Belara

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Belara (Chariva)

0.03 mg + 2 mg, coated tablets

Ethinylestradiol + Chlormadinone acetate
Belara and Chariva are different trade names for the same drug.
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This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. The user of the medicinal product can also contribute to this by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, see section 4.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "BLOOD CLOTS").

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be passed on to others. The medicine may harm another person.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Belara and what is it used for

Belara is a hormonal contraceptive for oral use. An oral contraceptive that contains two hormones, like Belara, is also called a combined hormonal contraceptive. Because each of the 21 coated tablets in the pack for use in one cycle contains the same amount of both hormones, Belara is also called a monophasic product.
Hormonal contraceptives, like Belara, do not protect against AIDS (HIV infection) and other sexually transmitted diseases. Only condoms can provide protection against these diseases.

2. Important information before taking Belara

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General notes

Before starting to take Belara, the information about blood clots in section 2 should be read. It is especially important to read about the symptoms of blood clots (see section 2 "BLOOD CLOTS").
Before starting to take Belara, the doctor will perform a thorough general and gynecological examination of the patient, rule out pregnancy, and decide, taking into account contraindications and precautions, whether the patient can take Belara. During the use of Belara, such an examination should be repeated every year.

When not to take Belara

Belara should not be taken if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• if the patient is hypersensitive to ethinylestradiol or chlormadinone acetate or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has (or has ever had) a blood clot in the deep veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if the patient has symptoms that may indicate the formation of blood clots, such as transient stabbing, pain, or a feeling of pressure;
• if the patient needs to undergo surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS");
• if the patient knows that they have blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient has diabetes, and blood sugar levels are not well controlled;
• if the patient has high blood pressure that is difficult to control or if blood pressure has risen significantly (sustained values above 140/90 mmHg);
• if the patient has had a heart attack or stroke;
• if the patient has had angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (transient symptoms of a stroke);
• if the patient has any of the following diseases that may increase the risk of arterial thrombosis:
• severe diabetes with vascular damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• hyperhomocysteinemia
• if the patient has had (or has) a type of migraine called "migraine with aura";
• if the patient has liver inflammation (e.g., viral) or jaundice, and liver function tests have not returned to normal;
• if the patient has itching all over the body or bile flow disorders, especially if such disorders occurred during a previous pregnancy or during treatment with estrogens;
• if the patient has elevated bilirubin levels in the blood (a breakdown product of the blood pigment) due to congenital bilirubin excretion disorders (Dubin-Johnson syndrome or Rotor syndrome);
• if the patient has had or has a liver tumor;
• if the patient has severe abdominal pain, liver enlargement, or symptoms of bleeding into the abdominal cavity;
• if the patient has had or has had a porphyria attack (a disorder of blood pigment metabolism);
• if the patient has had or has had hormone-dependent malignant tumors, such as breast or cervical cancer, or if such tumors are suspected;
• if the patient has had or has severe lipid metabolism disorders;

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• if the patient has had or has had pancreatitis with high levels of fats in the blood (triglycerides);
• if the patient has sudden vision or hearing disturbances;
• if the patient has sudden movement disorders (especially paresis);
• if the patient's epilepsy has worsened;
• if the patient has severe depression;
• if the patient has a certain type of hearing loss (otosclerosis) that worsened during a previous pregnancy;
• if the patient has unexplained absence of menstruation;
• if the patient has been diagnosed with abnormal growth of the uterine lining (endometrial hyperplasia);
• if the patient has vaginal bleeding of unknown cause.

Belara should not be taken in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section "Belara and other medicines").
If any of the above conditions occur during the use of Belara, the medicine should be stopped immediately.
Belara should not be taken or its use should be stopped immediately if the patient has or develops one or more serious risk factors for thrombosis.

Warnings and precautions

Before starting to take Belara, the patient should discuss it with their doctor or pharmacist.
When should the doctor be contacted?
The doctor should be contacted immediately

• if the patient notices possible symptoms of blood clots, which may indicate that the patient has blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), a heart attack, or a stroke (see below "BLOOD CLOTS". For a description of these serious side effects, see "How to recognize blood clots").

The patient should tell their doctor if they have any of the following conditions.

• if the patient smokes. Smoking during the use of hormonal contraceptives increases the risk of serious heart and blood vessel disorders. This risk increases with age and the number of cigarettes smoked. This applies especially to women over 35 years of age. Women over 35 years of age who smoke should use other contraceptive methods.

If these symptoms occur or worsen during the use of Belara, the doctor should also be informed.

• if the patient has symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, potentially with breathing difficulties, the doctor should be contacted immediately. Estrogen-containing products may cause or worsen symptoms of hereditary or acquired angioedema.
• if the patient has high blood pressure, abnormal lipid levels, overweight, or diabetes (see also section 2 "When not to take Belara" and "Other diseases"). In these cases, the risk of serious side effects (such as heart attack, embolism, stroke, or liver tumor) during the use of combined hormonal contraceptives is higher;
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);

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• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a hereditary disease of red blood cells);
• if the patient has elevated lipid levels in the blood (hypertriglyceridemia) or a positive family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to undergo surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS").
• if the patient has recently given birth, they are at increased risk of blood clots. The doctor should be consulted to determine how soon after childbirth Belara can be started;
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• if the patient has varicose veins.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Belara, is associated with an increased risk of blood clots compared to not using the therapy. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can form

• in veins (also called "venous thromboembolism" or "deep vein thrombosis"),
• in arteries (also called "arterial thromboembolism").

Not all patients recover fully after a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It should be remembered that the overall risk of serious blood clots caused by Belara is small.

HOW TO RECOGNIZE BLOOD CLOTS

The doctor should be contacted immediately if any of the following symptoms are noticed.

Is the patient experiencing any of these symptoms? What is the patient likely suffering from?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking,
• increased temperature in the affected leg,
• change in skin color of the leg, such as pallor, redness, or cyanosis. Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe stomach pain.

If the patient is unsure, they should contact their doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection.
Pulmonary embolism
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BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). However, these side effects are rare. Most often, they occur in the first year of using combined hormonal contraceptives.

• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of forming blood clots in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not using combined hormonal contraceptives.
If the patient stops taking Belara, the risk of blood clots returns to normal within a few weeks.
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What affects the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Belara is small.

• During the year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During the year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestrel will develop blood clots.
• The risk of blood clots associated with Belara is not yet known compared to the risk associated with combined hormonal contraceptives containing levonorgestrel.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

If the patient experiences an increase in the frequency or intensity of migraine attacks (which may indicate disturbances in blood flow to the brain) during the use of Belara, they should contact their doctor as soon as possible. The doctor may recommend stopping Belara immediately.

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Belara is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m2);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years of age). In this case, the patient may have hereditary coagulation disorders;
• if the patient needs to undergo surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS"). It may be necessary to stop taking Belara for a few weeks before surgery or immobilization. If the patient stops taking Belara, they should ask their doctor when they can resume taking the medicine;
• with age (especially over 35 years of age);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to inform the doctor if any of the above factors are present in the patient, even if the patient is unsure. The doctor may decide to stop Belara.
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The doctor should be informed if any of the above conditions change during the use of Belara, e.g., if someone in the patient's immediate family is diagnosed with a blood clot without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of a heart attack or stroke associated with Belara is very small, but it may increase:

• with age (over approximately 35 years of age);
• if the patient smokes. During the use of a hormonal contraceptive like Belara, it is recommended to quit smoking. If the patient cannot quit smoking and is over 35 years of age, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50 years of age). In this case, the patient may also be at increased risk of a heart attack or stroke;
• if the patient or someone in their immediate family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, arrhythmia called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
The doctor should be informed if any of the above conditions change during the use of Belara, e.g., if the patient starts smoking, someone in their immediate family is diagnosed with a blood clot without a known cause, or if the patient gains significant weight.
Cancer
In several studies, an increased risk of cervical cancer has been found in women infected with a specific sexually transmitted virus (human papillomavirus), who have been using contraceptives for a long time. However, it has not been clarified what other factors may influence the development of cervical cancer (e.g., a different number of sexual partners and the use of mechanical contraceptive methods).
Studies have shown a slightly increased risk of breast cancer in women taking combined hormonal contraceptives. Within 10 years after stopping the use of these medicines, the risk gradually returns to the age-related risk level. Since breast cancer is rare in women under 40 years of age, the increase in the number of diagnosed cases of this disease in women currently or previously using hormonal contraceptives is small compared to the risk of breast cancer over a lifetime.
In rare cases, the use of hormonal contraceptives has led to the development of benign or, even more rarely, malignant liver tumors. They can cause life-threatening internal bleeding. If the patient experiences severe, persistent abdominal pain, they should contact their doctor.
Other diseases
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Mental disorders:
Some women taking hormonal contraceptives, including Belara, have reported depression or mood swings. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should contact their doctor as soon as possible for further medical advice.
Many women taking hormonal contraceptives have a slight increase in blood pressure. If blood pressure rises significantly during the use of Belara, the doctor will recommend stopping Belara and prescribe a medicine to lower blood pressure. The use of Belara can be resumed when blood pressure returns to normal.
Women who have had herpes gestationis (a skin disease) during a previous pregnancy may experience it again during the use of hormonal contraceptives.
If the patient or their family members have a disorder of fat metabolism in the blood (hypertriglyceridemia), there is an increased risk of pancreatitis.
If the patient has acute or chronic liver function disorders, the doctor may recommend stopping Belara until liver function tests return to normal. If the patient had jaundice during a previous pregnancy or during the use of hormonal contraceptives and it recurs, the doctor will recommend stopping Belara.
If the patient is taking Belara and has diabetes, and blood sugar levels are well controlled, the doctor should carefully monitor the patient's condition during the use of Belara.
A change in the treatment of diabetes may be necessary.
Not very often, brown spots on the skin (chloasma) may appear, especially if such changes occurred during a previous pregnancy. If the patient is prone to chloasma, they should avoid direct exposure to sunlight and ultraviolet radiation during the use of Belara.
Belara and other diseases
Special clinical supervision is also required:

• if the patient has epilepsy;
• if the patient has multiple sclerosis;
• if the patient has severe muscle cramps (tetany);
• if the patient has migraines (see also section 2 "When not to take Belara");
• if the patient has asthma;
• if the patient has heart or kidney function disorders (see also section 2 "When not to take Belara");
• if the patient has chorea;
• if the patient has diabetes (see also section 2 "When not to take Belara" and "Other diseases");
• if the patient has liver function disorders (see also section 2 "When not to take Belara");
• if the patient has lipid metabolism disorders (see also section 2 "When not to take Belara");
• if the patient has an immune system disease (including systemic lupus erythematosus);
• if the patient is significantly overweight;
• if the patient has high blood pressure (see also section 2 "When not to take Belara");
• if the patient has endometriosis (when the tissue lining the uterus, called the endometrium, occurs outside the uterus) (see also section 2 "When not to take Belara");
• if the patient has varicose veins or phlebitis (see also section 2 "When not to take Belara");

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• if the patient has blood coagulation disorders (see also section 2 "When not to take Belara");
• if the patient has breast disease (mastopathy);
• if the patient has had a benign tumor of the uterus (uterine fibroids);
• if the patient had a pustular rash (herpes gestationis) during a previous pregnancy;
• if the patient has depression;
• if the patient has a chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).

The doctor should be informed if any of the above diseases have occurred in the past, are present, or occur during the use of Belara.
Efficacy
The contraceptive effect may be affected if the contraceptive is taken irregularly, or if vomiting or diarrhea occurs after taking the medicine (see section 3 "What to do if vomiting or diarrhea occurs while taking Belara"), or if the patient is taking certain medicines at the same time (see section 2 "Belara and other medicines"). In rare cases, metabolic disorders may affect the contraceptive effect.
Even if hormonal contraceptives are taken correctly, it cannot be guaranteed that the patient will be fully protected against pregnancy.
Irregular bleeding
During the use of hormonal contraceptives, irregular vaginal bleeding (breakthrough bleeding and/or spotting) may occur, especially in the first few months of taking the tablets. The doctor should be informed if irregular bleeding persists after 3 months from the start of taking the tablets or if it occurs after previously regular menstrual cycles.
Spotting may also indicate a decrease in contraceptive efficacy. In some patients, withdrawal bleeding may not occur after 21 days of taking Belara. If Belara has been taken according to the instructions in section 3 below, pregnancy is unlikely. If Belara was not taken according to the instructions before the first missed withdrawal bleeding, before further use of the medicine, it should be ensured that the patient is not pregnant.
Children and adolescents
Belara is indicated only after the onset of menstruation. The safety and efficacy of Belara in adolescents under 16 years of age have not been established.
Elderly people
The use of Belara is not indicated after menopause.

Belara and other medicines

The doctor or pharmacist should be informed about all medicines that the patient is currently taking or has recently taken, as well as any medicines that the patient plans to take.
Belara should not be taken in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as this may cause abnormal liver function test results in the blood (elevated liver enzyme activity). Before starting these medicines, the doctor will prescribe a different type of contraception. The use of Belara can be resumed 2 weeks after the end of the above-mentioned treatment. See section "When not to take Belara".
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Some medicines may affect the blood levels of Belara and cause reduced efficacy of Belara in preventing pregnancyor unexpected bleeding.
These include medicines used to treat:

• epilepsy (such as barbiturates, carbamazepine, phenytoin, topiramate, felbamate, oxcarbazepine, barbexaclone, primidone),
• tuberculosis (e.g., rifampicin, rifabutin),
• sleep disorders (modafinil),
• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• fungal infections (griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• herbal products containing St. John's wort ( Hypericum perforatum). If the patient wants to take herbal products containing St. John's wort while taking Belara, they should consult their doctor first.

Medicines that stimulate bowel movements (e.g., metoclopramide) and activated charcoal may change the absorption of the active substances of Belara and reduce their effect.
During treatment with the above-mentioned medicines, additional mechanical contraceptive methods (e.g., condoms) should be used. Additional mechanical contraceptive methods should be used throughout the time of concomitant drug therapy and for 28 days after the end of treatment. If concomitant drug therapy is started before the end of the current pack of combined hormonal contraceptives, the next pack should be started without the usual tablet-free interval.
If long-term treatment with the above-mentioned medicines is necessary, non-hormonal contraceptive methods should be used. The patient should ask their doctor or pharmacist for advice.
Interactions between Belara and other medicines may increase or enhance the side effects of Belara. The following medicines may have an unfavorable effect on the tolerance of Belara:

• ascorbic acid (a preservative, also known as vitamin C),
• paracetamol (a pain reliever and antipyretic),
• atorvastatin (a medicine to lower high cholesterol),
• troleandomycin (an antibiotic),
• imidazole antifungal medicines - e.g., fluconazole (used to treat fungal infections),
• indinavir (a medicine used to treat HIV infection).

Belara may affect the efficacy of other medicines. The efficacy or tolerance of the following medicines may be reduced by the use of Belara:

• certain benzodiazepines, e.g., diazepam (used to treat sleep disorders),
• cyclosporin (used to suppress the immune system),
• theophylline (used to treat asthma symptoms),
• corticosteroids, e.g., prednisolone (known as steroids, anti-inflammatory medicines used to treat, e.g., lupus, arthritis, psoriasis),
• lamotrigine (used to treat epilepsy),
• clofibrate (used to lower high cholesterol),
• paracetamol (a pain reliever and antipyretic),
• morphine (a strong pain reliever),
• lorazepam (used to treat anxiety disorders).

The patient should also read the leaflets of other medicines prescribed by their doctor.
The doctor should be informed if the patient is taking insulin or other medicines to lower blood sugar levels. A change in the dosage of these medicines may be necessary.
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It should be remembered that this information also applies to the situation when one of these active substances was used shortly before starting Belara.
The use of Belara may affect the results of some tests related to liver, kidney, adrenal, and thyroid function, as well as some blood proteins, carbohydrate metabolism parameters, and blood coagulation parameters. Changes usually remain within the normal laboratory range. Before performing tests, the doctor should be informed about the use of Belara.

Pregnancy and breastfeeding

The use of Belara is not indicated during pregnancy. If the patient becomes pregnant during the use of Belara, they should stop taking it immediately. However, previous use of Belara is not a reason to terminate the pregnancy.
It should be remembered that during the use of Belara while breastfeeding, milk production may be reduced, and the composition of milk may be changed. Very small amounts of the active substances may be excreted into the milk. Hormonal contraceptives like Belara can be used only after breastfeeding has been stopped.

Driving and using machines

The use of combined hormonal contraceptives is not known to have a negative effect on the ability to drive and use machines.

Belara contains lactose monohydrate

If the patient has an intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Belara

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the doctor or pharmacist should be consulted.
For oral use.

4. Possible side effects

Like all medicines, Belara can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones or changes in health that the patient considers to be related to the use of Belara, a doctor should be consulted.
A doctor should be contacted immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or hives potentially with breathing difficulties (see also "Warnings and precautions").
All women using combined hormonal contraceptives are at an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the different risk factors associated with the use of combined hormonal contraceptives, point 2 "Important information before using Belara" should be read.
The frequency of side effects is defined as follows:
Very common:occur in more than 1 in 10 patients
Nausea, discharge, painful menstruation, absence of menstruation.
Common:occur in no more than 1 in 10 patients
Depression, nervousness, irritability, dizziness, migraine [and/or worsening of migraine], vision disturbances, vomiting, acne, feeling of heaviness, abdominal pain, fluid retention, weight gain, fatigue, increased blood pressure.
Uncommon:occur in no more than 1 in 100 patients
Vaginal fungal infection, benign changes in breast tissue, hypersensitivity to the drug, including skin allergic reactions, changes in blood lipid levels, including increased triglyceride levels, decreased libido, abdominal pain, bloating, diarrhea, pigmentation disorders, brown spots on the face, hair loss, dry skin, excessive sweating, back pain, muscle complaints, breast discharge.
Rare:occur in no more than 1 in 1000 patients
Vaginitis, increased appetite, conjunctivitis, discomfort when wearing contact lenses, deafness, tinnitus, high blood pressure, low blood pressure, circulatory collapse, urticaria, rash, skin inflammation, itching, worsening of psoriasis, excessive hair growth on the body or face, prolonged and/or heavy menstrual bleeding, premenstrual syndrome (psychological and emotional problems before the start of menstrual bleeding).
Harmful blood clots in a vein or artery, for example:

• in the leg or foot (e.g. deep vein thrombosis),
• in the lungs (e.g. pulmonary embolism),
• heart attack,
• stroke,
• mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack,
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk of developing blood clots may be higher if the patient has other risk factors (see point 2 for more information on risk factors for blood clots and symptoms of blood clots).
Very rare:occur in no more than 1 in 10,000 patients
Erythema nodosum.
Additionally, after the marketing authorization of the drug, the following side effects have been reported in relation to the active substances, ethinylestradiol and chlormadinone acetate: weakness and allergic reactions, including deep skin swelling (angioedema).
Additionally, the use of combined hormonal contraceptives has increased the risk of serious diseases and side effects:

• venous or arterial thrombosis (see point 2 "Warnings and precautions");
• the risk of bile duct disorders (see point 2 "Warnings and precautions");
• the risk of tumor development (such as liver tumors, which in individual cases can cause life-threatening bleeding into the abdominal cavity, cervical cancer, and breast cancer; see point 2 "Warnings and precautions");
• worsening of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis; see point 2 "Warnings and precautions").

A doctor should be consulted for advice if necessary, and the information provided in point 2 "Warnings and precautions" should be read carefully.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, a doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the drug.

5. How to store Belara

The drug should be stored out of sight and reach of children.
Do not store above 30°C.
Do not use this drug after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Belara contains

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• The active substances of Belara are ethinylestradiol and chlormadinone acetate. One film-coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of chlormadinone acetate.
• The other ingredients are: Tablet core: lactose monohydrate, corn starch, povidone K 30, magnesium stearate. Tablet coating: hypromellose (type 2910), lactose monohydrate, titanium dioxide (E 171), talc, macrogol 6000, propylene glycol, iron oxide red (E 172).

What Belara looks like and what the package contains

Belara is a round, light pink, biconvex film-coated tablet without markings, with a diameter of about 6 mm.
Belara is packaged in PVC/PVDC/Aluminum blisters. The blisters are packaged in a cardboard box.
A cardboard sachet for the blister is attached to each package.
Package sizes:
1x21 film-coated tablets
3x21 film-coated tablets
6x21 film-coated tablets
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Portugal, the country of export:

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

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Portuguese marketing authorization number, country of export: 5606504
5606512
5606520

Parallel import authorization number: 86/18

Translation of day of the week symbols on each tablet on the immediate packaging:

Seg

• Monday Ter
• Tuesday Qua
• Wednesday Qui
• Thursday Sex
• Friday

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Sab

• Saturday Dom
• Sunday

Leaflet approval date: 20.02.2023
[Information about the trademark]
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