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. This will allow quick identification of new safety information. You can help by reporting any side effects you experience. The final part of section 4 includes information on how to report these side effects.

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of suffering a blood clot in veins and arteries, especially in the first year or when restarting use of 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 this leaflet carefully before you start taking this medicine, because it contains important information for you.

-Keep this 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 for you only. Do not pass it on to others even if their symptoms are the same. It may harm them.

-If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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.Storage of Belara

6.Contents of the pack and additional information

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

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

General Considerations

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

Do not take Belara

You should 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 ingredients or to any of the other components of this medication (including in section 6);

-If you have (or have had at any time) a blood clot in a vein of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs;

-If you present the initial symptoms of thrombosis, inflammation of the veins or embolism, such as the appearance of a brief stabbing pain, chest pain or pressure in the chest;

• If you know that 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 surgery or if you spend a lot of time without standing up (see section “Blood Clots”);

-If you have diabetes and present significant fluctuations in blood sugar levels;

• If you have uncontrolled high blood pressure or that increases significantly (constantly values above 140/90 mmHg);
• If you have ever had a heart attack or a stroke;
• If you have (or have had at any time) 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 symptoms of a stroke);
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • severe diabetes with vascular damage
  • very high blood pressure
  • very high levels of fat in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia
• Si have (or have had at any time) 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 have alterations in bile flow and especially during a previous pregnancy or during hormone treatment;
• If your bilirubin (a product of blood pigment degradation) in the blood is increased, for example by a congenital excretion disorder (Dubin-Johnson syndrome or Rotor syndrome);
• if you have meningioma or have ever been diagnosed with meningioma (a generally 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, liver enlargement or signs of internal bleeding in the abdomen;
• If you have porphyria (a disorder of blood pigment metabolism), whether or not it is the first time.
• If you have or have had or are suspected to have any malignant tumor that depends on hormone action, e.g., breast cancer or uterine cancer;
• If you have severe lipid metabolism disorders.
• If you have pancreatitis (inflammation of the pancreas) or a history of the same, in the case of being associated with severe hypertriglyceridemia (very high levels of triglycerides in the blood);

-If you have frequent or persistent episodes of severe unusual headaches;

• If you have sudden changes in perception (vision or hearing);

-If you present changes in movement (particularly signs of paralysis).

• If you observe worsening of 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 amenorrhea (absence of menstruation) due to an unknown cause;
• If you present an abnormal thickening of the uterine mucous membranes (endometrial hyperplasia);.
• If you have unjustified vaginal bleeding.

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

If you develop any of these conditions during the administration of Belara, you should stop taking Belara immediately. And inform your doctor immediately/notify your doctor.

You should not take Belara, or you should stop taking it immediately, if you have a high 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.

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

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

If the condition develops or worsens while using Belara, you should also inform your doctor:

• If you suffer from angioedema symptoms such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Estrogen-containing products can cause or worsen the symptoms of hereditary and acquired angioedema;
• If you have high blood pressure, abnormally high levels of lipids in the blood, obesity 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 (LES, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney insufficiency);
• If you have sickle cell anemia (a hereditary disorder of red blood cells);
• If you have high levels of fat in the blood (hypertriglyceridemia) or have a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas);
• If you need surgery or spend a lot of time without standing up (see section “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 superficial vein inflammation that is under the skin;
• If you have varicose veins.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Belara increases your risk of suffering 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 veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• in arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or ATE).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

It is essential 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 assistanceif 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 veins (venous thrombosis). However, these adverse 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 may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may 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 be higher also if you start taking a combined hormonal contraceptive again (the same medication or a different medication) 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 in 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.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or noretisterone or norgestimato, 5-7 will develop a blood clot in a year.
• We do not yet know how the risk of a blood clot compares with Belara and a combined hormonal contraceptive containing 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 Belara administration (which may indicate a change in 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 having a blood clot with Belara is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) greater than 30 kg/m2).
• If one of your close relatives has had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years old). In this case, you may have a hereditary disorder of blood clotting.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have a leg cast. You may need to stop taking Belara for several weeks before the surgery or while you have less mobility. If you need to stop taking Belara, ask your doctor when you can start using it again.
• With increasing age (especially over about 35 years old).
• If you have given birth recently.

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

Air travel (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 essential to inform your doctor if you suffer from any of the conditions above, even if you are unsure. Your doctor may decide that you need to stop taking Belara.

If any of the conditions above change while you are using Belara, for example, a close relative experiences a blood clot 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 blood 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 essential to note that the risk of a heart attack or stroke due to Belara is very small, but it may increase:

• With age (over about 35 years old).
• If you smoke.When using a combined hormonal contraceptive like Belara, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraception.
• If you are overweight.
• If you have high blood pressure.
• If one of your close relatives has had a heart attack or stroke at a young age (less than about 50 years old). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or one of your close relatives has 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, arrhythmia called atrial fibrillation).
• If you have diabetes.

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

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

Tumors

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

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

During the 10 years following the interruption of use, of AHC, this risk returns gradually to the age-related risk. Since breast cancer is rare in women under 40 years old, the number of excess diagnoses of breast cancer in current and recent users of AHC is small compared to the overall risk of breast cancer.

In rare cases, benign liver tumors have been reported, and more rarely malignant liver tumors, with hormone treatment. These can cause a life-threatening internal hemorrhage. 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 associated with 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 meningioma, your doctor will interrupt your treatment with Belara (see section “Do not take Belara”). If you notice symptoms such as changes in vision (e.g., double vision or blurred vision), loss of hearing or ringing in the ears, loss of smell, worsening headaches that last over time, loss of memory, seizures, or weakness in arms or legs, you should inform your doctor immediately.

Other pathologies

Mental disorders

Some women who use combined hormonal contraceptives, such as Belara, have reported depression or a depressive mood. Depression can be severe and sometimes may 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 combined hormonal contraceptives. If blood pressure increases significantly when taking Belara, you should consult your doctor, who will advise you to stop treatment and prescribe a medication to reduce blood pressure. Belara treatment can be resumed once blood pressure returns to normal values.

If you have had herpes gestational in a previous pregnancy, it may recur during the use of combined hormonal contraceptives.

If you have lipid metabolism disorders or have a family history, there is a higher risk of pancreatitis. If you experience acute or chronic liver function disorders, your doctor may advise you to stop taking Belara until liver function values return to normal. If you have had jaundice during a previous pregnancy or during the use of a combined hormonal contraceptive, and it recurs, your doctor will advise you to stop taking Belara.

If you are diabetic and your blood sugar levels are controlled, your doctor will monitor you closely while you are taking Belara. You may need to modify your diabetes treatment.

In rare cases, brown spots may appear on the skin (melasma), especially if they appeared during a previous pregnancy. If you know you are prone to it, you should avoid long periods of exposure to the sun or ultraviolet radiation while taking Belara.

Disorders 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);

-St. Vitus dance (chorea minor);

-diabetes (see also section 2);

-liver disease (see also section 2);

-lipid metabolism disorders (see also section 2);

-immune system disorders (including systemic lupus erythematosus);

-excessive obesity;

-high blood pressure (see also section 2);

-endometriosis (the tissue that lines the uterine cavity, called endometrium, is found outside this lining layer) (see also section 2);

-varicose veins or vein inflammation (see also section 2);

-blood clotting disorders (see also section 2);

-breast disease (mastopathy);

-benign tumors (fibroids) in the uterus;

-herpes gestational 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 conditions mentioned or if they occur during the administration of Belara.

Efficacy

If you do not take the contraceptive regularly, experience 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 may affect the contraceptive efficacy.

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

Irregular bleeding

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

Spotting (spotting) may also be a sign of reduced contraceptive efficacy. In these cases, bleeding may not occur after taking Belara for 21 days. If you have taken Belara following the instructions described in section 3, it is unlikely that you are pregnant. If you have not taken Belara following these instructions before the first absence of bleeding due to deprivation, you should rule out pregnancy before continuing with its use.

Children and adolescents

Belara is only indicated after menarche. The safety and efficacy of Belara have not been established in adolescents under 16 years old. There are no data.

Older patients

Belara is not indicated after menopause.

Other medications andBelara

Inform your doctor or pharmacist if you are using or have used recentlyor may need to use anyother medication.

Do not use Belara if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function parameters in the blood (elevated 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 the blood levels of Belara and make itless effective in preventing pregnancy, or may produce unexpected bleeding. These include medications used to treat:
• epilepsy (such as barbiturates, carbamazepine, phenytoin, topiramate, felbamate, oxcarbazepine, barbexaclona, primidone),
• tuberculosis (e.g. rifampicin, rifabutin),
• sleep disorders (modafinil),
• infections with HIV and hepatitis C viruses (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• fungus infections (griseofulvin),
• high blood pressure in the pulmonary blood vessels (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 may affect the absorption of Belara's active ingredients and reduce their effects.

During treatment with these medications, you should use additional barrier methods of contraception (e.g. condoms). These barrier methods of contraception should be used throughout the duration of concomitant treatment and for 28 days after treatment completion. If concomitant treatment with another medication is prolonged beyond the days for which the current package of combined hormonal contraceptives is intended, you should start with the next package of Belara without leaving the usual rest period.

You should not take St. John's Wort preparations while taking Belara.

If you need to follow a prolonged treatment with the previously mentioned active substances, you should use non-hormonal methods of contraception. Consult your doctor or pharmacist.

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

-ascorbic acid (a preservative, also known as vitamin C),

-paracetamol (relieves pain and controls fever),

-atorvastatin (reduces high cholesterol levels),

-troleandomycin (an antibiotic),

-3. How to take Belara

4. Possible Adverse Effects

5. Belara Storage

6. Contents of the packaging and additional information