Belara

Package leaflet: Information for the user

Belara, 0.03 mg + 2 mg, coated tablets
Ethinylestradiolum + Chlormadinoni acetas
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 side effects that occur
after using the medicine. For information on how to report side effects – see section 4.
Important information regarding 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 using the medicine, as it contains
important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any further 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 side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet 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 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 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 other 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 or early signs of blood clots, vein inflammation, 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 presence of 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 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 diseases, which 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 hyperhomocysteinaemia;
• if you currently 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 itching all over the body 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 the 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 membrane between the brain and skull);
• if you have or have had liver cancer;
• if you have severe abdominal pain, liver enlargement, or symptoms of bleeding into the abdominal cavity;
• if you currently have or have previously had an attack of porphyria (a disorder of blood pigment metabolism);
• if you currently have or have previously had hormone-dependent malignant tumours, such as breast or cervical cancer, or if such tumours are suspected;
• if you currently have or have previously had severe disorders of fat metabolism;
• if you currently 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 lining of the uterus (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 while taking Belara, you must stop taking the medicine immediately.
Do not take Belara or stop taking it immediately if you have or 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 should you contact your doctor?
Seek immediate medical advice if:

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

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

• if you have symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives, potentially with breathing difficulties, you should contact your doctor immediately. 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) while using 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 defence 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 levels of fats in the blood (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 long time (see section 2 “Blood clots”);
• if you have just given birth, 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 phlebitis (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 may block a blood vessel and cause serious problems.
Blood clots may occur:

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

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

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

Are you experiencing any of these symptoms? Likely reason for your symptoms

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

VENOUS BLOOD CLOTS
What can happen if blood clots form in the veins?

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thromboembolism). 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 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 taking combined hormonal contraceptives for the first time. The risk may also be higher 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 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 does the risk of venous blood clots depend on?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs with 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 with Belara is, compared 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 immediately. The doctor may recommend immediate discontinuation of Belara.

Factors increasing the risk of venous blood clots

The risk of blood clots associated with taking 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 family member 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 coagulation 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 periods of immobility. If the patient must stop taking Belara, ask the doctor when it is safe to restart 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, especially if the patient has another risk factor listed above.
It is important to inform your doctor if any of the listed factors apply to you, even if you are uncertain. The 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 the patient gains significant weight.

ARTERIAL BLOOD CLOTS

What can happen if blood clots form in arteries?
As with 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 taking 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 family member 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 family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly 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 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 use hormonal contraceptives long-term. However, it has not been clarified what influence other additional factors (e.g., differing numbers of sexual partners and use of mechanical contraceptive methods) may have on the development of cervical cancer.

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, 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 patient experiences severe, persistent abdominal pain, contact a 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 a meningioma is diagnosed in the patient, the doctor will discontinue treatment with Belara (see section 2 "When not to use Belara"). If the patient notices any symptoms such as vision changes (e.g., double or blurred vision), hearing loss or ringing in the ears, loss of smell, headache that worsens 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 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 increases significantly during treatment with Belara, the doctor will recommend discontinuing Belara and prescribe medication to lower blood pressure. Belara may be restarted once blood pressure returns to normal values.

Women who previously experienced pruritic urticarial papules and plaques of pregnancy (PUPPP) may experience 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 is using Belara and has diabetes, and blood sugar levels are well controlled, the doctor should carefully monitor the patient's condition during treatment with Belara. Changes in antidiabetic treatment may be necessary.

Brownish skin spots (chloasma) may appear not infrequently, particularly if such changes occurred during a previous pregnancy. If the patient is prone to chloasma, she should avoid direct exposure to 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 function disorders (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 immune system disorder (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 tissue lining the uterus, called endometrium, 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 coagulation 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 diseases 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 (intermenstrual bleeding and/or spotting) may occur while using hormonal contraceptives, especially during the first few months of tablet use. Inform your 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 instructions before the first missed withdrawal bleed, confirm that the patient is not pregnant 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 the patient 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 these may cause abnormal liver function test results (increased activity of liver enzymes ALT).
Before starting these medications, the doctor will prescribe another type of contraception.
Belara may be restarted approximately 2 weeks after completing the above-mentioned treatment. See section "When not to use Belara".

Some medicines may affect blood concentrations and cause reduced contraceptive effectiveness of Belara 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 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 concurrent use of medicines begins before finishing the tablets in the current blister pack of combined hormonal contraceptive, 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 intensify adverse effects of Belara. The following medicines may adversely affect the tolerability of Belara:

• ascorbic acid (a preservative, also known as vitamin C);
• paracetamol (a painkiller and fever reducer);
• atorvastatin (a medicine to lower high cholesterol);
• troleandomycin (an antibiotic);
• imidazole antifungal medicines – e.g., fluconazole (used to treat fungal infections);
• indinavir (a medicine used to treat HIV infection).

Belara may affect the action of other medicines. The efficacy or tolerability of the following medicines may be reduced due to 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);
• paracetamol (a painkiller and fever reducer);
• morphine (a specific strong painkiller);
• lorazepam (used to treat anxiety disorders).

Also, refer to the package leaflets of other prescribed medicines.
Inform your doctor if the patient is using insulin or other medicines that lower blood sugar levels. Dosage adjustments of these medicines may be necessary.
Remember that this information also applies if one of these active substances was used briefly before starting Belara.

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 coagulation parameters. Changes usually remain within normal laboratory ranges. Inform your doctor before undergoing any tests that you are taking Belara.

Pregnancy and breastfeeding

Belara should not be used during pregnancy. If the patient becomes pregnant while taking Belara, she must stop taking it immediately. However, prior 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 pass into breast milk. Hormonal contraceptives such as Belara should only be used after breastfeeding has been discontinued.

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

Belara contains lactose.
If the patient 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 according to the doctor's instructions. 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 compartment marked with the current day of the week (e.g. "Sun" for Sunday) 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. If possible, the interval between taking two consecutive tablets should always be 24 hours.
The day-of-the-week markings on the pack intended for use in the current cycle will help the patient verify 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 menstrual bleeding, usually occurs within two to four days after taking the last tablet. Begin the next pack of Belara after the 7-day tablet-free interval, regardless of whether the withdrawal bleeding has ended 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.
The contraceptive effect 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 ended or is still 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 menstrual bleeding, wait for the next menstrual period before starting Belara.
If the patient previously used another combined hormonal contraceptive
Take all tablets from the pack of the previously used medicine. 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 menstruation 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 injections or an 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 trimester
Belara may be started immediately after miscarriage or termination of pregnancy. There is no need to use an additional contraceptive method.
After childbirth or miscarriage between 3 and 6 months of pregnancy
Women who are not breastfeeding may start taking Belara between days 21 and 28 after childbirth. There is no need to use an additional mechanical contraceptive method.
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 occurred previously, pregnancy must be ruled out before starting Belara, or delay starting the tablets until the next menstrual period.
Note that women who are breastfeeding should not use Belara (see section "Pregnancy and breastfeeding").
How long to take 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 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 after taking a tablet, the active substances in Belara may not be completely absorbed. This situation is similar to missing one tablet, and a new tablet from a new blister pack should be taken. 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 than the recommended dose of Belara
There are no data on severe symptoms of poisoning after a single ingestion of a large number of tablets. Nausea, vomiting, and slight vaginal bleeding may occur, particularly in young girls. In such a case, 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, there is no need to use an additional contraceptive method, and tablet intake can continue as usual.
• If the delay exceeds 12 hours, the contraceptive effectiveness of Belara cannot be guaranteed. In this case, take the last 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, immediately start taking tablets from the next pack of Belara—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 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 missed one or more tablets in the first week and had sexual intercourse during 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 immediately starting a new blister of Belara without observing 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 taking tablets from the next pack. If the patient plans to delay the onset of menstrual bleeding, 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 of bleeding onset, 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 (drops or spots of blood) 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 doubts regarding 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 experiences them.
If any adverse effects occur, especially severe or persistent ones, or changes in health status that the patient considers to be 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 disorders) 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: occurs in more than 1 in 10 women
Nausea, vaginal discharge, 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
Fungal vaginal infection, benign changes in breast connective tissue, hypersensitivity to the medicine, including skin allergic reactions, changes in blood lipid levels, including increased triglyceride levels, decreased libido, abdominal pain, bloating, diarrhoea, pigmentary disturbances, brown facial spots, alopecia, dry skin, excessive sweating, back pain, muscle complaints, breast discharge.
Rare: occurs in up to 1 in 1,000 women
Vaginitis, increased appetite, conjunctivitis, discomfort during contact lens wear, 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), 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 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 factors increasing the risk of blood clots and symptoms of blood clots).
Very rare: occurs in up to 1 in 10,000 women
Erythema nodosum.
Additionally, 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 lead to life-threatening intra-abdominal haemorrhage, 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 Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
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. 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 package and other information

What Belara contains

• The active substances are ethinylestradiol and chlormadinone acetate. One coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of chlormadinone acetate.
• Other components are:
  Tablet core: monohydrate lactose, corn starch, povidone K-30, magnesium stearate.
  Tablet coating: hypromellose (type 2910), 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 indentations, approximately 6 mm in diameter.
Belara 0.03 mg/2 mg, coated tablets, is packed in aluminium//PVC/PVDC blisters.
The blisters are placed in a cardboard box.
Pack sizes:
1x21 coated tablets
3x21 coated tablets
6x21 coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

Manufacturer
Gedeon Richter Plc.
1103 Budapest
Gyömrői út 19-21.
Hungary

For further information about the medicinal product and its names in other European Economic Area countries, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]