BELARA DIARIO 2 mg/0.03 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Belara daily2 mg/0.03 mgfilm-coated tablets

ethinylestradiol/chlormadinone acetate

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may have. 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 aware and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Read the entire package leaflet carefully before starting to take this medicine, because it contains important information for you.

• Keep this package leaflet, as you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Belara daily and what is it used for

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

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

2. What you need to know before taking Belara daily

General considerations

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

Do not take Belara daily

You should not use Belara daily 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 (hypersensitive) to the active ingredients or to any of the other components of this medicine;
• If you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs;
• If you have 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 lot of time without getting up (see section "Blood clots");

• If you have diabetes and have significant fluctuations in blood sugar levels;
• If you have uncontrolled high blood pressure or significantly increased blood pressure (constantly above 140/90 mmHg);
• If you have ever had a heart attack or stroke;
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and can 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 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 (breakdown product of 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 or have had a liver tumor;
• If you have severe stomach pain, enlargement of the liver or signs of bleeding in the abdomen;
• If you have porphyria (a disorder of blood pigment metabolism), whether for the first time or not.
• If you have or have had a malignant tumor that depends on the action of hormones, e.g. breast or uterine cancer;
• If you have severe lipid metabolism disorders;
• If you have pancreatitis (inflammation of the pancreas) or a history of it, if it is associated with severe hypertriglyceridemia (very high levels of triglycerides in the blood);

• If you experience unusually intense, frequent, or persistent headaches;
• If you have sudden changes in perception (vision or hearing);

• If you experience movement disorders (especially signs of paralysis);
• If you experience worsening of epileptic seizures;
• If you have severe depression;
• If you have 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 experience abnormal thickening of the mucous membranes (singular) of the uterus (endometrial hyperplasia);
• If you experience unexplained vaginal bleeding for any reason.

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

Stop taking Belara daily immediately if you experience one of these disorders during the administration of Belara daily.

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

Warnings and precautions.

Consult your doctor or pharmacist before starting to take Belara daily.

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 tobacco consumption. Smoking particularly 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 daily, 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 can cause or worsen the symptoms of hereditary and acquired angioedema;
• If you have high blood pressure, abnormally high blood lipid levels, overweight, or diabetes (see also sections "Do not take Belara daily" and "Be careful with Belara daily", "Other diseases"). 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 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 lot of time without getting up (see section 2 "Blood clots");
• If you have just given birth, you are at a higher risk of suffering from blood clots. You should ask your doctor when you can start taking Belara daily 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 daily increases your risk of suffering from 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 (which is called "venous thrombosis", "venous thromboembolism" or VTE).
• in the arteries (which 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 essential to remember that the overall risk of a harmful blood clot due to Belara daily 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 of the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein of 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 in which 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 an interruption 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 daily, 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 daily is small.

• Of every 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.
• Of every 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 daily compares to 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 intensity of migraine attacks during the administration of Belara daily (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 daily immediately.

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

The risk of a blood clot with Belara daily 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 lot of time without getting up due to an injury or illness or if you have your leg in a cast. You may need to interrupt the use of Belara daily several weeks before the operation or while you have less mobility. If you need to interrupt the use of Belara daily, ask your doctor when you can start using it again;
• As you get older (especially above about 35 years);
• If you have given birth less than a few weeks ago.

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

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

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide to interrupt the use of Belara daily.

If any of the above conditions change while you are using Belara daily, for example, a close relative experiences a thrombosis without a known cause or you gain much 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 stroke.

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

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

• With age (above about 35 years);
• If you smoke.When you use a combined hormonal contraceptive like Belara daily, 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 a high level 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 further increased.

If any of the above conditions change while you are using Belara daily, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain much 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 can be attributed to other factors (e.g. multiple sexual partners, use of barrier contraceptive methods).

Studies have revealed a slight increase in the risk of breast cancer in women who take combined hormonal contraceptives. During a period of 10 years after stopping the use of combined hormonal contraceptives, this increased risk gradually returned to the age-related baseline risk. Since breast cancer is rare in women under 40 years old, the increase in

Years, the excessive number of breast cancer diagnoses in current and recent AHC users is small in relation to the global risk of breast cancer.

Rarely, cases of benign and, even more rarely, malignant liver tumors have been reported with hormonal contraceptive treatment. 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 clormadinone 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 interrupt your treatment with Belara daily (see section "Do not take Belara daily"). 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, headaches that worsen over time, memory loss, seizures, or weakness in arms or legs, you should inform your doctor immediately.

Other pathologies

Psychiatric disorders

Some women using hormonal contraceptives, such as Belara daily, 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 blood pressure increases considerably while taking Belara daily, you should consult your doctor, who will advise you to interrupt treatment and prescribe a medication to reduce blood pressure. The use of Belara daily 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 higher risk of pancreas inflammation. In case of acute or chronic alterations of liver function, your doctor may advise you to interrupt treatment with Belara daily until liver function values return to normal. If you have suffered from jaundice during a previous pregnancy or while using a hormonal contraceptive, and it reappears, your doctor will advise you to stop taking Belara daily.

If you are diabetic and your blood sugar level is controlledand you take Belara daily, your doctor will closely monitor you while you are taking Belara daily. 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 daily.

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 "Do not take Belara daily");
• asthma;
• heart or kidney disease (see also "Do not take Belara daily");
• chorea minor (Sydenham's chorea);
• diabetes (see also sections "Do not take Belara daily" and "Have special care with Belara daily", "Other diseases");
• liver disease (see also "Do not take Belara daily");
• lipid metabolism disorders (see also "Do not take Belara daily");
• immune system diseases (including systemic lupus erythematosus);
• excessive weight;
• high blood pressure (see also "Do not take Belara daily");
• endometriosis (the tissue that lines the uterine cavity, called endometrium, is found outside this lining) (see also "Do not take Belara daily");
• varices or vein inflammation (see also "Do not take Belara daily");
• blood coagulation disorders (see also "Do not take Belara daily");
• 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 mentioned disorders or if they occur during the administration of Belara daily.

Efficacy

If you do not take the contraceptive regularly, have vomiting or diarrhea after administration (see "If you interrupt treatment with Belara daily") or take other medications simultaneously (see "Other medications and Belara daily"), the efficacy of the contraceptive may be affected. In very rare cases, metabolic disorders 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 months of using hormonal contraceptives, irregular vaginal bleeding (bleeding or intermenstrual spotting) may appear. If the bleeding continues 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 daily for 21 days. If you have taken Belara daily following the instructions described below in section 3, it is unlikely that you are pregnant. If you have not taken Belara daily following these instructions, before the first absence of withdrawal bleeding, you should rule out pregnancy before continuing use.

Children and adolescents

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

Elderly patients

Belara daily is not indicated after menopause.

Other medications and Belara daily

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

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

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

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

Some medications may have some influence on the blood levels of Belara daily and make it less effective in preventing pregnancy, or may cause unexpected bleeding. These include medications used for the treatment of:

• epilepsy (such as barbiturates, carbamazepine, phenytoin, topiramate, felbamate, oxcarbazepine, barbexaclone, primidone),
• tuberculosis (e.g., rifampicin, rifabutin),
• sleep disorders (modafinil),
• HIV and hepatitis C virus infection (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 products containing St. John's Wort while taking Belara daily, you should consult your doctor first.

Medications that stimulate intestinal movement (e.g., metoclopramide) and activated charcoal may affect the absorption of the active substances of Belara daily.

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

If long-term treatment with the above-mentioned substances is necessary, you should use non-hormonal contraceptive methods. Consult your doctor or pharmacist.

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

• 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 (for treating fungal infections),
• indinavir (for treating HIV infection).

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

• certain benzodiazepines, e.g., diazepam (for treating sleep disorders),
• cyclosporin (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 treating epilepsy),
• clofibrate (lowers high cholesterol levels),
• paracetamol (relieves pain and controls fever),
• morphine (a potent specific analgesic that relieves pain),
• lorazepam (used for treating anxiety).

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

Inform 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 the administration of Belara daily.

The administration of Belara daily may affect the result 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 daily before undergoing a test.

Pregnancy and lactation

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

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

Driving and using machines

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

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 Daily

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

The blisters in each package are designed to help you remember to take the tablets. Each blister contains 28 tablets: 21 active pale pink tablets (tablets 1-21) and 7 inactive white tablets (tablets 22-28).

Administration Method

Oral route.

How and When to Take Belara Daily

Remove the first active pale pink tablet from the starting position in the blister and swallow it without chewing. You will take:

• one active pale pink tablet daily, following the direction of the arrow, for 21 days, and then
• one inactive white tablet daily, following the direction of the arrow, for 7 days.

Try to take the tablet at the same time every day, preferably at night. If possible, the interval between taking two tablets should always be 24 hours. When you start taking Belara daily, mark the day of the week on the blister of the cycle, which will allow you to determine the day of the week corresponding to each number printed on the blister of the cycle and check each day if you have already taken the tablet for that day.

Normally, withdrawal bleeding, equivalent to menstrual period, will begin 2-4 days after taking the last active pale pink tablet. After finishing the 28 tablets, continue taking the tablets from the next blister of Belara daily, whether or not bleeding has stopped.

When Can You Start Taking Belara Daily?

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

Take your first active pale pink tablet of Belara daily on the first day of your next menstrual cycle.

Contraception begins on the first day of administration and continues during the 7-day interval with inactive tablets.

If your period has already started, take the first active pale pink 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, please wait until the next period to start taking Belara daily.

If you have previously taken another combined hormonal contraceptive

Take all the tablets from the old blister following the usual guidelines. You should start taking Belara daily the day after the interval without an active tablet or placebo from your previous combined hormonal contraceptive method.

If you have taken a hormonal contraceptive that only contains progestogen ("minipill")

If you are taking a hormonal contraceptive that only contains a progestogen (minipill), you may not have withdrawal bleeding, equivalent to menstrual period. Take the first active pale pink tablet of Belara daily 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 active pale pink tablet of Belara daily on the same day of 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 daily 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 daily 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 must rule out the possibility of pregnancy or wait for the next period before starting to take Belara daily.

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

How Long Can You Take Belara Daily?

You can take Belara daily for as long as you want, as long as there are no risks to your health (see "Do Not Take Belara Daily" and "Be Aware of Belara Daily" section 2). Once you stop taking Belara daily, 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 Daily?

If vomiting or diarrhea occur within 4 hours after taking the active pale pink tablet, the absorption of the active ingredients of Belara daily may be incomplete. This situation is similar to having forgotten the active pale pink tablet and having taken a new active pale pink tablet from a new blister immediately. If possible, take the new active tablet within 12 hours after taking the last active tablet and continue taking Belara daily following your usual schedule. If it is not possible or if more than 12 hours have passed, follow the instructions in the "If You Forget to Take Belara Daily" section or consult your doctor.

If You Take More Belara Daily Than You Should

There is no evidence of severe toxicity symptoms after ingesting a large number of tablets in one dose. Symptoms such as nausea, vomiting, and, particularly in girls, mild vaginal bleeding may appear. In this case, consult your doctor. If necessary, they will monitor electrolytes, fluid balance, and 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 Forget to Take Belara Daily

The white tablets (tablets 22-28) are inactive placebo tablets. If you forget to take one of these tablets, it will have no effect on the reliability of Belara daily. You should discard the forgotten inactive tablet to avoid prolonging the placebo period, as this could have a negative effect on the reliability of Belara daily.

If you forget to take an active pale pink tablet (tablets 1-21), you should follow these instructions:

• If less than 12 hourshave passed since you should have taken the tablet, the effect of Belara daily will not be reduced. Take the tablet as soon as you realize and then take the following tablets according to your usual schedule. In this case, no additional contraceptive methods are necessary.
• If more than 12 hourshave passed, the contraceptive effect of Belara daily cannot be guaranteed. In this case, take the forgotten active pale pink tablet immediately and continue taking Belara daily according to your usual schedule. This may mean that you need to take 2 active pale pink tablets at the same time. In this case, you must use additional contraceptive methods (e.g., condoms) for the next seven days. If the current blister contains less than seven active pale pink tablets, you should start with the next blister of Belara daily as soon as you finish the active pale pink tablets in the current blister, i.e., you should not have an interval with placebo tablets between blisters. It is likely that withdrawal bleeding (menstrual period) will not occur until you have finished the next blister. However, you may experience intermenstrual bleeding or spotting while taking the tablets from the new blister.

The more active tablets you forget, the higher the risk that contraceptive protection will be reduced. If you have forgotten one or more active tablets during the first week and have had sexual intercourse in the week before forgetting, you should consider the possibility of pregnancy. The same applies if you have forgotten one or more active tablets and do not have menstruation during the next placebo tablet period. 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) by starting to take the active tablet from a new strip of Belara daily instead of the placebo tablet period, until you complete the second blister. You may experience spotting (drops or spots of blood) or intermenstrual bleeding while using this second blister. After the usual 7-day placebo tablet period, continue with the first active tablet of the next blister.

Before deciding to delay your menstrual period, consult your doctor.

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

If you are taking the tablets according to the instructions, your menstrual period/withdrawal bleeding will begin during the placebo tablet period. If you want to change this day, you can do so by shortening (never lengthening) the placebo tablet period. For example, if your placebo tablet period starts on a Friday and you want to change it to a Tuesday (3 days earlier), you should start taking the first active tablet of a new blister 3 days earlier than usual. If you shorten the placebo tablet period too much (e.g., 3 days or less), you may not experience withdrawal bleeding during this period. You may experience spotting (drops or spots of blood) or bleeding.

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

If You Interrupt Treatment with Belara Daily

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

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

4. Possible Side Effects

Like all medications, Belara daily may cause side effects, although not everyone will experience them. If you experience 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 daily, 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 "Warnings and Precautions" section).

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 You Start Using Belara Daily".

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

Very Common:may affect more than 1 in 10 people

Nausea, vaginal discharge, pain during menstruation, amenorrhea, intermenstrual bleeding.

Common:may affect up to 1 in 10 people

Depression, nervousness, irritability, dizziness, migraine (and/or worsening of this), visual disturbances, vomiting, acne, feeling of heaviness, abdominal pain, fatigue, fluid retention, weight gain, hypertension.

Uncommon:may affect up to 1 in 100 people

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

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

Vaginal inflammation, increased appetite, conjunctivitis, discomfort when wearing contact lenses, hearing loss, tinnitus, hypertension, hypotension, circulatory collapse, varicose veins, urticaria, eczema, skin inflammation, pruritus, worsening of psoriasis, excessive hair on the body or face, 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, known as a transient ischemic attack (TIA).
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk 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

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

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

• risk of thrombosis of the veins and arteries (see "Be Aware of Belara Daily"),
• risk of bile duct diseases (see "Be Aware of Belara Daily"),
• risk of tumors (e.g., liver tumors, which in isolated cases have caused potentially fatal bleeding in the abdominal cavity, cervical or breast cancer (see "Be Aware of Belara Daily"),
• worsening of chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, see "Be Aware of Belara Daily").

Read carefully the information presented in "Be Aware of Belara Daily" in section 2, and if necessary, consult your doctor immediately.

Reporting of Side Effects:

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

5. Storage of Belara Daily

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 after "EXP". The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition of Belara Daily

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

The white film-coated tablets do not contain active ingredients.

• Other components are:

Active Pale Pink Film-Coated Tablets:

Tablet core:

lactose monohydrate, cornstarch, povidone K 30, magnesium stearate

Tablet coating:

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

Inactive White Film-Coated Tablets:

Tablet core:

lactose monohydrate, povidone K 30, crospovidone, magnesium stearate

Tablet coating:

hypromellose, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E 171).

Appearance of the Product and Package Contents

Each blister contains 21 film-coated, round, pale pink tablets (tablets 1-21) and 7 film-coated, white, larger placebo tablets (tablets 22-28).

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 from 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

Spain Belara daily 2 mg / 0.03 mg film-coated tablets

France Belaracontinu film-coated 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/