Belara

Package leaflet: Information for the user

Belara 2 mg/0,03 mg film-coated tablets

Chlormadinone acetate, ethinylestradiol
Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods, if used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be vigilant and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this 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 an oral hormonal contraceptive. These products containing two hormones, such as BELARA,
are also called combined hormonal contraceptives (COC). The 21 tablets in a blister pack contain the
same amount of the two hormones, and therefore BELARA is also referred to as a "monophasic pill".
Other hormonal contraceptives like BELARA do not protect against AIDS (HIV infection) or other
sexually transmitted diseases. Only condoms can help protect you.

2. What you should know before taking Belara

General notes
Before starting to use Belara, you must read the information about blood clots in section 2. It is
particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
Before taking Belara, your doctor will perform a thorough general and gynecological examination, exclude any possible pregnancy, consider contraindications and precautions, and then decide whether Belara is suitable for you. This examination should be repeated annually while you are taking Belara.

Do not take Belara
Do not take Belara if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other methods of birth control that might be more suitable for your case:

• if you are allergic to ethinylestradiol or chlormadinone acetate, or to any of the other ingredients of this medicine (listed in section 6);
• if you have (or have ever had) a blood clot in a vein of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you experience early signs of a blood clot, vein inflammation, or embolism, such as sudden, transient stabbing pain or chest tightness;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are about to undergo surgery or will be bedridden for a prolonged period (see section “Blood clots”);
• if you have diabetes or uncontrolled fluctuations in blood sugar levels;
• if you have high blood pressure that is difficult to control, or if it increases significantly (values above 90/140 mm Hg);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which may increase the risk of clots forming in arteries:
  o severe diabetes with blood vessel damage, or very high blood pressure, or very high levels of fats (cholesterol or triglycerides) in the blood, or a condition known as hyperhomocysteinemia;
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you suffer from liver inflammation (e.g., caused by a virus) or jaundice and liver function values have not yet returned to normal;
• if you suffer from widespread itching or bile-related disorders, particularly if these occurred during a previous pregnancy or previous estrogen treatment;
• if bilirubin (a product of blood pigment breakdown) in your blood is above normal levels, for example due to congenital bile excretion disorders such as Dubin-Johnson syndrome or Rotor syndrome;
• if you have meningioma or have ever been diagnosed with meningioma (a usually benign tumor of the tissue layer between the brain and skull);
• if you currently suffer from, or have previously suffered from, liver cancer;
• if you experience severe stomach pain, liver enlargement, or signs of abdominal bleeding;
• if porphyria (a disorder of blood pigment metabolism) develops or recurs;
• if you currently have, have had in the past, or suspect you may have hormone-dependent malignant tumors, such as breast or uterine cancer;
• if you suffer from severe disorders of fat metabolism;
• if you develop pancreatitis or have had it in the past and also have severe elevation of blood fats (triglycerides);
• if you suffer from severe, frequent, and prolonged headaches;
• if you experience sudden sensory disturbances (vision or hearing);
• if you notice movement disorders (particularly signs of paralysis);
• if you observe worsening of epileptic seizures;
• if you suffer from severe depression;
• if you suffer from a certain type of hearing loss (otosclerosis) that worsened during previous pregnancies;
• if you have not had menstrual periods for unknown reasons;
• if you have abnormal thickening of the uterine lining (endometrial hyperplasia);
• if you have vaginal bleeding of unknown origin.

Do not use Belara if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir,
dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other
medicines and Belara”).
If any of these conditions occur while taking BELARA, stop taking Belara immediately.
You must not take Belara, or must stop immediately, if you have a serious risk or multiple risk factors for blood clotting disorders.

Warnings and precautions
Talk to your doctor or pharmacist before taking Belara.

When should you contact a doctor?
Seek urgent medical advice if:

• you notice possible signs of a blood clot that may indicate you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section "Blood clot (thrombosis)"). For a description of the symptoms of these serious side effects, refer to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.

• If you smoke. Smoking increases the risk of serious side effects on the heart and blood vessels when using combined hormonal contraceptives. The 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 conditions develop or worsen while you are using Belara, inform your doctor:

• if you develop symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives with potential breathing difficulties, contact your doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• if you have high blood pressure, elevated levels of fats in the blood, are overweight, or have diabetes (see also section 2). In these cases, the risk of side effects (e.g., heart attacks, embolism, stroke, or liver tumors) is increased by the use of hormonal contraceptives.
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE; a disease affecting the body’s natural defense system);
• if you have hemolytic uremic syndrome (HUS – a blood clotting disorder causing kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
• if you are about to undergo surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Belara;
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Belara increases the risk of developing a
blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and
cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or TEA).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such effects can be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Belara is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Belara, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE (venous thromboembolism) and the type of combined hormonal contraceptive you are using.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Belara is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing cyproterone acetate, such as Belara, about 6–9 women will develop a blood clot in one year.
• The likelihood of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

If you notice an increase in the frequency or intensity of migraine attacks while taking Belara (which may
indicate a disturbance in blood flow to the brain), consult your doctor as soon as possible. Your doctor may
advise you to stop taking Belara immediately.
Factors increasing the risk of developing a blood clot in a vein
The risk of developing a blood clot with Belara is low, but certain conditions can increase this risk. Your risk is higher:

• if you are significantly overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in the leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder.
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Belara several weeks before surgery or during periods of reduced mobility. If you need to stop taking Belara, ask your doctor when you can start taking it again.
• as you get older (especially over 35 years);
• if you have given birth within the last few weeks. The risk of developing a blood clot increases when you have multiple such conditions. Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have other risk factors listed above. It is important to inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to have you stop taking Belara. If any of the above conditions change while you are using Belara, for example, if a close relative develops thrombosis without a known cause or if you gain significant weight, contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems; for example, they can lead to a
heart attack or stroke.
Factors increasing the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Belara is very low
but may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive like Belara, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive.
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes. If you have more than one of these conditions or if one is particularly severe, the risk of developing a blood clot may be even higher. If any of the above conditions change while you are using Belara—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.
• Cancer It has been reported that women with cervical infection caused by certain sexually transmitted viruses (human papillomavirus) who use hormonal contraceptives for a long time may have an increased risk of developing cervical cancer. However, it is unclear how much this is due to other factors (e.g., differences in the number of sexual partners or use of mechanical contraceptive methods). Studies have shown that hormonal contraceptives may cause a slight increase in the risk of breast cancer. During the 10 years after stopping combined oral contraceptives (COCs), this increased risk gradually returns to age-related baseline levels. Since breast cancer is rare in women under 40, the number of additional breast cancer diagnoses in women who have recently used or are currently using COCs is small compared to the overall risk of breast cancer. In rare cases, use of hormonal contraceptives has been associated with benign, and even more rarely malignant, liver tumors, which can cause internal bleeding. If you experience severe stomach pain that does not resolve spontaneously, you should inform your doctor.

The use of chlormadinone acetate has been linked to the development of a generally benign tumor of the
tissue layer between the brain and the skull (meningioma). The risk increases especially when used at
high doses for a prolonged period (several years). If you are diagnosed with a meningioma, your doctor
will discontinue treatment with Belara (see section “Do not take Belara”). If you notice symptoms such as
vision changes (e.g., double or blurred vision), hearing loss or ringing in the ears, loss of smell, headaches
that worsen over time, memory loss, seizures, or weakness in the arms or legs, inform your doctor immediately.

• Other disorders

Psychiatric disorders
Some women using hormonal contraceptives, including Belara, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, consult your doctor as soon as possible for further medical advice.
Many women experience a slight increase in blood pressure while taking hormonal contraceptives. If your blood pressure increases significantly while using Belara, your doctor will advise you to stop taking Belara and may prescribe medication to lower your blood pressure. Once your blood pressure returns to normal, you may resume taking Belara.
If you have had herpes during a previous pregnancy, it may recur with the use of a hormonal contraceptive.
If you have abnormal blood fat levels (hypertriglyceridemia) or if this condition runs in your family, there is an increased risk of pancreatitis. If you develop acute or chronic liver function disorders, your doctor may advise you to stop taking Belara until liver values return to normal. If you experience a new episode of jaundice that occurred previously during a prior pregnancy or with the use of other hormonal contraceptives, your doctor will advise you to discontinue Belara.
If you are diabetic and your blood sugar level is under control and you are taking Belara, your doctor will monitor you closely throughout the time you are taking Belara. It may be necessary to adjust your antidiabetic treatment.
In rare cases, brown patches on the skin (chloasma) may appear, especially if they previously appeared during a prior pregnancy. If you are prone to such patches, avoid prolonged sun exposure or ultraviolet radiation while taking Belara.

• Conditions that may be negatively affected Medical supervision is also required:
  • if you have epilepsy;
  • if you have multiple sclerosis;
  • if you suffer from severe muscle cramps (tetany);
  • if you have migraine (see also section 2);
  • if you have asthma;
  • if you have heart or kidney disease (see also section 2);
  • if you have Huntington's chorea (St. Vitus' dance);
  • if you are diabetic (see also section 2);
  • if you have liver disease (see also section 2);
  • if you have fat metabolism disorders (see also section 2);
  • if you have an immune system disorder (including systemic lupus erythematosus);
  • if you are significantly overweight;
  • if you have high blood pressure (see also section 2);
  • if you have endometriosis (the tissue lining the uterine cavity, called endometrium, is located outside this lining) (see also section 2);
  • if you have varicose veins or suffer from vein inflammation (see also section 2);
  • if you have blood clotting disorders (see also section 2);
  • if you have breast disorders (mastopathy);
  • if you have a benign tumor (fibroid) of the uterus;
  • if you previously suffered from blisters (herpes gestationis) during pregnancy;
  • if you suffer from depression;
  • if you have chronic inflammatory bowel disease (Crohn’s disease, ulcerative colitis). Consult your doctor if you have or have previously had any of the above conditions, or if one develops during treatment with Belara.

Efficacy
If you have missed taking tablets, have vomited or had diarrhea after taking a tablet (see section 3), or are taking other medications (see section 2), the effectiveness of a hormonal contraceptive may be reduced. In very rare cases, metabolic disorders may impair contraceptive efficacy.
Even if you are taking the tablets correctly, a hormonal contraceptive cannot guarantee complete birth control.
Irregular cycle
Especially during the first few months of taking hormonal contraceptives, you may experience irregular vaginal bleeding (intermenstrual bleeding/spotting). If irregular bleeding continues for 3 months or reappears in subsequent regular cycles, consult your doctor.
Spotting may also be a sign of reduced contraceptive effectiveness.
In some cases, after taking Belara for 21 days, withdrawal bleeding may not occur. If you have taken the pills as directed in section 3, it is unlikely that you are pregnant. If BELARA has not been taken according to the instructions before the absence of withdrawal bleeding, a possible pregnancy must be definitively ruled out before continuing use.
Children and adolescents
Belara is indicated only after the onset of first menstruation. The safety and efficacy of Belara in adolescents under 16 years of age have not been established.
Elderly
Belara is not indicated after menopause.
Other medicines and Belara
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Do not use Belara if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, or glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications can cause increases in liver function test results (elevated liver enzymes ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these medications.
Belara can be resumed approximately 2 weeks after completing this treatment. See section “How to take Belara”.
Some medicines may affect the levels of Belara in the blood and may make it less effective in preventing pregnancy, or may cause unexpected bleeding. These include medicines used for:

• epilepsy (e.g., barbiturates, carbamazepine, phenytoin, topiramate, felbamate, oxcarbazepine, barbital, primidone),
• tuberculosis (e.g., rifampicin, rifabutin),
• sleep disorders (modafinil),
• HIV or hepatitis C virus infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz),
• fungal infections (griseofulvin),
• high blood pressure in the pulmonary vessels (bosentan),
• herbal preparations containing St. John's wort ( Hypericum perforatum ). If you wish to use herbal products containing St. John's wort while using Belara, you must first consult your doctor.

Medicines that stimulate intestinal peristalsis (e.g., metoclopramide) and activated charcoal may reduce
the absorption of the active ingredients in Belara and reduce their effects.
During treatment with these medicines, you must use a mechanical contraceptive method (e.g., condom). You must use a mechanical contraceptive method throughout the entire period of concomitant drug therapy and for 28 days after the end of treatment.
If concomitant drug therapy continues after finishing the current pack of COCs, the next pack should be started immediately after the previous one, without the usual break.
If long-term treatment with the above-mentioned active substances is required, you should use non-hormonal contraceptive methods. Ask your doctor or pharmacist for advice.
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 (for pain relief and fever control),
• atorvastatin (lowers blood cholesterol),
• troleandomycin (an antibiotic),
• imidazole antifungals – e.g., fluconazole (for treating fungal infections),
• indinavir (a medication for treating HIV infection).

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

• certain benzodiazepines, e.g., diazepam (for treating sleep disorders),
• cyclosporine (a medicine that suppresses the immune system),
• theophylline (for treating asthma symptoms),
• corticosteroids, e.g., prednisolone (known as steroids, anti-inflammatory medicines for conditions such as lupus, arthritis, psoriasis),
• lamotrigine (for treating epilepsy),
• clofibrate (lowers elevated cholesterol levels),
• paracetamol (for pain relief and fever control),
• morphine (a potent specific analgesic – pain reliever),
• lorazepam (used to treat anxiety disorders).

Also read the package leaflets of other prescribed medications.
Inform your doctor if you are taking insulin or other medicines to lower blood glucose levels. The dosage
of these medicines may need to be adjusted.
Remember that these data also apply if you took one of these medicines shortly before starting Belara therapy.
Administration of Belara may alter certain laboratory tests assessing liver, kidney, adrenal gland, and thyroid function, certain blood proteins, carbohydrate metabolism, and blood coagulation. Changes generally remain within the normal laboratory range. Before having a blood test, inform your doctor that you are taking Belara.
Pregnancy and breastfeeding
Belara is not indicated during pregnancy. If you become pregnant while taking Belara, you must stop treatment immediately. Use of Belara prior to pregnancy does not justify termination of pregnancy.
If you are taking Belara while breastfeeding, remember that milk quantity may decrease and its quality may change. Small amounts of active substances pass into breast milk. Hormonal contraceptives such as Belara should only be taken after breastfeeding has been discontinued.
Driving and operating machinery
No negative effects of combined hormonal contraceptives on the ability to drive or operate machinery are known.
Belara contains monohydrate lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Belara

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Instructions for use
For oral administration.

When and how should Belara be taken?
Take the first tablet from those marked with the corresponding day of the week (e.g. Sun for Sunday), swallowing it whole without chewing. Then take one tablet every day, following the direction of the arrow, preferably at the same time each day, ideally in the evening. If possible, the interval between two tablets should be 24 hours. The day indicators printed on the pack will help you keep track of whether you have taken the tablet for that specific day.

Take 1 tablet daily for 21 days. After this, take a 7-day break. Usually, 2 to 4 days after taking the last tablet, you will experience a withdrawal bleed similar to menstruation. After the 7-day break, start taking tablets from the new pack of Belara, regardless of whether your menstrual bleeding has stopped.

When can you start taking Belara?

If you were not using a hormonal contraceptive (during your last menstrual cycle):
Take the first tablet of Belara on the first day of your menstrual period. Contraceptive protection begins on the first day of tablet intake and continues throughout the 7-day break.

If your period has already started, you may take the first tablet between the 2nd and 5th day of your period, even if menstrual bleeding has not yet ended. However, in this case, you must also use another contraceptive method for the first 7 days (the "7-day rule").

If your menstrual bleeding started more than 5 days ago, you should wait for your next period and then start taking Belara.

If you were previously using another combined hormonal contraceptive:
Take all tablets of your previous medication as usual. Start taking Belara the day after the end of the tablet-free or placebo tablet interval of your previous combined hormonal contraceptive.

If you were using a progestogen-only hormonal contraceptive (mini-pill):
If you are using a progestogen-only contraceptive, you may not have menstrual bleeding. In this case, take the first tablet of Belara the day after taking the last "mini-pill". However, you must also use another contraceptive method for the first 7 days.

If you were using a hormonal injectable contraceptive or a contraceptive implant:
Take the first tablet of Belara on the day the implant is removed or on the day you were scheduled to receive the next injection. However, you must also use another contraceptive method for the first 7 days.

After a curettage or abortion in the first trimester of pregnancy:
You may start taking Belara immediately after a curettage or abortion. In this case, no additional contraceptive method is needed.

After childbirth or abortion in the second trimester of pregnancy:
If you are not breastfeeding, you may start taking Belara 21–28 days after childbirth. No additional contraceptive method is required.

If more than 28 days have passed since childbirth, you must use an additional contraceptive method for the first 7 days.

If you have already had sexual intercourse, you must either exclude the possibility of pregnancy or wait for the next menstrual period before starting Belara.

Remember that you must not take Belara if you are breastfeeding (see section on pregnancy and breastfeeding).

How long should you take Belara?
You may take Belara for as long as desired, provided that its use is not limited by health risks (see section 2). After stopping Belara, your next menstrual period may be delayed by about one week.

What to do in case of vomiting or diarrhoea during Belara treatment?
If you vomit or have diarrhoea within 4 hours of taking a tablet, the active ingredients in Belara may not be fully absorbed. This situation is similar to missing a tablet. Therefore, take another tablet immediately from a new pack. If possible, take the new tablet within 12 hours of taking the last tablet, and continue taking Belara at your usual time. If this is not possible, or if more than 12 hours have passed, follow the instructions in section 3 “If you forget to take Belara” or contact your doctor.

If you take more Belara than you should
There is no evidence of severe symptoms of intoxication from taking multiple tablets in a single dose. Possible symptoms include nausea, vomiting, and, in young girls, slight vaginal bleeding. In such cases, consult a doctor, who may, if necessary, monitor your fluid and electrolyte balance and liver function.

If you forget to take 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 required, and you may continue taking the tablets as usual.

If the delay is more than 12 hours, the contraceptive effect of Belara is no longer guaranteed. In this case, take the missed tablet immediately and continue taking Belara as usual, even if this means taking two tablets in one day. However, you must also use another contraceptive method (e.g. a condom) for the next 7 days. If during these 7 days you finish the tablets in the current pack, immediately start the next pack of Belara without observing the 7-day break (the "7-day rule"). Withdrawal bleeding will likely not occur until after the second pack is completed; however, you may experience increased intermenstrual bleeding or spotting during the intake of the new pack.

The more tablets you miss, the higher the risk of reduced pregnancy protection. If you miss one or more tablets during the first week and had sexual intercourse in the week before the missed tablet(s), consider the possibility of pregnancy. The same applies if you miss one or more tablets and do not have a withdrawal bleed during the tablet-free interval. In these cases, contact your doctor.

If you wish to delay your menstrual period
Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) by starting a new pack of Belara immediately, without taking the 7-day break, continuing until the end of the second pack. During use of the second pack, you may experience spotting or breakthrough bleeding. After the usual 7-day break, continue with the next pack. Before deciding to delay your period, consult your doctor.

If you wish to shift the first day of your menstrual period
If you take the tablets as directed, your menstrual period/withdrawal bleeding will occur during the tablet-free interval. If you wish to shift this day, you may do so by shortening the tablet-free interval (but never extending it!). For example, if the tablet-free interval starts on Friday and you wish to shift it to Tuesday (3 days earlier), you should start the new pack 3 days earlier than usual. If you shorten the tablet-free interval too much (e.g. to 3 days or less), you may not experience any bleeding during this interval. Spotting or breakthrough bleeding may occur.

If you have any doubts about how to proceed, consult your doctor.

If you stop treatment with Belara
When you stop taking Belara, your ovaries will quickly return to full activity, and you may become pregnant.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to Belara, inform your doctor. Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with potential breathing difficulties (see also section “Warnings and precautions”).

An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the various risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before using Belara”.

The frequencies of reported side effects are defined as follows:
Very common: may affect more than 1 in 10 people
Nausea, vaginal spotting, menstrual pain, absence of menstruation.

Common: may affect up to 1 in 10 people
Depression, nervousness, irritability, dizziness, headache (and/or worsening of headache), visual disturbances, vomiting, acne, feeling of heaviness, abdominal pain, fatigue, fluid retention, weight gain, increased blood pressure.

Uncommon: may affect up to 1 in 100 people
Fungal vaginal infection, benign changes in breast connective tissue, hypersensitivity to the drug including allergic reaction, changes in blood lipids including increased triglycerides, decreased libido, stomach ache, intestinal rumbling, diarrhoea, pigmentation disorders, brown spots on the face, hair loss, dry skin, increased sweating, back pain, muscle problems, breast secretion.

Rare: may affect up to 1 in 1,000 people
Vaginal inflammation, increased appetite, conjunctivitis, discomfort when wearing contact lenses, hearing loss, tinnitus, high blood pressure, low blood pressure, circulatory collapse, varicose veins, urticaria, eczema, inflamed skin, itching, worsening of psoriasis, excessive hair growth on body or face, breast enlargement, longer and/or heavier menstrual periods, premenstrual syndrome (physical and emotional problems before the start of menstruation).

• Harmful blood clots in a vein or an artery, for example:
  • in a leg or foot (DVT)
• in a lung (PE)
• heart attack
• stroke
• mini-stroke or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestines, kidneys or eye. The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Very rare: may affect up to 1 in 10,000 people
Erythema nodosum.

In addition, the following adverse reactions have been reported during post-marketing use and are associated with the active substances, ethinylestradiol and chlormadinone acetate: weakness and allergic reactions including swelling of the deeper layers of the skin (angioedema).

Combined hormonal contraceptives have also been associated with an increased risk of serious diseases and side effects:

• risk of blockage of veins and arteries (see section 2)
• risk of gallbladder disease (see section 2)
• risk of tumours (e.g. liver tumours, which in isolated cases have caused severe, even fatal, intra-abdominal haemorrhage; cervical and breast cancer; see section 2)
• worsening of chronic inflammatory bowel diseases (Crohn’s disease, ulcerative colitis; see section 2). Please read carefully the information provided in section 2 and, if necessary, consult your doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Belara

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton and on the blister (therapy cycle)
after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose
of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Belara contains

• The active substances are ethinylestradiol and chloromadinone acetate. One film-coated tablet contains 0.030 mg of ethinylestradiol and 2.0 mg of chloromadinone acetate.
• The other components are:

Tablet core: lactose monohydrate, maize starch, povidone K 30, magnesium stearate.
Coating: hypromellose, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E171), red iron oxide (E172).

Description of the appearance of Belara and contents of the pack
Belara is available in packs of 21 round, slightly pink, film-coated tablets per blister (one treatment cycle).
Pack sizes: 1 × 21, 3 × 21, 6 × 21, 13 × 21 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary
For any information regarding this medicinal product, please contact the Marketing Authorisation Holder.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Belara – Filmtabletten
Belgium Bellina 0.03 mg/2 mg – Filmomhulde tabletten
France Belara comprimés pelliculés
Germany Belara Filmtabletten
Italy Belara 2 mg/0.03 mg compresse rivestite con film
Luxembourg Bellina 0.03 mg/2 mg – Filmomhulde tabletten
Portugal Belara 2 mg + 0.03 mg comprimidos
Slovenia Belara 0.03 mg/2 mg filmsko obložene tablete
Spain Belara comprimidos recubiertos con película.