Belara

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate 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 for rapid identification of new safety information. You can also help by reporting any suspected adverse reactions 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 developing 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 a blood clot (see section 2 "BLOOD CLOTS").

Please read this leaflet carefully before taking the medicine, as it contains important information for you

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

Table of contents:

1. What Belara is and what it is used for
2. What you need to know 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 orally. An oral contraceptive containing 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 over 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 HIV infection (AIDS) and other sexually transmitted infections. 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 treatment with 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 using Belara, such examinations should be repeated annually.

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 the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you have 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 long time (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 have (or have previously had) 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 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 have (or have previously had) 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 excretion, especially if such disorders occurred during a previous pregnancy or during oestrogen treatment;
• 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 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 previously had hormone-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 previously had pancreatitis associated 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 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 overgrowth of the uterine lining (endometrial hyperplasia);
• 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 and other medicines").
If any of the above conditions occur during treatment with Belara, you must stop taking the medicine immediately.
Do not take Belara or discontinue its use immediately if you 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 should you contact your doctor?
Seek medical advice immediately:

• 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 adverse effects on the heart and blood vessels. This risk increases with age and the number of cigarettes smoked. This particularly affects women over the age of 35. Women over 35 who smoke should use alternative methods of contraception.

If any of these symptoms appear or worsen during treatment with Belara, 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, contact your doctor immediately. 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 tumour) 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 defence system);
• if you have haemolytic-uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (a hereditary red blood cell disorder);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a long time (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 for advice on how soon after delivery you can start taking Belara;
• if you have superficial thrombophlebitis (inflammation of 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 can block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (hereinafter referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (hereinafter 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.
Note that the overall risk of harmful blood clots caused by using Belara is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek medical advice immediately if you notice 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:
  Deep vein thrombosis

  • 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. paleness, redness, or blueness.

• sudden onset of unexplained shortness of breath or rapid breathing;
  Pulmonary embolism

• sudden cough without obvious cause, which may be associated with coughing up blood;

• sharp chest pain, which may worsen with deep breathing;

• severe dizziness or vertigo;

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 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 using 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 a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a 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 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 small, but 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 relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, 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 the 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 listed risk factor.
It is important to inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue Belara.
Inform the doctor if any of the above conditions change during treatment with Belara, for example, if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the arteries?
Similar to venous blood clots, arterial clots can 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 the use of Belara is very low, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Belara, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of blood lipids (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve disorders, heart rhythm disturbances such 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 the doctor if any of the above conditions change during treatment with Belara, for example, if the patient starts smoking, a close relative 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., number 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 the baseline age-related risk 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 abdominal pain that does not resolve spontaneously, contact the doctor immediately.
The 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 especially with high doses and prolonged use (several years). If meningioma is diagnosed, the doctor will discontinue treatment with Belara (see section 2 "When not to use Belara"). If the patient notices any symptoms such as changes in vision (e.g., double or blurred vision), hearing loss or tinnitus, loss of smell, headaches that worsen over time, memory loss, seizures, or weakness in 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 the doctor as soon as possible 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 may prescribe antihypertensive medication. Belara may be restarted once blood pressure returns to normal values.
Women who previously experienced herpes gestationis during pregnancy may have a 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 advise 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 advise discontinuing Belara.
If the patient has diabetes and blood glucose levels are well controlled, the doctor should carefully monitor the patient during treatment with Belara. Changes in antidiabetic treatment may be necessary.
Brownish skin patches (melasma) may occur, although not frequently, especially if such changes occurred during a previous pregnancy. If the patient 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 patient has epilepsy;
• if the patient has multiple sclerosis;
• if the patient has severe muscle spasms (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 lipid 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 high blood pressure (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 pemphigoid gestationis (herpes gestationis) during a previous pregnancy;
• if the patient has depression;
• if the patient 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.

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 while taking Belara"), 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 while using hormonal contraceptives, especially during the first few months of tablet use. Inform the doctor if irregular bleeding persists after 3 months of starting the tablets 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 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 the 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 have not been established in adolescents under 16 years of age.

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 these may cause abnormal liver function test results in blood (increased liver enzyme AlAT activity).
Before starting these medications, the doctor will prescribe another type 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, barbexaclon, 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 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, 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 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 stopping treatment. If concomitant therapy is started before completing the tablets from the current blister pack of combined hormonal contraceptive, the next pack should be started without the usual break.
If long-term treatment with the above-mentioned medicines is necessary, non-hormonal contraceptive methods should be used. Consult your doctor or pharmacist for advice.
Interactions between Belara and other medicines may increase or intensify adverse effects of Belara. The following medicines may negatively affect the tolerability of Belara:

• ascorbic acid (preservative, also known as vitamin C),
• paracetamol (painkiller and fever reducer),
• 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 the use of Belara:

• certain benzodiazepines, e.g., diazepam (used to treat sleep disorders),
• cyclosporine (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 levels),
• paracetamol (painkiller and fever reducer),
• morphine (specific strong painkiller),
• lorazepam (used to treat anxiety disorders).

Also, refer to the package leaflets of other prescribed medicines.
Inform the doctor if the patient is using insulin or other blood glucose-lowering medicines. Dose adjustments of these medicines may be necessary.
Remember that this information also applies if any of these active substances were used shortly before starting Belara.
The use of Belara may affect the results of certain tests assessing 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 the doctor about taking Belara before undergoing any tests.

Pregnancy and breastfeeding
Belara is not indicated during pregnancy. If the patient becomes pregnant while taking Belara, she must discontinue the medication immediately. However, prior use of Belara is not a reason to terminate the 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 may only be used after discontinuation of breastfeeding.

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 patient has intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to use Belara

This medicine should always be used exactly as your doctor has instructed. If you are unsure, consult
your doctor or pharmacist.
For oral use only.
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
symbol corresponding to the current day of the week (e.g. "zo/di/So" for Sunday – see "Explanation of
day-of-the-week symbols next to each tablet on the immediate packaging" at the end of this leaflet)
and swallow it whole without chewing. Then take one tablet daily, following the direction indicated
by the arrow, preferably at the same time each day, ideally in the evening. The interval between two
consecutive tablets should always be 24 hours, if possible. The day-of-the-week markings on the
pack will help the patient verify whether the tablet for that 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 a menstrual period, usually occurs 2 to 4 days after taking the last tablet. The next
pack of Belara should be started 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 menstruation has already started, take the first tablet between the 2nd and 5th 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 onset of menstruation, wait for the next menstrual
bleeding and only then start taking Belara.
If the patient has previously used another combined hormonal contraceptive
Take all tablets from the pack of the previously used contraceptive. Take the first tablet of Belara
on the day following the usual tablet-free interval or on the day after taking the last placebo tablet
of the previously used combined hormonal contraceptive.
If the patient has previously used a progestogen-only hormonal contraceptive (progestogen-only
pill, POP)
If the patient has previously used a progestogen-only hormonal contraceptive, 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 was
scheduled. 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 between 3 and 6 months of pregnancy
Women who are not breastfeeding may start taking Belara between 21 and 28 days after delivery.
No additional mechanical contraceptive method is required.
However, if more than 28 days have passed since delivery, an additional contraceptive method must
be used for the first 7 days of tablet intake.
If there has been recent sexual intercourse, pregnancy must be excluded before starting Belara, or
the start of tablet intake should be delayed until the next menstrual period.
Note: Women who are breastfeeding should not use Belara (see section "Pregnancy and
breastfeeding").
How long to use Belara
There is no time limit for the use of 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 after taking a tablet, the active substances in Belara
may not be fully 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.
Overdose of Belara
There are no reports of severe poisoning symptoms after a single ingestion of a large number of
tablets. Symptoms such as nausea, vomiting, and slight vaginal bleeding may occur, particularly in
young girls. In such cases, consult your doctor. If necessary, your 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 may continue as usual.
• If the delay exceeds 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 within these 7 days, immediately start the next pack of Belara without a break – this means no tablet-free interval is allowed (7-day rule). Withdrawal bleeding will likely not occur until after the second pack is completed. However, breakthrough bleeding or spotting may occur on 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 has 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 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 blister of Belara 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 during use of the second blister. Then, after the usual 7-day tablet-free interval,
continue with the next pack. If the patient wishes to delay her period, she may consult her doctor for
advice.
Changing the day of menstrual bleeding onset
If the patient takes the tablets as directed, menstrual bleeding and/or withdrawal bleeding will occur
during the tablet-free week. If the patient wishes to change the day on which bleeding occurs, she may
shorten the tablet-free interval (but never lengthen it!). For example, if the tablet-free interval
normally 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 less), bleeding may not occur at all. Light spotting or intermenstrual bleeding may occur.
If the patient has any doubts about how to proceed, 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 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 related to the use of Belara, medical advice should be sought from a doctor.
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 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 disorders). 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 medicine, including skin allergic reactions, changes in blood lipid concentrations, including increased triglyceride levels, decreased libido, abdominal pain, bloating, diarrhoea, pigmentation disorders, brown patches on the face, 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 during contact lens use, 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 problems 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 stroke-like symptoms, known as transient ischaemic attack,
• 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 factors increasing this risk (see section 2 for further information on factors increasing the risk of blood clots 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 blood clots (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, if necessary, consult your doctor for advice.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Belara contains

• The active substances in this medicine are ethinylestradiol and chlormadinone acetate. One coated tablet contains 0.03 mg ethinylestradiol and 2 mg chlormadinone acetate.
• Other components 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 a round, light pink, biconvex coated tablet without any engraving, approximately 6 mm in diameter.
Belara is packed in PVC/PVDC/Aluminium blisters. The blisters are placed in a cardboard box.
A cardboard pouch is included with the pack, in which the blister should be stored.
Pack sizes:
1x21 coated tablets
3x21 coated tablets
For more detailed information, please contact the marketing authorisation holder 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation number in Belgium, country of export: BE352554
Parallel Import Licence number: 23/24

Translation of the weekday symbols printed next to each tablet 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