Lybella

Package leaflet: Information for the user

Lybella 2 mg + 0.03 mg film-coated tablets

Chlormadinone acetate/Ethinylestradiol
Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods when 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.
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Lybella is and what it is used for

Lybella is an oral hormonal contraceptive. These products, which contain two hormones, such as Lybella, are also called combined oral contraceptives (COCs). The 21 tablets in one blister contain the same amount of the two hormones, so Lybella is also referred to as a "monophasic pill". Other hormonal contraceptives like Lybella do not protect you against AIDS (HIV infection) or other sexually transmitted diseases. Only condoms can help protect you.

2. What you need to know before taking Lybella

General information
Before starting to use Lybella, you must read the information about blood clots in section 2. It is
particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
Before taking Lybella, your doctor will carry out a thorough general and gynecological examination, exclude
any possible pregnancy, consider contraindications and precautions, and then decide whether Lybella is suitable for you. This examination should be repeated annually while you are taking Lybella.

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

• If you are allergic to ethinylestradiol or chlormadinone acetate, or to any of the other ingredients of this medicine (listed in section 6);
• if you have (or have ever had) a blood clot in a vein of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you experience early signs of a blood clot, vein inflammation, or embolism, such as transient sharp or pressing chest pain;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to have surgery or will be bedridden for a prolonged period (see section “Blood clots”);
• if you have diabetes or if your blood sugar levels are uncontrollably fluctuating; if you have high blood pressure that is difficult to control or if it increases significantly (values above 90/140 mm Hg);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and which may be an early sign of heart attack) or transient ischemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which could increase the risk of clots forming in the arteries:
  o severe diabetes with blood vessel damage, or very high blood pressure, or very high levels of fats (cholesterol or triglycerides) in the blood, or a condition known as hyperhomocysteinemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you suffer from liver inflammation (e.g., caused by a virus) or jaundice and liver function values have not yet returned to normal;
• if you suffer from widespread itching or bile-related disorders, particularly if these occurred during a previous pregnancy or previous estrogen treatment;
• if bilirubin (a breakdown product of blood pigment) in the blood is above normal levels, for example due to congenital bile excretion disorders (Dubin-Johnson syndrome or Rotor syndrome);
• If you have meningioma or have ever been diagnosed with meningioma (a usually benign tumor of the tissue layer between the brain and skull);
• if you currently have or have previously had liver cancer;
• if you have severe stomach pain, liver enlargement, or signs of abdominal bleeding;
• if porphyria (a disorder of blood pigment metabolism) develops or recurs;
• if you currently have, have had in the past, or suspect you have a hormone-dependent malignant tumor, e.g., breast or uterine cancer;
• if you suffer from severe disorders of fat metabolism;
• if you develop pancreatitis or have had it in the past and also have severely elevated fat levels in the blood (triglycerides);
• if you suffer from severe, frequent, and prolonged headaches;
• if you experience sudden sensory disturbances (vision or hearing);
• if you notice movement disorders (especially signs of paralysis);
• if you notice worsening of epileptic seizures;
• if you suffer from severe depression;
• if you suffer from a certain type of hearing loss (otosclerosis) that worsened during previous pregnancies;
• if you have had no menstruation for unknown reasons;
• if you have abnormal thickening of the uterine lining (endometrial hyperplasia);
• in case of vaginal bleeding of unknown origin.

Do not use Lybella if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir,
dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other
medicines and Lybella”).
If any of these conditions occur while taking Lybella, stop taking Lybella immediately.
You must not take Lybella, or must stop it immediately, if you have a serious risk or multiple risk factors for blood clotting disorders.

Warnings and precautions
Talk to your doctor or pharmacist before using Lybella.

When should you contact a doctor?
Seek urgent medical advice

• if you notice possible signs of a blood clot, which 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 section “Blood clot (thrombosis)”). For a description of symptoms of these serious side effects, refer to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you

• If you smoke. Smoking increases the risk of serious side effects on the heart and blood vessels when using combined hormonal contraceptives. The risk increases with age and the number of cigarettes smoked. This particularly affects women over 35 years of age. Women over 35 who smoke should use other contraceptive methods.

If any of the following conditions develop or worsen while you are using Lybella, inform your doctor:

• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with potential breathing difficulties, contact your doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• if you have high blood pressure, elevated levels of fats in the blood, if you are overweight, or if you are diabetic (see also section 2). In these cases, the risk of side effects (e.g., heart attacks, embolism, stroke, or liver tumors) is increased by the use of hormonal contraceptives.
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defense system);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
• if you are due to have surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Lybella.
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins.

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

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

Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, and very rarely, such effects can be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with Lybella is low.

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

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of first-time use of a combined hormonal contraceptive. The risk may also be higher when restarting a combined hormonal contraceptive (the same or a different product) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than in women not using a combined hormonal contraceptive.
When you stop taking Lybella, 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 individual underlying risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are using.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Lybella is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing chloromadinone acetate, such as Lybella, about 6–9 women will develop a blood clot in one year.
• The risk of developing a blood clot depends on your personal medical history (see below “Factors that increase the risk of developing a blood clot”).

If you notice an increase in the frequency or intensity of migraine attacks while taking Lybella (which may indicate impaired blood flow to the brain), consult your doctor as soon as possible. Your doctor may advise you to stop taking Lybella immediately.

Factors increasing the risk of developing a blood clot in a vein

The risk of developing a blood clot with Lybella is low, but certain conditions can increase this risk. Your risk is higher:

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

The risk of developing a blood clot increases when you have multiple such conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed above.

It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to have you stop taking Lybella.

If any of the above conditions change while you are using Lybella—for example, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY

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

Factors increasing 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 Lybella is very low but may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Lybella, it is advisable to stop smoking. If you cannot stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive.
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher.

If any of the above conditions change while you are using Lybella—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Tumour

It has been reported that women with cervical infection from certain sexually transmitted viruses (human papillomavirus) who use hormonal contraceptives for a long time may have an increased risk of developing cervical cancer. However, it is unclear how much this is due to other factors (e.g., differences in the number of sexual partners or use of mechanical contraceptive methods).

Studies have shown that hormonal contraceptives may cause a slight increase in the risk of breast cancer. During the 10 years after stopping combined oral contraceptives (COCs), this increased risk gradually returns to age-related baseline levels. Since breast cancer is rare in women under 40, the number of additional breast cancer diagnoses in women who have recently used or are currently using COCs is small compared to the overall risk of breast cancer.

In rare cases, benign and even more rarely malignant liver tumours have been observed with the use of hormonal contraceptives, which may cause internal bleeding. If you experience severe stomach pain that does not resolve spontaneously, you must inform your doctor.

The use of chlormadinone acetate has been linked to the development of a generally benign tumour of the tissue layer between the brain and the skull (meningioma). The risk increases especially when used at high doses over a prolonged period (several years). If you are diagnosed with a meningioma, your doctor will discontinue treatment with Lybella (see section "Do not take Lybella"). If you notice symptoms such as changes in vision (e.g., double or blurred vision), hearing loss or ringing in the ears, loss of smell, worsening headaches, memory loss, seizures, or weakness in the arms or legs, inform your doctor immediately.

Other disorders

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

Many women experience a slight increase in blood pressure while taking hormonal contraceptives. If your blood pressure increases significantly while using Lybella, your doctor will advise you to stop taking Lybella and may prescribe medication to lower your blood pressure. Once your blood pressure returns to normal, you may resume taking Lybella.

If you have suffered from herpes during a previous pregnancy, it may recur with the use of a hormonal contraceptive.

If you have abnormal blood fat levels (hypertriglyceridemia) or if this condition runs in your family, there is an increased risk of pancreatic disease. If you develop acute or chronic liver function disorders, your doctor may have you stop taking Lybella until liver values return to normal. If you experience a new episode of jaundice that previously occurred during a prior pregnancy or with the use of other hormonal contraceptives, your doctor will advise you to discontinue Lybella.

If you are diabetic and your blood sugar levels are under control while taking Lybella, your doctor will monitor you closely throughout the time you take Lybella. It may be necessary to adjust your antidiabetic treatment.

In rare cases, brown skin patches (chloasma) may appear, especially if they previously appeared during a prior pregnancy. If you are prone to such pigmentation, avoid prolonged sun exposure or ultraviolet radiation while taking Lybella.

Conditions that may be negatively influenced

Medical supervision is also required:

• if you suffer from epilepsy;
• if you suffer from multiple sclerosis;
• if you suffer from severe muscle cramps (tetany);
• if you suffer from migraine (see also section 2);
• if you suffer from asthma;
• if you suffer from heart or kidney disorders (see also section 2);
• if you have St. Vitus’ dance (minor chorea);
• if you are diabetic (see also section 2);
• if you have liver disease (see also section 2);
• if you have disorders of fat metabolism (see also section 2);
• if you suffer from immune system disorders (including systemic lupus erythematosus);
• if you are significantly overweight;
• if you suffer from high blood pressure (see also section 2);
• if you suffer from endometriosis (the tissue lining the uterine cavity, called endometrium, is located outside this lining layer) (see also section 2);
• if you have varicose veins or suffer from vein inflammation (see also section 2);
• if you have blood clotting disorders (see also section 2);
• if you suffer from breast disorders (mastopathy);
• if you have a benign tumour (fibroid) of the uterus;
• if you previously had blisters (herpes gestationis) during pregnancy;
• if you suffer from depression;
• if you suffer from chronic inflammatory bowel disease (Crohn’s disease, ulcerative colitis). Consult your doctor if you have or have previously had any of the above conditions, or if any of them develop during treatment with Lybella.

Efficacy

If you have missed taking tablets, have vomited or had diarrhoea after taking a tablet (see section 3), or are taking other medicines (see section 2), the effectiveness of a hormonal contraceptive may be reduced. In very rare cases, metabolic disorders may impair contraceptive effectiveness.

Even if you are taking the tablets correctly, a hormonal contraceptive cannot guarantee complete birth control.

Irregular cycle

Especially during the first few months of taking hormonal contraceptives, you may experience irregular vaginal bleeding (intermenstrual bleeding/spotting). If irregular bleeding continues for 3 months or reappears in subsequent regular cycles, consult your doctor.

Spotting may also be a sign of reduced contraceptive effectiveness.

In some cases, after taking Lybella for 21 days, withdrawal bleeding may not occur. If you have taken the pills according to the instructions in section 3, it is unlikely that you are pregnant. However, if Lybella has not been taken according to the instructions before the absence of withdrawal bleeding, a possible pregnancy must be ruled out before continuing use.

Children and adolescents

Lybella is indicated only after the first menstruation. The safety and efficacy of Lybella in adolescents under 16 years of age have not been established.

Elderly

Lybella is not indicated after menopause.

Other medicines and Lybella

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not use Lybella if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver function test results (elevated liver enzyme ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. Lybella may be resumed approximately 2 weeks after completing this treatment. See section "How to take Lybella".

Some medicines may affect the blood levels of Lybella and reduce its effectiveness in preventing pregnancy, or may cause unexpected bleeding. These medicines include those used for:

• epilepsy (e.g. barbiturates, carbamazepine, phenytoin, topiramate, felbamate, oxcarbazepine, barbexaclone, primidone),
• tuberculosis (e.g. rifampicin, rifabutin),
• sleep disorders (modafinil),
• HIV or hepatitis C virus infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz),
• fungal infections (griseofulvin),
• high blood pressure in the pulmonary blood vessels (bosentan),
• herbal preparations containing St. John’s wort (Hypericum perforatum). If you wish to use herbal products containing St. John’s wort during use of Lybella, you must first consult your doctor.

Medicines that stimulate intestinal peristalsis (e.g. metoclopramide) and activated charcoal may reduce the absorption of the active ingredients in Lybella and reduce their effects.

During treatment with these medicines, you must use a mechanical contraceptive method (e.g. condom). You must use a mechanical contraceptive throughout the entire period of concomitant drug therapy and for 28 days after the end of treatment.

If concomitant drug therapy continues after the current COC pack has been completed, the next pack of Lybella should be started immediately after the previous one, without the usual break.

If long-term treatment with the active substances mentioned above is required, you should use non-hormonal contraceptive methods. Ask your doctor or pharmacist for advice.

Interactions between Lybella and other medicines may increase or intensify the side effects of Lybella. The following medicines may adversely affect the tolerability of Lybella:

• ascorbic acid (a preservative, also known as vitamin C),
• paracetamol (for pain relief and fever control),
• atorvastatin (lowers blood cholesterol),
• troleandomycin (an antibiotic),
• imidazole antifungals – e.g. fluconazole (for treating fungal infections),
• indinavir (a preparation for treating HIV infection).

Lybella may affect the action of other medicines. The efficacy or tolerability of the following medicines may be reduced by Lybella:

• certain benzodiazepines, e.g. diazepam (for treatment of sleep disorders),
• cyclosporine (a medicine that suppresses the immune system),
• theophylline (treatment of asthma symptoms),
• corticosteroids, e.g. prednisolone (known as steroids, anti-inflammatory medicines for conditions such as lupus, arthritis, psoriasis),
• lamotrigine (for treatment of epilepsy),
• clofibrate (reduces elevated cholesterol levels),
• paracetamol (for pain relief and fever control),
• morphine (a potent specific analgesic – pain relief),
• lorazepam (used to treat anxiety disorders).

Also read the package leaflets of other prescribed preparations.

Inform your doctor if you are taking insulin or other medicines to lower blood sugar levels. The dosage of these medicines may need to be adjusted.

Remember that these data apply even if you took one of these medicines for a short time before starting Lybella treatment.

Administration of Lybella may alter certain laboratory tests assessing liver, kidney, adrenal gland, and thyroid function, certain blood proteins, carbohydrate metabolism, and blood clotting. Changes generally remain within the normal laboratory range. Therefore, before having a blood test, inform your doctor that you are taking Lybella.

Pregnancy and breastfeeding

Lybella is not indicated during pregnancy. If you become pregnant while taking Lybella, you must stop treatment immediately. The use of Lybella prior to pregnancy does not justify termination of pregnancy.

If you are taking Lybella while breastfeeding, remember that milk quantity may decrease and its quality may change. Small amounts of active substances pass into breast milk. Hormonal contraceptives such as Lybella should only be taken after breastfeeding has been discontinued.

Driving and use of machinery

No negative effects of combined hormonal contraceptives on the ability to drive vehicles or operate machinery are known.

Lybella contains lactose monohydrate

If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Lybella

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Instructions for use
For oral use.

When and how should Lybella be taken?
Take the first tablet from those marked with the day corresponding to the current day of the week (e.g. Sun for Sunday), and swallow it without chewing. Then take one tablet every day, following the direction of the arrow, preferably at the same time each day, ideally in the evening. The interval between two tablets should ideally be 24 hours. The day indicators printed on the packaging will help you keep track of whether you have taken the tablet for that specific day.

Take 1 tablet daily for 21 days. After this, take a 7-day break. Usually, 2–4 days after taking the last tablet, you will experience a withdrawal bleed similar to menstruation. After the 7-day break, start taking tablets from the new pack of Lybella, regardless of whether your menstrual bleeding has stopped.

When can you start taking Lybella?

If you were not using a hormonal contraceptive (during the previous menstrual cycle)
Take the first tablet of Lybella on the first day of your menstrual period. Contraceptive protection begins on the first day of intake and continues during the 7-day break.

If your period has already started, you may take the first tablet between the 2nd and 5th day of your period, even if menstrual bleeding has not yet ended. However, in this case, you must also use another contraceptive method for the first 7 days (7-day rule).

If your period started more than 5 days ago, you should wait for your next menstrual period and then start taking Lybella.

If you were using another combined hormonal contraceptive
Take all the tablets of your previous contraceptive as usual. Start taking Lybella the day after the end of the hormone-free interval or after the placebo tablets of your previous combined hormonal contraceptive.

If you were using a progestogen-only contraceptive (mini-pill)
If you are using a hormonal contraceptive containing only progestogen, you may not have menstrual bleeding. In this case, take the first tablet of Lybella the day after taking the last "mini-pill". However, you must also use another contraceptive method for the first 7 days.

If you were using a hormonal injectable contraceptive or an implant
Take the first tablet of Lybella on the day the implant is removed or on the day you were due to receive the next injection. However, you must also use another contraceptive method for the first 7 days.

If you had a curettage or an abortion in the first trimester of pregnancy
After a curettage or abortion, you may start taking Lybella immediately. In this case, additional contraceptive methods are not required.

After childbirth or an abortion in the second trimester of pregnancy
If you are not breastfeeding, you may start taking Lybella 21–28 days after childbirth. Additional contraceptive methods are not required.

If more than 28 days have passed since childbirth, you must use another contraceptive method for the first 7 days.

If you have already had sexual intercourse, you must either exclude the possibility of pregnancy or wait for the next menstrual period before starting Lybella.

Remember that you must not take Lybella if you are breastfeeding (see section “Pregnancy and breastfeeding”).

How long should Lybella be taken?
You may take Lybella for as long as desired, provided that its use is not limited by health risks (see section 2). After stopping Lybella, your next menstrual period may be delayed by about one week.

What to do in case of vomiting or diarrhoea during treatment with Lybella?
If you vomit or have diarrhoea within 4 hours of taking a tablet, the active substances in Lybella may not be completely absorbed. This situation is similar to missing a tablet. Therefore, take another tablet immediately from a new pack. If possible, take the new tablet within 12 hours of the last tablet taken, and continue taking Lybella at your usual time. If this is not possible or more than 12 hours have passed, follow the instructions in section 3 “If you forget to take Lybella” or contact your doctor.

If you take more Lybella than you should
There is no evidence of severe intoxication symptoms from taking multiple tablets at once in a single dose. Nausea, vomiting, and slight vaginal bleeding in young girls may occur. In this case, consult a doctor, who may, if necessary, monitor your fluid and electrolyte balance and liver function.

If you forget to take Lybella
If you forget to take a tablet at the usual time, take it as soon as possible, but no later than 12 hours after the usual time. In this case, no additional contraceptive methods are needed, and you may continue taking the tablets as usual.

If the delay is more than 12 hours, the contraceptive effect of Lybella is no longer guaranteed. In this case, take the missed tablet immediately and continue taking Lybella as usual, even if this means taking two tablets in one day. However, you must also use another contraceptive method (e.g. a condom) for the next 7 days. If during these 7 days you finish the tablets in the current pack, start immediately with the next pack of Lybella without observing the 7-day break (7-day rule). Withdrawal bleeding will probably not occur until after the second pack is finished; however, you may experience increased intermenstrual bleeding or spotting during the intake of the new pack.

The more tablets you miss, the higher the risk that contraceptive protection will be reduced. If you miss one or more tablets in the first week and had unprotected intercourse in the week before the missed dose, consider the possibility of pregnancy. The same applies if you miss one or more tablets and do not have withdrawal bleeding during the hormone-free interval. In these cases, contact your doctor.

If you wish to delay your menstrual period
Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) by starting a new pack of Lybella immediately, without taking the 7-day break, and continuing until the end of the second pack. During the second pack, you may experience spotting or breakthrough bleeding. After completing the second pack, take the usual 7-day break before starting the next pack. Before deciding to delay your period, consult your doctor.

If you wish to shift the first day of your menstrual period
If you take the tablets as instructed, your menstrual period/withdrawal bleeding will start during the hormone-free interval. If you wish to shift this day, you may do so by shortening the hormone-free interval (but never lengthening it!). For example, if the hormone-free interval normally starts on Friday and you wish to shift it to Tuesday (3 days earlier), begin the new pack 3 days earlier than usual. If you shorten the hormone-free interval too much (e.g. to 3 days or less), you may not have any withdrawal bleeding during this interval. Spotting or breakthrough bleeding may occur.

If you have any doubts about how to proceed, consult your doctor.

If you stop treatment with Lybella
When you stop taking Lybella, your ovaries will quickly return to full activity, and you may become pregnant.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to Lybella, inform your doctor. Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with potential breathing difficulties (see also section “Warnings and precautions”).

An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before using Lybella”.

The frequencies of reported side effects are defined as follows:

Very common: may affect more than 1 in 10 people
Nausea, vaginal spotting, menstrual pain, absence of menstruation.

Common: may affect up to 1 in 10 people
Depression, irritability, nervousness, dizziness, migraine (and/or worsening of migraine), visual disturbances, vomiting, acne, feeling of heaviness, abdominal pain, fatigue, fluid retention, weight gain, increased blood pressure.

Uncommon: may affect up to 1 in 100 people
Fungal vaginal infection, benign changes in breast connective tissue, hypersensitivity to the drug including allergic reaction, changes in blood lipids including increased triglycerides, decreased libido, stomach discomfort, intestinal rumbling, diarrhoea, pigmentation disorders, brown patches on the face, hair loss, dry skin, increased tendency to sweat, back pain, muscle problems, breast discharge.

Rare: may affect up to 1 in 1,000 people
Inflammation of the vagina, increased appetite, conjunctivitis, discomfort when wearing contact lenses, deafness, tinnitus, high blood pressure, low blood pressure, circulatory collapse, varicose veins, urticaria, eczema, inflamed skin, pruritus, worsening of psoriasis, excessive hair growth on body or face, prolonged and/or heavier menstrual bleeding, premenstrual syndrome (physical and emotional problems before the onset of menstruation).

Blood clots in a vein or artery, for example:

• in a leg or foot (DVT)
• in a lung (PE)
• heart attack
• stroke
• mini-stroke or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestines, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Very rare: may affect up to 1 in 10,000 people
Erythema nodosum.

In addition, during post-marketing use, the following adverse reactions have been reported with the active substances, ethinylestradiol and chloromadinone acetate: weakness and allergic reactions including swelling of the deeper layers of the skin (angioedema).

Combined hormonal contraceptives have also been associated with an increased risk of serious diseases and adverse effects:

• Risk of blockage of veins and arteries (see section 2)
• Risk of gallbladder disease (see section 2)
• Risk of tumours (e.g. liver tumours, which in isolated cases have caused severe, even fatal, intra-abdominal bleeding; cervical and breast tumours; see section 2)
• Worsening of chronic inflammatory bowel diseases (Crohn’s disease, ulcerative colitis; see section 2). Please read the information in section 2 carefully and, if necessary, consult your doctor immediately.

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

5. How to store Lybella

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton and blister pack (treatment cycle) following EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Lybella contains

• The active substances are ethinylestradiol and chloromadinone acetate. One film-coated tablet contains 2 mg of chloromadinone acetate and 0.03 mg of ethinylestradiol.
• The other components are:

Tablet core: monohydrate lactose, corn starch, povidone K 30, magnesium stearate.
Coating: hypromellose, monohydrate lactose, macrogol 6000, propylene glycol,
talc, titanium dioxide (E 171), iron oxide red (E 172).

Description of the appearance of Lybella and package contents

Lybella is available in packs of 21 round, slightly pink, film-coated tablets per blister (one treatment cycle).
Pack sizes: 1x21, 3x21, 6x21 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

Manufacturer
Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary

For any information concerning this medicinal product, please contact the Marketing Authorisation Holder.

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria Balanca - Filmtabletten
Germany Balanca Filmtabletten
Italy Lybella 2 mg + 0.03 mg film-coated tablets
Portugal Libeli 2 mg + 0.03 mg film-coated tablets
Spain Balianca film-coated tablets