Belara

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Belara (Chariva)
0.03 mg + 2 mg, coated tablets
Ethinylestradiolum + Chlormadinoni acetas
Belara and Chariva are different trade 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 adverse reactions
that occur after using the medicine. For information on how to report adverse reactions – 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 venous and arterial blood clots, 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 so that you can read it again if necessary.
• If you have any questions, 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.

Contents of the leaflet:

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 by mouth. A hormonal contraceptive containing two hormones, such as Belara, is also called 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

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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 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 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 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 deep 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, phlebitis, or embolism, such as transient stabbing pain, chest pain, or a feeling of pressure in the chest;
• if you require surgery or will be immobile for a prolonged period (see section "BLOOD CLOTS");
• if you know you have blood clotting disorders—such as 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 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 blood fats (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 bile flow disorders, particularly if such disorders occurred during a previous pregnancy or during estrogen treatment;
• if you have increased 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 have or have previously had a liver tumour;
• if you have severe abdominal pain, liver enlargement, or symptoms of intra-abdominal bleeding;
• if you have or have previously 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 previously had severe disorders of fat metabolism;

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• if you have or have previously had pancreatitis associated with high levels of blood fats (triglycerides);
• if you experience sudden visual or hearing disturbances;
• if you experience sudden movement disorders (especially paralysis);
• if your epileptic seizures have worsened;
• if you have severe depression;
• if you have 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 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/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section "Belara and other medicines").
If any of the above conditions occur while taking Belara, stop taking the medicine immediately.
Do not take Belara or stop taking it immediately if you have or develop one serious risk factor or several risk factors for developing blood clots.

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

When to contact your doctor?
Seek medical advice immediately:

• if you notice possible symptoms of blood clots, which may indicate 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". 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 is particularly relevant for women over 35 years of age. Women over 35 who smoke should use alternative methods of contraception.

If 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, seek immediate medical attention. Medicinal products containing estrogens 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 immune system);

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• if you have hemolytic-uremic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anemia (a hereditary disorder of red blood cells);
• if you have been diagnosed with high blood fat levels (hypertriglyceridemia) or have a family history of 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 immediately postpartum, as you are at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Belara after delivery;
• if you have phlebitis of the superficial veins (superficial thrombophlebitis);
• 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 therapy. In rare cases, a blood clot may block a blood vessel and cause serious complications.
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").

Complete recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by 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 condition?

• 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., pallor, redness, or blueness.

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

• sudden cough without obvious cause, possibly accompanied by coughing up blood;

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

• severe dizziness or vertigo;

• rapid or irregular heartbeat;

• severe stomach pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as respiratory infection.
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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 the veins (venous thrombosis). 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 developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of first-time use of combined hormonal contraceptives. 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 compared to not using combined hormonal contraceptives at all.
If a woman stops taking Belara, the risk of developing blood clots returns to normal within a few weeks.
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What factors influence the risk of developing blood clots?
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 associated with the use of Belara is low.

• In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and who are not pregnant will develop blood clots.
• In the course of 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 the use of Belara 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), you should contact your doctor as soon as possible. The doctor may recommend immediate discontinuation of Belara.

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

• if the patient is significantly 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 such a 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 the patient must stop taking Belara, ask the doctor when it is safe to resume;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, particularly if the patient has another risk factor listed above.
It is important to inform 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 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 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. While 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 blood lipids (cholesterol or triglycerides);
• if the patient has migraines, particularly migraines with aura;
• if the patient has heart disease (valve disorders, heart rhythm disorders 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 family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Tumors
Several studies have shown an increased risk of cervical cancer in women infected with a specific sexually transmitted virus (human papillomavirus) who have used hormonal contraceptives for a long time. However, the influence of other additional factors (e.g., number of sexual partners, use of mechanical contraception) on the development of cervical cancer 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 overall lifetime risk of breast cancer.
In rare cases, hormonal contraceptives have led to the development of benign or, even more rarely, malignant liver tumors. These may cause dangerous internal bleeding. If the patient experiences severe, persistent abdominal pain, contact the doctor immediately.

Other diseases
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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 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 recommend discontinuing Belara and may 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 have a recurrence while using hormonal contraceptives.
If the patient or a family member has a lipid metabolism disorder (hypertriglyceridemia), there is an increased risk of pancreatitis.
If the patient has acute or chronic liver function disorders, the doctor may recommend temporarily discontinuing Belara until liver function parameters return to normal. If the patient previously had jaundice during pregnancy or while using hormonal contraceptives and it recurs, the doctor will recommend discontinuing Belara.
If the patient uses Belara and has diabetes, and blood glucose levels are well controlled, the doctor should carefully monitor the patient’s condition during treatment. A change in antidiabetic therapy may be necessary.
Brownish skin spots (melasma) may appear, particularly 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 migraines (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 immune system disorder (including systemic lupus erythematosus);
• if the patient is significantly overweight;
• if the patient has hypertension (see also section 2 "When not to use Belara");
• if the patient has endometriosis (when endometrial tissue is present outside the uterine cavity) (see also section 2 "When not to use Belara");
• if the patient has varicose veins or phlebitis (see also section 2 "When not to use Belara");

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• 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 (intermenstrual bleeding and/or 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. In some patients, no withdrawal bleeding may occur 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 in adolescents under 16 years of age have not been established.

Elderly patients
Belara is not indicated after menopause.

Belara and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Do not use Belara in patients with hepatitis C who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as this may lead to abnormal liver function test results (increased liver enzyme AlAT activity). Before starting these medications, the doctor will prescribe another form of contraception. Belara may be restarted approximately 2 weeks after completing the above-mentioned treatment. See section "When not to use Belara".

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Some medicines may affect blood levels 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, primidone, 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),
• pulmonary hypertension (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 initiated 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 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 (an analgesic and antipyretic),
• atorvastatin (a cholesterol-lowering agent),
• troleandomycin (an antibiotic),
• imidazole antifungal agents—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 by taking 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 agents used to treat, e.g., lupus, arthritis, psoriasis),
• lamotrigine (used to treat epilepsy),
• clofibrate (used to lower high cholesterol levels),
• paracetamol (an 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 patient is using insulin or other blood glucose-lowering medicines. A dosage adjustment of these medicines may be necessary.

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Note 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 laboratory tests assessing liver, kidney, adrenal, and thyroid function, certain blood proteins, carbohydrate metabolism parameters, and blood coagulation parameters. Changes usually remain within normal laboratory ranges. Inform the doctor about Belara use before undergoing any laboratory tests.

Pregnancy and breastfeeding
Belara is not indicated during pregnancy. If the patient 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 pass into breast milk. Hormonal contraceptives such as Belara should only be used after discontinuing breastfeeding.

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

Belara contains lactose monohydrate
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 space marked with
the symbol corresponding to the current day of the week (e.g. "Sun" for Sunday – see "Translation of
the symbols for days of the week located next to each tablet on the immediate packaging" at the end
of this leaflet) and swallow it 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 check whether the
tablet for that day has already been taken.
Take one tablet daily for 21 consecutive days, then stop taking tablets for 7 days. 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 ended or is still ongoing.
When to start taking Belara
If the patient has not previously used hormonal contraceptives (during the last menstrual cycle)
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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 during the 7-day break from tablets.
If menstrual bleeding has already started, take the first tablet between the second and fifth day of
the cycle, regardless of whether the bleeding has ended or is still ongoing. However, in this case, an
additional mechanical 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 start of menstrual bleeding, wait for the next menstrual
bleeding and only then start taking Belara.
If the patient has previously used another combined hormonal contraceptive
Take all the tablets from the previously used pack. Take the first tablet of Belara the day after the
usual break in tablet intake or the day after taking the last placebo tablet of the previously used
combined hormonal contraceptive.
If the patient has previously used a progestogen-only hormonal contraceptive (progestogen-only
pill, POP)
If the patient has 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. An additional barrier method of contraception must be used
for the first 7 days of tablet intake.
If the patient has previously used hormonal contraception in the form of injections or an implant
Take the first tablet of Belara on the day of implant removal or on the day the next injection is due.
An additional barrier method of contraception must be used for the first 7 days of tablet intake.
After miscarriage or termination of pregnancy in the first three months of pregnancy
Belara may be started immediately after miscarriage or termination of pregnancy. 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 mechanical 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 there has been prior sexual intercourse, pregnancy must be ruled out before starting Belara, or
the start of tablet intake must be delayed until the next menstrual period.
Note that women who are breastfeeding should not take Belara (see section "Pregnancy and
breastfeeding").
How long to take Belara
There is no time limit for using Belara, provided there is no health risk contraindicating its further
use (see section 2 "When not to take Belara"). After stopping Belara, the next menstrual bleeding
may be delayed by about a week.
What to do if vomiting or diarrhoea occurs while taking Belara
If vomiting or diarrhoea occurs within 4 hours of taking a tablet, the active substances in Belara may
not be completely absorbed. This situation is similar to missing a tablet, and a new tablet 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 Belara than you should
There are no data on severe symptoms of poisoning following a single ingestion of a large number
of tablets. Nausea, vomiting and slight vaginal bleeding may occur, especially in young girls. In such
a case, 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 within the next 12 hours. In this case, there is no need to use an additional method of contraception, and tablet intake can continue as usual.
• If the interval is longer than 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 mechanical method of contraception (e.g. a condom) must be used for the next 7 days. If the pack is finished within these 7 days, start taking tablets from the next pack of Belara immediately – this means that no break should be taken between packs (7-day rule). Withdrawal bleeding will probably not occur until 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 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 these cases, consult your doctor.
Delayed 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 break, 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 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 onset of menstrual bleeding
If the patient takes the tablets as recommended, menstrual bleeding and/or withdrawal bleeding will
occur during the tablet-free week. If the patient wishes to change the day of bleeding, she may shorten
the tablet-free interval (but never extend it!). For example, if the tablet-free interval usually starts on
Friday and the patient wishes to change it to Tuesday (three days earlier), she should start the new
blister three days earlier than usual. If the tablet-free interval is very short (e.g. 3 or fewer days), no
bleeding may occur during this time. 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, the ovaries quickly resume full function and pregnancy may occur.
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If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Belara, medical advice should be sought.
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 reactions is defined as follows:
Very common: occurs in more than 1 in 10 women
Nausea, hot flushes, painful menstruation, absence of menstruation.
Common: occurs in up to 1 in 10 women
Depression, nervousness, irritability, dizziness, migraine [and (or) worsening of migraine], visual disturbances, vomiting, acne, feeling of heaviness, abdominal pain, fluid retention, weight gain, fatigue, increased blood pressure.
Uncommon: occurs in up to 1 in 100 women
Fungal vaginal infection, benign changes in breast connective tissue, hypersensitivity to the drug, including allergic skin reactions, changes in blood lipid levels, including increased triglyceride levels, decreased libido, abdominal pain, bloating, diarrhoea, pigmentary disorders, brown patches on the face, alopecia, dry skin, excessive sweating, back pain, muscle complaints, breast discharge.
Rare: occurs in up to 1 in 1000 women
Vaginitis, increased appetite, conjunctivitis, discomfort when wearing contact lenses, deafness, tinnitus, high blood pressure, low blood pressure, circulatory collapse, urticaria, rash, dermatitis, pruritus, exacerbation of psoriasis, hirsutism (excessive hair growth on body or face), breast enlargement, prolonged and (or) heavy menstrual bleeding, premenstrual syndrome (emotional and psychological 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/intestine, kidneys or eye.

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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 their occurrence).
Very rare: occurs in up to 1 in 10,000 women
Nodular erythema.
Additionally, after marketing authorization, the following adverse reactions related to the active substances, ethinylestradiol and chlormadinone acetate, have been reported: 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 reactions:

• venous or arterial thrombosis (see section 2 "Warnings and precautions");
• risk of disorders of the biliary tract (see section 2 "Warnings and precautions");
• risk of tumours (such as liver tumours, which in isolated cases may lead to life-threatening intra-abdominal 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, if necessary, consult your doctor for advice.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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 reactions helps to improve the safety information available on 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 specified 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 pack and other information

What Belara contains
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• The active substances are ethinylestradiol and chloromadinone acetate. Each coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of chloromadinone acetate.
• The other ingredients are:
  Tablet core: monohydrate lactose, maize starch, povidone K 30, magnesium stearate.
  Tablet coating: hypromellose (type 2910), 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 any engravings, with a diameter of approximately 6 mm.
Belara is packed in PVC/PVDC/Aluminium blisters. The blisters are packed into a cardboard box.
Each pack includes a cardboard sleeve for the blister.
Pack sizes:
1x21 coated tablets
3x21 coated tablets
6x21 coated tablets

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Portugal, 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
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Portugal, country of export: 5606504
Parallel Import Authorisation Number: 86/18
Translation of the weekday symbols printed next to each tablet on the immediate packaging:
Seg - Monday
Ter - Tuesday
Qua - Wednesday
Qui - Thursday
Sex - Friday
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Sab - Saturday
Dom - Sunday
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