Belara

Package leaflet: Information for the user

Warning! Keep the leaflet – the information on the outer packaging is in a foreign language
Belara (Bellina)
0.03 mg + 2 mg, coated tablets
Ethinylestradiolum + Chlormadinoni acetas
Belara and Bellina are different brand names for the same medicinal product.
This medicinal product will be subject to additional monitoring. This will allow rapid identification of new safety information. You, as a user of the medicine, can also help by reporting any adverse reactions that occur after using the medicine. For information on how to report adverse reactions – see section 4.
Important information about combined hormonal contraceptives

• When 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 during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2 “BLOOD CLOTS”).

Please read all of this leaflet carefully before starting to use the medicine, because it contains
important information for you

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Belara is and what it is used for
2. What you need to know before using 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 Belara is and what it is used for

Belara is a hormonal contraceptive medicine taken by mouth. A hormonal contraceptive taken orally that contains two hormones, such as Belara, is also known as a combined hormonal contraceptive. Since each of the 21 coated tablets in a pack intended for use in one cycle contains the same amount of both hormones, Belara is also referred to as a monophasic product.
Hormonal contraceptives such as 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 using Belara

General notes
Before starting to take Belara, you should read the information about blood clots in section 2. It is particularly important to be aware of the symptoms of blood clots – see section 2 “BLOOD CLOTS”.
Before starting Belara, your doctor will perform a thorough general and gynaecological examination, exclude pregnancy, and decide, taking into account contraindications and precautions, whether you can take Belara. While taking Belara, such examinations should be repeated once a year.

When not to use Belara
Do not use Belara if any of the following conditions apply to you. If any of the following conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you are allergic (hypersensitive) to ethinylestradiol or chlormadinone acetate or any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have ever had) a blood clot in the veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs;
• if you have signs or symptoms indicating the onset of blood clots, phlebitis, or embolism, such as transient stabbing pain, chest pain, or a feeling of pressure in the chest;
• if you require surgery or will be immobile for a prolonged period (see section “BLOOD CLOTS”);
• if you know you have blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you have diabetes with uncontrolled blood sugar levels;
• if you have high blood pressure that is difficult to control or if your blood pressure increases significantly (persistent values above 140/90 mmHg);
• if you have had a heart attack or stroke;
• if you currently suffer (or have suffered in the past) from angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you suffer from any of the following conditions, which may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of blood fats (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia;
• if you currently have (or have had in the past) a type of migraine called “migraine with aura”;
• if you have hepatitis (e.g. viral) or jaundice and liver function test results have not returned to normal;
• if you have generalized itching or bile flow disorders, particularly if such disorders occurred during a previous pregnancy or during oestrogen treatment;
• if you have increased bilirubin levels (a breakdown product of blood pigment) in your blood, e.g. due to congenital disorders in bilirubin excretion (Dubin-Johnson syndrome or Rotor syndrome);
• if you currently have meningioma or have ever been diagnosed with meningioma (usually a benign tumour of the tissue layer between the brain and skull);
• if you have or have had liver cancer;
• if you have severe abdominal pain, liver enlargement, or symptoms of intra-abdominal bleeding;
• if you have or have had an attack of porphyria (a disorder of blood pigment metabolism);
• if you have or have had hormonally dependent malignant tumours, such as breast or cervical cancer, or if such tumours are suspected;
• if you have or have had severe disorders of fat metabolism;
• if you have or have had pancreatitis with high blood fat levels (triglycerides);
• if you experience sudden visual or hearing disturbances;
• if you experience sudden movement disorders (especially paralysis);
• if your epileptic seizures worsen;
• if you have severe depression;
• if you have or have had a certain type of hearing loss (otosclerosis) that worsened during a previous pregnancy;
• if you have no menstrual bleeding for unknown reasons;
• if you have been diagnosed with abnormal endometrial hyperplasia (overgrowth of the uterine lining);
• if you have vaginal bleeding of unknown cause.

Do not use Belara in patients with hepatitis C who are taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section “Belara with other medicines”).
If any of the above conditions occur while taking Belara, stop taking the medicine immediately.
Do not take Belara or stop taking it immediately if you develop one serious risk factor or several risk factors for developing blood clots.

Warnings and precautions
Before starting to take Belara, discuss this with your doctor or pharmacist.

When to contact your doctor?
Seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below “BLOOD CLOTS”. For a description of symptoms of these serious adverse effects, see “How to recognize the occurrence of blood clots”.

You should inform your doctor if any of the following conditions apply to you:

• if you smoke. Smoking while taking hormonal contraceptives increases the risk of serious adverse effects related to the heart and blood vessels. This risk increases with age and the number of cigarettes smoked. This particularly affects women over 35 years of age. Women over 35 who smoke should use other methods of contraception.

If any of these symptoms appear or worsen during treatment with Belara, you should also inform your doctor:

• if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria, potentially with breathing difficulties, seek immediate medical advice. Medicinal products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• if you have high blood pressure, abnormal increases in blood fat levels, overweight, or diabetes (see also section 2 “When not to use Belara” and “Other diseases”). In such cases, the risk of serious adverse effects (such as myocardial infarction, embolism, stroke, or liver cancer) during treatment with combined hormonal contraceptives is higher;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the body’s natural immune system);
• if you have haemolytic-uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have been diagnosed with high blood fat levels (hypertriglyceridaemia) or have a positive family history for this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 “BLOOD CLOTS”);
• if you have recently given birth, as you are then in a group at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Belara;
• if you have phlebitis of the superficial veins (superficial thrombophlebitis);
• if you have 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 such treatment. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in the veins (referred to as “venous thrombosis” or “venous thromboembolic disease”),
• in the arteries (referred to as “arterial thrombosis” or “arterial thromboembolic events”).

Recovery after a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by taking Belara is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.

Are you experiencing any of these symptoms? Likely reason

• swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:
  • pain or tenderness in the leg, which may occur only when standing or walking
  • increased warmth in the affected leg
  • change in skin colour of the leg, e.g. pallor, redness, or bluish discolouration
    Deep vein thrombosis

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 developing blood clots in veins (venous thrombosis). However, these adverse events are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher compared to not using combined hormonal contraceptives at all.
If a patient stops taking Belara, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive being used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Belara is low.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• It is not yet known how the risk of blood clots with Belara compares to the risk with combined hormonal contraceptives containing levonorgestrel.
• The risk of developing blood clots depends on the individual's medical history (see "Factors that increase the risk of blood clots" below).

If an increase in the frequency or intensity of migraine attacks occurs while taking Belara (which may indicate disturbances in blood flow to the brain), contact your doctor as soon as possible. The doctor may recommend immediate discontinuation of Belara.

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Belara is low; however, certain factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In such cases, the patient may have inherited clotting disorders;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Belara several weeks before surgery or immobilization. If Belara must be discontinued, ask your doctor when it is safe to resume taking the medication;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks).

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, particularly if the patient has another risk factor listed above.

It is important to inform your doctor if any of the listed risk factors apply to you, even if you are uncertain. Your doctor may decide to discontinue Belara.
Inform your doctor if any of the above conditions change during treatment with Belara, for example, if a close family member is diagnosed with unexplained thrombosis or if you gain significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
Similar to venous blood clots, arterial clots may lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with Belara use is very low, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using hormonal contraceptives such as Belara, smoking should be discontinued. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another form of contraception;
• if the patient has overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In such cases, the patient may also be at increased risk of heart attack or stroke;
• if high levels of lipids in the blood (cholesterol or triglycerides) have been diagnosed in the patient or a close family member;
• if the patient has migraines, particularly migraines with aura;
• if the patient has heart disease (valve disorders, cardiac arrhythmia known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be further increased. Inform your doctor if any of the above conditions change during treatment with Belara, for example, if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Tumors
Several studies have shown an increased risk of cervical cancer in women infected with a specific sexually transmitted virus (human papillomavirus) who have used hormonal contraceptives long-term. However, the influence of other additional factors (e.g., varying numbers of sexual partners and use of mechanical contraceptive methods) on cervical cancer development has not been fully clarified.

Studies have shown a slightly increased risk of breast cancer in women using combined hormonal contraceptives. This risk gradually returns to age-related baseline levels within 10 years after stopping these medications. Since breast cancer is rare in women under 40 years of age, the increase in diagnosed cases among women currently or previously using hormonal contraceptives is small compared to the lifetime risk of developing breast cancer.

In rare cases, hormonal contraceptives have led to the development of benign or, even more rarely, malignant liver tumors. These may cause dangerous internal bleeding. If the patient experiences severe, persistent abdominal pain, contact a doctor immediately.

Use of chlormadinone acetate has been associated with the development of usually benign tumors of the tissue layer between the brain and skull (meningioma). This risk increases particularly with high doses and prolonged use (several years). If a meningioma is diagnosed, the doctor will discontinue Belara treatment (see section 2 "When not to use Belara"). If the patient experiences any symptoms such as vision changes (e.g., double or blurred vision), hearing loss or tinnitus, loss of smell, headache that worsens over time, memory loss, seizures, or weakness in the arms or legs, inform the doctor immediately.

Other diseases
Psychiatric disorders:
Some women using hormonal contraceptives, including Belara, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact a doctor as soon as possible for further medical advice.

Many women using hormonal contraceptives experience a slight increase in blood pressure. If blood pressure rises significantly during Belara use, the doctor will recommend discontinuing Belara and prescribe medication to lower blood pressure. Belara may be restarted once blood pressure returns to normal levels.

Women who previously experienced chloasma during pregnancy may experience its recurrence while using hormonal contraceptives.

If the patient or family members have a disorder of fat metabolism in the blood (hypertriglyceridemia), there is an increased risk of pancreatitis. If the patient has acute or chronic liver function disorders, the doctor may recommend discontinuing Belara until liver function parameters return to normal. If the patient previously had jaundice during pregnancy or while using hormonal contraceptives and it recurs, the doctor will recommend discontinuing Belara.

If the patient uses Belara and has diabetes, and blood glucose levels are well controlled, the doctor should carefully monitor the patient during Belara use. Changes in antidiabetic treatment may be necessary.

Brown skin patches (chloasma) may occur not infrequently, particularly if such changes occurred during a previous pregnancy. If the patient is prone to chloasma, direct exposure to sunlight and ultraviolet radiation should be avoided during Belara use.

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 cramps (tetany);
• if the patient has migraine (see also section 2 "When not to use Belara");
• if the patient has bronchial asthma;
• if the patient has heart or kidney dysfunction (see also section 2 "When not to use Belara");
• if the patient has Huntington's disease;
• if the patient has diabetes (see also section 2 "When not to use Belara" and "Other diseases");
• if the patient has liver function disorders (see also section 2 "When not to use Belara");
• if the patient has fat metabolism disorders (see also section 2 "When not to use Belara");
• if the patient has an autoimmune disease (including systemic lupus erythematosus);
• if the patient has significant overweight;
• if the patient has hypertension (see also section 2 "When not to use Belara");
• if the patient has endometriosis (when endometrial tissue is present outside the uterine cavity) (see also section 2 "When not to use Belara");
• if the patient has varicose veins or phlebitis (see also section 2 "When not to use Belara");
• if the patient has blood clotting disorders (see also section 2 "When not to use Belara");
• if the patient has breast disease (mastopathy);
• if the patient previously had benign uterine tumors (fibroids);
• if the patient had pruritic urticarial papules and plaques of pregnancy (PUPPP) during a previous pregnancy;
• if the patient has depression;
• if the patient has chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).

Inform your doctor if any of the above conditions occurred in the past, are currently present, or develop during Belara use.

Efficacy
Contraceptive effectiveness may be reduced if the contraceptive is taken irregularly, if vomiting or diarrhea occurs after taking the tablet (see section 3 "What to do if vomiting or diarrhea occurs during Belara use"), or if the patient is taking certain other medications simultaneously (see section 2 "Belara and other medicines"). In rare cases, metabolic disorders may affect contraceptive efficacy.

Even when hormonal contraceptives are taken correctly, complete protection against pregnancy cannot be guaranteed.

Irregular bleeding
Irregular vaginal bleeding (bleeding and/or intermenstrual spotting) may occur during use of hormonal contraceptives, especially during the first few months of tablet use. Inform your doctor if irregular bleeding persists after 3 months of tablet use or if it occurs after previously regular menstrual cycles.

Spotting may also indicate reduced contraceptive effectiveness.

Some patients may not experience withdrawal bleeding after 21 days of Belara use. If Belara has been taken according to the instructions in section 3 below, pregnancy is unlikely. If Belara was not taken according to instructions before the first missed withdrawal bleed, pregnancy should be ruled out before continuing treatment.

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 indicated after menopause.

Belara and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.

Do not use Belara in patients with hepatitis C who are 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 (increased liver enzyme AlAT activity). Before starting these medications, the doctor will prescribe another form of contraception. Belara may be restarted approximately 2 weeks after completion of the above-mentioned treatment. See section "When not to use Belara".

Some medicines may affect blood concentrations and cause reduced effectiveness of Belara in preventing pregnancy or cause unexpected bleeding.

These include medicines used to treat:

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

Medicines that stimulate intestinal motility (e.g., metoclopramide) and activated charcoal may alter the absorption of Belara's active substances and reduce their effectiveness.

During treatment with the above-mentioned medicines, additional mechanical contraceptive methods (e.g., condoms) should be used. Additional mechanical contraception should be used throughout the duration of concomitant therapy and for 28 days after its completion. If concomitant use of medicines begins before finishing the tablets in the current blister pack of combined hormonal contraceptives, start the next pack without the usual break.

If long-term treatment with the above-mentioned medicines is required, non-hormonal contraceptive methods should be used. Consult your doctor or pharmacist for advice.

Interactions between Belara and other medicines may increase or worsen Belara's adverse effects. The following medicines may negatively affect Belara's tolerability:

• ascorbic acid (preservative, also known as vitamin C);
• paracetamol (analgesic and antipyretic);
• atorvastatin (cholesterol-lowering medicine);
• troleandomycin (antibiotic);
• imidazole antifungal medicines – e.g., fluconazole (used to treat fungal infections);
• indinavir (medicine used to treat HIV infection).

Belara may affect the action of other medicines. The efficacy or tolerability of the following medicines may be reduced due to Belara use:

• certain benzodiazepines, e.g., diazepam (used to treat sleep disorders);
• cyclosporine (used to suppress immune system activity);
• 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 levels);
• paracetamol (analgesic and antipyretic);
• morphine (specific strong analgesic);
• lorazepam (used to treat anxiety disorders).

Also refer to the package leaflets of other prescribed medicines. Inform your doctor if you are using insulin or other medicines that lower blood glucose levels. Dose adjustments of these medicines may be necessary.

Remember that this information also applies if one of these active substances was used shortly before starting Belara.

Belara use may affect the results of certain laboratory tests for liver, kidney, adrenal gland, and thyroid function, certain blood proteins, carbohydrate metabolism parameters, and blood clotting parameters. Changes usually remain within normal laboratory ranges. Inform your doctor about Belara use before undergoing any tests.

Pregnancy and breastfeeding
Belara should not be used during pregnancy. If pregnancy occurs while taking Belara, treatment must be stopped immediately. However, prior use of Belara is not a reason to terminate pregnancy.

Note that during Belara use while breastfeeding, milk production may be reduced and milk composition may be altered. Very small amounts of active substances may be excreted in breast milk. Hormonal contraceptives such as Belara should only be used after breastfeeding has been discontinued.

Driving and operating machinery
No negative effect of combined hormonal contraceptives on the ability to drive or operate machinery is known.

Belara contains monohydrate lactose
If the patient has intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to use Belara

This medicine should always be used exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
For oral use only.
How and when to take Belara
Press out the first tablet from the pack intended for the current cycle, from the space marked with the symbol corresponding to the current day of the week (e.g. "zo/di/So" for Sunday – see "Explanation of symbols for days of the week on the immediate packaging" at the end of the leaflet) and swallow it whole, without chewing. Then take one tablet daily, following the direction of the arrow, preferably at the same time each day, ideally in the evening. If possible, the interval between taking two consecutive tablets should always be 24 hours. The day-of-the-week markings on the pack will help the patient check whether the tablet for a given day has already been taken.
Take one tablet daily for 21 consecutive days, followed by a 7-day tablet-free interval. Withdrawal bleeding, similar to menstruation, usually occurs within two to four days after taking the last tablet. Start the next pack of Belara after the 7-day tablet-free interval, regardless of whether the withdrawal bleeding has stopped or is still ongoing.

When to start taking Belara
If the patient has not previously used hormonal contraceptives (during the last menstrual cycle):
Take the first tablet of Belara on the first day of the next menstrual bleeding.
Contraceptive protection begins on the first day of tablet intake and continues throughout the 7-day tablet-free interval.
If menstrual bleeding has already started, the first tablet may be taken between the second and fifth day of the cycle, regardless of whether bleeding has stopped or is ongoing. However, in this case, an additional barrier method of contraception must be used for the first 7 days of tablet intake (7-day rule).
If more than 5 days have passed since the beginning of menstrual bleeding, wait for the next menstrual period before starting Belara.

If the patient has previously used another combined hormonal contraceptive:
Take all tablets from the current pack of the previously used contraceptive. Take the first tablet of Belara the day after the usual tablet-free interval or the day after taking the last placebo tablet of the previously used combined hormonal contraceptive.

If the patient has previously used a progestogen-only contraceptive (progestogen-only pill, POP):
Withdrawal bleeding similar to menstruation may not occur. Take the first tablet of Belara the day after stopping the progestogen-only tablets. An additional barrier method of contraception must be used for the first 7 days of tablet intake.

If the patient has previously used hormonal contraception in the form of injections or an implant:
Take the first tablet of Belara on the day of implant removal or on the day the next injection is due. An additional barrier method of contraception must be used for the first 7 days of tablet intake.

After miscarriage or termination of pregnancy in the first three months of pregnancy:
Belara may be started immediately after miscarriage or termination of pregnancy. No additional contraceptive method is required.

After childbirth or miscarriage in the 3rd to 6th month of pregnancy:
Women who are not breastfeeding may start taking Belara between 21 and 28 days after childbirth. No additional mechanical contraceptive method is required.
However, if more than 28 days have passed since childbirth, an additional contraceptive method must be used for the first 7 days of tablet intake.
If sexual intercourse has occurred previously, pregnancy must be ruled out before starting Belara, or tablet intake should be delayed until the next menstrual period.
Note: Breastfeeding women should not use Belara (see section "Pregnancy and breastfeeding").

How long to use Belara
There is no time limit for using Belara, provided there are no health risks contraindicating its continued use (see section 2 "When not to use Belara"). After stopping Belara, the next menstrual bleeding may be delayed by about one week.

What to do if vomiting or diarrhoea occurs while taking Belara
If vomiting or diarrhoea occurs within 4 hours of taking a tablet, the active substances in Belara may not be completely absorbed. This situation is similar to missing a tablet, and a new tablet should be taken from a new blister pack. Take a new tablet within 12 hours of the last tablet taken, if possible, and continue taking Belara at the usual time. If this is not possible or more than 12 hours have passed, follow the advice given in section 3 "Missed dose of Belara" or contact your doctor.

Overdose of Belara
There are no data on severe poisoning symptoms after a single intake of a large number of tablets. Nausea, vomiting, and slight vaginal bleeding may occur, particularly in young girls. In such cases, consult a doctor. If necessary, the doctor may order blood tests.

Missed dose of Belara

• If the patient forgets to take a tablet at the usual time, she should take it within the next 12 hours. In this case, no additional contraceptive method is required, and tablet intake can continue as usual.
• If the delay is longer than 12 hours, contraceptive protection with Belara cannot be guaranteed. In this case, take the missed tablet as soon as possible and continue taking Belara at the usual time. This may mean taking two tablets on the same day. However, an additional barrier method of contraception (e.g. condom) must be used for the next 7 days. If the current pack is finished during these 7 days, immediately start taking tablets from the next pack of Belara – this means no break between packs is allowed (7-day rule). Withdrawal bleeding will probably not occur until the second pack is finished. However, breakthrough bleeding or spotting may occur during the days when tablets from the new pack are taken.
  The greater the number of missed tablets, the higher the risk of reduced contraceptive effectiveness. If the patient missed one or more tablets in the first week and had sexual intercourse in the week preceding the missed tablets, pregnancy should be considered. This also applies if the patient forgot to take one or more tablets and withdrawal bleeding did not occur during the tablet-free interval. In such cases, consult a doctor.

Delaying the onset of menstrual bleeding
Although not recommended, it is possible to delay the onset of menstrual bleeding (withdrawal bleeding) by starting a new Belara blister immediately, without observing the usual tablet-free interval, and continuing until the second blister is finished. Breakthrough bleeding or spotting (drops or blood spots) may occur during intake of the second blister. After the usual 7-day tablet-free interval, continue with the next pack. If the patient plans to delay her period, she may consult her doctor for advice.

Changing the day of menstrual bleeding
If the patient takes the tablets as directed, menstrual and/or withdrawal bleeding will occur during the tablet-free week. If the patient wishes to change the day of bleeding, she may shorten the tablet-free interval (but never extend it!). For example, if the tablet-free interval usually starts on Friday and the patient wishes to change it to Tuesday (three days earlier), she should start the new blister three days earlier than usual. If the tablet-free interval is very short (e.g. 3 days or fewer), no bleeding may occur. Light spotting or intermenstrual bleeding may occur.
If the patient has any doubts about what to do, she should consult her doctor for advice.

Stopping Belara
After stopping Belara, ovarian function resumes quickly and pregnancy may occur.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everyone experiences them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Belara, medical advice should be sought from a physician.
Immediate medical attention must be sought 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 accompanied by breathing difficulties (see also section "Warnings and precautions").

All women using combined hormonal contraceptives have an increased risk of venous thromboembolism (venous thromboembolic disease) or arterial thromboembolism (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before taking Belara".

The frequency of adverse reactions is defined as follows:

Very common: occurs in more than 1 in 10 women
Nausea, hot flushes, painful menstruation, absence of menstruation.

Common: occurs in up to 1 in 10 women
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: occurs in up to 1 in 100 women
Vaginal fungal infection, benign changes in breast connective tissue, hypersensitivity to the drug including skin allergic reactions, changes in blood lipid concentrations, including increased triglyceride levels, decreased libido, abdominal pain, bloating, diarrhoea, pigmentation disorders, brown spots on the face, alopecia, dry skin, excessive sweating, back pain, muscle complaints, breast discharge.

Rare: occurs in up to 1 in 1000 women
Vaginitis, increased appetite, conjunctivitis, discomfort during contact lens use, deafness, tinnitus, high blood pressure, low blood pressure, circulatory collapse, urticaria, rash, dermatitis, itching, exacerbation of psoriasis, hirsutism (excessive hair growth on body or face), prolonged and (or) heavy menstrual bleeding, premenstrual syndrome (psychological and emotional problems before onset of menstrual bleeding). Harmful blood clots in veins or arteries, 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 ischaemic attack (TIA),
• blood clots in the liver, stomach/intestines, kidneys or eye. The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Very rare: occurs in up to 1 in 10,000 women
Erythema nodosum.

Additionally, the following adverse reactions related to the active substances, ethinylestradiol and chloromadinone acetate, have been reported since the product was placed on the market: asthenia and allergic reactions, including swelling of deeper skin layers (angioedema).

Furthermore, the use of combined hormonal contraceptives has been associated with an increased risk of serious diseases and adverse reactions:

• venous or arterial thrombosis (see section 2 "Warnings and precautions");
• risk of disorders of the biliary tract (see section 2 "Warnings and precautions");
• risk of tumours (such as liver tumours, which in isolated cases may lead to life-threatening intra-abdominal bleeding, cervical cancer and breast cancer; see section 2 "Warnings and precautions");
• exacerbation of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis; see section 2 "Warnings and precautions").

Please read carefully the information provided in section 2 "Warnings and precautions" and consult your doctor if necessary.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.

Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Belara

Keep this medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Belara contains

• The active substances in Belara are ethinylestradiol and chlormadinone acetate. One coated tablet contains 0.03 mg ethinylestradiol and 2 mg chlormadinone acetate.
• Other ingredients are:
  Tablet core: monohydrate lactose, corn starch, povidone K 30, magnesium stearate.
  Tablet coating: hypromellose 6 mPas, monohydrate lactose, titanium dioxide (E 171), talc, macrogol 6000, propylene glycol, red iron oxide (E 172).

What Belara looks like and contents of the pack
Belara is in the form of round, light pink, biconvex coated tablets without embossing, with a diameter of approximately 6 mm.
Belara is packed in PVC/PVDC/Aluminium blisters. The blisters are placed in a cardboard box.
A cardboard wallet is included with each package, in which the blister should be stored.
Pack sizes:
1x21 coated tablets
3x21 coated tablets
6x21 coated tablets

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Belgium, 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Belgium, country of export, Marketing Authorisation Number: BE352554
Parallel Import Authorisation Number: 249/24

Translation of the day-of-the-week symbols on the immediate 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