain or heart, stroke
• distonia (muscle disorder that produces, e.g., an abnormal posture)
• dry or irritated eyes
• vision disorders (oscillopsia, vision deterioration)
• sudden hearing loss (hearing loss), deterioration of hearing
• tinnitus
• vestibular disorders (feeling of dizziness, vertigo)
• rapid heart rate
• increase in diastolic blood pressure (increase in the minimum blood pressure value)
• dizziness or fainting after standing up from a sitting or lying position (orthostatic hypotension)
• hot flashes
• inflammation of the veins (thrombophlebitis)
• varicose veins (varices), venous disorders, or pain in the veins
• asthma
• increased respiratory rate (hyperventilation)
• inflammation of the gastric mucosa (gastritis), intestinal inflammation (enteritis)
• stomach discomfort (dyspepsia)
• skin reactions/disorders, including allergic reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis
• excessive sweating
• brownish spots (also called pregnancy spots), especially on the face (chloasma), changes in pigmentation/increased pigmentation.
• oily skin (seborrhea)
• dandruff
• excessive body hair (hirsutism)
• orange peel skin (cellulite)
• vascular spider (a red spot with reddish extensions that radiate outward like a spider's web)
• back pain, chest pain
• discomfort in the bones and muscles, muscle pain (myalgia), pain in the arms and legs
• cervical dysplasia (abnormal growth of cells on the surface of the cervix)
• pain or cysts in the Fallopian tubes or ovaries
• breast cysts, benign breast growths (fibrocystic mastopathy), swelling of congenital accessory breast glands (accessory breasts)
• pain during sexual intercourse
• secretion from the breast glands, breast secretion
• menstrual disorders
• peripheral edema (fluid accumulation in the body)
• pseudoflu syndrome, inflammation, pyrexia (fever)
• increased levels of triglycerides or cholesterol in the blood (hypertriglyceridemia, hypercholesterolemia)
• weight loss or variations (increase, decrease, 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
• mild stroke or temporary symptoms similar to those of a stroke, known as a transient ischemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The possibility of having 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 the available data)

• mood changes
• increased or decreased sexual desire (libido)
• irritation of the eyes when wearing contact lenses
• hives (itching)
• erythema nodosum (red and painful nodules on the skin)
• erythema multiforme (red target-like rash or blisters)
• breast secretion
• fluid retention.

Reporting of Adverse Effects

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

5. Storage of Sibilla

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

Do not use this medicine after the expiration date indicated on the box, after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Sibilla

The active ingredients are 2 mg of dienogest and 0.03 mg of ethinylestradiol in each film-coated tablet.

The other components are:

Core of the tablet:

Lactose monohydrate, cornstarch, hypromellose type 2910, talc, potassium polacrylate, magnesium stearate

Coating of the tablet:

Polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc

Appearance of the Product and Package Contents

White or almost white, round, biconvex film-coated tablets, with a diameter of approximately 5.5 mm.

"G53" engraved on one side; the other side without engraving.

Sibilla 2 mg/0.03 mg film-coated tablets EFG are packaged in white PVC/PE/PVDC//aluminum blisters. The blisters are packaged in a cardboard box with the leaflet and a blister sleeve included in each box.

Package sizes:

21 tablets

3×21 tablets

6×21 tablets

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

Gedeon Richter Ibérica, S.A.

Sabino Arana, 28 - 4º 2ª

08028 Barcelona

Spain

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

Germany: Sibilla 2 mg/0.03 mg Filmtabletten

Austria: Sibilla 0.03 mg/2 mg 21 Filmtabletten

Spain: Sibilla 2 mg/0.03 mg film-coated tablets EFG

Italy: Sibilla

Portugal: Sibilla

Date of the last revision of this leaflet:December 2022

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