Belara

Leaflet accompanying the packaging: patient information

Belara, 0.03 mg + 2 mg, coated tablets

Ethinylestradiol + Chlormadinone acetate
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, see point 4.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they 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 point 2 "Blood clots").

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicinal product has been prescribed to a specific person. It should not be passed on to others. The medicinal product may harm another person.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See point 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 adverse reactions
• 5. How to store Belara
• 6. Contents of the packaging 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 packaging intended for use in one cycle contains the same amount of both hormones, Belara is also called a monophasic product.
Hormonal contraceptives, such as 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

General notes

Before starting to take Belara, the patient should read the information about blood clots in point 2. It is especially important to read about the symptoms of blood clots - see point 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 (allergic) to ethinylestradiol or chlormadinone acetate or any of the other ingredients of this medicinal product (listed in point 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 in the chest;
• if the patient needs to undergo surgery or will be immobilized for a long time (see point 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 (persistent 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 currently has) a type of migraine called "migraine with aura";
• if the patient has (or has had) 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 a meningioma or has been diagnosed with a meningioma (usually a benign tumor of the tissue layer between the brain and the skull);
• if the patient has (or has had) a liver tumor;
• if the patient has severe abdominal pain, liver enlargement, or symptoms of bleeding into the abdominal cavity;
• if the patient has (or has had) a porphyria attack (a disorder of blood pigment metabolism);
• if the patient has (or has had) hormonally dependent malignant tumors, such as breast or cervical cancer, or if such tumors are suspected;
• if the patient has (or has had) severe lipid metabolism disorders;
• if the patient has (or has had) pancreatitis with high levels of fats in the blood (triglycerides);
• if the patient experiences sudden vision or hearing disturbances;
• if the patient experiences sudden movement disturbances (especially paresis);
• if the patient's epilepsy worsens;
• 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 by patients with hepatitis C and taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also point "Belara and other medicines").
If any of the above conditions occur during the use of Belara, the medicinal product should be stopped immediately.
Belara should not be taken or its use should be discontinued 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.

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 cardiovascular and cerebrovascular adverse reactions. 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 patient should also tell their doctor:

• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, potentially with breathing difficulties, they should contact their doctor immediately. Estrogen-containing products may cause or worsen symptoms of hereditary and acquired angioedema.
• if the patient has high blood pressure, abnormal lipid levels, overweight, or diabetes (see also point 2 "When not to take Belara" and "Other diseases"). In these cases, the risk of serious adverse reactions may be higher
• -if the patient notices possible symptoms of blood clots, which may indicate that they have 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 (thrombosis)"). To find a description of these serious adverse reactions, see "How to recognize blood clots".

(such as myocardial infarction, 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);
• 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 been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a 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 point 2 "Blood clots").
• if the patient has recently given birth, they are at increased risk of blood clots. The patient should consult their doctor to find out how soon they can start taking Belara after giving birth;
• 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 them. 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 who have had a blood clot will fully recover. In rare cases, the consequences of a blood clot can be long-term 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 patient should contact their doctor immediately if they notice any of the following symptoms.

Is the patient experiencing any of these symptoms? Why is the patient likely to be suffering?

• 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

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 adverse reactions are rare. They most often occur in the first year of use of 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 lodges 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 blood clots in a vein is highest during the first year of use of 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 medicinal product) 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.

What factors increase the risk of blood clots in veins?

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

• if the patient is severely 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 due to injury or illness or has a leg in a cast. It may be necessary to stop taking Belara for a few weeks before surgery or immobilization. If the patient needs to stop taking Belara, they should ask their doctor when they can resume taking the medicinal product;
• 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 apply to the patient, even if they are not sure. The doctor may decide to stop the use of Belara.
The patient should inform their doctor if any of the above conditions change during the use of Belara, e.g., if someone in their 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 is unable to 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 having 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 patient should inform their doctor if any of the above conditions change during the use of Belara, e.g., if they start smoking, someone in their immediate family is diagnosed with a blood clot without a known cause, or if they gain 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 used contraceptives for a long time. However, it has not been clarified what other factors (e.g., different numbers of sexual partners and the use of mechanical contraceptive methods) may have an impact on the development of cervical cancer.
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 medicinal products, the risk returns to the level of risk associated with age. 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.
The use of chlormadinone acetate has been associated with the development of usually benign brain tumors (meningioma). This risk increases especially with high doses and long-term use (several years). If the patient is diagnosed with a meningioma, the doctor will stop the treatment with Belara (see point 2 "When not to take Belara"). If the patient notices any symptoms, such as changes in vision (e.g., double vision or blurred vision), hearing loss or ringing in the ears, loss of smell, worsening headache, memory loss, seizures, weakness of the arms or legs, they should immediately inform their doctor.
Other diseases
Psychiatric disorders:
Some women taking hormonal contraceptives, including Belara, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, the patient should contact their doctor as soon as possible for further medical advice.
Many women taking hormonal contraceptives experience a slight increase in blood pressure. If blood pressure rises significantly during the use of Belara, the doctor will recommend stopping the medicinal product and prescribe a medicinal product to lower blood pressure. The use of Belara can be resumed when blood pressure returns to normal.
In women who had pruritus of pregnancy during a previous pregnancy, it may recur during the use of hormonal contraceptives.
If the patient or their family members have a disorder of fat metabolism (hypertriglyceridemia), there is an increased risk of pancreatitis. If the patient has acute or chronic liver function disorders, the doctor may recommend stopping the use of 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 the use of 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 may appear on the skin (chloasma), 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 monitoring is also required:

• if the patient has epilepsy;
• if the patient has multiple sclerosis;
• if the patient has severe muscle spasms (tetany);
• if the patient has migraines (see also point 2 "When not to take Belara");
• if the patient has asthma;
• if the patient has heart or kidney function disorders (see also point 2 "When not to take Belara");
• if the patient has chorea;
• if the patient has diabetes (see also point 2 "When not to take Belara" and "Other diseases");
• if the patient has liver function disorders (see also point 2 "When not to take Belara");
• if the patient has lipid metabolism disorders (see also point 2 "When not to take Belara");
• if the patient has an immune system disease (including systemic lupus erythematosus);
• if the patient is severely overweight;
• if the patient has high blood pressure (see also point 2 "When not to take Belara");
• if the patient has endometriosis (when the tissue lining the uterus, called the endometrium, occurs outside the uterine cavity) (see also point 2 "When not to take Belara");
• if the patient has varicose veins or phlebitis (see also point 2 "When not to take Belara");
• if the patient has blood coagulation disorders (see also point 2 "When not to take Belara");
• if the patient has breast disease (mastopathy);
• if the patient has had a benign tumor of the uterus (fibroids);
• if the patient had pruritus of pregnancy during a previous pregnancy;
• if the patient has depression;
• if the patient has a chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).

The patient should tell their doctor if they have had any of the above diseases in the past, currently have them, or develop them 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 medicinal product (see point 3 "What to do in case of vomiting or diarrhea during the use of Belara") or if the patient is taking certain medicinal products at the same time (see point 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 during the first few months of use. The patient should inform their doctor 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 point 3 below, pregnancy is unlikely. If Belara was not taken according to the instructions before the first absence of withdrawal bleeding, before continuing the use of the medicinal product, 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 patients
The use of Belara is not indicated after menopause.

Belara and other medicines

The patient should tell their doctor or pharmacist about all medicinal products they are currently taking or have recently taken, as well as any medicinal products they plan to take.
Belara should not be taken by patients with hepatitis C and taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results (elevated liver enzyme levels).
Before starting to take these medicinal products, the doctor will prescribe a different contraceptive method.
The use of Belara can be resumed 2 weeks after the end of the above-mentioned treatment. See point "When not to take Belara".
Certain medicinal products may affect the levels of Belara in the blood and cause a decrease in its contraceptive efficacyor unexpected bleeding.
These include medicinal products 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 first consult their doctor.

Medicinal products 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 the use of the above-mentioned medicinal products, additional mechanical contraceptive methods (e.g., condoms) should be used. Additional mechanical contraceptive methods should be used throughout the period 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 Belara, the next pack should be started without the usual tablet-free interval.
If long-term treatment with the above-mentioned medicinal products is necessary, non-hormonal contraceptive methods should be used. The patient should ask their doctor or pharmacist for advice.
Interactions between Belara and other medicinal products may increase or enhance the adverse reactions of Belara. The following medicinal products 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 medicinal product to lower high cholesterol levels),
• troleandomycin (an antibiotic),
• imidazole antifungal medicinal products - e.g., fluconazole (used to treat fungal infections),
• indinavir (a medicinal product used to treat HIV infection).

Belara may affect the efficacy of other medicinal products. The efficacy or tolerance of the following medicinal products 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 medicinal products used to treat, e.g., lupus, arthritis, psoriasis),
• lamotrigine (used to treat epilepsy),
• clofibrate (used to lower high cholesterol levels),
• paracetamol (a pain reliever and antipyretic),
• morphine (a specific strong pain reliever),
• lorazepam (used to treat anxiety disorders).

The patient should also read the package leaflets of other medicinal products prescribed by their doctor.
The patient should inform their doctor if they are taking insulin or other medicinal products to lower blood sugar levels. A change in the dosage of these medicinal products may be necessary.
The patient should remember that this information also applies to situations where one of these active substances was used shortly before starting to take Belara.
The use of Belara may affect the results of certain laboratory tests related to liver, kidney, adrenal, and thyroid function, as well as certain blood proteins, carbohydrate metabolism parameters, and blood coagulation parameters. Changes usually remain within the normal laboratory range. Before performing laboratory tests, the patient should inform their doctor that they are taking Belara.

Pregnancy and breastfeeding

The use of Belara is not indicated during pregnancy. If the patient becomes pregnant while taking 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 breastfeeding, the use of Belara may reduce milk production and change the composition of milk. Very small amounts of the active substances may be excreted into breast milk. Hormonal contraceptives like Belara can only be used after breastfeeding has been stopped.

Driving and using machines

There is no known negative effect of combined hormonal contraceptives on the ability to drive and use machines.

Belara contains lactose.

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

3. How to take Belara

This medicinal product should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
For oral use.

4. Possible side effects

Like all medicines, this medicine 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 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: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives potentially with breathing difficulties (see also "Warnings and precautions").
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, point 2 "Important information before using Belara" should be consulted.
The frequency of side effects is defined as follows:
Very common:occurs in more than 1 in 10 patients
Nausea, discharge, painful menstruation, absence of menstruation.
Common:occurs 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, water retention, weight gain, fatigue, increased blood pressure.
Uncommon:occurs 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 discomfort, breast discharge.
Rare:occurs in no more than 1 in 1000 patients
Vaginitis, increased appetite, conjunctivitis, discomfort when wearing contact lenses, hearing loss, tinnitus, high blood pressure, low blood pressure, circulatory collapse, hives, rash, skin inflammation, itching, worsening of psoriasis, excessive hair growth on the body or face, prolonged and/or severe menstrual bleeding, premenstrual syndrome (psychic and emotional disorders before the start of menstrual bleeding).
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 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:occurs in no more than 1 in 10,000 patients
Erythema nodosum.
Additionally, after the marketing of the drug, the following side effects related to the active substances, ethinylestradiol and chlormadinone acetate, have been reported: 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 blood clots (see point 2 "Warnings and precautions");
• the risk of biliary tract disorders (see point 2 "Warnings and precautions");
• the risk of tumors (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");
• the exacerbation of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis; see point 2 "Warnings and precautions").

Point 2 "Warnings and precautions" should be read carefully, and if necessary, a doctor should be consulted for advice.

Reporting side effects

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

5. How to store Belara

The medicine should be stored out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date. The expiry date is 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

• The active substances of Belara are ethinylestradiol and chlormadinone acetate. One coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of chlormadinone acetate.
• Other ingredients are: Tablet core: lactose monohydrate, cornstarch, 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 0.03 mg/2 mg, film-coated tablets are packaged in aluminum/PVC/PVDC blisters.
The blisters are packaged in a cardboard box.
Package sizes:
1x21 film-coated tablets
3x21 film-coated tablets
6x21 film-coated tablets
Not all package sizes may be marketed.

Marketing authorization holder

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

Manufacturer

Gedeon Richter Plc.
1103 Budapest
Gyömrői út 19-21.
Hungary
To obtain more detailed information about the drug and its names in other European Economic Area member states, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet: February 2023.