Belara

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Belara (Balanca), 0.03 mg + 2 mg, film-coated tablets
Ethinylestradiolum + Chlormadinoni acetas
Belara and Balanca are different trade 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 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 this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm them.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

Belara is a hormonal contraceptive medicine taken by mouth. A hormonal contraceptive containing two hormones, such as Belara, is also known as a combined hormonal contraceptive.
Since each of the 21 film-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 treatment with Belara, you should read the information about blood clots in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section 2 "Blood clots").
Before starting treatment with Belara, your doctor will perform a thorough general and gynecological examination, exclude pregnancy, and decide—taking into account contraindications and precautions—whether you can take Belara. While using Belara, such examinations should be repeated once a year.

When not to use Belara
Do not use Belara if you have any of the conditions listed below. If you have any of these conditions, 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 to 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 symptoms indicating or early signs of blood clots, vein inflammation, or embolism, such as transient stabbing pain, pain, or 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 disorders affecting blood clotting—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you have diabetes with uncontrolled fluctuations in 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 have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (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 disorders of bile flow, particularly if such disorders occurred during a previous pregnancy or while taking estrogens;
• if you have elevated bilirubin levels (a breakdown product of blood pigment) in the blood, e.g., due to congenital disorders of bilirubin excretion (Dubin-Johnson syndrome or Rotor syndrome);
• if you currently have meningioma or have ever been diagnosed with meningioma (usually a benign tumor of the tissue layer between the brain and the skull);
• if you have or have had liver cancer;
• if you have severe abdominal pain, enlarged liver, 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 tumors, such as breast or cervical cancer, or if such tumors are suspected;
• if you have or have had severe disorders of fat metabolism;
• if you have or have had pancreatitis with high levels of fats in the blood (triglycerides);
• if you experience sudden disturbances in vision or hearing;
• if you experience sudden movement disorders (especially paralysis);
• if your epileptic seizures have worsened;
• 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 (endometrial overgrowth);
• 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 discontinue treatment immediately if you have or develop one serious risk factor or several risk factors for developing blood clots.

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

When to contact your doctor
Seek immediate medical attention if:

• you notice possible symptoms of blood clots, which may indicate that 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 blood clots".

Tell your doctor if you have any of the following conditions:

• if you smoke. Smoking while using hormonal contraceptives increases the risk of serious cardiovascular side effects. 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 alternative 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 hives, potentially with breathing difficulties, seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• if you have high blood pressure, abnormal increases in blood lipid levels, overweight, or diabetes (see also section 2 "When not to use Belara" and "Other diseases"). In such cases, the risk of severe adverse effects (such as myocardial infarction, embolism, stroke, or liver cancer) during use of 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 defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anemia (an inherited disorder of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history for this condition. Hypertriglyceridemia 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 are in the immediate postpartum period, as you are then at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Belara;
• if you have phlebitis (inflammation of superficial veins under the skin);
• if you have varicose veins.

BLOOD CLOTS
Using 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 veins (referred to as "venous thrombosis" or "venous thromboembolic disease"),
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Complete recovery after a blood clot is not always achieved. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Note that the overall risk of harmful blood clots caused by using Belara is small.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical attention if you notice any of the following symptoms.
Is the patient experiencing any of these symptoms? Likely reason
for the patient's
condition

• swelling of the leg or swelling along a vein in the leg or foot, deep vein thrombosis, especially if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking;
• increased temperature in the affected leg;
• change in skin color of the leg, such as pallor, redness, or blueness.

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thromboembolism). However, these adverse effects 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 venous blood clots highest?
The risk of developing venous blood clots is greatest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (either 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 than in women who do not use combined hormonal contraceptives.
If a woman stops taking Belara, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of blood clots?
The risk depends on the woman’s natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used. The overall risk of 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 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 individual medical history of the woman (see "Factors increasing the risk of blood clots" below).

Risk of developing blood clots
within one year
Women who do not use combined hormonal tablets, patches, or vaginal systems and are not pregnant: About 2 out of 10,000 women
Women using combined oral contraceptives containing levonorgestrel, norethisterone, or norgestimate: About 5–7 out of 10,000 women
Women using Belara: Not yet known

If during treatment with Belara there is an increase in the frequency or intensity of migraine attacks (which may indicate disturbances in blood flow to the brain), contact a doctor immediately. The doctor may advise 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, but certain factors may increase this risk. The risk is higher:

• if the woman is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, the woman may have an inherited clotting disorder;
• if the woman needs to undergo 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 the woman must stop taking Belara, she should ask her doctor when she can restart it;
• with increasing age (especially over 35 years);
• if the woman has recently given birth (within the last few weeks).

The risk of developing blood clots increases with the number of risk factors present in the woman.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the woman has another risk factor present.
It is important to inform the doctor if any of these risk factors apply to the woman, even if she is uncertain. The doctor may decide to discontinue Belara.
Inform the doctor if any of the above conditions change during treatment with Belara, e.g., if a close family member is diagnosed with unexplained thrombosis or if the woman gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with 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 is very low, but it may increase:

• with age (over approximately 35 years);
• if the woman smokes. While using a hormonal contraceptive such as Belara, it is recommended to stop smoking. If the woman cannot stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the woman is overweight;
• if the woman has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the woman may also be at increased risk of heart attack or stroke;
• if the woman or a close family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the woman has migraines, especially migraines with aura;
• if the woman has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the woman has diabetes.

If the woman has more than one of the above conditions or if any of them is particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Belara, e.g., if the woman starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the woman 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 contraceptives for a long time. However, it has not been clarified to what extent other factors (e.g., number of sexual partners and use of mechanical contraception methods) influence cervical cancer development.
Studies have shown a slightly increased risk of breast cancer in women using combined hormonal contraceptives. Over 10 years after stopping these contraceptives, this risk gradually returns to the level associated with age. 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 breast cancer.
In rare cases, the use of hormonal contraceptives has led to the development of benign or, even more rarely, malignant liver tumors. These may cause dangerous internal bleeding. If the woman experiences severe, persistent abdominal pain, she should contact a doctor.
The use of chloromadinone acetate has been associated with the development of usually benign tumors of the tissue layer between the brain and skull (meningioma). This risk increases especially with high doses and prolonged use (several years). If a woman is diagnosed with meningioma, the doctor will discontinue treatment with Belara (see section 2 "When not to use Belara"). If the woman notices 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 arms or legs, she should immediately inform the doctor.

Other diseases
Psychiatric disorders:
Some women using hormonal contraceptives, including Belara, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact a doctor immediately for further medical advice.
Many women using hormonal contraceptives experience a slight increase in blood pressure. If blood pressure increases significantly during treatment with Belara, the doctor will advise discontinuing Belara and prescribe medication to lower blood pressure. Belara may be restarted once blood pressure returns to normal values.
Women who previously experienced herpes gestationis during pregnancy may experience a recurrence while using hormonal contraceptives.
If the woman or her family members have a lipid metabolism disorder (hypertriglyceridemia), there is an increased risk of pancreatitis.
If the woman has acute or chronic liver function disorders, the doctor may advise discontinuing Belara until liver function parameters return to normal. If the woman previously had jaundice during pregnancy or while using hormonal contraceptives and it recurs, the doctor will advise discontinuing Belara.
If the woman has diabetes and blood glucose levels are well controlled, the doctor should carefully monitor her condition while using Belara. A change in antidiabetic treatment may be necessary.
Brown skin patches (melasma) may occur not infrequently, especially if such changes occurred during a previous pregnancy. If the woman is prone to melasma, she should avoid direct sunlight and ultraviolet radiation while using Belara.

Belara and other diseases
Special clinical monitoring is also required:

• if the woman has epilepsy;
• if the woman has multiple sclerosis;
• if the woman has severe muscle spasms (tetany);
• if the woman has migraine (see also section 2 "When not to use Belara");
• if the woman has bronchial asthma;
• if the woman has heart or kidney function disorders (see also section 2 "When not to use Belara");
• if the woman has Huntington's disease;
• if the woman has diabetes (see also section 2 "When not to use Belara" and "Other diseases");
• if the woman has liver function disorders (see also section 2 "When not to use Belara");
• if the woman has lipid metabolism disorders (see also section 2 "When not to use Belara");
• if the woman has an autoimmune disease (including systemic lupus erythematosus);
• if the woman is significantly overweight;
• if the woman has hypertension (see also section 2 "When not to use Belara");
• if the woman has endometriosis (when endometrial tissue is present outside the uterine cavity) (see also section 2 "When not to use Belara");
• if the woman has varicose veins or phlebitis (see also section 2 "When not to use Belara");
• if the woman has blood clotting disorders (see also section 2 "When not to use Belara");
• if the woman has breast disease (mastopathy);
• if the woman previously had benign uterine tumors (fibroids);
• if the woman had bullous eruption (herpes gestationis) during a previous pregnancy;
• if the woman has depression;
• if the woman has chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).

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

Effectiveness
Contraceptive effectiveness may be reduced if the contraceptive is taken irregularly, or if vomiting or diarrhea occurs after taking the tablet (see section 3 "What to do if vomiting or diarrhea occurs while taking Belara") or if the woman 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
While using hormonal contraceptives, irregular vaginal bleeding (breakthrough bleeding and/or spotting) may occur, especially during the first few months of tablet use. Inform the doctor if irregular bleeding persists after 3 months of starting tablets or if it occurs after previously regular menstrual cycles.
Spotting may also indicate reduced contraceptive effectiveness.
Some women may not experience withdrawal bleeding after 21 days of taking Belara. If Belara has been taken according to the instructions in section 3 below, pregnancy is unlikely. If Belara was not taken according to 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
Belara is not indicated after menopause.

Belara and other medicines
Tell your doctor or pharmacist about all medicines the woman is currently taking, has recently taken, or plans to take.
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 AlAT enzyme activity). Before starting these medicines, the doctor will prescribe another type of contraception. Belara may be restarted approximately 2 weeks after stopping 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, barbexaclone, 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 woman wishes to use herbal products containing St. John's wort while taking Belara, she should first consult her doctor.

Medicines that stimulate intestinal motility (e.g., metoclopramide) and activated charcoal may alter the absorption of the active substances in Belara and reduce their effect.
During treatment with the above-mentioned medicines, additional mechanical contraception (e.g., condoms) should be used. Additional mechanical contraception should be used throughout the duration of concomitant therapy and for 28 days after stopping treatment. If concomitant therapy is started before completing the tablets from the current blister pack of the combined hormonal contraceptive, the next pack should be started without the usual break.
If long-term treatment with the above-mentioned medicines is required, non-hormonal contraception methods should be used. Ask your doctor or pharmacist for advice.
Interactions between Belara and other medicines may increase or worsen adverse effects of Belara. The following medicines may adversely affect the tolerability of Belara:

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

Belara may affect the action of other medicines. The efficacy or tolerability of the following medicines may be reduced by using Belara:

• 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 agents used to treat, e.g., lupus, arthritis, psoriasis),
• lamotrigine (used to treat epilepsy),
• clofibrate (used to lower high cholesterol),
• paracetamol (analgesic and antipyretic),
• morphine (a specific strong analgesic),
• lorazepam (used to treat anxiety disorders).

Also refer to the package leaflets of other prescribed medicines.
Inform the doctor if the woman is using insulin or other blood glucose-lowering medicines. 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.
Using Belara may affect test results for liver, kidney, adrenal, and thyroid function, certain blood proteins, carbohydrate metabolism parameters, and blood clotting parameters. Changes usually remain within normal laboratory ranges. Inform the doctor about taking Belara before undergoing any tests.

Pregnancy and breastfeeding
Belara should not be used during pregnancy. If a woman becomes pregnant while taking Belara, she must stop taking it immediately. However, previous use of Belara is not a reason to terminate pregnancy.
Note that while using Belara during 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 weaning.

Driving and operating machinery
The negative impact of combined hormonal contraceptives on the ability to drive and operate machinery is unknown.

Belara contains monohydrate lactose
If the woman has intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to take Belara

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
For oral use.
How and when to take Belara
From the pack intended for the current cycle, press out the first tablet from the space marked with
the current day of the week symbol (e.g. Mo – Monday; see “Explanation of day-of-week symbols
next to each tablet in the primary packaging” at the end of the leaflet) and swallow it without
chewing. Then take one tablet daily, following the direction of the arrow, preferably at the same
time each day, ideally in the evening.
The interval between taking two consecutive tablets should always be as close as possible to
24 hours. The day-of-week markings on the pack intended for use during the current cycle will help
the patient check whether the tablet for that day has already been taken.
Take one tablet daily for 21 consecutive days, followed by a 7-day break from taking tablets.
Withdrawal bleeding, similar to menstrual bleeding, usually occurs within two to four days after
taking the last tablet. Start the next pack of Belara after the 7-day break, 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, take the first tablet between the second and fifth day
of the cycle, regardless of whether bleeding has stopped or is still ongoing. However, in this case,
an additional barrier method of contraception (e.g. condom) must be used for the first 7 days of
tablet intake (7-day rule).
If more than 5 days have passed since the start of menstrual bleeding, wait for the next menstrual
bleeding and only then start taking Belara.
If the patient previously used another combined hormonal contraceptive
Take all tablets from the 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 previously used a progestogen-only hormonal contraceptive (progestogen-only pill, POP)
If the patient previously used a progestogen-only hormonal contraceptive, withdrawal bleeding
similar to menstrual bleeding may not occur. Take the first tablet of Belara the day after stopping
the progestogen-only tablets. Additionally, use a barrier method of contraception for the first
7 days of tablet intake.
If the patient previously used hormonal contraception in the form of an injection or implant
Take the first tablet of Belara on the day of implant removal or on the scheduled day of injection.
Additionally, use a barrier method of contraception 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. There is no
need to use an additional method of contraception.
After childbirth or miscarriage between 3 and 6 months of pregnancy
Women who are not breastfeeding may start taking Belara between 21 and 28 days after
childbirth. There is no need to use an additional barrier method of contraception.
However, if more than 28 days have passed since childbirth, an additional method of contraception
must be used for the first 7 days of tablet intake.
If sexual intercourse occurred previously, pregnancy must be ruled out before starting Belara, or
the start of tablet intake should be delayed until the next menstrual period.
Note that women who are breastfeeding should not take Belara (see section “Pregnancy and
breast-feeding”).
How long to take Belara
There is no time limit for taking Belara, provided there are no health risks contraindicating its
continued use (see section 2 “When not to take 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, it is possible that the active
substances in Belara have not been completely absorbed. This situation is similar to missing a
tablet, and a new tablet should be taken from a new blister pack. Take the new tablet within
12 hours of taking the last tablet, 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.
Taking more Belara than prescribed
There are no data on severe poisoning symptoms after a single ingestion of a large number of
tablets. Nausea, vomiting, and slight vaginal bleeding may occur, particularly in young girls. In such
cases, contact your 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 as soon as possible, within the next 12 hours. In this case, no additional contraceptive method is necessary, and tablets should be continued as usual.
• If the delay is longer than 12 hours, contraceptive protection from 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, in this case, 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, start the next pack of Belara immediately—this means no break between packs (7-day rule). Withdrawal bleeding will probably not occur until after 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 before 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 your doctor.
Delaying the onset of menstrual bleeding
Although not recommended, it is possible to delay the onset of menstrual bleeding (withdrawal bleeding) by immediately starting a new Belara blister pack without taking the usual tablet-free interval, continuing until the second blister is finished. Breakthrough bleeding or spotting (drops or spots of blood) may occur while taking tablets from the second blister. Then, after the usual 7-day break, continue with the next pack. If the patient plans to delay the onset of menstrual bleeding, she may consult her doctor for advice.
Changing the day when menstrual bleeding starts
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 when bleeding occurs, 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),
bleeding may not occur at all. Spotting (drops or spots of blood) 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, the ovaries quickly resume full function and pregnancy may occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers to be related to the use of Belara, medical advice should be sought.
Patients should contact their doctor immediately if they experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria potentially associated with breathing difficulties (see also section "Warnings and precautions").

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic events). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Belara".

The frequency of adverse effects is defined as follows:
Very common: affects more than 1 in 10 women
Nausea, hot flushes, painful menstruation, absence of menstruation.

Common: affects 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: affects up to 1 in 100 women
Fungal vaginal 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 facial spots, hair loss, dry skin, excessive sweating, back pain, muscle complaints, breast discharge.

Rare: affects up to 1 in 1,000 women
Vaginitis, increased appetite, conjunctivitis, discomfort when wearing contact lenses, deafness, tinnitus, high blood pressure, low blood pressure, circulatory collapse, urticaria, rash, dermatitis, itching, worsening of psoriasis, excessive body or facial hair growth, breast enlargement, prolonged and (or) heavy menstrual bleeding, premenstrual syndrome (psychological and emotional disturbances before the 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 other risk factors (see section 2 for further information on risk factors and symptoms of blood clots).

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

In addition, the following adverse effects related to the active substances, ethinylestradiol and chlormadinone acetate, have been reported since the medicine was placed on the market: weakness 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 effects:

• 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 cause 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 effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Belara

Keep this medicine out of sight and reach of children.
Do not store at temperatures 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 packaging and other information

What Belara contains

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

What Belara looks like and contents of the pack
Belara is a round, light pink, biconvex coated tablet without embossing, approximately 6 mm in diameter.
Belara is packed in PVC/PVDC/Aluminium blisters placed in a cardboard box. A sachet is included in the packaging, in which the blister should be placed.
Pack sizes:
1 x 21 coated tablets
3 x 21 coated tablets
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Austria, 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:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing Authorisation number in Austria, country of export: 1-26296
Parallel import licence number: 32/25
Translation of the weekday symbols printed next to each tablet on the immediate packaging:
Mo – Monday
Di – Tuesday
Mi – Wednesday
Do – Thursday
Fr – Friday
Sa – Saturday
So – Sunday