Belara

Patient Information Leaflet

Warning! Keep this leaflet! 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 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. Patients can also help by reporting any suspected adverse reactions that occur after starting 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 the medicine 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 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 you personally. 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 or pharmacist. 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 by mouth. A contraceptive medicine containing two hormones, such as Belara, is also known as a combined hormonal contraceptive.
Since each of the 21 coated tablets in the pack designed 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 HIV infection (AIDS) or other sexually transmitted infections. Only condoms can provide protection against these infections.

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 become familiar with 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 the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you are allergic (hypersensitive) to ethinylestradiol or chlormadinone acetate or to any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have ever had) a blood clot in the veins of your legs (deep vein thrombosis), in 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, or pressure in the chest;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you know you have disorders affecting blood clotting—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you have diabetes with uncontrolled fluctuations in blood sugar levels;
• if you have high blood pressure that is difficult to control or if your blood pressure increases significantly (persistent values above 140/90 mmHg);
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions, 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 hyperhomocysteinemia;
• if you have (or have had in the past) a type of migraine called "migraine with aura";
• if you have hepatitis (e.g., viral) or jaundice, and liver function tests 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 inherited disorders of bilirubin excretion (Dubin-Johnson syndrome or Rotor syndrome);
• 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 have or have had porphyria (a disorder of blood pigment metabolism);
• if you have or have had hormone-dependent malignant tumors, such as breast or cervical cancer, or if such tumors are suspected;
• if you have or have had severe disorders of fat metabolism;
• if you have or have had pancreatitis with high levels of fats in the blood (triglycerides);
• if you experience sudden disturbances in vision or hearing;
• if you experience sudden movement disorders (especially paralysis);
• if your epileptic seizures worsen;
• if you have severe depression;
• if you have a certain type of deafness (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 with other medicines").
If any of the above conditions occur while taking Belara, stop taking the medicine immediately.
Do not take Belara or discontinue its use immediately if you develop or already have one serious risk factor or multiple risk factors for developing blood clots.

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

When to contact your doctor
Seek 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 the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".

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

• if you smoke. Smoking while using hormonal contraceptives increases the risk of serious cardiovascular side effects. This risk increases with age and the number of cigarettes smoked. This particularly affects women over 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 hives, potentially with breathing difficulties, seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• if you have increased arterial blood pressure, abnormal increases in blood lipid levels, overweight, or diabetes (see also section 2 "When not to use Belara" and "Other diseases").

In such cases, the risk of severe adverse effects (such as myocardial infarction, embolism, stroke, or liver cancer) during use of combined hormonal contraceptives is higher;

• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the body's natural defense system);
• if you have hemolytic-uremic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anemia (a hereditary disorder of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history for this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have recently 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 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 therapy.
In rare cases, a blood clot can block a blood vessel and cause serious health problems.
Blood clots can occur:

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

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

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

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

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

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

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

When is the risk of venous blood clots highest?
The risk of developing venous blood clots is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or another product) after a break of 4 weeks or more. After the first year, the risk decreases, although it remains higher than in women not using combined hormonal contraceptives. If a woman stops taking Belara, the risk of blood clot formation returns to normal within a few weeks.

What factors influence the risk of 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 blood clots in the legs or lungs associated with the use of Belara is small.

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

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

If, during the use of Belara, the frequency or intensity of migraine attacks increases (which may indicate disturbances in blood flow to the brain), contact a 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 small, but certain factors may increase this risk. The risk is higher:

• if the patient is overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, the patient may have inherited clotting disorders;
• if the patient needs to undergo surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Belara for 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 last few weeks).

The risk of venous 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 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, e.g., if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots may cause 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 small, but 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 cannot 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, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

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

Tumors
Several studies have shown an increased risk of cervical cancer in women infected with a specific sexually transmitted virus (human papillomavirus) who have used hormonal contraceptives long-term. However, it has not been clarified what influence other additional factors (e.g., number of sexual partners, use of mechanical contraception) may have on cervical cancer development.
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 contraceptives. Since breast cancer is rare in women under 40, the increase in diagnosed cases among women currently or previously using hormonal contraceptives is small compared to the lifetime risk of breast cancer.
In rare cases, hormonal contraceptives have led to the development of benign or, even more rarely, malignant liver tumors. These may cause dangerous internal bleeding. If the patient experiences severe, persistent abdominal pain, contact a doctor immediately.

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

Many women using hormonal contraceptives experience a slight increase in blood pressure. If blood pressure increases significantly during treatment with Belara, the doctor will recommend discontinuing Belara and prescribe antihypertensive medication.
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 a recurrence while using hormonal contraceptives.

If the patient or a family member has 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 has diabetes and blood glucose levels are well controlled, the doctor should carefully monitor the patient during treatment with Belara. A change in antidiabetic treatment may be necessary.

Brown skin patches (melasma) may occur, 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 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 is significantly overweight;
• if the patient has hypertension (see also section 2 “When not to use Belara”);
• if the patient has endometriosis (endometrial tissue 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 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, or if vomiting or diarrhea occurs after taking the tablet (see section 3 “What to do if vomiting or diarrhea occurs during treatment with 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
During use of hormonal contraceptives, irregular vaginal bleeding (intermenstrual spotting and/or bleeding) may occur, especially during the first few months of tablet use. Inform the doctor if irregular bleeding persists after 3 months of starting tablets or if it occurs after previously regular menstrual cycles.
Spotting may also indicate reduced contraceptive effectiveness.
Some women may not experience withdrawal bleeding after 21 days of taking Belara. If Belara has been taken according to the instructions in section 3 below, pregnancy is unlikely. If Belara was not taken according to instructions before the first missed withdrawal bleed, pregnancy should be ruled out before continuing treatment.

Children and adolescents
Belara is indicated only after the onset of menstruation. The safety and efficacy of Belara in adolescents under 16 years of age have not been established.

Elderly patients
Belara is not indicated after menopause.

Belara and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, including those planned for future use.

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 activity of liver enzymes AlAT).
Before starting these medications, the doctor will prescribe another form of contraception.
Belara may be restarted approximately 2 weeks after completion of the above-mentioned treatment. See section “When not to use Belara”.

Some medicines may affect blood concentrations and cause reduced effectiveness of Belara in preventing pregnancy or cause unexpected bleeding.
These include medicines used to treat:

• epilepsy (e.g., 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);
• 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 a doctor.

Medicines that stimulate intestinal motility (e.g., metoclopramide) and activated charcoal may alter the absorption of Belara’s active substances and reduce their effect.
During treatment with the above-mentioned medicines, additional mechanical contraception (e.g., condoms) should be used. Additional mechanical contraception should be used throughout the duration of concomitant therapy and for 28 days after stopping treatment. If concomitant therapy is started before finishing the tablets from the current blister pack of the combined hormonal contraceptive, the next pack should be started without the usual break.

If long-term treatment with the above-mentioned medicines is required, non-hormonal contraception should be used. Consult a 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 lipid-lowering agent);
• troleandomycin (an antibiotic);
• imidazole antifungals – e.g., fluconazole (used to treat fungal infections);
• indinavir (used to treat HIV infection).

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

• certain benzodiazepines, e.g., diazepam (used to treat sleep disorders);
• cyclosporine (used to suppress the immune system);
• theophylline (used to treat asthma symptoms);
• corticosteroids, e.g., prednisolone (steroids, anti-inflammatory agents used to treat, e.g., lupus, arthritis, psoriasis);
• lamotrigine (used to treat epilepsy);
• clofibrate (used to lower high cholesterol);
• paracetamol (analgesic and antipyretic);
• morphine (a specific strong analgesic);
• lorazepam (used to treat anxiety disorders).
  Also refer to the package leaflets of other prescribed medicines.

Inform the doctor if the patient is using insulin or other blood glucose-lowering medicines. Dose adjustments of these medicines may be necessary.

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 for 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 tests.

Pregnancy and breastfeeding
Belara is not indicated during pregnancy. If a woman becomes pregnant while using Belara, she must immediately stop taking it. 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 be excreted in breast milk. Hormonal contraceptives such as Belara may only be used after cessation of breastfeeding.

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

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

3. How to use Belara

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
For oral use only.
How and when to take Belara
From the pack designated for the current cycle, take the tablet marked with the current day of the week (e.g. ma / lu / Mo – Monday; see translation of weekday symbols at the end of this leaflet), remove it from the blister and swallow whole without chewing. Then take one tablet daily, following the direction of the arrows, preferably at the same time each day, ideally in the evening.
The interval between taking two consecutive tablets should always be 24 hours, if possible. The day-of-week markings on the pack will help you check whether you have taken the tablet for each day.
Take one tablet daily for 21 consecutive days, followed by a 7-day tablet-free interval. Withdrawal bleeding, similar to menstrual bleeding, usually occurs 2 to 4 days after taking the last tablet. Start the next pack of Belara after the 7-day tablet-free interval, regardless of whether the withdrawal bleeding has ended or is still ongoing.
When to start taking Belara
If you have not previously used hormonal contraceptives (during the last menstrual cycle)
Take the first tablet of Belara on the first day of your next menstrual bleeding.
Contraceptive protection begins on the first day of tablet intake and continues throughout the 7-day tablet-free interval.
If your menstrual bleeding has already started, you may take the first tablet between day 2 and day 5 of your cycle, regardless of whether bleeding has stopped or not. However, in this case, you must use an additional barrier method of contraception (e.g. condoms) for the first 7 days of tablet intake (the 7-day rule).
If more than 5 days have passed since the start of your menstrual bleeding, wait for the onset of your next menstrual period before starting Belara.
If you have previously used another combined hormonal contraceptive
Finish all active tablets in your current pack. Take the first tablet of Belara the day after your usual tablet-free interval or the day after taking the last placebo tablet of your previous combined hormonal contraceptive.
If you have previously used a progestogen-only contraceptive (progestogen-only pill, POP)
Withdrawal bleeding similar to menstruation may not occur when switching from a progestogen-only pill. Take the first tablet of Belara the day after stopping the progestogen-only tablets. Use an additional barrier method of contraception for the first 7 days of tablet intake.
If you have previously used hormonal contraception in the form of an injection or implant
Take the first tablet of Belara on the day of implant removal or on the day your next injection would have been due.
Use an additional barrier method of contraception for the first 7 days of tablet intake.
After miscarriage or termination of pregnancy in the first trimester
You may start taking Belara immediately after miscarriage or termination of pregnancy. There is no need to use an additional contraceptive method.
After childbirth or miscarriage in the second or third trimester (3 to 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 contraceptive method.
However, if more than 28 days have passed since childbirth, you should use an additional contraceptive method for the first 7 days of tablet intake.
If you have had sexual intercourse, pregnancy must be ruled out before starting Belara, or you should wait until your next menstrual period before starting the tablets.
Note: Breastfeeding women 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 use 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 fully absorbed. This situation is similar to missing a tablet. Take a new tablet from a new blister pack within 12 hours of taking the last tablet, if possible, and continue taking Belara at your usual time. If this is not possible or more than 12 hours have passed, follow the advice 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 may include nausea, vomiting, and slight vaginal bleeding, especially in young girls. In such cases, consult your doctor. If necessary, your doctor may order blood tests.
Missed dose of Belara

• If you forget to take a tablet at your usual time, take it as soon as possible, but no later than 12 hours after the usual time. In this case, no additional contraceptive method is needed. Continue taking tablets at your usual time.
• If the delay is more than 12 hours, contraceptive protection cannot be guaranteed. Take the missed tablet as soon as possible and continue taking Belara at your usual time. This may mean taking two tablets on the same day. In this case, use an additional barrier method of contraception (e.g. condoms) for the next 7 days. If you finish the current pack during these 7 days, start the next pack immediately without a break (i.e. do not observe the 7-day tablet-free interval – the 7-day rule). Withdrawal bleeding may not occur until after finishing the second pack. However, breakthrough bleeding or spotting may occur during the days you take tablets from the new pack.

The more tablets missed, the greater the risk of reduced contraceptive effectiveness. If you missed one or more tablets in week 1 and had sexual intercourse during the week before the missed tablets, consider the possibility of pregnancy. This also applies if you forgot 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 (withdrawal) bleeding by starting a new pack of Belara immediately without taking the usual 7-day break, continuing until the second pack is finished. Breakthrough bleeding or spotting may occur during the second pack. Then, after the usual 7-day tablet-free interval, continue with the next pack. If you plan to delay your period, consult your doctor for advice.
Changing the day of menstrual bleeding onset
If you take the tablets as directed, menstrual and/or withdrawal bleeding will occur during the 7-day tablet-free interval. If you wish to change the day of bleeding, you may shorten the tablet-free interval (but never extend it). For example, if your tablet-free interval starts on Friday and you wish to change it to Tuesday (three days earlier), start the new pack three days earlier than usual. If the tablet-free interval is very short (e.g. 3 days or less), bleeding may not occur. You may experience slight spotting or intermenstrual bleeding.
If you have any doubts about what to do, consult your doctor.
Stopping Belara
After stopping Belara, ovarian function usually resumes quickly, and pregnancy may occur.
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 advice 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 venous blood clots (venous thromboembolic disease) or arterial blood clots (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
Vaginal fungal infection, benign changes in breast connective tissue, hypersensitivity to the drug, including skin allergic reactions, changes in blood lipid concentrations, including increased triglyceride levels, decreased libido, abdominal pain, bloating, diarrhoea, pigmentary disturbances, brown facial spots, hair loss, dry skin, excessive sweating, back pain, muscle complaints, breast discharge.

Rare: occurs in up to 1 in 1000 women
Vaginitis, increased appetite, conjunctivitis, discomfort during contact lens wear, deafness, tinnitus, high blood pressure, low blood pressure, circulatory collapse, urticaria, rash, dermatitis, itching, exacerbation of psoriasis, excessive body or facial hair growth, breast enlargement, prolonged and (or) heavy menstrual bleeding, premenstrual tension 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
Nodular erythema.

Additionally, the following adverse reactions 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 reactions:

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

Please carefully read the information provided in section 2 "Warnings and precautions" and, if necessary, consult your physician for advice.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 collect more information on the safety of the medicine.

5. How to store Belara

Keep the medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Belara contains

• The active substances are ethinylestradiol and chlormadinone acetate. Each coated tablet contains 0.03 mg ethinylestradiol and 2 mg chlormadinone acetate.
• Other ingredients are:
  Tablet core: monohydrate lactose, corn starch, povidone K 30, magnesium stearate.
  Tablet coating: hypromellose (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 embossing, with a diameter of approximately 6 mm.
Belara 0.03 mg/2 mg, coated tablets, is packed in PVC/PVDC/Aluminium blisters placed in a cardboard box. A sachet is included in the package, in which the blister should be placed.
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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorisation number in Belgium, country of export: BE352554
Parallel import authorisation number: 338/22

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