Belara

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in foreign languages

Belara(Bellina)

0.03 mg + 2 mg, film-coated tablets

Ethinylestradiol + Chlormadinone acetate
Belara and Bellina are different trade names for the same medicine.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Users of the medicine can also help by reporting any adverse reactions they experience while taking the medicine. 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.
• 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 blood clot symptoms have occurred (see point 2 "BLOOD CLOTS").

The patient should carefully read the contents of the leaflet before taking the medicine, 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 medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should tell 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 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 film-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) or 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 medicine (listed in point 6);
• if the patient currently has (or has 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 of a blood clot, such as transient chest pain, or pain and swelling in the legs;
• if the patient needs to have surgery or will be immobilized for a long time (see point 2 "BLOOD CLOTS");
• if the patient knows 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 their blood sugar levels are not well controlled;
• if the patient has high blood pressure that is not well controlled or if their blood pressure is significantly elevated (systolic blood pressure above 140 mmHg or diastolic blood pressure above 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 a sign of an impending heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• hyperhomocysteinemia (a condition characterized by elevated levels of homocysteine in the blood),
• if the patient has (or has had) a type of migraine called "migraine with aura";
• if the patient has (or has had) liver disease (e.g., viral hepatitis) or jaundice, and liver function tests have not returned to normal;
• if the patient has itching all over their body or liver disorders, especially if these disorders occurred during a previous pregnancy or while taking estrogens;
• if the patient has elevated levels of bilirubin (a breakdown product of the blood pigment) in the blood, e.g., due to congenital disorders of bilirubin excretion (Dubin-Johnson syndrome or Rotor syndrome);
• if the patient has a meningioma (a usually 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 signs of bleeding into the abdominal cavity;
• if the patient has (or has had) a porphyria attack (a disorder of the metabolism of the blood pigment);
• 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 weakness);
• 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 menstrual bleeding;
• 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, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also point "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 blood clots.

Warnings and precautions

Before starting to take Belara, the patient should discuss this with their doctor or pharmacist.
When should the patient contact their doctor?

• if the patient notices any of the symptoms of a blood clot, which may indicate that they have a blood clot in their leg (deep vein thrombosis), blood clot in their lungs (pulmonary embolism), heart attack, or stroke (see point below "BLOOD CLOTS". To find out about the symptoms of these serious side effects, see "How to recognize a blood clot").

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

• -if the patient smokes. Smoking while taking 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 old. Women over 35 years old who smoke should use another method of contraception.

If these symptoms occur or worsen while taking 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 or acquired angioedema.
• -if the patient has high blood pressure, abnormal increases in blood fats, overweight, or diabetes (see also point 2 "When not to take Belara" and "Other diseases"). In these cases, the risk of serious side effects (such as heart attack, thrombosis, stroke, or liver tumor) while taking combined hormonal contraceptives is higher;

(such as heart attack, thrombosis, stroke, or liver tumor) while taking 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 have surgery or will be immobilized for a long time (see point 2 "BLOOD CLOTS").
• -if the patient has recently given birth, as they are at increased risk of blood clots. The patient should ask their doctor 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

Taking combined hormonal contraceptives, such as Belara, is associated with an increased risk of blood clots compared to not taking them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

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

Not all patients who have a blood clot will recover fully. 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 a blood clot while taking Belara is small.

HOW TO RECOGNIZE A BLOOD CLOT

The patient should contact their doctor immediately if they notice any of the following symptoms.

Is the patient experiencing any of these symptoms? What could be the reason for the patient's condition?

• 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 the color of the leg, such as pallor, redness, or cyanosis Deep vein thrombosis

BLOOD CLOTS IN VEINS

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

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). However, these side effects are rare. They most often occur in the first year of taking 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 travels to 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 a blood clot in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming 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 than when not taking 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 depends on the patient's 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.

• -In one year, about 2 out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop a blood clot.
• -In one year, about 5-7 out of 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop a blood clot.
• -It is not yet known what the risk of blood clots is with Belara compared to the risk 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 severity of migraine attacks (which may indicate disturbances in blood flow to the brain) while taking 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 severely overweight (body mass index (BMI) over 30 kg/m2);
• if someone in the patient's immediate family has had a blood clot in their leg, lung, or other organ at a young age (e.g., under 50 years old). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to have 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 start taking it again;
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop Belara.
The patient should inform their doctor if any of these conditions change while taking Belara, e.g., if someone in their immediate family is diagnosed with a blood clot without a known cause or if the patient gains weight significantly.

BLOOD CLOTS IN ARTERIES

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

As with blood clots in veins, blood clots in arteries can cause serious complications, 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 heart attack or stroke associated with Belara is very small, but it may increase:

• with age (over about 35 years old);
• -if the patient smokes.While taking a hormonal contraceptive like Belara, it is recommended to quit smoking. If the patient cannot quit smoking and is over 35 years old, the doctor may recommend 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 old). 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 these 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 these conditions change while taking 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 weight significantly.
Cancer
Some studies have shown an increased risk of cervical cancer in women infected with a specific sexually transmitted virus (human papillomavirus) who have taken oral contraceptives for a long time. However, it is not clear what other factors (e.g., different numbers of sexual partners and use of barrier methods) may have contributed to the development of cervical cancer.
Studies have shown a slightly increased risk of breast cancer in women taking combined hormonal contraceptives. Within 10 years of stopping the use of these medicines, the risk returns to the level associated with age. Since breast cancer is rare in women under 40 years old, the increase in the number of breast cancer cases diagnosed in women currently or formerly taking 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. These tumors 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 a usually benign tumor of the tissue layer between the brain and the skull (meningioma). This risk increases, especially with high doses and long-term use (several years). If a meningioma is diagnosed in the patient, the doctor will stop Belara treatment (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 in the arms or legs, they should contact their doctor immediately.
Other diseases
Psychiatric 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 experience a slight increase in blood pressure. If the patient's blood pressure increases significantly while taking Belara, the doctor will recommend stopping Belara and prescribe a medicine to lower blood pressure. Belara can be taken again when the blood pressure returns to normal.
Women who have had pemphigoid gestationis (a skin disease) during a previous pregnancy may experience it again while taking hormonal contraceptives.
If the patient or someone in their family has a disorder of fat metabolism (hypertriglyceridemia), there is an increased risk of pancreatitis. If the patient experiences acute or chronic liver disorders, the doctor may recommend stopping Belara until liver function tests return to normal. If the patient had jaundice during a previous pregnancy or while taking hormonal contraceptives and it recurs, the doctor will recommend stopping Belara.
If the patient takes Belara and has diabetes, and their blood sugar levels are well controlled, the doctor should carefully monitor the patient's condition while taking 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 while taking 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 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 disorders (see also point 2 "When not to take Belara");
• if the patient has disorders of fat metabolism (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 uterus) (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 clotting 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 pemphigoid 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 patient should tell their doctor if they have had any of these diseases in the past, if they have them now, or if they occur while taking Belara.
Efficacy
The contraceptive effect may be affected if the contraceptive is taken irregularly, or if the patient experiences vomiting or diarrhea after taking the medicine (see point 3 "What to do if the patient vomits or has diarrhea while taking Belara") or if the patient is taking certain medicines 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 not become pregnant.
Irregular bleeding
While taking hormonal contraceptives, the patient may experience irregular vaginal bleeding (breakthrough bleeding and/or spotting), especially during the first few months of use. The patient should inform their doctor if irregular bleeding persists after 3 months of taking the tablets or if it occurs after previously regular menstrual cycles.
Spotting may also indicate a decrease in contraceptive effectiveness.
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 missed withdrawal bleeding, the patient should ensure they are not pregnant before continuing to take the medicine.
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
Belara is not intended for use in postmenopausal women.

Belara and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Belara should not be taken in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as they may cause abnormal liver function test results (elevated liver enzymes). Before starting these medicines, the doctor will prescribe a different contraceptive method. Belara can be taken again after about 2 weeks after the end of the above-mentioned treatment. See point "When not to take Belara".
Some medicines may affect the levels of Belara in the blood 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, the patient should use additional mechanical methods of contraception (e.g., condoms). Additional mechanical methods of contraception should be used throughout the time of concurrent medication and for 28 days after the end of treatment. If concurrent medication is started before the end of the current pack of combined hormonal contraceptives, the next pack should be started without the usual break in tablet-taking.
If long-term treatment with the above-mentioned medicines is necessary, the patient should use non-hormonal methods of contraception. 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 antifungals - e.g., fluconazole (used to treat fungal infections),
• indinavir (a medicine used to treat HIV infection).

Belara may affect the action 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 patient should inform their doctor if they are taking insulin or other medicines to lower blood sugar levels. A change in the dosage of these medicines may be necessary.
The patient should remember that this information also applies if one of these active substances was taken shortly before starting Belara.
Taking Belara may affect the results of some tests of liver, kidney, adrenal, and thyroid function, as well as some blood proteins, carbohydrate metabolism parameters, and blood clotting parameters. Changes usually remain within the normal laboratory range. Before having any tests, the patient should tell their doctor that they are taking Belara.

Pregnancy and breastfeeding

Belara is not intended for use during pregnancy. If the patient becomes pregnant while taking Belara, they should stop taking it immediately. However, previous use of Belara does not justify termination of 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 pass into the 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 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 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 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 urticaria 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 consulted.
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], visual 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 breast tissue changes, hypersensitivity to the drug, including skin allergic reactions, changes in blood lipid levels, including increased triglyceride levels, decreased libido, abdominal pain, bloating, diarrhea, pigmentation changes, 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, hearing loss, 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 (psychic and emotional disorders 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 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 related to the active substances, ethinylestradiol and chlormadinone acetate, have been reported: weakness and allergic reactions, including deep skin hypersensitivity (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 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 worsening of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis; see point 2 "Warnings and precautions").

A doctor should be consulted to obtain advice, and the information 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 or pharmacist should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 or parallel importer.
Reporting side effects will help 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 medicine 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

• 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.
• Other ingredients are: Tablet core: lactose monohydrate, corn starch, povidone K 30, magnesium stearate. Tablet coating: hypromellose 6 mPas, 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 engravings, 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 is attached to the packaging, in which the blister should be placed.
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 consulted.

Marketing authorization holder in Belgium, 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Belgium, the country of export: BE352554

Parallel import authorization number: 249/24

Translation of day of the week symbols on the packaging:
ma/lu/Mo– Monday
di/ma/Di– Tuesday
wo/me/Mi– Wednesday
do/jeu/Do– Thursday
vrij/ven/Fr– Friday
za/sam/Sa– Saturday
zo/di/So– Sunday

Date of leaflet approval: 18.06.2024

[Information about the trademark]