Belara Diario 2 mg/0.03 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Belara diario 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 have symptoms of a blood clot (see section 2 “Blood clots”).

Read this entire 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 effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Belara diario is and what it is used for
2. What you need to know before taking Belara diario
3. How to take Belara diario
4. Possible side effects
5. How to store Belara diario
6. Contents of the pack and other information

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

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

Hormonal contraceptives such as Belara daily do not protect 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 daily

General considerations

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

Do not take Belara daily

You must not use Belara daily if you have any of the conditions listed below. Inform your doctor if you have any of these conditions. 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 experience 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 will be immobile for long periods (see section “Blood clots”);

• If you have diabetes with significant fluctuations in blood sugar levels;

• If you have poorly controlled high blood pressure or markedly increased blood pressure (consistently 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 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 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 viral infection) 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, particularly if these occurred during a previous pregnancy or during estrogen treatment;

• 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 skull);

• If you currently have or have previously had a liver tumor;

• If you have severe stomach pain, liver enlargement, or signs of abdominal bleeding;

• If you have porphyria (a disorder of blood pigment metabolism), whether or not it is the first occurrence;

• If you have, have had, or are suspected of having a malignant hormone-dependent tumor, 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 pancreatitis, especially if associated with severe hypertriglyceridemia (very high triglyceride levels in the blood);

• If you experience unusually severe, frequent, or persistent headaches;

• If you have 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 absence of menstruation (period) for unknown reasons;

• If you have abnormal thickening of the uterine mucous membrane (endometrial hyperplasia);

• If you experience unexplained vaginal bleeding.

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 (see also section “Other medicines and Belara daily”).

Stop taking Belara daily immediately if you develop any of these conditions while taking Belara daily.

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

Warnings and precautions

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

When should you consult your doctor? Seek urgent medical assistance 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 side effects, see “How to recognize a blood clot”.

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

• If you smoke, since tobacco increases the risk of serious heart and blood vessel side effects when using combined hormonal contraceptives. This risk increases with age and the amount smoked. Smoking is particularly harmful for women over 35 years of age. Women over 35 who smoke should use other contraceptive methods.

If any of the following conditions develop or worsen while taking 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 hives with possible breathing difficulties, contact a doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• If you have hypertension, abnormally elevated blood lipid levels, overweight, or diabetes (see also section 2). In such cases, the risk of serious side effects associated with combined hormonal contraceptives increases (such as myocardial infarction, embolism, stroke, or liver tumors).
• 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 defense system);
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure);
• If you have sickle cell anemia (an inherited red blood cell disorder);
• If you have high levels of 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 a prolonged period (see section 2 “Blood clots”);
• If you have recently given birth, you are at increased risk of blood clots. You should ask your doctor when you can start taking Belara daily 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 daily increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots may form:

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

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

It is important 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.

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., if it becomes 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 on deep breathing 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 vision loss.	Retinal vein thrombosis (blood clot in the eye)
Chest pain, discomfort, pressure, or heaviness Feeling of tightness or fullness in the chest, arm, or below the sternum Sensation of fullness, indigestion, or suffocation Upper body discomfort spreading 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 difficulty 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 more frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in 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 of first-time use of a combined hormonal contraceptive. 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 somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Belara daily, 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 daily 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 to 7 will develop a blood clot within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing chloromadinone, such as Belara daily, between 6 and 9 will develop a blood clot within one year.
• Your 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 daily	About 6–9 out of 10,000 women

If you notice an increase in the frequency or intensity of migraine attacks while taking Belara daily (which may indicate impaired blood supply to the brain), consult your doctor as soon as possible. Your doctor may advise you to stop taking Belara daily immediately.

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

The risk of developing a blood clot with Belara daily 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 have had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you might have an inherited blood coagulation disorder.
• If you require surgery or will be immobile for a prolonged period due to injury, illness, or a plaster cast on your leg. You may need to stop taking Belara daily several weeks before surgery or during periods of reduced mobility. If you need to interrupt the use of Belara daily, 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 last 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 risk factors listed above.

It is important to inform your doctor if you have any of the conditions listed above, even if you are uncertain. Your doctor may decide that you should stop using 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 significant weight—inform your doctor.

BLOOD CLOTS IN AN ARTERY

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

Just like 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 the use of Belara daily 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 daily, you are advised to stop smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or a close relative have high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorders, cardiac rhythm disorders such as 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 daily—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

Tumors

Some studies have observed 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, use of barrier contraceptive methods).

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

Over a 10-year period after stopping CHCs, this increased risk gradually returned to the baseline age-related risk. Since breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent users of CHCs is small in relation to the overall risk of breast cancer.

Benign liver tumors have been rarely reported, and malignant liver tumors even more rarely, with hormonal contraceptive use. These may cause dangerous internal bleeding. If you experience severe abdominal pain that does not resolve 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 over a prolonged period (several years). If you are diagnosed with meningioma, your doctor will discontinue 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 must inform your doctor immediately.

Other conditions

Psychiatric disorders

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

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

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 conditions, there is an increased risk of pancreatitis. In cases of acute or chronic liver function impairment, your doctor may advise interrupting treatment with Belara daily until liver function values return to normal. If you previously had jaundice during 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 controlled while taking Belara daily, your doctor will monitor you closely. Your diabetes treatment may need to be adjusted.

Rarely, 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 daily.

Conditions 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);
• Sydenham's chorea (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 overweight;
• Hypertension (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 coagulation 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 conditions listed above during treatment with Belara daily.

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. Very rarely, 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 spotting or bleeding) may occur. If bleeding continues for 3 months or reappears after several consecutive cycles, consult your doctor.

Spotting may also indicate reduced contraceptive effectiveness. In such cases, withdrawal bleeding may not occur after taking Belara daily for 21 days. If you have taken Belara daily according to the instructions described below in section 3, it is unlikely that you are pregnant. If you have not taken Belara daily according to these instructions before the first absence of withdrawal bleeding, pregnancy should be ruled out 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 medicines and Belara daily

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

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 blood tests measuring liver function (elevated liver enzyme ALT).

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

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

Some medications may affect blood levels of Belara daily, making it less effective in preventing pregnancy, or may cause unexpected bleeding. These include medications used to treat:

• Epilepsy (such as barbiturates, carbamazepine, phenytoin, topiramate, felbamate, oxcarbazepine, 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),
• 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 motility (e.g., metoclopramide) and activated charcoal may affect the absorption of the active substances in Belara daily and reduce their effects.

During treatment with these medications, you should use additional barrier contraceptive methods (e.g., condoms). These additional barrier methods should be used throughout the duration of concomitant treatment and for 28 days after its completion. If concomitant treatment extends beyond the days covered by the current combined hormonal contraceptive blister pack, the placebo tablets should be discarded and the next blister pack of Belara daily should be started immediately.

If long-term treatment with the above-mentioned active substances is required, non-hormonal contraceptive methods should be used. Consult your doctor or pharmacist.

Interactions between Belara daily and other medicines may increase or intensify adverse effects of Belara daily. The following medicines may negatively affect the tolerability of Belara daily:

• 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 (used to treat fungal infections),
• Indinavir (used to treat HIV infection).

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

• Some benzodiazepines, e.g., diazepam (used to treat sleep disorders),
• Cyclosporine (an immunosuppressant),
• Theophylline (used to treat asthma symptoms),
• Corticosteroids, e.g., prednisolone (known as steroids, anti-inflammatory medicines for conditions such as lupus, arthritis, psoriasis),
• Lamotrigine (used to treat epilepsy),
• Clofibrate (lowers elevated cholesterol levels),
• Paracetamol (relieves pain and controls fever),
• Morphine (a potent specific analgesic for pain relief),
• Lorazepam (used to treat anxiety).

Read the package leaflet of any other prescribed medicines.

Inform your doctor if you are taking insulin or other medications to lower blood sugar. The dose of these medications 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 daily.

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

Pregnancy and breastfeeding

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

If you take Belara daily, you should be aware 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 daily should only be used after breastfeeding has ended.

Driving and using machines

No negative effects of combined hormonal contraceptives on the ability to drive or operate machinery are known.

This medicine contains lactose

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

3. How to take Belara daily

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

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

Method of administration

Oral use.

How and when should you take Belara daily?

Remove the first pinkish-white active tablet from the blister position marked “Start” and swallow it without chewing. You will take:

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

Take the tablet at approximately the same time each day, preferably in the evening. The interval between two tablets should always be 24 hours if possible. When you start taking Belara daily, mark the day of the week on the cycle blister pack, which will allow you to determine the corresponding day of the week for each number printed on the blister and check each day whether you have already taken that day’s tablet.

Withdrawal bleeding (equivalent to menstruation) usually begins 2–4 days after taking the last pinkish-white active tablet. After finishing all 28 tablets, continue taking tablets from the next Belara daily blister pack regardless of whether bleeding has stopped or not.

When can you start taking Belara daily?

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

Take your first pinkish-white active tablet of Belara daily on the first day of your next menstrual cycle.

Contraceptive protection begins on the first day of administration and continues throughout the 7-day interval with inactive tablets.

If your period has already started, take the first pinkish-white active tablet on day 2–5 of your period, regardless of whether bleeding has stopped. However, in this case, you must use additional barrier contraceptive methods for the first 7 days of administration (the seven-day rule).

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

If you previously used another combined hormonal contraceptive:

Take all tablets from the previous blister pack according to the usual instructions. Start taking Belara daily the day after the usual hormone-free or placebo interval of your previous combined hormonal contraceptive method.

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 menstruation. Take the first pinkish-white active tablet of Belara daily the day after taking your last mini-pill. In this case, you must use additional contraceptive precautions for the first seven days.

If you previously used hormonal contraceptive injections or contraceptive implants:

Take the first pinkish-white active tablet of Belara daily on the same day the implant is removed or on the day corresponding to your next scheduled injection. In this case, you must use additional contraceptive precautions for 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 daily immediately. In this case, no additional contraceptive method is required.

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 daily 21–28 days after childbirth. No additional barrier contraceptive method is required.

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

If you have already had sexual intercourse, pregnancy must be ruled out or you must wait for your next period before starting Belara daily.

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

How long can you take Belara daily?

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

What should you do in case of vomiting or diarrhea while taking Belara daily?

If vomiting or diarrhea occurs within 4 hours after taking the pinkish-white active tablet, absorption of the active ingredients of Belara daily may be incomplete. This situation is similar to having missed an active pinkish-white tablet, and you must take a new active pinkish-white tablet from a new blister pack immediately. If possible, take the new active tablet within 12 hours of taking the last active tablet and continue taking Belara daily according to your usual schedule. If this is not possible or if more than 12 hours have passed, follow the instructions in section 3, “If you forget to take Belara daily,” or contact your doctor.

If you take more Belara daily than you should

There is no evidence of serious toxic symptoms after ingestion of a high 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 electrolytes and fluid balance, and 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 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 extending the placebo period, as this could negatively affect the reliability of Belara daily.

If you forget to take a pinkish-white active tablet (tablets 1–21), follow these instructions:

• If less than 12 hours have passed since you were supposed to take the tablet, the effectiveness of Belara daily is not reduced. Take the tablet as soon as you remember, then continue taking the following tablets according to your usual schedule. In this case, no additional contraceptive methods are needed.
• If more than 12 hours have passed, the contraceptive effect of Belara daily is not guaranteed. In this case, take the forgotten pinkish-white active tablet immediately and continue taking Belara daily according to your usual schedule. This may even mean taking two pinkish-white active 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 pack contains fewer than seven pinkish-white active tablets, you must start the next Belara daily blister pack as soon as the active tablets in the current blister pack are finished, meaning there should be no interval with placebo tablets between blister packs. Withdrawal bleeding (menstrual period) will probably not occur until after finishing the next blister pack. However, intermenstrual bleeding or spotting may increase while taking tablets from the new blister pack.

The more active tablets you miss, the greater the risk that contraceptive protection will be reduced. If you have missed one or more active tablets during week 1 and have had sexual intercourse in the week before the missed dose, consider that there is a risk of pregnancy. The same applies if you have missed one or more active tablets and do not have bleeding during the next placebo tablet interval. 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) by starting the active tablet from a new Belara daily blister pack instead of taking the placebo tablets, continuing until the second blister pack is finished. Spotting (drops or stains of blood) or intermenstrual bleeding may occur while using this second blister pack. After the usual 7-day placebo tablet interval, continue with the first active tablet of the next blister pack.

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 as instructed, your menstrual period/withdrawal bleeding will begin during the placebo tablet interval. If you wish to change this day, you may do so by shortening (but never lengthening) the placebo tablet interval. For example, if your placebo tablet interval starts on a Friday and you wish to change it to Tuesday (3 days earlier), you should start taking the first active tablet of a new blister pack 3 days earlier than usual. If you shorten the placebo tablet interval significantly (e.g., 3 days or less), you may not have bleeding during this placebo interval. Spotting (drops or stains of blood) or bleeding may occur.

If you are unsure about what to do, consult your doctor.

If you stop treatment with Belara daily

When you stop taking Belara daily, 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, Belara diario may cause adverse effects, although not everyone experiences them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any health changes you think may be due to Belara diario, 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 diario”.

The frequencies at which adverse effects have been reported are defined below:

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 migraine), 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 connective tissue, hypersensitivity to the medicine including skin allergic reactions, changes in blood lipids including increased triglycerides, decreased libido, stomach pain, intestinal noises, diarrhoea, pigmentation disorders, brown facial spots, hair loss, dry skin, increased tendency to sweat, back pain, muscle disorders, galactorrhoea.

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 collapse, varicose veins, urticaria, eczema, skin inflammation, pruritus, worsening of psoriasis, excessive body or facial hair growth, breast enlargement, prolonged and/or increased menstruation, premenstrual syndrome (physical and emotional symptoms before menstruation starts).

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.
• mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).
• 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 about 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 chloromadinone acetate have been reported during post-marketing experience: weakness and allergic reactions including deep skin layer swelling (angioedema).

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

• risk of venous and arterial thrombosis (see section 2),
• risk of biliary tract diseases (see section 2),
• risk of tumours (e.g., liver tumours, which in isolated cases have led to potentially life-threatening intra-abdominal haemorrhage, 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 adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Belara daily

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton and on the blister pack 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 diario

• The active substances are ethinylestradiol and chlormadinone acetate. Each light 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 any active substances.

• Other components are:

Light pink film-coated active tablets:

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

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

White film-coated inactive placebo 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 contents of the pack

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 further information about this medicinal product from the local representative of the Marketing Authorisation Holder.

Gedeon Richter Ibérica S.A.

Sabino Arana, 28 4º 2º

08028 Barcelona

+34 93 2034300

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany Belara diario Filmtabletten

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

France Belaracontinu comprimés pelliculés

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/