Belara

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Belara (Chariva)
0.03 mg + 2 mg, coated tablets
Ethinylestradiol + Chlormadinone acetate
Belara and Chariva are different trade names for the same medicinal product.
▼ This medicinal product is subject to additional monitoring. This will allow for rapid
identification of new safety information. You can help by reporting any adverse reactions you
experience 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 using the medicine, as it contains important information for you.
• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not give it to others. The medicine 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.

Contents of the leaflet:

1. What Belara is and what it is used for
2. Before you take 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 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 AIDS (HIV infection) or other sexually transmitted infections. Only condoms can provide protection against these diseases.

2. Important information before using Belara

General notes
Before starting to take Belara, you should read the information about blood clots in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 “Blood clots”).
Before starting Belara, your doctor will perform a thorough general and gynaecological examination, exclude pregnancy, and decide—taking into account contraindications and precautions—whether you can take Belara. While using Belara, such examinations should be repeated annually.

When not to use Belara
Do not use Belara if you have any of the conditions listed below. If you have any of these conditions, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you are allergic (hypersensitive) to ethinylestradiol or chlormadinone acetate or any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you have symptoms indicating the onset of blood clots, phlebitis, or embolism, such as transient stabbing pain, 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 blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or 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 mm Hg);
• 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 ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a condition called hyperhomocysteinemia;
• if you currently have (or have had in the past) a type of migraine called “migraine with aura”;
• if you have hepatitis (e.g. viral) or jaundice, and liver function test results have not returned to normal;
• if you have generalized itching or 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 of bilirubin excretion (Dubin-Johnson syndrome or Rotor syndrome);
• if you have or have had a liver tumour;
• if you have severe abdominal pain, liver enlargement, or symptoms of intra-abdominal bleeding;
• if you have or have had an attack of porphyria (a disorder of blood pigment metabolism);
• if you have or have had hormonally dependent malignant tumours, such as breast or cervical cancer, or if such tumours are suspected;
• if you have or have had severe lipid metabolism disorders;
• if you have or have had pancreatitis associated with high levels of fats in the blood (triglycerides);
• if you experience sudden visual or auditory disturbances;
• if you experience sudden motor disturbances (especially paralysis);
• if your epileptic seizures worsen;
• 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 with other medicines”).
If any of the above conditions occur while using Belara, stop taking the medicine immediately.
Do not take Belara or stop using it immediately if you have or develop one serious risk factor or several risk factors for blood clots.

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

When to contact a 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 stroke (see section below “Blood clots”). For a description of the symptoms of these serious adverse effects, see “How to recognize blood clots”.

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

• if you smoke. Smoking while using hormonal contraceptives increases the risk of serious cardiovascular side effects. This risk increases with age and the number of cigarettes smoked. This particularly affects women over 35 years of age. Women over 35 who smoke should use alternative contraceptive methods.

If any of the following 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 oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• if you have high blood pressure, abnormal increases in blood lipid levels, overweight, or diabetes (see also section 2 “When not to use Belara” and “Other diseases”). In such cases, the risk of 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);
• if you have haemolytic-uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have been diagnosed with high blood fat levels (hypertriglyceridaemia) or have a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, as you are then in a high-risk group for blood clots. Consult your doctor for advice on how soon after delivery you can start taking Belara;
• if you have phlebitis (inflammation of superficial veins under the skin);
• if you have varicose veins.

BLOOD CLOTS
Using combined hormonal contraceptives such as Belara is associated with an increased risk of blood clots compared to not using such treatment. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

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

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 low.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical attention if you experience any of the following symptoms.

Do you experience any of these symptoms? What is the likely reason?

• 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 warmth in the affected leg;
• change in skin colour 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 (either the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than when not using combined hormonal contraceptives.
If a patient stops taking Belara, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of blood clots?
The risk depends on the 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 one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• It is not yet known what the risk of blood clots is with Belara compared to the risk with combined hormonal contraceptives containing levonorgestrel.
• The risk of blood clots depends on the 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, or vaginal systems and are not pregnant: Approximately 2 out of 10,000 women
Women using combined hormonal contraceptive tablets containing levonorgestrel, norethisterone, or norgestimate: Approximately 5–7 out of 10,000 women
Women using Belara: Not yet known

If, while using Belara, there is an increase in the frequency or intensity of migraine attacks (which may indicate disturbances in blood flow to the brain), the patient should contact her doctor as soon as possible. The doctor may advise immediate discontinuation of Belara.

Factors increasing the risk of venous blood clots
The risk of blood clots associated with using Belara is low, but 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 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, will be immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Belara several weeks before surgery or immobilization. If the patient must stop taking Belara, she should ask her doctor when she can resume taking it;
• 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 the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue Belara.
The patient should inform her doctor if any of the above conditions change during treatment with Belara, e.g., if a close family member is diagnosed with thrombosis of unknown cause, 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 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 using 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 cannot stop smoking and is over 35 years old, the doctor may recommend using a different 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 fats (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, 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 is particularly severe, the risk of blood clots may be further increased.
The patient should inform her doctor if any of the above conditions change during treatment with Belara, e.g., if she starts smoking, if a close family member is diagnosed with thrombosis of unknown cause, or if she 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, it has not been clarified what influence other additional factors (e.g., number of sexual partners, use of barrier contraception) have on the development of cervical cancer.
Studies have shown a slightly increased risk of breast cancer in women taking combined hormonal contraceptives. Over 10 years after stopping these medications, this risk gradually returns to the baseline age-related risk. Since breast cancer is rare in women under 40 years of age, the increase in diagnosed cases among women currently or previously using hormonal contraceptives is small compared to the lifetime risk of breast cancer.
In rare cases, the use of hormonal contraceptives has led to the development of benign or, even more rarely, malignant liver tumors. These may cause dangerous internal bleeding. If the patient experiences severe, persistent abdominal pain, she should contact her doctor.

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

A slight increase in blood pressure may occur in many women using hormonal contraceptives. If blood pressure increases significantly during treatment with Belara, the doctor will advise stopping Belara and prescribe medication to lower blood pressure. Belara may be restarted once blood pressure returns to normal values.

Women who previously experienced prurigo gestationis during pregnancy 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 advise stopping Belara until liver function parameters return to normal. If the patient previously had jaundice during pregnancy or while using hormonal contraceptives and it recurs, the doctor will advise stopping Belara.

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

Brown skin patches (chloasma) may occur, 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 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 immunological 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”);
• 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 prurigo gestationis (pregnancy rash) during a previous pregnancy;
• if the patient has depression;
• if the patient has chronic inflammatory bowel disease (Crohn’s disease, ulcerative colitis).
  The patient should inform her 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
While using hormonal contraceptives, irregular vaginal bleeding (bleeding and/or intermenstrual spotting) may occur, especially during the first few months of tablet use. The patient should inform her 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 the instructions before the first missed withdrawal bleed, pregnancy should be ruled out before continuing treatment.

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

Elderly patients
Belara is not indicated after menopause.

Belara and other medicines
The patient should inform her doctor or pharmacist about all medicines currently or recently taken, as well as any medicines she plans to take.

Belara must not be used 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 activity, AlAT).
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.”

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 effect. During treatment with the above-mentioned medicines, additional barrier contraceptive methods (e.g., condoms) should be used. Additional barrier methods should be used throughout the duration of concomitant therapy and for 28 days after stopping the treatment. If concomitant use of these medicines is started before completing the tablets from the current blister pack of combined hormonal contraceptive, the next pack should be started without the usual break.

If long-term treatment with the above-mentioned medicines is required, non-hormonal contraceptive methods should be used. The patient should seek advice from her doctor or pharmacist.

Interactions between Belara and other medicines may increase or intensify the 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 the use of Belara:

• certain benzodiazepines, e.g., diazepam (used to treat sleep disorders),
• cyclosporine (used to suppress the immune system),
• theophylline (used to treat asthma symptoms),
• corticosteroids, e.g., prednisolone (known as steroids, anti-inflammatory medicines used to treat, e.g., lupus, arthritis, psoriasis),
• lamotrigine (used to treat epilepsy),
• clofibrate (used to lower high cholesterol),
• paracetamol (a painkiller and fever reducer),
• morphine (a specific strong painkiller),
• lorazepam (used to treat anxiety disorders).

The patient should also read the package leaflets of other prescribed medicines.
The patient should inform her doctor if she is using insulin or other blood glucose-lowering medicines, as dosage adjustments may be necessary.
It should be remembered 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 gland, and thyroid function, certain blood proteins, carbohydrate metabolism parameters, and blood coagulation parameters. Changes are usually within normal laboratory ranges. The patient should inform her doctor about taking Belara before undergoing any tests.

Pregnancy and breastfeeding
Belara must not be used 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 a pregnancy.
It should be noted that while using Belara during breastfeeding, milk production may be reduced and milk composition may be altered. Very small amounts of the active substances may be excreted in breast milk. Hormonal contraceptives such as Belara may only be used after weaning.

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

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

3. How to use Belara

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
For oral use.
How and when to take Belara
From the pack intended for the current cycle, press out the first tablet from the space marked with
the current day of the week (e.g. Mon – Monday; see translation of weekday symbols at the end of
the leaflet) and swallow it 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. 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 during the current cycle will help the patient verify whether
the tablet for that day has already been taken.
Take one tablet daily for 21 consecutive days, followed by a 7-day break from tablets.
Withdrawal bleeding, similar to menstrual bleeding, usually occurs 2 to 4 days after taking the last
tablet. Begin the next pack of Belara after the 7-day break, regardless of whether the withdrawal
bleeding has stopped or is still ongoing.
When to start taking Belara
If the patient has not previously used hormonal contraceptives (during the last menstrual cycle)
Take the first tablet of Belara on the first day of the next menstrual bleeding.
Contraceptive protection begins on the first day of tablet intake and continues throughout the 7-day
tablet-free interval.
If menstrual bleeding has already started, take the first tablet between the second and fifth day of
the cycle, regardless of whether bleeding has stopped or is ongoing. However, in this case, an
additional barrier method of contraception must be used for the first 7 days of tablet intake (the 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 begin taking Belara.
If the patient has previously used another combined hormonal contraceptive
Take all tablets from the pack of the previously used contraceptive. Take the first tablet of Belara
the day after the usual tablet-free break or the day after the last placebo tablet of the previously
used combined hormonal contraceptive.
If the patient has previously used a progestogen-only contraceptive (ang. progestogen-only-pill, POP)
If the patient has previously used a progestogen-only contraceptive, withdrawal bleeding similar
to menstruation may not occur. Take the first tablet of Belara the day after stopping the
progestogen-only tablets. An additional barrier method of contraception must be used for the first 7
days of tablet intake.
If the patient has previously used hormonal contraception in the form of injections or an implant
Take the first tablet of Belara on the day of implant removal or on the scheduled day of injection.
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 trimester
Belara may be started immediately after miscarriage or termination of pregnancy. No additional
contraceptive method is required.
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. No additional mechanical contraceptive method is required.
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 there has been prior sexual intercourse, pregnancy must be ruled out before starting Belara, or
the start of tablet intake should be delayed until the next menstrual period.
Note that women who are breastfeeding should not use Belara (see section "Pregnancy and
breastfeeding").
How long to take Belara
There is no time limit for the use of Belara, provided there are no health risks contraindicating its
continued use (see section 2 "When not to take Belara"). After stopping Belara, the next menstrual
bleeding may be delayed by about one week.
What to do if vomiting or diarrhoea occurs while taking Belara
If vomiting or diarrhoea occurs within 4 hours of taking a tablet, the active ingredients of Belara may
not be fully absorbed. This situation is similar to missing a tablet, and a new tablet should be taken
from a new blister pack. Take a 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 in section 3 "Missed dose of Belara" or contact a doctor.
Overdose of Belara
There are no data on severe poisoning symptoms following a single ingestion of a large number of
tablets. Nausea, vomiting, and slight vaginal bleeding may occur, especially in young girls. In such
cases, 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, it should be taken within the next 12 hours. In this case, no additional contraceptive method is needed, and the patient may continue taking tablets as usual.
• If the delay is longer than 12 hours, contraceptive protection with Belara cannot be guaranteed. In this case, take the missed tablet as soon as possible and continue taking Belara at the usual time. This may mean taking two tablets on the same day. However, an additional barrier method of contraception (e.g. a condom) must be used for the next 7 days. If the pack is finished during these 7 days, start the next pack of Belara immediately—this means no break between packs (7-day rule). Withdrawal bleeding will probably not occur until after the second pack is completed. However, breakthrough bleeding or spotting may occur on days when tablets from the new pack are taken. The greater the number of missed tablets, the higher the risk of reduced contraceptive effectiveness. If the patient 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 no bleeding occurred during the tablet-free interval. In these 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 starting a new Belara blister pack immediately, without observing the usual tablet-free
interval, continuing until the second blister is finished. Breakthrough bleeding or spotting (drops or
stains of blood) may occur during use of the second blister. Then, after the usual 7-day break,
continue taking tablets from the next pack. If the patient plans to delay menstrual bleeding, she may
consult a doctor for advice.
Changing the day of menstrual bleeding
If the patient takes 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, she may shorten the
tablet-free interval (but never extend it!). For example, if the tablet-free interval normally starts on
Friday and the patient wishes to change it to Tuesday (three days earlier), she should start the new
blister three days earlier than usual. If the tablet-free interval is very short (e.g. 3 days or less),
bleeding may not occur. Light spotting or intermenstrual bleeding may occur.
If the patient has any doubts about how to proceed, she should consult a doctor for advice.
Stopping Belara
After stopping Belara, ovarian function resumes quickly and pregnancy may occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially if they are severe and persistent, or changes in health which the patient considers to be related to the use of Belara, medical advice should be sought from a doctor.
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 developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before taking Belara".

The frequency of adverse effects is defined as follows:
Very common: 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 medicine, including skin allergic reactions, changes in blood lipid concentrations, including increased triglyceride levels, decreased libido, abdominal pain, bloating, diarrhoea, pigmentation disorders, brown facial spots, hair loss, dry skin, excessive sweating, back pain, muscle complaints, breast discharge.

Rare: occurs in up to 1 in 1000 women
Vaginitis, increased appetite, conjunctivitis, discomfort during contact lens use, 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 indicating their occurrence).

Very rare: occurs in up to 1 in 10,000 women
Nodular erythema.

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, if necessary, consult your doctor for advice.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Belara

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date. The expiry date refers to the last day of the stated month.
Medicines should 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. One coated tablet contains 0.03 mg ethinylestradiol and 2 mg chlormadinone acetate.
• Other components are:
  Tablet core: monohydrate lactose, corn starch, povidone K 30, magnesium stearate.
  Tablet coating: hypromellose (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 indentations, approximately 6 mm in diameter.
Belara 0.03 mg/2 mg, coated tablets, is packed in aluminium/PVC/PVDC blisters 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
6x21 coated tablets
For further 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Portugal, country of export: 5606504
Parallel Import Licence Number: 291/17
Translation of the day-of-the-week symbols printed next to each tablet on the immediate packaging:
Seg - Monday
Ter - Tuesday
Qua - Wednesday
Qui - Thursday
Sex - Friday
Sab - Saturday
Dom - Sunday