Belara 2 mg/0.03 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

ethinylestradiol/chlormadinone acetate

Important things you need to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of developing a blood clot in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may be experiencing 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, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Belara is and what it is used for

2. What you need to know before taking Belara

3. How to take Belara

4. Possible side effects

5. How to store Belara

6. Contents of the pack and other information

1. What Belara is and what it is used for

Belara is a hormonal contraceptive taken orally. When hormonal contraceptives contain two hormones like Belara, they are also called "combined hormonal contraceptives" (CHCs). The 21 tablets in the blister pack for one cycle contain the same amount of both hormones, so Belara is also referred to as a "monophasic preparation".

Hormonal contraceptives such as Belara will not protect you against AIDS (HIV infection) or other sexually transmitted infections. Only condoms can help protect against these.

2. What you need to know before starting Belara

General considerations

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

Before you start taking Belara, your doctor will perform a general examination and a gynecological check-up, will rule out the possibility of pregnancy, and, taking into account the contraindications and precautions, will decide whether Belara is suitable for you. These medical check-ups should be carried out annually while you are taking Belara.

Do not take Belara

You must 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 which alternative method 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 are experiencing early symptoms of thrombosis, vein inflammation, or embolism, such as sudden sharp pain, chest pain, or chest tightness;
• If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• If you require surgery or if you will be immobile for a prolonged period (see section “Blood clots”);
• If you have diabetes and experience significant fluctuations in your blood sugar levels;
• If you have high blood pressure that is difficult to control or that increases significantly (values constantly above 140/90 mm Hg);
• If you have ever had a heart attack or stroke;
• If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms);
• If you have any of the following conditions that may increase your risk of developing a blood clot in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high fat levels in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinaemia
• 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 disturbances in bile flow, especially if this occurred during a previous pregnancy or during treatment with oestrogens;
• If your bilirubin (a breakdown product of blood pigment) in the blood is elevated, for example due to a congenital excretion disorder (Dubin-Johnson syndrome or Rotor syndrome);
• If you have meningioma or have ever been diagnosed with meningioma (a usually benign tumor of the tissue layer between the brain and the skull);
• If you have a liver tumour or have had one in the past;
• If you have severe stomach pain, liver enlargement, or signs of bleeding in the abdomen;
• If you have porphyria (a disorder of blood pigment metabolism), whether or not it is the first occurrence;
• If you have or have had, or if it is suspected that you have, a hormone-dependent malignant tumour, e.g., breast or uterine cancer;
• If you have severe disorders of lipid metabolism.
• If you have pancreatitis (inflammation of the pancreas) or a history of it, especially if associated with severe hypertriglyceridaemia (very high triglyceride levels in the blood);
• If you suffer from frequent or persistent episodes of unusual severe headaches;
• If you experience sudden disturbances in perception (vision or hearing);
• If you have movement disorders (particularly signs of paralysis);
• If you notice 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 an absence of menstruation (period) for unknown reasons;
• If you have abnormal thickening of the uterine mucosal lining (endometrial hyperplasia);
• If you experience unexplained vaginal bleeding for any reason.

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

If any of these conditions develop while taking Belara, you must stop taking Belara immediately and contact your doctor immediately/inform your doctor without delay.

You must not take Belara, or must 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.

When should you consult your doctor? Seek urgent medical attention if you notice possible signs of a blood clot, which may indicate that you are experiencing a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack, or a stroke (see section “Blood clot (thrombosis)” below). For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

Inform your doctor if you have any of the following conditions.

• If you smoke, as tobacco increases the risk of serious side effects on the heart and blood vessels when using combined hormonal contraceptives. This risk increases with age and the amount smoked. It particularly affects women over 35 years of age. Women who smoke and are over 35 should use other contraceptive methods.

If any of the following conditions develop or worsen while you are using Belara, you must 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 hives with possible breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema;
• If you have high blood pressure, abnormally elevated blood lipid levels, 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 tumours) increases;
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• If you have systemic lupus erythematosus (SLE), a disease affecting your body's natural defence system;
• If you have haemolytic uraemic syndrome (HUS), a blood clotting disorder causing kidney failure;
• If you have sickle cell anemia (an inherited disorder of the 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 require surgery or will be immobile for long periods (see section 2 "Blood clots");
• If you have recently given birth, you are at higher risk of developing blood clots. You should ask your doctor when you can start taking Belara after childbirth;
• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis);
• If you have varicose veins.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Belara increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious complications.

Blood clots can form:

• in veins (known as "venous thrombosis", "venous thromboembolism" or VTE);
• in arteries (known as "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. Rarely, there may be long-lasting serious effects, and very rarely, they may 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.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticed when standing or walking Increased warmth in the affected leg Change in skin color of the leg, e.g. turning pale, red, or blue	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing Sudden cough without clear cause, possibly bringing up blood Sharp chest pain that may worsen when breathing deeply Severe dizziness or lightheadedness Rapid or irregular heartbeat Severe stomach pain If you are unsure, consult a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition like a respiratory infection (e.g. a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision, or Painless blurred vision, which may progress to loss of vision.	Retinal vein thrombosis (blood clot in the eye)
Chest pain, discomfort, pressure, heaviness Feeling of tightness or fullness in the chest, arm, or below the breastbone Feeling of fullness, indigestion, or suffocation Upper body discomfort radiating to the back, jaw, throat, arm, or stomach Sweating, nausea, vomiting, or dizziness Severe weakness, anxiety, or shortness of breath Rapid or irregular heartbeat	Heart attack
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body Sudden confusion, difficulty speaking or understanding speech Sudden vision problems in one or both eyes Sudden difficulty walking, dizziness, loss of balance or coordination Sudden, severe, or prolonged headache without known cause Loss of consciousness or fainting, with or without seizures Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb Severe stomach pain (acute abdomen)	Blood clots blocking other blood vessels

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 most frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

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

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

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

What is the risk of developing a blood clot?

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

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

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing chloromadinone, such as Belara, between 6 and 9 women will develop a blood clot within one year.
• Your individual risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5–7 out of 10,000 women
Women who use Belara	About 6–9 out of 10,000 women

If you notice an increase in the frequency or intensity of migraine attacks while taking Belara (which may indicate impaired 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 developing a blood clot with Belara is small, but certain conditions increase this risk. Your risk is higher:

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years). In this case, you might have an inherited blood clotting disorder.
• If you require surgery or will be immobile for long periods due to injury, illness, or having a leg in a cast. You may need to stop taking Belara several weeks before surgery or during periods of reduced mobility. If you need to interrupt Belara, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years of age).
• If you have given birth within the past few weeks.

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

Long-distance air travel (over 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other listed risk factors.

It is important to inform your doctor if you have any of the above conditions, even if you are uncertain. 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 an unexplained thrombosis or you gain significant weight—inform your doctor.

BLOOD CLOTS IN AN ARTERY

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

As with a blood clot in a vein, a clot in an artery can cause serious problems. For example, it may lead to a heart attack or stroke.

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

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

• With age (especially over 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 a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have a higher risk of heart attack or stroke.
• If you or a close relative have high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorders, 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, your risk of developing a blood clot may be further increased.

If any of the above conditions change while you are using Belara—for example, you start smoking, a close relative experiences an unexplained thrombosis, or you gain significant weight—inform your doctor.

Tumors

Some studies have reported an increased risk of cervical cancer in women infected with a sexually transmitted virus (human papillomavirus) who have been taking the pill for a long time. However, it is unclear to what extent these results may be due to other factors (e.g., multiple sexual partners, lack of barrier contraceptive use).

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

Within 10 years after stopping combined hormonal contraceptives (CHCs), this risk gradually returns to the baseline risk associated with age. Since breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent CHC users is small in relation to the overall risk of breast cancer.

Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported with hormonal contraceptive treatment. These may cause dangerous internal bleeding. If you experience severe, persistent abdominal pain, 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 with high doses used over a prolonged period (several years). If you are diagnosed with 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, memory loss, seizures, or weakness in arms or legs, you must inform your doctor immediately.

Other conditions

Psychiatric disorders

Some women using hormonal contraceptives, such as Belara, have reported depression or a depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for further medical advice as soon as possible.

Many users experience a slight increase in blood pressure during hormonal contraceptive use. If your blood pressure increases significantly while taking Belara, you should consult your doctor, who may advise stopping the treatment and prescribe medication to lower your blood pressure. Use of Belara may be resumed once blood pressure returns to normal values.

If you previously had herpes gestationis during pregnancy, it may reappear during the use of hormonal contraceptives.

If you have lipid metabolism disorders (hypertriglyceridemia) or a family history of such, there is an increased risk of pancreatitis. In cases of acute or chronic liver function impairment, your doctor may advise interrupting Belara treatment until liver function values return to normal. If jaundice, which occurred during a previous pregnancy or while using a hormonal contraceptive, reappears, your doctor will advise you to stop taking Belara.

If you are diabetic and your blood sugar level is controlled while taking Belara, your doctor will monitor you closely. Adjustment of your diabetes treatment may be necessary.

Occasionally, brown patches on the skin (chloasma) may appear, especially if they occurred during a previous pregnancy. If you know you are predisposed to this, you should avoid prolonged exposure to sunlight or ultraviolet radiation while taking Belara.

Conditions that may be negatively affected

You will also need special medical supervision if you have:

• epilepsy;
• multiple sclerosis;
• severe muscle cramps (tetany);
• migraine (see also section 2);
• asthma;
• heart or kidney disease (see also section 2);
• Sydenham's chorea;
• 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 overweight;
• high blood pressure (see also section 2);
• endometriosis (tissue lining the uterine cavity, called endometrium, is located 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;
• blisters (herpes gestationis) in a previous pregnancy;
• depression;
• chronic inflammatory bowel disease (Crohn’s disease, ulcerative colitis).

Consult your doctor if you have, have had, or develop any of the mentioned disorders while taking Belara.

Efficacy

If you do not take the contraceptive regularly, if you vomit or have diarrhea after taking it (see section 3), or if you take other medications simultaneously (see section 2), the contraceptive's effectiveness may be reduced. In very rare cases, metabolic disorders may affect contraceptive efficacy.

Even when hormonal contraceptives are taken correctly, they do not guarantee complete protection against pregnancy.

Irregular bleeding

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

Spotting may also be a sign of reduced contraceptive effect. In such cases, withdrawal bleeding after taking Belara for 21 days may not occur. If you have taken Belara as instructed in section 3 below, it is unlikely you are pregnant. If you have not taken Belara as instructed before the first missed withdrawal bleed, pregnancy should be ruled out 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 has not been established. No data are available.

Elderly patients

Belara is not indicated after menopause.

Other medicines and Belara

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

Do not use Belara 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 blood tests measuring liver function (elevated liver enzyme ALT).

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

Belara may be restarted approximately 2 weeks after completing this treatment. See section “Do not take Belara”.

Some medicines may affect the blood levels of Belara and make it less effective in preventing pregnancy, or may cause unexpected bleeding. These include medicines used to treat:

• epilepsy (such as barbiturates, carbamazepine, phenytoin, topiramate, felbamate, oxcarbazepine, barbexaclona, primidone),

• tuberculosis (e.g., rifampicin, rifabutin),

• sleep disorders (modafinil),

• HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz),

• fungal infections (griseofulvin),

• high blood pressure in the pulmonary blood vessels (bosentan),

• herbal preparations containing St. John’s wort (Hypericum perforatum). If you need to take St. John’s wort preparations while taking Belara, you should consult your doctor first.

Medicines that stimulate intestinal motility (e.g., metoclopramide) and activated charcoal may affect the absorption of Belara’s active ingredients and reduce their effects.

During treatment with these medicines, 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 stopping it. If concomitant treatment with another medicine extends beyond the days covered by the current blister pack of combined hormonal contraceptives, you should start the next Belara pack without the usual break.

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

Interactions between Belara and other medicines may increase or intensify Belara’s adverse effects. The following medicines may negatively affect Belara’s tolerability:

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

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

• some benzodiazepines, e.g., diazepam (for treating sleep disorders),
• cyclosporine (an immunosuppressant),
• theophylline (for treating asthma symptoms),
• corticosteroids, e.g., prednisolone (known as steroids, anti-inflammatory medicines for conditions such as lupus, arthritis, psoriasis),
• lamotrigine (for treating epilepsy),
• clofibrate (lowers elevated cholesterol levels),
• paracetamol (relieves pain and controls fever),
• morphine (a potent specific analgesic for pain relief),
• lorazepam (used for treating anxiety).

Read the package leaflet of any other prescribed medicines.

Inform your doctor if you are taking insulin or other medicines to lower blood sugar. The dose of these medicines may need to be adjusted.

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

The administration of Belara may affect the results of certain laboratory tests, such as liver, adrenal, and thyroid function tests, certain plasma proteins, carbohydrate metabolism, and blood clotting. Changes generally remain within the laboratory's normal range. Inform your doctor that you are taking Belara before undergoing any blood tests.

Pregnancy and breastfeeding

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

If you take Belara, 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 such as Belara should only be used after breastfeeding has ended.

Driving and use of machines

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

This medicine contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Belara

Follow exactly the instructions for taking this medicine as given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Method of administration

Oral use.

How and when should you take Belara?

Remove the first tablet, choosing the one marked with the correct day of the week (e.g., "Sun" for Sunday), and swallow it whole without chewing. Then take one tablet daily, following the direction of the arrow, preferably at the same time each day, ideally in the evening. Whenever possible, the interval between taking two tablets should always be 24 hours. The days printed on the blister pack help you check each day whether you have already taken that day's tablet.

Take one tablet daily for 21 consecutive days. This is followed by a 7-day break. Withdrawal bleeding, equivalent to a menstrual period, usually begins 2–4 days after taking the last tablet. After the 7-day break, start taking tablets from the next Belara blister pack, regardless of whether bleeding has stopped or not.

When can you start taking Belara?

If you have not previously used any hormonal contraceptives (during the last menstrual cycle):

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

Contraceptive protection begins on the first day of intake and continues throughout 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. However, in this case, you must use additional barrier contraceptive methods during the first 7 days of intake (seven-day rule).

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

If you previously used another combined hormonal contraceptive:

Take all tablets from your previous pack according to the usual instructions. Start taking Belara the day after the usual break between tablet intakes, or the day after completing the placebo tablets of your previous combined hormonal contraceptive.

If you previously used a progestogen-only hormonal contraceptive (progestogen-only pill, “POP”):

If you are taking a progestogen-only hormonal contraceptive, you may not experience withdrawal bleeding equivalent to a menstrual period. In this case, take the first Belara tablet the day after taking your last mini-pill. In this case, you must use additional contraceptive measures during the first seven days.

If you previously used hormonal contraceptive injections or contraceptive implants:

Take the first Belara tablet on the same day the implant is removed or on the day the next injection would have been due. In this case, you must use additional contraceptive measures during the first seven days.

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

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

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

If you are not breastfeeding, you may 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, pregnancy must be ruled out, or you must wait until your next period before starting Belara.

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

How long can you take Belara?

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

What should you do if you experience vomiting or diarrhea while taking Belara?

If vomiting or diarrhea occurs within 4 hours after taking the tablets, absorption of the active ingredients in Belara may be incomplete. This situation is similar to missing a tablet, and you should immediately take a new tablet from a new blister pack. Whenever possible, take the new tablet within 12 hours of taking the last tablet, and then continue taking Belara as usual. If this is not possible or more than 12 hours have passed, follow the instructions in section 3, “If you forget to take Belara,” or contact your doctor.

If you take more Belara than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 915620420, indicating the medicine and the amount ingested.

If you forget to take Belara

• If you forget to take a tablet at the usual time, you should take it within 12 hours at the latest. In this case, no additional contraceptive methods are needed, and you may continue taking tablets as usual.

• If the delay is more than 12 hours, the contraceptive effect of Belara is not guaranteed. In this case, take the missed tablet immediately and continue taking Belara as usual. This may mean taking two tablets on the same day. In this case, you must use additional contraceptive methods (e.g., condoms) for the next seven days. If during these seven days you finish the current blister pack, immediately start taking tablets from the next Belara blister pack—i.e., there should be no break between packs (seven-day rule). Withdrawal bleeding (period) will likely not occur until you have finished the next blister pack. However, you may experience intermenstrual spotting or bleeding while taking tablets from the new blister.

The more tablets you miss, the greater the risk that protection against pregnancy may be reduced. If you missed one or more tablets in the first week and had sexual intercourse in the week before missing the tablets, you should be aware that there is a risk of pregnancy. The same applies if you missed one or more tablets and did not have bleeding during the following break period. In these cases, consult your doctor.

If you wish to delay your menstrual period

Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new blister pack by starting a second Belara blister pack instead of taking the usual 7-day break between tablet intakes. You may experience spotting (drops or blood stains) or intermenstrual bleeding during use of the second blister pack. After completing the 7-day break, continue with the next blister pack.

You should seek advice from your doctor before deciding to delay your menstrual period.

If you wish to change the first day of your menstrual period

If you take the tablets as instructed, your menstrual period/withdrawal bleeding will begin during the tablet-free week. If you need to change this day, you can do so by shortening (but never extending) the tablet-free interval. For example, if your tablet-free interval 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 tablet-free interval very short (e.g., 3 days or less), you may not have bleeding during this period. You may then experience spotting (drops or blood stains) or intermenstrual bleeding.

If you stop treatment with Belara

When you stop taking Belara, ovarian function will quickly return to normal, and you may become pregnant.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If you experience any adverse effect, especially if it is severe and persistent, or if you notice any change in your 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 hives with possible difficulty breathing (see also section “Warnings and precautions”).

All women taking combined hormonal contraceptives have an increased 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 associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting Belara”.

The frequencies of reported adverse effects 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 migraines), 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 connective tissue, hypersensitivity to the medicine including skin allergic reactions, changes in blood lipids including increased triglycerides, decreased libido, stomach pain, intestinal noises, diarrhea, pigmentation disorders, brown spots on the face, hair loss, dry skin, tendency to sweat, back pain, muscle disorders, breast discharge.

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

Vaginal inflammation, increased appetite, conjunctivitis, discomfort when wearing contact lenses, deafness, tinnitus, hypertension, hypotension, circulatory blockage, 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 symptoms before menstruation begins).

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.
• transient ischaemic attack (TIA) or mild stroke-like symptoms.
• blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

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

Erythema nodosum.

Additionally, the following adverse reactions associated with the active substances ethinylestradiol and chlormadinone acetate have been reported during post-marketing experience: weakness and allergic reactions including swelling 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 adverse effects:

• risk of venous and arterial thrombosis (see section 2),
• risk of biliary tract diseases (see section 2),
• risk of tumors (e.g., liver tumors, which in isolated cases have led to potentially life-threatening intra-abdominal bleeding), cervical or breast cancer (see section 2),
• worsening of chronic inflammatory bowel disease (Crohn’s disease, ulcerative colitis, see section 2).

Please read carefully the information provided in section 2 and, if necessary, consult your doctor immediately.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Belara

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the carton and on the blister pack (cycle packaging) after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Belara

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

• The other components are:

Tablet core: monohydrate lactose, corn starch, povidone K 30, magnesium stearate.

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

Appearance of the product and contents of the pack

Belara is available in blisters containing 21 film-coated tablets, round, light pink in colour, one cycle per blister.

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

Only certain 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

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Gedeon Richter Ibérica S.A.

Sabino Arana, 28 4º 2º

08028 Barcelona

+34 93 2034300

This medicinal product 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 most recent review of this leaflet:

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/