Belara Conti

Leaflet accompanying the packaging: patient information

Belara CONTI, 2 mg + 0.03 mg, film-coated tablets

Chlormadinone acetate + Ethinylestradiol

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.
• One should be vigilant and consult a doctor 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 using the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be re-read.
• In case of any doubts, one should consult a doctor or pharmacist.
• 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 or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Belara CONTI and what is it used for

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

2. Important information before using Belara CONTI

General notes

Before starting to use Belara CONTI, one should read the information about blood clots in section 2.
It is especially important to read about the symptoms of blood clots - see section 2 "Blood clots".
Before starting to use Belara CONTI, 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 use Belara CONTI.
During the use of Belara CONTI, such an examination should be repeated once a year.

When not to use Belara CONTI

Belara CONTI should not be used 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 chlormadinone acetate or ethinylestradiol 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), lungs (pulmonary embolism), or other organs;
• if the patient has symptoms of a blood clot, such as transient chest pain, or symptoms of a stroke or heart attack;
• if the patient needs to undergo surgery or will be immobilized for a long time (see section 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 difficult to control or if their 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 (or 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 (temporary stroke symptoms);
• if the patient has any of the following diseases that 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
• if the patient has (or has ever 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 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 severe lipid metabolism disorders;
• if the patient has (or has had) pancreatitis with high levels of fats in the blood (triglycerides);
• if the patient has an unusually severe, frequent, or prolonged headache;
• if the patient experiences sudden disturbances in perception (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 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 CONTI should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Belara CONTI and other medicines").
If any of the above conditions occur during the use of Belara CONTI, the use of this medicine should be stopped immediately.
Belara CONTI should not be taken or its use should be stopped immediately if the patient has one serious risk factor or several risk factors for blood clots.

Warnings and precautions

Before starting to use Belara CONTI, one should discuss it with their doctor or pharmacist.
When should one contact their doctor?
One should contact their doctor immediately

• -if the patient notices possible symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (i.e., deep vein thrombosis), blood clots in the lungs (i.e., pulmonary embolism), a heart attack, or a stroke (see below "Blood clots (thrombosis)"). To get a description 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 using hormonal contraceptives increases the risk of serious side effects related to the heart and blood vessels. 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 other contraceptive methods.

If these symptoms occur or worsen during the use of Belara CONTI, one 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, one 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 fat levels, overweight, or diabetes (see also section 2 "When not to use Belara CONTI" and "Other diseases");
• 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 positive family history for 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. One should consult their doctor to find out how soon they can start using Belara CONTI after giving birth;
• if the patient has superficial thrombophlebitis (inflammation of veins under the skin);
• if the patient has varicose veins.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Belara CONTI, is associated with an increased risk of blood clots, compared to not using these medicines.
Blood clots can occur

• in veins (also known as "venous thromboembolism" or VTE),
• in arteries (also known as "arterial thromboembolism" or ATE).

Not all patients who have a blood clot will recover fully. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

It should be remembered that the total risk of having a harmful blood clot due to Belara CONTI is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

Is the patient experiencing any of these symptoms? What might the patient be 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 the color of the leg skin, such as pallor, redness, or discoloration. Deep vein thrombosis

BLOOD CLOTS IN VEINS

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

The use of combined hormonal contraceptives is associated with an increased risk of blood clots in 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 of the leg or foot, it can lead to the development of deep vein thrombosis (DVT).
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 veins highest?

The risk of forming a blood clot 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 using Belara CONTI, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots in veins?

The risk depends on the natural risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive used.

• The total risk of having a blood clot in the leg (DVT) or lungs (pulmonary embolism) due to Belara CONTI is small.
• In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop a blood clot.
• In a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop a blood clot.
• Out of 10,000 women using Belara CONTI, about 6-9 will develop a blood clot in a year.
• The risk of a blood clot depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

If the frequency or severity of migraine attacks increases during the use of Belara CONTI (which may indicate disturbances in blood flow to the brain), one should contact their doctor as soon as possible.
The doctor may recommend stopping the use of Belara CONTI.

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Belara CONTI 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/m);
• 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 old). In this case, the patient may have inherited blood clotting 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 using Belara CONTI for a few weeks before surgery or immobilization. If the patient needs to stop using Belara CONTI, they should ask their doctor when they can resume using the medicine;
• 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.
Air travel (more than 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 unsure.
The doctor may decide to stop the use of Belara CONTI.
One should inform the doctor if any of the above conditions change during the use of Belara CONTI, 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 a blood clot forms in an artery?

Similar to blood clots in veins, blood clots in arteries can cause severe 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 CONTI is very small, but it may increase:

• with age (over about 35 years old);
• if the patient smokes.While using a hormonal contraceptive like Belara CONTI, it is recommended to quit smoking. If the patient cannot quit smoking and is over 35 years old, 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 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, heart rhythm disturbance called atrial fibrillation);
• if the patient has diabetes. If the patient has diabetes, the doctor should carefully monitor their condition while using Belara CONTI;

Cancer
Some studies have shown an increased risk of cervical cancer in women infected with a specific sexually transmitted virus (i.e., human papillomavirus) who have used oral contraceptives for a long time.
However, it is not clear what other factors may influence the development of cervical cancer (e.g., the number of sexual partners and the use of barrier methods of contraception).
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 returns to the age-related risk level.
Since breast cancer is rare in women under 40 years old, 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.
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 usually benign tumors 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 the treatment with Belara CONTI (see section 2 "When not to use Belara CONTI").
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, headaches that worsen over time, memory loss, seizures, weakness in the arms or legs, they should contact their doctor immediately.
Other diseases
Psychiatric disorders
Some women using hormonal contraceptives, including Belara CONTI, have reported depression or low mood.
Depression can be severe and sometimes lead to suicidal thoughts.
If mood changes or symptoms of depression occur, one 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 rises significantly while using Belara CONTI, the doctor will recommend stopping the use of Belara CONTI and prescribe a medicine to lower blood pressure.
The use of Belara CONTI can be resumed when the blood pressure returns to normal.
Women who had pruritus of pregnancy during a previous pregnancy may experience it again while using 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 has acute or chronic liver function disorders, the doctor may recommend stopping the use of Belara CONTI 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 the use of Belara CONTI.
If the patient uses Belara CONTI and has diabetes, and their blood sugar levels are well controlled, the doctor should carefully monitor the patient's condition while using Belara CONTI.
A change in the treatment of diabetes may be necessary.
Not very often, brown spots on the skin (chloasma) may occur, 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 using Belara CONTI.
Belara CONTI 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 section 2 "When not to use Belara CONTI");
• if the patient has asthma;
• if the patient has heart or kidney function disorders (see also section 2 "When not to use Belara CONTI");
• if the patient has chorea;
• if the patient has diabetes (see also section 2 "When not to use Belara CONTI" and "Other diseases");
• if the patient has liver function disorders (see also section 2 "When not to use Belara CONTI");
• if the patient has disorders of fat metabolism (see also section 2 "When not to use Belara CONTI");
• 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 section 2 "When not to use Belara CONTI");
• if the patient has endometriosis (when the tissue lining the uterus, called endometrium, occurs outside the uterine cavity) (see also section 2 "When not to use Belara CONTI");
• if the patient has varicose veins or phlebitis (see also section 2 "When not to use Belara CONTI");
• if the patient has blood clotting disorders (see also section 2 "When not to use Belara CONTI");
• if the patient has breast disease (mastopathy);
• if the patient has had a benign tumor of the uterus (fibroids);
• if the patient had pustular psoriasis (impetigo herpetiformis) during a previous pregnancy;
• if the patient has depression;
• if the patient has chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).

One should tell their doctor if any of the above diseases have occurred in the past, are present, or occur while using Belara CONTI.
Efficacy
The contraceptive effect may be altered if the contraceptive is not taken regularly, or if vomiting or diarrhea occurs after taking the medicine (see section 3 "What to do if vomiting or diarrhea occurs while using Belara CONTI") or if the patient is taking certain medicines (see section 2 "Belara CONTI 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 using hormonal contraceptives, irregular vaginal bleeding (breakthrough bleeding and/or spotting) may occur, especially during the first few months of use.
One should inform their doctor if irregular bleeding persists after 3 months from the start of tablet use 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 using Belara CONTI.
If Belara CONTI has been taken according to the instructions in section 3 below, pregnancy is unlikely.
If Belara CONTI was not taken according to the instructions before the first missed withdrawal bleeding, one should make sure the patient is not pregnant before continuing to use the medicine.

Belara CONTI and other medicines

One 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 CONTI should not be used 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 enzyme ALT).
Before starting to take these medicines, the doctor will prescribe a different contraceptive method.
The use of Belara CONTI can be resumed after about 2 weeks from the end of the above-mentioned treatment.
See section "When not to use Belara CONTI".
Certain medicines may affect the levels of Belara CONTI in the blood and cause a decrease in its contraceptive effector 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 use herbal products containing St. John's Wort while taking Belara CONTI, they should consult their doctor first.

Medicines that stimulate bowel movements (e.g., metoclopramide) and activated charcoal may alter the absorption of the active substances of Belara CONTI and reduce their effect.
During treatment with the above-mentioned medicines, one should use additional mechanical methods of contraception (e.g., condoms).
Additional mechanical methods of contraception should be used throughout the entire 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, the next pack of Belara CONTI should be started without taking the placebo tablets.
If long-term treatment with the above-mentioned medicines is necessary, one should use non-hormonal methods of contraception.
One should ask their doctor or pharmacist for advice.
Interactions between Belara CONTI and other medicines may increase or enhance the side effects of Belara CONTI.
The following medicines may have an unfavorable effect on the tolerance of Belara CONTI:

• 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 CONTI may affect the action of other medicines.
The efficacy or tolerance of the following medicines may be reduced when using Belara CONTI:

• 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 specific strong pain reliever),
• lorazepam (used to treat anxiety disorders).

One should also read the package leaflets of other medicines prescribed by their doctor.
One 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.
One should remember that this information also applies to situations where one of these active substances was used shortly before starting to use Belara CONTI.
During the use of Belara CONTI, the results of some tests to determine liver, adrenal, and thyroid function, certain blood proteins, carbohydrate metabolism parameters, and blood clotting parameters may change.
Therefore, before having blood tests, one should tell their doctor that they are using Belara CONTI.

Pregnancy and breastfeeding

The use of Belara CONTI is not recommended during pregnancy.
If the patient becomes pregnant while using Belara CONTI, they must stop taking it immediately.
However, previous use of Belara CONTI is not a reason to terminate the pregnancy.
It should be remembered that during breastfeeding, while using Belara CONTI, milk production may decrease, and the composition of milk may change.
Very small amounts of the active substances may be excreted into the milk.
Hormonal contraceptives like Belara CONTI 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 CONTI contains lactose

This medicine contains 66.07 mg of lactose in one active film-coated tablet and 94.44 mg of lactose in one placebo film-coated tablet.
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to use Belara CONTI

This medicine should always be used as directed by the doctor.
In case of doubt, one should consult their doctor or pharmacist.
The blisters in each pack are designed to help the patient remember to take the tablets.
Each blister contains 28 tablets: 21 pink active tablets (tablets 1-21) and 7 white inactive tablets (tablets 22-28).

Method of administration:

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 CONTI, a doctor should be consulted.
Severe side effects
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").
In all women using combined hormonal contraceptives, there is an increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in arteries (arterial thromboembolism (ATE)). For detailed information on the different risk factors associated with the use of combined hormonal contraceptives, see point 2 "Important information before using Belara CONTI".
The frequency of side effects is defined as follows:
Very common(occurring in more than 1 in 10 patients):
Nausea, discharge, painful menstruation, absence of menstruation.
Common(occurring 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, fatigue, water retention, weight gain, increased blood pressure.
Uncommon(occurring in no more than 1 in 100 patients):
Vaginal fungal infection, mild 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(occurring 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, varicose veins, hives, rash, skin inflammation, itching, worsening of psoriasis, excessive hair growth on the body or face, breast enlargement, prolonged and/or severe 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 (i.e., deep vein thrombosis),
• in the lungs (i.e., 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 likelihood of developing blood clots may be higher if the patient has any other risk-increasing factors (see point 2 for more information on risk-increasing factors and symptoms of blood clots).

Very rare(occurring in no more than 1 in 10,000 patients):
Nodular vasculitis.
Additionally, after the marketing authorization of the drug, the following side effects related to the active substances, chlormadinone acetate, and ethinylestradiol, have been reported: weakness and allergic reactions, including skin allergic reactions, angioedema.
Additionally, the use of combined hormonal contraceptives, including Belara CONTI, 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 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");
• exacerbation of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis, see point 2"Warnings and precautions"). A careful reading of the information provided in point 2 "Warnings and precautions" is recommended, and if necessary, a doctor should be consulted.

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 CONTI

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 refers to the last day of the month stated.
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. Contents of the packaging and other information

What Belara CONTI contains:

• The active substances of Belara CONTI are chlormadinone acetate and ethinylestradiol. One light-pink coated tablet contains 2.0 mg of chlormadinone acetate and 0.030 mg of ethinylestradiol.
• White coated tablets do not contain active substances.
• Other ingredients are:

Coated tablets containing active substances:
Core:
lactose monohydrate, cornstarch, povidone K-30, magnesium stearate.
Coating:
hypromellose (type 2910), lactose monohydrate, titanium dioxide (E 171), talc, macrogol 6000, propylene glycol, iron oxide red (E 172).
Coated placebo tablets:
Core:
lactose monohydrate, povidone K-30, crospovidone type A, magnesium stearate.
Coating:
hypromellose (type 2910), lactose monohydrate, talc, titanium dioxide (E 171), macrogol 6000, propylene glycol.

What Belara CONTI looks like and what the packaging contains

Light-pink, round, biconvex coated tablet containing active substances, without engraving. Diameter approximately 6 mm.
White to almost white, round, biconvex coated placebo tablet, without engraving. Diameter approximately 7 mm.
Belara CONTI 2 mg + 0.03 mg, coated tablets, are packaged in PVC/PVDC/Aluminum blisters. The blisters are packaged in a cardboard box.
Each box contains 1, 3, or 6 calendar packagings containing 21 coated tablets with active substances + 7 coated placebo tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
To obtain more detailed information about this medicinal product, 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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany
Belara 28
Poland
Belara CONTI

Date of last revision of the leaflet: June 2024