Belara conti

Package leaflet: Information for the user

Belara CONTI, 2 mg + 0,03 mg, coated tablets
Chlormadinone acetate + Ethinylestradiol
Important information regarding combined hormonal contraceptives:

• When used correctly, they are one of the most reliable, reversible forms of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, particularly during the first year of use or after restarting use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the user suspects symptoms of blood clot formation (see section 2 “Blood clots”).

Please read this leaflet carefully before taking the medicine, as it contains
important information for the user.

• 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 a specific individual. Do not pass it on to others. The medicine may harm someone else.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Belara CONTI is a hormonal contraceptive medicine taken orally.
An oral contraceptive containing two hormones, such as Belara CONTI, is also known as a
combined hormonal contraceptive. The 21 light pink tablets in the pack intended for use in one cycle contain the same amount of both hormones; therefore, Belara CONTI is also referred to as a monophasic product.
Hormonal contraceptives such as Belara CONTI do not protect against HIV infection (AIDS) and other sexually transmitted infections. Only condoms can provide protection against these diseases.

2. Important information before using Belara CONTI

General notes
Before starting treatment with Belara CONTI, you should read the information about blood clots in section 2. It is particularly important to be aware of the symptoms of blood clots – see section 2 “Blood clots”.
Before starting Belara CONTI, your doctor will perform a thorough general and gynecological examination, exclude pregnancy, and decide, taking into account contraindications and precautions, whether you can use Belara CONTI. During treatment with Belara CONTI, such examinations should be repeated annually.

When not to use Belara CONTI
Do not use Belara CONTI if you have any of the conditions listed below. If you have any of these conditions, inform your doctor. Your doctor will discuss with you which alternative contraceptive method would be more suitable.

• if you are allergic (hypersensitive) to chlormadinone acetate or ethinylestradiol or to any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you have symptoms indicating or early signs of blood clots, vein inflammation, or embolism, such as transient stabbing, pain, or pressure in the chest;
• if you require surgery or will be immobile for a prolonged period (see section “Blood clots”);
• if you know you have disorders affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you have diabetes with uncontrolled blood sugar levels;
• if you have high blood pressure that is difficult to control or if your blood pressure increases significantly (persistent values above 140/90 mmHg);
• if you have had a heart attack or stroke;
• if you currently suffer (or have suffered in the past) from angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischemic attack (temporary stroke-like symptoms);
• if you have any of the following diseases, which may increase the risk of arterial clot formation:
  • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high blood lipid levels (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia;
• if you currently have (or have had in the past) a type of migraine called “migraine with aura”;
• if you have hepatitis (e.g. viral) or jaundice, and liver function test results have not returned to normal;
• if you have generalized itching or bile flow disorders, particularly if such disorders occurred during a previous pregnancy or during estrogen treatment;
• if you have increased bilirubin levels (a breakdown product of blood pigment) in the blood, e.g. due to congenital disorders of bilirubin excretion (Dubin-Johnson syndrome or Rotor syndrome);
• if you currently have meningioma or have ever been diagnosed with meningioma (usually a benign tumor of the tissue layer between the brain and skull);
• if you have or have had liver cancer;
• if you have severe abdominal pain, enlarged liver, or symptoms of intra-abdominal bleeding;
• if you have or have had an attack of porphyria (a disorder of blood pigment metabolism);
• if you have or have had hormonally dependent malignant tumors, such as breast or cervical cancer, or if such tumors are suspected;
• if you have or have had severe lipid metabolism disorders;
• if you have or have had pancreatitis associated with high blood lipid levels (triglycerides);
• if you experience exceptionally severe, frequent, or prolonged headaches;
• if you experience sudden sensory disturbances (visual or hearing impairments);
• if you experience sudden motor disturbances (especially paralysis);
• if your epileptic seizures worsen;
• if you have severe depression;
• if you have a certain type of hearing loss (otosclerosis) that worsened during a previous pregnancy;
• if you have no menstrual bleeding for unknown reasons;
• if you have been diagnosed with abnormal endometrial hyperplasia (endometrial overgrowth);
• if you have vaginal bleeding of unknown cause.

Do not use Belara CONTI in patients with hepatitis C who are taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section “Belara CONTI and other medicines”).
If any of the above conditions occur during treatment with Belara CONTI, stop taking the medicine immediately.
Do not take Belara CONTI or discontinue treatment immediately if you have one serious risk factor or several risk factors for developing blood clots.

Warnings and precautions
Before starting treatment with Belara CONTI, discuss this with your doctor or pharmacist.

When should you contact your doctor?
Seek immediate medical advice:

• if you notice possible symptoms of blood clots, which may indicate that you have a blood clot in the leg (i.e. deep vein thrombosis), in the lungs (i.e. pulmonary embolism), a heart attack, or a stroke (see section below “Blood clots (thrombosis)”. For a description of symptoms of these serious adverse effects, see “How to recognize the occurrence of blood clots”.

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

• if you smoke. Smoking while using hormonal contraceptives increases the risk of serious cardiovascular adverse effects. This risk increases with age and the number of cigarettes smoked. This particularly affects women over 35 years of age. Women over 35 who smoke should use alternative contraceptive methods.

If any of these symptoms appear or worsen during treatment with Belara CONTI, inform your doctor:

• if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria, potentially with breathing difficulties, seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• if you have increased arterial blood pressure, abnormal increase in blood lipid levels, overweight, or diabetes (see also section 2 “When not to use Belara CONTI” and “Other diseases”). In such cases, the risk of severe adverse effects (such as myocardial infarction, embolism, stroke, or liver cancer) during use of combined hormonal contraceptives is higher;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the body’s natural immune system);
• if you have hemolytic uremic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anemia (an inherited disorder of red blood cells);
• if you have been diagnosed with elevated blood lipid levels (hypertriglyceridemia) or have a positive family history for this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”);
• if you are in the immediate postpartum period, as you are at increased risk of blood clots. Consult your doctor to determine how soon after delivery you can start taking Belara CONTI;
• if you have phlebitis (inflammation of superficial veins under the skin);
• if you have varicose veins.

BLOOD CLOTS
Using combined hormonal contraceptives such as Belara CONTI is associated with an increased risk of blood clots compared to not using such therapy. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to below as “venous thrombosis”, “venous thromboembolic disease”, or VTE),
• in arteries (referred to below as “arterial thrombosis”, “arterial thromboembolic disorders”, or ATE).

Complete recovery after a blood clot is not always achieved. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by using Belara CONTI is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.
Is the patient experiencing any of these symptoms? Likely reason

• swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:
  • pain or tenderness in the leg, which may occur only while standing or walking
  • increased warmth in the affected leg
  • skin discoloration of the leg, e.g. pallor, redness, or cyanosis.

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?
The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thromboembolism). However, these adverse events are rare. They most commonly occur during the first year of using combined hormonal contraceptives.

If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis (DVT).

If a blood clot travels from the leg and lodges in the lungs, it can cause pulmonary embolism.

In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.

After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.

If a woman stops taking Belara CONTI, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots?
The risk depends on the individual's natural risk of venous thromboembolic disease (VTE) and the type of combined hormonal contraceptive used.

• The overall risk of developing blood clots in the legs (DVT) or lungs (pulmonary embolism, PE) with the use of Belara CONTI is low.
• In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• Among 10,000 women using combined hormonal contraceptives containing chlormadinone, such as Belara CONTI, approximately 6 to 9 women will develop blood clots within one year.
• The risk of developing blood clots depends on the individual’s medical history (see “Factors that increase the risk of blood clots,” below).

If migraine attacks increase in frequency or intensity while taking Belara CONTI, which may indicate disturbances in blood flow to the brain, you should contact your doctor as soon as possible. The doctor may advise immediate discontinuation of Belara CONTI.

Factors increasing the risk of venous blood clots

The risk of blood clots associated with the use of Belara CONTI is small; however, certain factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index [BMI] above 30 kg/m²);
• if a close family member has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In such cases, the patient may have inherited clotting disorders;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Belara CONTI several weeks before surgery or during immobilization. If Belara CONTI must be discontinued, consult your doctor about when it is safe to resume treatment;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of blood clots increases with the number of risk factors present in the patient.

Air travel (>4 hours) may temporarily increase the risk of blood clots, particularly if the patient has another risk factor present.

It is important to inform your doctor if any of these factors apply to you, even if you are uncertain. Your doctor may decide to discontinue Belara CONTI.

Inform your doctor if any of the above conditions change during treatment with Belara CONTI, for example, if a close family member is diagnosed with unexplained thrombosis or if you gain significant weight.

ARTERIAL BLOOD CLOTS

What can happen if blood clots form in the arteries?

As with venous blood clots, arterial clots may lead to serious consequences such as heart attack or stroke.

Factors increasing the risk of arterial blood clots

It is important to emphasize that the risk of heart attack or stroke associated with Belara CONTI is very low, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Belara CONTI, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In such cases, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood fats (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve disorders, heart rhythm disturbances such as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased. Inform your doctor if any of the above conditions change during treatment with Belara CONTI, for example, if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Tumors

Several studies have shown an increased risk of cervical cancer in women infected with a specific sexually transmitted virus (human papillomavirus) who have used hormonal contraceptives long-term. However, the influence of other contributing factors (e.g., number of sexual partners and use of mechanical contraception methods) on cervical cancer development has not been fully clarified.

Studies have shown a slightly increased risk of breast cancer in women using combined hormonal contraceptives. This risk gradually returns to the baseline age-related risk within 10 years after stopping these medications. Since breast cancer is rare in women under 40 years of age, the increase in diagnosed cases among women currently or previously using hormonal contraceptives is small compared to the lifetime risk of breast cancer.

In rare cases, the use of hormonal contraceptives has led to the development of benign, or even more rarely, malignant liver tumors. These may cause dangerous internal bleeding. If the patient experiences severe, persistent abdominal pain, she should contact her doctor immediately.

The use of chlormadinone acetate has been associated with the development of usually benign meningiomas (tumors of the tissue layer between the brain and skull). This risk increases particularly with high doses and prolonged use (several years). If a meningioma is diagnosed, the doctor will discontinue treatment with Belara CONTI (see section 2 "When not to use Belara CONTI").

If the patient notices any symptoms such as visual disturbances (e.g., double or blurred vision), hearing loss or tinnitus, loss of smell, headaches that worsen over time, memory loss, seizures, or weakness in the arms or legs, she should immediately inform her doctor.

Other diseases

Psychiatric disorders

Some women using hormonal contraceptives, including Belara CONTI, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice.

Many women using hormonal contraceptives experience a slight increase in blood pressure. If blood pressure increases significantly during treatment with Belara CONTI, the doctor may recommend discontinuing Belara CONTI and prescribe medication to lower blood pressure. Belara CONTI may be restarted once blood pressure returns to normal levels.

Women who previously experienced herpes gestationis during pregnancy may have a recurrence while using hormonal contraceptives.

If the patient or a family member has a disorder of fat metabolism in the blood (hypertriglyceridemia), there is an increased risk of pancreatitis.

If the patient has acute or chronic liver function disorders, the doctor may recommend discontinuing Belara CONTI until liver function parameters return to normal. If the patient previously experienced jaundice during pregnancy or while using hormonal contraceptives and it recurs, the doctor will advise discontinuing Belara CONTI.

If the patient is using Belara CONTI and has diabetes, and blood glucose levels are well controlled, the doctor should carefully monitor her condition during treatment with Belara CONTI. A change in antidiabetic treatment may be necessary.

Brown skin patches (chloasma) may occur, particularly if such changes occurred during a previous pregnancy. Women prone to chloasma should avoid direct sunlight and ultraviolet radiation while using Belara CONTI.

Belara CONTI and other diseases

Special clinical monitoring is required also:

• if the patient has epilepsy;
• if the patient has multiple sclerosis;
• if the patient has severe muscle spasms (tetany);
• if the patient has migraines (see also section 2 "When not to use Belara CONTI");
• if the patient has bronchial asthma;
• if the patient has heart or kidney dysfunction (see also section 2 "When not to use Belara CONTI");
• if the patient has Huntington's disease;
• if the patient has diabetes (see also section 2 "When not to use Belara CONTI" and "Other diseases");
• if the patient has liver function disorders (see also section 2 "When not to use Belara CONTI");
• if the patient has lipid metabolism disorders (see also section 2 "When not to use Belara CONTI");
• if the patient has an autoimmune disease (including systemic lupus erythematosus);
• if the patient is significantly overweight;
• if the patient has hypertension (see also section 2 "When not to use Belara CONTI");
• if the patient has endometriosis (when endometrial tissue is found outside the uterine cavity) (see also section 2 "When not to use Belara CONTI");
• if the patient has varicose veins or phlebitis (see also section 2 "When not to use Belara CONTI");
• if the patient has blood coagulation disorders (see also section 2 "When not to use Belara CONTI");
• if the patient has breast disease (mastopathy);
• if the patient previously had benign uterine tumors (fibroids);
• if the patient had pemphigoid gestationis (herpes gestationis) during a previous pregnancy;
• if the patient has depression;
• if the patient has chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).

Inform your doctor if any of the above conditions occurred in the past, are currently present, or develop during treatment with Belara CONTI.

Efficacy

Contraceptive effectiveness may be reduced if the contraceptive is taken irregularly, if vomiting or diarrhea occurs after taking the tablet (see section 3 "What to do if vomiting or diarrhea occurs during treatment with Belara CONTI"), or if the patient is taking certain other medications simultaneously (see section 2 "Belara CONTI and other medicines").

In rare cases, metabolic disorders may affect contraceptive efficacy.

Even when hormonal contraceptives are taken correctly, complete protection against pregnancy cannot be guaranteed.

Irregular bleeding

Irregular vaginal bleeding (intermenstrual spotting and/or bleeding) may occur during use of hormonal contraceptives, especially during the first few months of tablet use. Inform your doctor if irregular bleeding persists after 3 months of treatment or if it occurs after previously regular menstrual cycles.

Spotting may also indicate reduced contraceptive effectiveness.

Some patients may not experience withdrawal bleeding after 21 days of taking Belara CONTI. If Belara CONTI has been taken according to the instructions in section 3 below, pregnancy is unlikely. If Belara CONTI was not taken according to the instructions before the first missed withdrawal bleed, pregnancy should be ruled out before continuing treatment.

Belara CONTI and other medicines

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.

Do not use Belara CONTI in patients with hepatitis C who are taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these may cause abnormal liver function test results (increased liver enzyme AlAT activity).

Before starting these medications, the doctor will prescribe a different type of contraception.

Belara CONTI may be restarted approximately 2 weeks after completion of the above-mentioned treatment. See section "When not to use Belara CONTI".

Some medications may affect blood concentrations and cause reduced contraceptive efficacy of Belara CONTI or 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 virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• fungal infections (griseofulvin);
• pulmonary hypertension (bosentan);
• herbal products containing St. John's wort (Hypericum perforatum). If the patient wishes to use herbal products containing St. John's wort during treatment with Belara CONTI, she should first consult her doctor.

Medications that increase intestinal motility (e.g., metoclopramide) and activated charcoal may alter the absorption of the active substances in Belara CONTI and reduce their effectiveness.

During treatment with the above-mentioned medications, additional mechanical contraception (e.g., condoms) should be used. Additional mechanical contraception should be used throughout the duration of concomitant therapy and for 28 days after stopping treatment. If concomitant therapy is started before completing the active tablets in the current blister pack, the next pack should be started without taking the placebo tablets.

If long-term treatment with the above-mentioned medications is required, non-hormonal contraception methods should be used. Consult your doctor or pharmacist for advice.

Interactions between Belara CONTI and other medications may increase or exacerbate adverse effects of Belara CONTI. The following medications may negatively affect the tolerability of Belara CONTI:

• ascorbic acid (a preservative, also known as vitamin C);
• paracetamol (analgesic and antipyretic);
• atorvastatin (cholesterol-lowering medication);
• troleandomycin (antibiotic);
• imidazole antifungals—e.g., fluconazole (used to treat fungal infections);
• indinavir (used to treat HIV infection).

Belara CONTI may affect the action of other medications. The efficacy or tolerability of the following medications may be reduced by Belara CONTI:

• certain benzodiazepines, e.g., diazepam (used to treat sleep disorders);
• cyclosporine (used to suppress immune system activity);
• theophylline (used to treat asthma symptoms);
• corticosteroids, e.g., prednisolone (steroids, anti-inflammatory drugs used to treat, e.g., lupus, arthritis, psoriasis);
• lamotrigine (used to treat epilepsy);
• clofibrate (used to lower high cholesterol levels);
• paracetamol (analgesic and antipyretic);
• morphine (a specific strong analgesic);
• lorazepam (used to treat anxiety disorders).

Also, refer to the package leaflets of other prescribed medications. Inform your doctor if you are using insulin or other medications that lower blood glucose levels, as dosage adjustments may be necessary.

Remember that this information also applies when any of these active substances were used shortly before starting Belara CONTI.

While using Belara CONTI, results of certain laboratory tests assessing liver, adrenal, and thyroid function, certain blood proteins, carbohydrate metabolism parameters, and blood coagulation parameters may be altered. Therefore, inform your doctor about using Belara CONTI before undergoing blood tests.

Pregnancy and breastfeeding

Belara CONTI should not be used during pregnancy. If the patient becomes pregnant while taking Belara CONTI, she must immediately stop taking it. However, prior use of Belara CONTI is not a reason to terminate pregnancy.

Note that while using Belara CONTI during breastfeeding, milk production may be reduced and milk composition may change. Very small amounts of active substances may be excreted in breast milk. Hormonal contraceptives such as Belara CONTI may only be used after breastfeeding has been discontinued.

Driving and operating machinery

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

Belara CONTI contains lactose

This medicine contains 66.07 mg of lactose per coated tablet containing active substances and 94.44 mg of lactose per placebo coated tablet. If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to use Belara CONTI

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

The blister packs in each package have been designed to help the patient remember to take the tablets. Each blister contains 28 tablets: 21 light pink tablets containing active substances (tablets 1–21) and 7 white inactive tablets (tablets 22–28).

Method of administration:
For oral use.

How and when to take Belara CONTI
Push out the first light pink tablet containing active substances from the place marked on the package cycle with the symbol "start" and swallow it without chewing. You should take:

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

If possible, take the tablet at the same time of day, preferably in the evening. If possible, the interval between taking two consecutive tablets should always be 24 hours. The day of the week on which the patient starts taking Belara CONTI should be marked on the cycle package. The circled numbers on the package indicate the days of the cycle, with number 1 marked "start" indicating the first day of the cycle. Marking the day of the week on the package intended for use in the current cycle will help the patient check whether the tablet for that day has already been taken.

Usually, withdrawal bleeding similar to menstrual bleeding occurs within two to four days after taking the last active light pink tablet. After completing all 28 tablets, continue taking tablets from the next pack of Belara CONTI regardless of whether the withdrawal bleeding has stopped or is still ongoing.

When to start taking Belara CONTI

If the patient has not previously used hormonal contraceptives (during the last menstrual cycle):
Take the first light pink tablet of Belara CONTI on the first day of the next menstrual bleeding.

The contraceptive effect begins on the first day of tablet intake and continues during the seven days of taking the inactive tablets.

If menstrual bleeding has already started, take the first light pink active tablet between the second and fifth day of the cycle, regardless of whether the bleeding has stopped or is still ongoing. However, in this case, an additional mechanical method of contraception must be used for the first 7 days of tablet intake (7-day rule).

If more than 5 days have passed since the onset of menstrual bleeding, wait for the next menstrual bleeding and only then start taking Belara CONTI.

If the patient previously used another combined hormonal contraceptive:
Take all tablets from the previous contraceptive pack. Take the first tablet of Belara CONTI the next day after the usual tablet-free interval or the next day after taking the last placebo tablet of the previously used combined hormonal contraceptive.

If the patient previously used a progestogen-only hormonal contraceptive (progestogen-only pill, POP):
If the patient previously used a progestogen-only hormonal contraceptive, withdrawal bleeding similar to menstrual bleeding may not occur. Take the first light pink active tablet of Belara CONTI the day after completing the progestogen-only tablets. An additional mechanical method of contraception must be used for the first 7 days of tablet intake.

If the patient previously used hormonal contraception in the form of injections or an implant:
Take the first light pink active tablet of Belara CONTI on the day of implant removal or on the scheduled day of injection. An additional mechanical method of contraception must be used for the first 7 days of tablet intake.

After miscarriage or termination of pregnancy during the first three months of pregnancy:
Belara CONTI may be started immediately after miscarriage or termination of pregnancy. There is no need to use an additional method of contraception.

After childbirth or miscarriage between 3 and 6 months of pregnancy:
Women who are not breastfeeding may start taking Belara CONTI between 21 and 28 days after childbirth. There is no need to use an additional mechanical method of contraception. However, if more than 28 days have passed since childbirth, an additional method of contraception should be used for the first 7 days of tablet intake.

If sexual intercourse has occurred previously, pregnancy should be ruled out before starting Belara CONTI, or the start of tablet intake should be delayed until the next menstrual period.

Note that women who are breastfeeding should not use Belara CONTI (see section "Pregnancy and breastfeeding").

How long to use Belara CONTI
There is no time limit for using Belara CONTI, provided there are no health risks contraindicating its continued use (see section 2 "When not to use Belara CONTI"). After stopping Belara CONTI, the next menstrual bleeding may be delayed by about one week.

What to do if vomiting or diarrhoea occurs while taking Belara CONTI
If vomiting or diarrhoea occurs within 4 hours after taking a light pink tablet containing active substances, it is possible that the active ingredients of Belara CONTI are not fully absorbed. This situation is similar to missing one light pink active tablet, and a new light pink active tablet should be taken from a new blister pack. Take a new light pink active tablet within 12 hours of taking the last tablet, if possible, and continue taking Belara CONTI at the usual time. If this is not possible or more than 12 hours have passed, follow the advice given in the section "Missed dose of Belara CONTI" or contact your doctor.

Overdose of Belara CONTI
There are no data on severe poisoning symptoms following a single ingestion of a large number of tablets. Nausea, vomiting, and slight vaginal bleeding may occur, especially in young girls. In such a case, contact your doctor. If necessary, the doctor may order tests to assess water-electrolyte balance and liver function.

Missed dose of Belara CONTI
The white tablets (tablets 22–28) do not contain active substances; they are placebo tablets. If the patient forgets to take one of the white tablets, this does not affect the effectiveness of Belara CONTI. In this case, the forgotten inactive white tablet should be discarded to avoid prolonging the placebo period, as this could negatively affect the effectiveness of Belara CONTI.

If a light pink active tablet (tablets 1–21) is missed, follow the instructions below:

• If the patient forgets to take the tablet at the usual time, it should be taken within the next 12 hours. In this case, the effectiveness of Belara CONTI is not reduced, no additional contraceptive method is needed, and tablet intake can continue as usual.
• If the interval is longer than 12 hours, contraceptive protection with Belara CONTI cannot be guaranteed. In this case, take the last missed light pink active tablet immediately and continue taking Belara CONTI at the usual time. This may mean taking up to two light pink active tablets on the same day. However, in this case, an additional mechanical method of contraception (e.g., condom) must be used for the next 7 days. If there are fewer than 7 light pink active tablets left in the pack, immediately start taking light pink active tablets from the next pack of Belara CONTI immediately after taking the last active coated tablet from the current pack—this means no inactive tablets should be taken between packs. Withdrawal bleeding will probably not occur until the end of the second pack. However, breakthrough bleeding or intermenstrual spotting may occur on the days when tablets from the new pack are taken.

The greater the number of missed active tablets, the higher the risk of reduced contraceptive effectiveness. If the patient missed one or more active tablets in week 1 and had sexual intercourse during the week before the missed tablets, pregnancy should be considered. This also applies if the patient forgot to take one or more active tablets and withdrawal bleeding did not occur during the placebo tablet period. In such cases, contact your doctor.

Delaying the onset of menstrual bleeding
Although not recommended, it is possible to delay the onset of menstrual bleeding (withdrawal bleeding) by immediately starting a new blister of Belara CONTI containing active tablets, without taking the placebo tablets, and continuing with active tablets until the end of the new blister. Breakthrough bleeding (spotting or small blood drops) or intermenstrual spotting may occur during use of the second blister. After taking the placebo tablets, continue taking active tablets from the next pack.

If the patient plans to delay the onset of menstrual bleeding, she may consult her doctor for advice.

Changing the first day of menstrual bleeding
If the patient takes the tablets as directed, menstrual bleeding and/or withdrawal bleeding will occur during the placebo tablet period. If the patient wishes to change the day of bleeding onset, she may shorten the placebo tablet period (but never extend it!). For example, if the placebo tablet period starts on Friday and the patient wants to change it to Tuesday (three days earlier), she should start the new blister three days earlier than usual. If the placebo tablet period is very short (e.g., 3 or fewer days), no bleeding may occur. Light spotting (drops or small blood spots) or intermenstrual bleeding may occur.

If the patient has any doubts about how to proceed, she should consult her doctor for advice.

Discontinuing Belara CONTI
After stopping Belara CONTI, the ovaries quickly resume full function, and pregnancy may occur.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Belara CONTI, medical advice should be sought.

Serious adverse effects
Seek immediate medical attention if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria potentially associated with breathing difficulties (see also section "Warnings and precautions").

All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease, VTE) or arterial blood clots (arterial thromboembolic disorders, ATE). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before taking Belara CONTI".

The frequency of adverse effects is defined as follows:
Very common (affects more than 1 in 10 women):
Nausea, hot flushes, painful menstruation, absence of menstruation.

Common (affects up to 1 in 10 women):
Depression, nervousness, irritability, dizziness, migraine (and/or worsening of migraine), visual disturbances, vomiting, acne, feeling of heaviness, abdominal pain, fatigue, fluid retention, weight gain, increased blood pressure.

Uncommon (affects up to 1 in 100 women):
Vaginal fungal infection, benign changes in breast connective tissue, hypersensitivity to the medicine, including skin allergic reactions, changes in blood lipid levels, including increased triglyceride levels, decreased libido, abdominal pain, bloating, diarrhoea, pigmentation disorders, brown patches on the face, alopecia, dry skin, excessive sweating, back pain, muscle complaints, breast discharge.

Rare (affects up to 1 in 1,000 women):
Vaginitis, increased appetite, conjunctivitis, discomfort during contact lens use, deafness, tinnitus, high blood pressure, low blood pressure, circulatory collapse, varicose veins, urticaria, rash, dermatitis, pruritus, exacerbation of psoriasis, hirsutism (excessive hair growth on body or face), breast enlargement, prolonged and/or heavy menstrual bleeding, premenstrual syndrome (emotional and psychological disturbances before the onset of menstrual bleeding).

Harmful blood clots in a vein or artery, for example:

• in the leg or foot (i.e. deep vein thrombosis),
• in the lungs (i.e. pulmonary embolism),
• heart attack,
• stroke,
• mini-stroke or transient ischaemic attack (TIA),
• blood clots in the liver, stomach/intestines, kidneys or eye.
  The likelihood of blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Very rare (affects up to 1 in 10,000 women):
Erythema nodosum.

Additionally, the following adverse effects related to the active substances, chlormadinone acetate and ethinylestradiol, have been reported after the medicine was placed on the market: weakness and allergic reactions, including swelling of deeper skin layers (angioedema).

Furthermore, the use of combined hormonal contraceptives, including Belara CONTI, has been associated with an increased risk of serious diseases and adverse effects:

• venous or arterial blood clots (see section 2 "Warnings and precautions");
• risk of disorders of the biliary tract (see section 2 "Warnings and precautions");
• risk of tumours (such as liver tumours, which in isolated cases may lead to life-threatening intra-abdominal bleeding, cervical cancer and breast cancer; see section 2 "Warnings and precautions");
• exacerbation of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis; see section 2 "Warnings and precautions").
  Please read carefully the information provided in section 2 "Warnings and precautions" and consult your physician if necessary.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Belara CONTI

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. The expiry date refers to the last day of the month stated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Belara CONTI contains:

• The active substances are: chloromadinone acetate and ethinylestradiol. One light pink film-coated tablet contains 2.0 mg chloromadinone acetate and 0.030 mg ethinylestradiol.
• The white film-coated tablets do not contain active substances.
• Other components are:

Film-coated tablets containing active substances:
Tablet core:
monohydrate lactose, corn starch, povidone K-30, magnesium stearate.
Tablet coating:
hypromellose (type 2910), monohydrate lactose, titanium dioxide (E 171), talc, macrogol 6000, propylene glycol, iron oxide red (E 172).

Placebo film-coated tablets:
Tablet core:
monohydrate lactose, povidone K-30, crospovidone type A, magnesium stearate.
Tablet coating:
hypromellose (type 2910), monohydrate lactose, talc, titanium dioxide (E 171), macrogol 6000, propylene glycol.

What Belara CONTI looks like and contents of the pack
Light pink, round, biconvex film-coated tablet containing active substances, unmarked. Diameter approximately 6 mm.
White to almost white, round, biconvex film-coated placebo tablet, unmarked. Diameter approximately 7 mm.
Belara CONTI 2 mg + 0.03 mg, film-coated tablets, are packed in blisters made of PVC/PVDC/Aluminium. The blisters are placed in a cardboard box.
Each box contains 1, 3 or 6 calendar packs, each containing 21 film-coated tablets with active substances + 7 film-coated placebo tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

For further information about this medicinal product, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: +48 (22) 755 96 48
[email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany Belara 28
Poland Belara CONTI