BELARA 2 mg/0.03 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Belara 2 mg/0.03 mg film-coated tablets

ethinylestradiol/chlormadinone acetate

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

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 having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”)

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may harm them.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Belara is and what it is used for
2. What you need to know before you start taking Belara
3. How to take Belara
4. Possible side effects
5. Storing Belara
6. Package contents and further information

1. What Belara is and what it is used for

Belara is an oral hormonal contraceptive. If this type of hormonal contraceptive contains two hormones like Belara, it is also called a "combined hormonal contraceptive" (CHC). The 21 tablets in the blister pack for one cycle contain the same amount of both hormones, so Belara is also called a "monophasic preparation".

Hormonal contraceptives like Belara will not protect you against HIV (AIDS) or other sexually transmitted diseases. Only condoms can help you with this.

2. What you need to know before you start taking Belara

General considerations

Before you start using Belara, you should read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 “Blood clots”).

Before you start taking Belara, your doctor will perform a general medical examination and a gynecological examination, rule out pregnancy, and considering the contraindications and precautions, decide if Belara is suitable for you. These medical examinations should be performed annually while you are taking Belara.

Do not take Belara

Do not use Belara if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6);

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE) or in other organs;
• If you have the initial symptoms of thrombosis, inflammation of the veins or embolism, such as brief stabbing pain, chest pain or tightness in the chest;
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies;
• If you need an operation or if you spend a long time sitting or lying down (see section “Blood clots”);

• If you have diabetes and have significant fluctuations in your blood sugar levels;
• If you have high blood pressure that is difficult to control or that has increased significantly (values consistently above 140/90 mm Hg);
• If you have ever had a heart attack or a stroke;
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms);
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fat in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia
• If you have (or have ever had) a type of migraine called “migraine with aura”;
• If you have liver inflammation (e.g., due to a virus) or jaundice, as long as your liver values have not returned to normal;
• If you have generalized itching or suffer from alterations in bile flow and especially during a previous pregnancy or during treatment with estrogens;
• If your bilirubin (a breakdown product of the blood pigment) in the blood is elevated, for example due to a congenital disorder of excretion (Dubin-Johnson syndrome or Rotor syndrome);
• if you have a meningioma or have ever been diagnosed with a meningioma (a usually benign tumor of the tissue layer between the brain and the skull);
• if you have a liver tumor or have had one in the past;
• If you have severe stomach pain, enlargement of the liver or signs of bleeding in the abdomen;
• If you suffer from porphyria (a disorder of the blood pigment metabolism), whether for the first time or not.
• If you have or have had or are suspected of having a malignant tumor that depends on the action of hormones, e.g., breast or uterine cancer;
• If you suffer from severe lipid metabolism disorders.
• If you suffer from pancreatitis (inflammation of the pancreas) or a history of it, in case it is associated with severe hypertriglyceridemia (very high levels of triglycerides in the blood);

• If you suffer from frequent or persistent episodes of severe headaches;
• If you have sudden changes in perception (vision or hearing);

• If you have movement disorders (in particular, signs of paralysis).
• If you experience 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 had the absence of a menstrual period (period) for an unknown reason;
• If you have an abnormal thickening of the mucous membranes of the uterus (endometrial hyperplasia);
• If you experience unjustified vaginal bleeding.

Do not use Belara if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section Other medicines and Belara).

If one of these disorders occurs during the administration of Belara, you should stop taking Belara immediately. And go to your doctor immediately/inform your doctor.

You should not take Belara, or you should stop taking it immediately, if you have a serious risk factor or multiple risk factors for arterial or venous thrombosis (see section 2).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Belara.

Tell your doctor if you suffer from any of the following conditions.

• If you smoke, as tobacco increases the risk of serious side effects for the heart and blood vessels with the use of combined hormonal contraceptives. This risk increases with age and with tobacco consumption. It especially affects women over 35 years old. Smoker women over 35 years old should use other contraceptive methods.

If the condition develops or worsens while you are using Belara, you should also 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 with possible difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema;
• If you have high blood pressure, abnormally high levels of lipids in the blood, overweight or diabetes (see also section 2). In this case, the risk of serious side effects associated with combined hormonal contraceptives (such as myocardial infarction, embolism, stroke or liver tumors) increases;
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• If you have sickle cell anemia (a hereditary disease of red blood cells);
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas);
• If you need an operation or spend a long time sitting or lying down (see section 2 “Blood clots”);
• If you have recently given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Belara after childbirth.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis);
• If you have varicose veins.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Belara increases your risk of having a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• in the veins (this is called “venous thrombosis”, “venous thromboembolism” or VTE).
• in the arteries (this is called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Belara is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent 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 blood clots in the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in your leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from your leg and lodges in your lung, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ such as the eye (retinal vein thrombosis)

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year that you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Belara, your risk of a blood clot returns to normal within a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Belara is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 will have a blood clot in a year.
• It is not yet known how the risk of a blood clot with Belara compares with the risk with a combined hormonal contraceptive that contains levonorgestrel.
• The risk of a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below)

If you notice an increase in the frequency or severity of migraine attacks during the use of Belara (which may indicate a disorder of blood supply to the brain), consult your doctor as soon as possible, who may advise you to stop taking Belara immediately.

Factors that increase your risk of a blood clot in a vein

The risk of a blood clot with Belara is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung or other organ at a young age (i.e., before the age of about 50). In this case, you may have a hereditary disorder of blood clotting.
• If you need an operation or if you spend a long time sitting or lying down due to an injury or illness or if you have a leg in a cast. You may need to stop using Belara several weeks before the operation or while you have less mobility. If you need to stop using Belara, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have recently given birth.

The risk of a blood clot increases the more conditions you have.

Long-haul flights (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is important to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using Belara.

If any of the above conditions change while you are using Belara, for example, a close relative experiences a thrombosis without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of a heart attack or stroke due to Belara is very small, but it can increase:

• With age (above about 35 years).
• If you smoke.When using a combined hormonal contraceptive like Belara, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, the risk of a blood clot may be increased further.

If any of the above conditions change while you are using Belara, for example, you start smoking, a close relative experiences a thrombosis without a known cause or you gain a lot of weight, inform your doctor.

Tumors

In some studies, an increased risk of cervical cancer has been observed in women infected with a sexually transmitted virus (human papillomavirus) and who have been taking the pill for a long time. However, it is not clear to what extent these results may be due to other factors (e.g., multiple sexual partners, use of barrier contraceptive methods).

Studies have shown a slight increase in the risk of breast cancer in women who are taking combined hormonal contraceptives.

During the 10 years following the cessation of use of CHC, this risk gradually returns to the basic risk associated with age. Since breast cancer is rare in women under 40 years old, the excess number of breast cancer diagnoses in current and recent users of CHC is small in relation to the overall risk.

and breast cancer.

Rarely, cases of benign liver tumors, and even more rarely malignant, have been reported with the use of hormonal contraceptives. These can cause dangerous internal bleeding. If you experience severe abdominal pain in the stomach that does not subside spontaneously, you should consult 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 your treatment with Belara (see section "Do not take Belara"). If you notice symptoms such as changes in vision (e.g., double or blurred vision), hearing loss or ringing in the ears, loss of smell, worsening headaches over time, memory loss, seizures, or weakness in arms or legs, you should inform your doctor immediately.

Other pathologies

Psychiatric disorders

Some women who use hormonal contraceptives, such as Belara, have reported depression or a depressive mood. Depression can be severe and sometimes can induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Many users experience a slight increase in blood pressure during the use of hormonal contraceptives. If your blood pressure increases significantly while taking Belara, you should consult your doctor, who will advise you to discontinue treatment and prescribe a medication to reduce blood pressure. The use of Belara can be resumed once blood pressure returns to normal values.

If you have suffered from gestational herpes in a previous pregnancy, it may reappear during the use of hormonal contraceptives.

If you have lipid value disorders in the blood (hypertriglyceridemia) or have a family history, there is a greater risk of pancreatitis. In case of acute or chronic alterations of liver function, your doctor may advise you to discontinue treatment with Belara until liver function values return to normal. If you have suffered from jaundice during a previous pregnancy or while taking a hormonal contraceptive, and it reappears, your doctor will advise you to stop taking Belara.

If you are diabetic and your blood sugar level is controlledand you take Belara, your doctor will closely monitor you while you are taking Belara. It may be necessary to modify your diabetes treatment.

Rarely, brown spots may appear on the skin (chloasma), especially if they appeared in a previous pregnancy. If you know you are prone to this, you should avoid long periods of sun exposure or ultraviolet radiation when taking Belara.

Diseases that may be negatively affected

You will also need special medical supervision if you suffer from:

• epilepsy;
• multiple sclerosis;
• severe muscle cramps (tetany);
• migraine (see also section 2);
• asthma;
• heart or kidney disease (see also section 2);
• chorea minor (Sydenham's chorea);
• diabetes (see also section 2);
• liver disease (see also section 2);
• lipid metabolism disorders (see also section 2);
• diseases of the immune system (including systemic lupus erythematosus);
• excessive weight;
• high blood pressure (see also section 2);
• endometriosis (the tissue that lines the uterine cavity, called endometrium, is found outside this lining) (see also section 2);
• varices or vein inflammation (see also section 2);
• blood coagulation disorders (see also section 2);
• breast disease (mastopathy);
• benign tumors (myoma) in the uterus;
• blisters (gestational herpes) in a previous pregnancy;
• depression;
• chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).

Consult your doctor if you have, or have had, any of the disorders mentioned or if they occur during the administration of Belara.

Efficacy

If you do not take the contraceptive regularly, have vomiting or diarrhea after administration (see section 3), or take other medications simultaneously (see section 2), the efficacy of the contraceptive may be affected. In very rare cases, metabolic disorders can affect contraceptive efficacy.

Even taking hormonal contraceptives correctly, they do not completely guarantee that you will not become pregnant.

Irregular bleeding

Particularly in the first few months of using hormonal contraceptives, irregular vaginal bleeding (bleeding or intermenstrual spotting) may appear. If the bleeding persists or occurs for 3 months, or reappears after several consecutive cycles, consult your doctor.

Spotting may also be a sign of reduced contraceptive effect. In these cases, the withdrawal bleeding may not appear after taking Belara for 21 days. If you have taken Belara following the instructions described below in section 3, it is unlikely that you are pregnant. If you have not taken Belara following these instructions before the first absence of withdrawal bleeding, you should rule out pregnancy before continuing use.

Children and adolescents

Belara is only indicated after menarche. The safety and efficacy of Belara in adolescents under 16 years of age have not been established. No data are available.

Elderly patients

Belara is not indicated after menopause.

Other medications andBelara

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

Do not use Belara if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications can cause increases in blood parameters that measure liver function (increase in liver enzyme ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Belara can be restarted approximately 2 weeks after completing this treatment. See section "Do not take Belara".

• Some medications may have some influence on Belara blood levels and make it less effective in preventing pregnancy, or may cause unexpected bleeding. These include medications 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 infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• fungal infections (griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• preparations containing St. John's Wort (Hypericum perforatum). If you need to take preparations containing St. John's Wort while taking Belara, you should consult your doctor first.

Medications that stimulate intestinal movement (e.g., metoclopramide) and activated charcoal can affect the absorption of Belara's active ingredients and reduce their effects.

During treatment with these medications, you should use additional barrier contraceptive methods (e.g., condoms). These additional barrier methods should be used throughout the duration of concomitant treatment and for 28 days after the end of treatment. If concomitant treatment with another medication is prolonged beyond the days for which the hormonal contraceptive combination blister is intended, you should start with the next Belara blister without leaving the usual rest interval.

You should not take medicinal plants containing St. John's Wort with Belara.

If you need to undergo prolonged treatment with the aforementioned active substances, you should use non-hormonal contraceptive methods. Consult your doctor or pharmacist.

Interactions between Belara and other medications can increase or intensify the adverse effects of Belara. The following medications can negatively affect the tolerability of Belara:

• ascorbic acid (a preservative, also known as vitamin C),
• paracetamol (relieves pain and controls fever),
• atorvastatin (lowers high cholesterol levels),
• troleandomycin (an antibiotic),
• imidazole antifungals – e.g., fluconazole (to treat fungal infections),
• indinavir (for the treatment of HIV infection).

Belara can influence the effect of other medications. The efficacy or tolerability of the following medications may be reduced by Belara:

• certain benzodiazepines, e.g., diazepam (for the treatment of sleep disorders),
• cyclosporine (an immunosuppressive drug),
• theophylline (treatment of asthma symptoms),
• corticosteroids, e.g., prednisolone (known as steroids, anti-inflammatory medications for e.g., lupus, arthritis, psoriasis),
• lamotrigine (for the treatment of epilepsy),
• clofibrate (lowers high cholesterol levels),
• paracetamol (relieves pain and controls fever),
• morphine (a potent specific analgesic relieves pain),
• lorazepam (used for the treatment of anxiety).

Read the package insert of the other medications that have been prescribed to you.

Tell your doctor if you are taking insulin or other medications to lower blood sugar levels. It may be necessary to change the dose of these medications.

Remember that the details mentioned above also apply if you have taken any of these medications shortly before starting Belara administration.

The administration of Belara can affect the results of some laboratory tests, such as liver, adrenal, and thyroid function tests, certain plasma proteins, carbohydrate metabolism, and blood coagulation. The changes usually remain within the normal laboratory range. Inform your doctor that you are taking Belara before undergoing a laboratory test.

Pregnancy and lactation

Belara is not indicated during pregnancy. If you become pregnant while taking Belara, you should stop taking it immediately. However, previous use of Belara does not justify the interruption of pregnancy.

If you take Belara, you should remember that milk production may decrease and its quality may be affected. Very small amounts of the active ingredients pass into breast milk. Hormonal contraceptives like Belara should only be used once the lactation period has ended.

Driving and using machines

No negative effects of combined hormonal contraceptives on the ability to drive or operate machinery have been described.

This medication contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Belara

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Method of Administration

Oral.

How and When Should You Take Belara?

Extract the first tablet, choosing the one marked with the correct day of the week (e.g., "Sun" on Sunday), and swallow it without chewing. Then take another tablet every day, following the direction of the arrow, preferably at the same time of day, ideally at night. If possible, the interval between taking the tablets should always be 24 hours. The printed days on the blister pack of the cycle allow you to check each day if you have already taken the tablet for that day.

Take one tablet daily for 21 consecutive days. This is followed by a 7-day break. Normally, withdrawal bleeding, equivalent to menstrual period, will begin 2-4 days after taking the last tablet. After the 7-day break, continue taking the tablets from the next blister pack of Belara, whether or not bleeding has stopped.

When Can You Start Taking Belara?

If you have not taken any hormonal contraceptive previously (during the last menstrual cycle)

Take your first Belara tablet on the first day of your next menstrual cycle.

Contraception begins on the first day of administration and continues during the 7-day break.

If your period has already started, take the first tablet on the 2nd-5th day of your period, regardless of whether bleeding has stopped or not. However, in this case, you must use additional barrier contraceptive methods during the first 7 days of administration (7-day rule).

If your period started more than five days ago, wait until the next period to start taking Belara.

If you have previously taken another combined hormonal contraceptive

Take all the tablets from the old blister pack following the usual guidelines. You should start taking Belara the day after the usual break interval between tablet intake or the day after finishing the placebo tablets from your previous combined hormonal contraceptive.

If you have taken a progestin-only hormonal contraceptive

If you are taking a hormonal contraceptive that only contains a progestin, you may not have withdrawal bleeding equivalent to a menstrual period. In this case, take the first Belara tablet the day after taking the last minipill. In this case, you must take additional contraceptive measures during the first seven days.

If you have previously used hormonal contraceptive injections or implants

Take the first Belara tablet on the same day as the implant removal or the day corresponding to the next injection. In this case, you must take additional contraceptive measures during the first seven days.

If you have had a spontaneous or induced abortion in the first three months of pregnancy

After a spontaneous or induced abortion, you can start taking Belara immediately. In this case, you do not need to use any additional contraceptive method.

If you have given birth or have had a spontaneous or induced abortion between the third and sixth month of pregnancy

If you are not breastfeeding, you can start taking Belara 21-28 days after delivery. You do not need to use any additional barrier contraceptive method.

However, if more than 28 days have passed since delivery, you must use additional barrier contraceptive methods during the first seven days.

If you have already had sexual intercourse, you should rule out the possibility of pregnancy or wait for the next period before starting to take Belara.

Remember that you should not take Belara if you are breastfeeding (see section "Pregnancy and Breastfeeding").

How Long Can You Take Belara?

You can take Belara for as long as you desire, as long as there are no risks to your health (see section 2). Once you stop taking Belara, the start of your next cycle may be delayed by approximately one week.

What Should You Do in Case of Vomiting or Diarrhea While Taking Belara?

If vomiting or diarrhea occur within 4 hours after taking the tablets, it is possible that the absorption of the active ingredients of Belara may be incomplete. This situation is similar to that which occurs if you forget to take a tablet and have to take a new tablet from a new blister pack immediately. Whenever possible, take the new tablet before 12 hours from the ingestion of the last tablet and then continue taking Belara following your usual schedule. If it is not possible or more than 12 hours have passed, follow the instructions in section 3, "If you forgot to take Belara," or contact your doctor.

If You Take More Belara Than You Should

There is no evidence that serious toxicity symptoms occur after ingesting a high number of tablets in one dose. Symptoms such as nausea, vomiting, and, particularly in girls, light vaginal bleeding may appear. In this case, consult your doctor. If necessary, they will monitor electrolytes and fluid balance, as well as liver function.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 915620420, indicating the medication and the amount ingested.

If You Forgot to Take Belara

• If you forgot to take a tablet at the usual time, you should take it as soon as possible within the next 12 hours. In this case, no other contraceptive methods are necessary, and you can continue taking the tablets as usual.

• If the interval is more than 12 hours, the contraceptive effect of Belara is not guaranteed. In this case, take the forgotten tablet immediately and continue taking Belara following your usual schedule. This may even mean that you have to take 2 tablets on the same day. In this case, you must use additional contraceptive methods (e.g., condoms) during the next seven days. If during these seven days you finish the blister pack you started, begin taking the tablets from the next Belara blister pack immediately, i.e., there should be no break between blister packs (7-day rule). Probably, withdrawal bleeding will not occur until you have finished the next blister pack. However, you may experience intermenstrual bleeding or spotting while taking the tablets from the new blister pack.

The more tablets you have forgotten, the higher the risk that pregnancy protection may be reduced. If you have forgotten one or more tablets in the first week and have had sexual intercourse in the week prior to forgetting the tablets, you should be aware that there is a risk of pregnancy. The same applies if you forgot one or more tablets and did not have bleeding during the next break interval. In these cases, consult your doctor.

If You Want to Delay Your Menstrual Period

Although it is not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new blister pack if you start taking a second Belara blister pack instead of continuing with the break interval between tablet intake. You may experience spotting (drops or spots of blood) or intermenstrual bleeding during the use of the second blister pack. After the 7-day break interval, you will continue with the next blister pack.

You should ask your doctor for advice before deciding to delay your menstrual period.

If You Want to Change the First Day of Your Menstrual Period

If you take the tablets according to the instructions, your menstrual period/withdrawal bleeding will begin during the break interval between tablet intake. If you need to change that day, you can do so by shortening (but never lengthening) the break interval between tablet intake. For example, if your break interval between tablet intake starts on Friday and you want to change it to Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual. If you make the break interval between tablet intake too short (e.g., 3 days or less), you may not experience bleeding during this period. You may then experience spotting (drops or spots of blood) or intermenstrual bleeding.

If you are unsure how to proceed, consult your doctor for advice.

If You Interrupt Treatment with Belara

When you stop taking Belara, ovarian function will be completely restored soon, and you may become pregnant.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them. If you suffer from any side effect, especially if it is severe and persistent, or if you have any change in health that you think may be due to Belara, consult your doctor.

Contact a 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 urticaria with possible difficulty breathing (see also the section "Warnings and Precautions").

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2, "What you need to know before taking Belara."

The frequencies with which side effects have been reported are defined as follows:

Very Common:may affect more than 1 in 10 people

Nausea, vaginal discharge, menstrual pain, absence of menstruation.

Common:may affect up to 1 in 10 people

Depression, nervousness, irritability, dizziness, migraine (and/or worsening of these), 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

Vaginal fungal infection, benign changes in breast tissue, hypersensitivity to the medication, including allergic skin reactions, changes in blood lipids, including increased triglycerides, decreased libido, stomach pain, intestinal noises, diarrhea, pigmentation problems, brown spots on the face, hair loss, dry skin, tendency to sweat, back pain, muscle disorders, breast secretion.

Rare:may affect up to 1 in 1,000 people

Vaginal inflammation, increased appetite, conjunctivitis, discomfort when wearing contact lenses, deafness, tinnitus, hypertension, hypotension, blockage of blood circulation, varicose veins, urticaria, eczema, skin inflammation, pruritus, worsening of psoriasis, excessive body or facial hair, breast enlargement, prolonged and/or increased menstruation, premenstrual syndrome (physical and emotional disorders before starting menstruation).

Harmful blood clots in a vein or artery, for example:

• in a leg or foot (i.e., DVT).
• in a lung (i.e., PE).
• heart attack.
• stroke.
• stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA).
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances of having 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.

Additionally, the following adverse reactions associated with the active ingredients ethinylestradiol and chlormadinone acetate have been reported in post-marketing experience: weakness and allergic reactions, including inflammation of the deep layers of the skin (angioedema).

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

• risk of venous and arterial thrombosis (see section 2),
• risk of bile duct diseases (see section 2)
• risk of tumors (e.g., liver tumors, which in isolated cases have caused potentially fatal bleeding in the abdominal cavity, cervical cancer or breast cancer (see section 2),
• worsening of chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, see section 2).

Read carefully the information presented in section 2, and if necessary, consult your doctor immediately.

Reporting of Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Belara

Keep this medication out of sight and reach of children.

Do not store above 30°C.

Do not use this medication after the expiration date shown on the box and on the blister pack (cycle pack) after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Belara

• The active ingredients are chlormadinone acetate and ethinylestradiol. Each film-coated tablet contains 2.0 mg of chlormadinone acetate and 0.030 mg of ethinylestradiol.

• The other ingredients are:

Core of the tablet: lactose monohydrate, cornstarch, povidone K 30, magnesium stearate.

Coating of the tablet: hypromellose, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E 171), red iron oxide (E 172).

Appearance of the Product and Package Contents

Belara is presented in blister packs containing 21 film-coated tablets, round, pale pink in color, for one cycle per blister pack.

Packages: 1x21, 3x21, 6x21, 13x21 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Gedeon Richter Plc.

Gyömroi út 19-21

1103 Budapest

Hungary

Manufacturer

Gedeon Richter Plc.

Gyömroi út 19-21

1103 Budapest

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

Gedeon Richter Ibérica S.A.

Sabino Arana, 28 4º 2º

08028 Barcelona

+34 93 2034300

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany Belara Filmtabletten

Austria Belara – Filmtabletten

Belgium Bellina 0.03 mg/2 mg – Filmomhulde tabletten

Slovenia Belara 0.03 mg/2 mg filmsko obložene tablete

Spain Belara 2 mg / 0.03 mg film-coated tablets

France Belara comprimés pelliculés

Italy Belara 0.03 mg/2 mg compresse rivestite con film

Luxembourg Bellina 0.03 mg/2 mg – Filmomhulde tabletten

Portugal Belara 2 mg + 0.03 mg tablets

Date of the Last Revision of this Leaflet:February 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/