Prospect: information for the user

Belara diario2 mg/0.03 mgfilm-coated tablets

ethinylestradiol/chlormadinone acetate

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Important things you should 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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting the use of a combined hormonal contraceptive after a pause 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 prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1.What isBelara diarioand what is it used for

2.What you need to know before starting to takeBelara diario

3.How to takeBelara diario

4.Adverse effects

5.Storage ofBelara diario

6.Contents of the package and additional information

Belara daily is a hormonal contraceptive taken orally. If this type of hormonal contraceptive contains two hormones like Belara daily, they are also known as "combined hormonal contraceptives" (CHCs). The 21 active pink-colored tablets in the blister pack for a cycle contain the same amount of both hormones, so Belara daily is also known as "monophasic preparation".

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

General Considerations

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

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

Do not take Belara daily

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

• If you are allergic (hypersensitive) to the active ingredients or to any of the other components of this medication;
• If you have (or have had at any time) a blood clot in a leg vein (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 experience significant fluctuations in blood sugar levels;
• If you have uncontrolled high blood pressure or significantly increased blood pressure (constantly above 140/90 mmHg);
• If you have ever had a heart attack or 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, 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

• If you have (or have had at any time) a type of migraine called “migraine with aura”;
• If you have inflammation of the liver (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, due to 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 liver cancer or have had it 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 have had it in the past, especially if it is associated with severe hypertriglyceridemia (very high levels of triglycerides in the blood);

-If you have episodes of unusually intense, frequent, or persistent headaches;

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

-If you have movement disorders (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 have abnormal thickening of the uterine mucous membranes (endometrial hyperplasia);
• If you experience unexplained vaginal bleeding;

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

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

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

Warnings and Precautions

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

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

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

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

-If you experience symptoms of angioedema 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 symptoms of hereditary and acquired angioedema;

-If you have high blood pressure, high levels of lipids in the blood, obesity, or diabetes (see also sections “Do not take Belara daily” and “Be careful with Belara daily”, "Other Diseases"). In this case, the risk of serious side effects associated with combined hormonal contraceptives (such as myocardial infarction, embolism, stroke, or liver tumors) increases;

-If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);

-If you have systemic lupus erythematosus (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 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. Ask your doctor when you can start taking Belara daily after childbirth;

-If you have superficial thrombophlebitis;

-If you have varicose veins.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Belara daily increases your risk of developing 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 blood clot causing harm due to Belara daily is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attentionif 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 in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

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

The risk of a blood clot in a vein is higher during the first year when taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a 4-week or longer interruption.

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

When you stop taking Belara daily, your risk of a blood clot returns to normal 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 daily 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 daily to the risk with 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 experience an increase in the frequency or intensity of migraine attacks during the administration of Belara daily (which may indicate an alteration in blood supply to the brain), consult your doctor as soon as possible, who may advise you to stop taking Belara daily immediately.

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

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

• If you are overweight (body mass index (BMI) above 30 kg/m2);
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years old). In this case, you may have an inherited 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 daily for several weeks before the surgery or while you have limited mobility. If you need to stop taking Belara daily, ask your doctor when you can start taking it again;
• With increasing age (especially over about 35 years);
• If you have given birth recently.

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

Long flights (over 4 hours) may temporarily increase your 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 experience any of the conditions above, even if you are unsure. Your doctor may decide that you need to stop taking Belara daily.

If any of the conditions above change while you are using Belara daily, 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 daily is very small, but it may increase:

• With age (over about 35 years);
• If you smoke.When using a combined hormonal contraceptive like Belara daily, 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 any of your close relatives have 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 a heart attack or stroke;
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides);

• If you have migraines, especially migraines with aura:;
• If you have a heart problem (valve disorder, 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 daily, 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 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 a 10-year period after stopping the use of combined hormonal contraceptives, this increased risk gradually returns to the age-related baseline risk. Since breast cancer is relatively rare in women under 40 years old, the number of excess breast cancer diagnoses in current and recent users of combined hormonal contraceptives 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, which 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 stop your treatment with Belara daily (see section “Do not take Belara daily”). If you experience symptoms such as changes in vision (e.g., double vision or blurred vision), loss of hearing, or ringing in the ears, you should inform your doctor immediately.

Other Pathologies

Mental disorders

Some women who use hormonal contraceptives, such as Belara daily, 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 as soon as possible to obtain additional medical advice.

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 will advise you to stop treatment and prescribe a medication to reduce blood pressure. Belara daily can be resumed once your blood pressure returns to normal.

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

If you have lipid metabolism disorders or 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 treatment with Belara daily until your liver function values return to normal. If you have had jaundice during a previous pregnancy or during the use of a hormonal contraceptive, and it recurs, your doctor will advise you to stop taking Belara daily.

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

Disorders 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 “Do not take Belara daily”);

-asthma;

-heart or kidney disease (see also “Do not take Belara daily”);

-St. Vitus dance (chorea minor);

-diabetes (see also sections “Do not take Belara daily” and “Be careful with Belara daily”, "Other Diseases");

-liver disease (see also “Do not take Belara daily”);

-lipid metabolism disorders (see also “Do not take Belara daily”);

-immune system disorders (including systemic lupus erythematosus);

-obesity;

-high blood pressure (see also “Do not take Belara daily”);

-endometriosis (the tissue that lines the uterine cavity, called endometrium, is found outside this lining layer) (see also “Do not take Belara daily”);

-varicose veins or inflammation of the veins (see also “Do not take Belara daily”);

-blood clotting disorders (see also “Do not take Belara daily”);

-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 daily.

Efficacy

If you do not take the contraceptive regularly, experience vomiting or diarrhea after administration (see “If you interrupt treatment with Belara daily”), or take other medications simultaneously (see “Other Medications and Belara Daily”), the efficacy of the contraceptive may be affected. In rare cases, metabolic disorders can affect contraceptive efficacy.

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

Irregular bleeding

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

Spotting (light bleeding) may also be a sign of reduced contraceptive efficacy. In these cases, menstruation may not occur after taking Belara daily for 21 days. If you have taken Belara daily as described in section 3, it is unlikely that you are pregnant. If you have not taken Belara daily as described in section 3, before the first absence of menstruation, you should rule out pregnancy before continuing with its 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 old. No data are available.

Older patients

Belara daily is not indicated after menopause.

Other medications and Belara daily

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

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

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

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

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

• epilepsy (such as barbiturates, carbamazepine, phenytoin, topiramate, felbamate, oxcarbazepine, barbexaclone, primidone),
• tuberculosis (e.g., rifampicin, rifabutin),
• sleep disorders (modafinil),
• HIV and hepatitis C infection (the so-called 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 movement (e.g., metoclopramide) and activated charcoal may affect the absorption of the active substances in Belara daily.

During treatment with these medications, you should use additional barrier contraceptives (e.g., condoms). These barrier contraceptives should be used throughout the treatment and for 28 days after the treatment is completed. If the concomitant treatment is prolonged beyond the days planned for the current blister pack of combined hormonal contraceptives, you should start the next blister pack of Belara daily without the usual break.

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

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

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

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

• some benzodiazepines, e.g.,

  3. How to take Belara daily

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

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

  Administration mode

  Oral.

  How and when to take Belara daily

  Remove the first active pale pink tablet from the position in the blister where it says “Start” and swallow it without chewing. You will:

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

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

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

  When can you start taking Belara daily?

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

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

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

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

  If your period started more than 5 days ago, please wait until the next period to start taking Belara daily.

  If you have taken a previous combined hormonal contraceptive

  Take all the tablets from the old blister following the usual schedule. You must start taking Belara daily on the day after the usual interval without active or placebo tablets of your previous combined hormonal contraceptive method.

  If you have taken a hormonal contraceptive that only contains progestogens (“mini-pill")

  If you are taking a hormonal contraceptive that only contains a progestogen (mini-pill), you may not have withdrawal bleeding, equivalent to menstrual bleeding. Take the first active pale pink tablet of Belara daily on the day after taking the last mini-pill. In this case, you must take additional contraceptive measures during the first 7 days.

  If you have previously used injectable hormonal contraceptives or implantable contraceptives

  Take the first active pale pink tablet of Belara daily on the same day as the removal of the implant or the day corresponding to the next injection. In this case, you must take additional contraceptive measures during the first 7 days.

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

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

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

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

  However, if more than 28 days have passed since delivery, you must use additional barrier contraceptive methods during the first 7 days.

  If you have already had sexual intercourse, you must rule out pregnancy or wait until the next period before starting Belara daily.

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

  How long can you take Belara daily?

  You can take Belara daily for as long as you want, as long as there are no risks to your health (see “Do not take Belara daily” and “Be careful with Belara daily” section 2). Once you stop taking Belara daily, your next cycle may be delayed by about a week.

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

  If vomiting or diarrhea occurs within 4 hours of taking the active pale pink tablet, the absorption of the active principles of Belara daily may be incomplete.This situation is similar to having forgotten the active pale pink tablet and taking a new active pale pink tablet from a new blister immediately. If possible, take the new active tablet within 12 hours of taking the last active tablet and continue taking Belara daily following your usual schedule. If not possible or if more than 12 hours have passed, follow the instructions in the section “If you forgot to take Belara daily” or consult your doctor.

  If you take moreBelara dailythan you should

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

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

  If you forgot to take Belara daily

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

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

  • Ifmore than 12 hourshave not passed since you were supposed to take the tablet, the effect of Belara daily is not reduced. Take the tablet as soon as you remember and then take the next tablets following your usual schedule. In this case, additional contraceptive methods are not necessary.
  • Ifmore than 12 hourshave passed, the anticonceptive effect of Belara daily is not guaranteed. In this case, take the forgotten active pale pink tablet immediately and continue taking Belara daily following your usual schedule. This may mean taking 2 active pale pink tablets at the same time.In this case, you must use additional contraceptive methods (e.g., condoms) during the next 7 days.If the current blister contains less than 7 active pale pink tablets, you must start with the next blister of Belara daily as soon as you finish the active pale pink tablets from the current blister, i.e., you must not have an interval with placebo tablets between blisters.You may not experience withdrawal bleeding (menstrual bleeding) until you have finished the next blister. However, you may experience intermenstrual bleeding or spotting while taking the tablets from the new blister.

  The more active pale pink tablets you forget, the greater the risk of reduced contraceptive protection. If you forget to take one or more active pale pink tablets during week 1 and have had sexual intercourse in the week before forgetting, you must consider the risk of pregnancy. The same applies if you have forgotten one or more active pale pink tablets and do not have a period during the next placebo tablet period. In these cases, consult your doctor.

  If you want to delay your menstrual period

  Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) by starting to take the active tablet from a new blister of Belara daily instead of the placebo tablet period, until you complete the second blister. You may experience spotting (drops or spots of blood) or intermenstrual bleeding while using this second blister. After the usual 7-day placebo tablet period, continue with the first active tablet from the next blister.

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

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

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

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

  If you interrupt treatment with Belara daily

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

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

  4. Possible Adverse Effects

  Like all medicines, Belara daily may cause side effects, although not everyone will experience them.If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be due to Belara daily, consult your doctor.

  Seek medical attention immediately if you experience any of the following angioedema symptoms: swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria with possible difficulty breathing (see also the "Warnings and precautions" section).

  All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section2 "What you need to know before starting to use Belara daily".

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

  Very common:may affect more than 1 in 10 people

  Nausea, vaginal discharge, menstrual pain, amenorrhea, intermenstrual bleeding.

  Common:may affect up to 1 in 10 people

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

  Uncommon:may affect up to 1 in 100 people

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

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

  Vaginal inflammation, increased appetite, conjunctivitis, discomfort when wearing contact lenses, hearing loss, tinnitus, hypertension, hypotension, circulatory collapse, varicose veins, urticaria, eczema, skin inflammation, pruritus, worsening of psoriasis, excessive hair growth on the body or face, breast enlargement, prolonged and/or increasedmenstruation, premenstrual syndrome (physical and emotional disorders before menstruation).

  Deleterious 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 ischemic attack (TIA) or symptoms similar to a stroke.
  • blood clots in the liver, stomach/intestine, kidneys, or eye.

  The likelihood of having a blood clot may be higher if you have any other condition that increases this risk (see section2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

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

  Erythema nodosum

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

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

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

  Read the information presented in "Be careful with Belara daily" in section 2 and, if necessary, consult your doctor immediately.

  Reporting of adverse reactions:

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

  5. Belara Daily Conservation

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

  Do not store at a temperature above30°C.

  Do not use this medication after the expiration date that appears on the box and on the blister pack after “CAD". The expiration date is the last day of the month indicated.

  Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

  6. Contents of the packaging and additional information

  Belara Daily Composition

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

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

  • The other components are:

  Film-coated active tablets:

  Tablet core:

  lactose monohydrate, cornstarch, povidone K 30, magnesium stearate

  Tablet coating:

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

  Film-coated inactive 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).

  Product appearance and packaging contents

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

  Marketing authorization holder and manufacturer

  Marketing authorization holder:

  Gedeon Richter Plc.

  Gyömroi út 19-21

  1103 Budapest

  Hungary

  Manufacturer

  Gedeon Richter Plc.

  Gyömroi út 19-21

  1103 Budapest

  Hungary

  For more information about this medication, 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 medication is authorized in the European Economic Area member states with the following names:

  GermanyBelara Filmtabletten

  SpainBelara diario 2 mg / 0.03 mg film-coated tablets

  FranceBelaracontinu comprimés pelliculés

  Last review date of this leaflet:February 2023

  For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/