Belara®

Brand Grünentalh GmbH

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Available since: 2019-09-19

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Clinical Pharmacology

Pharmacodynamics:
Prolonged (over 21 days) use of the BELARA drug leads to a decrease in the secretion of follicle-stimulating hormone and luteinizing hormone, and, consequently, suppression of ovulation, endometrial proliferation and its secretory transformation. At the same time, the mucus properties of the cervical canal change, which is accompanied by difficulty in passing sperm through the cervical canal and a violation of their mobility.

Chlormadinone acetate, a progestogen that is part of BELARA, has antiandrogenic properties. Its action is based on the ability to replace androgens at specific receptors, eliminating and weakening the effect of endogenous and exogenous androgens. To completely suppress ovulation, 1.7 mg of chlormadinone acetate is required daily. The required dose per cycle is 25 mg.
The other active component of BELARA, ethinyl estradiol, inhibits the secretion of skin sweat glands. It also significantly increases the production of globulin that binds sex hormones, thereby reducing the amount of free testosterone in the blood plasma. Interacts with specialized estrogen receptors in target organs (in the fallopian tubes, cervix, vagina, external genital organs, excretory ducts of the mammary glands), causes proliferation of the endometrium.
In addition to a reliable contraceptive effect, the positive effect of the BELARA drug is manifested in the normalization of the menstrual cycle, reduction in the manifestation of premenstrual syndrome, the incidence of iron deficiency anemia, dysmenorrhea, functional ovarian cysts, ectopic pregnancy, endometrial and ovarian malignancies, some benign diseases of the mammary glands and inflammatory diseases pelvic organs.

Pharmacokinetics
When ingested, chlormadinone acetate and ethinyl estradiol are quickly and completely absorbed. The maximum concentration of ethinyl estradiol is reached after 1.5 hours. The maximum concentration of chlormadinone acetate is reached after 1–2 hours.
The half-life of chlormadinone acetate is approximately 34–39 h, ethinyl estradiol is 12–14 h. The metabolites of chlormadinone acetate are excreted by the kidneys and through the intestine in a 2: 3 ratio.
The elimination half-life of ethinyl estradiol is approximately 12-14 hours.
Ethinyl estradiol metabolites are water soluble derivatives of sulphate or glucuronic conjugation. Ethinyl estradiol metabolites are excreted by the kidneys and through the intestine at a ratio of 4: 6.

Indications

Oral contraception.

Composition

One film coated tablet contains
active substances: chlormadinone acetate 2 mg and ethinyl estradiol 0.03 mg;
Excipients: Povidone K 30 - 4.5 mg, corn starch - 9.0 mg, lactose monohydrate - 68.97 mg, magnesium stearate - 0.5 mg
film cover: hypromellose 6 mPa.s - 1.115 mg, lactose monohydrate - 0.575 mg, macrogol 6000 - 0.279 mg, propylene glycol - 0.093 mg, talc - 0.371 mg, titanium dioxide dye, E 171 - 0.557 mg, iron dye red oxide (III), E 172-0.01 mg.

Belara® is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Belara	Grünentalh GmbH	Germany	pills
Belara	Gedeon Richter	Hungary	pills

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Dosage and Administration

Belara pills begin to take on the 1st day of the menstrual cycle and continue to receive daily (preferably at the same time) for 21 days. Then you should take a 7-day break, during which menstrual-like bleeding should begin. After a 7-day break, you should resume taking the drug from the next blister, regardless of whether the menstrual-like bleeding has stopped or not.
If ahormonal contraceptives have not been applied during the previous menstrual cycle, pills should be started on the first day of the normal menstrual cycle (the first day of menstruation). Contraceptive action begins on the first day of administration. If menstruation lasts more than one day, the first pill should be taken on the 5th day of menstruation, regardless of whether the bleeding has stopped or not. In this case, you should use additional, non-hormonal methods of contraception during the first 7 days. If more than 5 days have passed since the onset of menstruation, then a woman is recommended to start taking the drug from the next menstrual cycle.
Withtransition from another hormonal contraceptive containing 21 active pills, you should finish taking all the pills of the old package. The first pill of Belara must be taken the next day. There should not be a break in taking pills; the patient should not wait for the next menstrual cycle.
Withswitching from another hormonal contraceptive containing 28 pills, the first Belara pill should be taken the next day after taking the last active pill from the package of the previous contraceptive preparation (ie, after taking 21 active pills). There should not be a break in taking pills; the patient should not wait for the next menstrual cycle.
Withtransition from contraceptives containing only gestagen (mini-drank), a woman can start taking Belara on any day (without a break); atthe transition from the use of an implant containing a gestagen, - on the day of its removal; attransition from progestin in an injection form - from the day when the next injection was to be done. In all cases, it is necessary to use additional barrier methods of contraception during the first 7 days of taking Belar.
Afterabortion in the first trimester of pregnancy You should start taking the drug immediately after the abortion. Additional contraceptive methods are optional.
Afterchildbirth non-breastfeeding women can start taking Belar on the 21-28th day of the postpartum period. In this case, additional contraceptive measures should not be taken. If the use of the drug in the postpartum period begins 28 days after delivery, then additional contraceptive measures should be taken within 7 days. If a woman had sexual intercourse, before pregnancy the drug should be eliminated and the next menstrual cycle should be waited.
If athe patient did not take the drug at the usual time and less than 12 hours have passed since the prescribed time of administration, the contraceptive effect of the drug is preserved, and the missed pill should be taken as soon as possible. The next pill must be taken at the scheduled time.
When,if more than 12 hours have passed since the set reception timemay reduce the contraceptive effect of the drug. You must immediately take the missed pill and continue to take the drug at the usual time. It is necessary to use additional barrier methods of contraception over the next 7 days. If during these 7 days the pills in the package have run out, then taking the pills from the next package should be started immediately after the pills in the previous package have been completed, i.e.no pause between taking pills from different packages. If there was no menstrual bleeding after taking the second pack, pregnancy should be excluded.
Withthe occurrence of vomiting or diarrhea against the background of taking Belar pills, it is recommended to use additional methods of contraception, since contraceptive effect of the drug may be reduced due to incomplete absorption of the active substances of the drug in the intestine.
pills should be swallowed whole, choosing the tablet that is marked on the corresponding day of the week. The choice of pills is determined by the direction of the arrow on the package.

Adverse reactions

There may be adverse reactions from the following organs and systems:
The immune system.
Infrequently: hypersensitivity to the components of the drug including allergic reactions from the skin.
Metabolism.
Infrequently: changes in blood lipid composition including hypertriglyceridemia.
Seldom: increased appetite.
Psycho-emotional sphere.
Often: depression, nervousness, irritability.
Infrequently: decreased libido.
Nervous system.
Often: dizziness, migraine (and / or its intensification).
Bodies of sight.
Often: visual impairment.
Seldom: conjunctivitis, intolerance to contact lenses.
Organs of hearing and vestibular apparatus.
Seldom: unexpected hearing loss, tinnitus.
The cardiovascular system.
Often: increase in arterial pressure.
Seldom: hypertension, hypotension, cardiovascular collapse, varicose veins, venous thrombosis.
Digestive system.
Often: nausea.
Often: vomiting.
Infrequently: abdominal pain, flatulence, diarrhea.
Skin and subcutaneous tissue.
Often: acne.
Infrequently: pigmentation disorders, chloasma, hair loss, dry skin, hyperhidrosis.
Seldom: urticaria, eczema, erythema, itchy skin, increased psoriasis, hypertrichosis.
Very rarely: erythema nodosum.
Musculoskeletal system.
Often: feeling of heaviness.
Infrequently: back pain, muscle disorders.
Reproductive system and mammary glands.
Often: increased mucous discharge from the vagina, dysmenorrhea, amenorrhea.
Often: pain in the lower abdomen.
Infrequently: galactorrhea, breast fibroadenoma, vaginal candidiasis.
Seldom: enlargement of the mammary glands, vulvovaginitis, menoragia, premenstrual syndrome.
Common disorders.
Often: fatigue, swelling, weight gain.
The use of combined oral contraceptives (CCP), including those containing 0.03 mg of ethinyl estradiol and 2 mg of chlormadinone acetate, also noted the following undesirable effects:
- increased risk of venous and arterial thromboembolism (for example, venous thrombosis, pulmonary embolism, stroke, myocardial infarction). The risk may be exacerbated by additional factors, see the section “Special Instructions”.
- increased risk of biliary tract disease,
- in rare cases, an increased risk of developing benign liver tumors (and even more rarely, malignant liver tumors) and isolated cases can lead to life-threatening intra-abdominal bleeding (see also “Special Instructions”),
- exacerbation of chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).

Contraindications

Combined oral contraception (CPC) is contraindicated in the cases listed below. Reception of Belara should be immediately discontinued if at least one of the following symptoms appears:

the presence of thrombosis (venous and arterial) currently or in history (for example, deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke);
also the presence of the first signs of thrombosis, thrombophlebitis or symptoms of embolism (for example, transient ischemic attacks, angina pectoris);
the planned surgical intervention (at least 4 weeks before it) and the period of immobilization, for example, after injury (including after applying plaster cast);
diabetes with vascular complications;
diabetes mellitus that is not adequately controlled;
uncontrolled hypertension or a significant increase in blood pressure (more than 140/90 mm Hg, see the section "Special instructions");
hereditary or acquired susceptibility to the development of venous or arterial thrombosis, such as increased resistance of the organism to activated C-protein (APC-resistance);
antithrombin III deficiency, C-protein deficiency, S-protein deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);
hepatitis, jaundice, abnormal liver function (until normalization of liver test scores);
generalized itching, cholestasis, especially in the period of a previous pregnancy or estrogen therapy;
Dubin-Johnson Syndrome, Rotor Syndrome; conditions / diseases involving a violation of bile outflow;
the presence or current history of liver tumors;
severe epigastric pain, liver enlargement or. symptoms of intra belly bleeding (see the section "Side effect");
manifestation for the first time or recurrence of porphyria (all three forms, especially acquired porphyria);
the presence of hormone-dependent malignant diseases, including a history of (for example, breast or uterus) or suspicion of them;
pronounced disorders of lipid metabolism;
pancreatitis currently or in history, in combination with severe hypertriglyceridemia;
first attacks of migraine pain or frequent severe headaches;
migraine in combination with local neurological symptoms (associated migraine);
acute sensory impairments, such as visual or hearing impairment;
movement disorders (especially paresis);
weighting of the course of epilepsy;
severe depression;
otosclerosis during previous pregnancies;
amenorrhea of unclear etiology;
endometrial hyperplasia;
bleeding from the vagina of unknown etiology;
hypersensitivity to the drug;
pregnancy or suspicion of it;
breastfeeding period;
smoking over the age of 35 years (see section "Special Instructions").

CAREFULLY
The use of an estrogen / progestogen combination can have a negative effect on the course of certain diseases / conditions.
Special medical supervision is required in the following cases: epilepsy, multiple sclerosis; convulsive syndrome (tetany); migraine; bronchial asthma; heart or kidney failure; chorea; diabetes with uncomplicated course; diabetes mellitus (see also section "Contraindications"); liver disease (see also the section "Contraindications"); impaired lipid metabolism, dyslipoproteinemia (see also the section "Contraindications"); autoimmune diseases (including systemic lupus erythematosus); obesity; hypertension (see also section "Contraindications"); endometriosis; varicose diseases; phlebitis (see also section "Contraindications"); violation of the blood coagulation system; mastopathy; uterine fibroids; herpes pregnant; depression (see also the section "Contraindications"); chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).

Drug interactions

Interaction of ethinyl estradiol, estrogen component of BELARA preparation^®, with other drugs may cause an increase or decrease in serum ethinyl estradiol concentration. If you need long-term treatment with these drugs, you should go to non-hormonal contraceptives.
A decrease in the concentration of ethinyl estradiol in the blood serum can lead to an increase in episodes of breakthrough bleeding, disruption of the cycle and a decrease in the contraceptive effectiveness of BELARA^®. Increasing serum ethinyl estradiol concentrations may increase the frequency and severity of side effects.
The following drugs / actives may reduce serum ethinyl estradiol concentration:
- all drugs that enhance the motility of the gastrointestinal tract (for example, metoclopramide) or violate adsorption (for example, activated carbon);
- active substances that induce microsomal liver enzymes such as rifampicin, rifabutin, barbiturates, antiepileptics (e.g., carbamazepine, oxcarbazepine, phenytoin and topiramate) anticonvulsant felbamate, phenylbutazone, griseofulvin, barbeksaklon, primidone, modafinil, some protease inhibitors (e.g., ritonavir) and Hypericum preparations;
- some antibiotics (for example, ampicillin, tetracycline, rifampicin) - due to a decrease in the enterohepatic circulation of estrogen.
With the simultaneous use of such drugs / active substances with BELARA pills^® It is necessary to use additional barrier methods of contraception, both during treatment and within 7 days after it. When taking active substances that reduce the concentration of ethinyl estradiol in the blood serum due to the induction of hepatic microsomal enzymes, additional barrier methods (condoms, spermicides) should be used within 28 days after the end of treatment.
The following drugs / active substances may increase serum ethinyl estradiol concentration:
- active substances that inhibit the sulfation of ethinyl estradiol in the intestinal wall, for example, ascorbic acid or paracetamol;
- atorvastatin;
- substances that inhibit the activity of hepatic microsomal enzymes, such as antifungal imidazoles (for example, fluconazole), indinavir or troleandomycin.
Ethinyl estradiol may affect the metabolism of other substances:
- suppress the activity of hepatic microsomal enzymes and, accordingly, increase the concentration in the blood serum of such active substances as diazepam (and other benzodiazepines, which are metabolized through hydroxylation), cyclosporine, theophylline and prednisolone;
- to induce glucuronidation in the liver and, accordingly, reduce the concentration in serum, for example, clofibrate, paracetamol, morphine and lorazepam.
The need for insulin and oral antidiabetic agents may change due to the effect of the drug on glucose tolerance.

Pregnancy and Lactation

Pregnancy: use of the drug Belara during pregnancy is contraindicated. Before you start using the drug Belar, it is necessary to exclude the presence of pregnancy. When pregnancy occurs while taking Belara, the drug should be stopped immediately. The data available to date do not contain information on the development of teratogenic or embryotoxic effects in women who accidentally took during pregnancy drugs containing estrogen and progesterone in the same combination as in the Belar preparation.

Lactation period: It is not recommended to use Belara during breastfeeding, because the drug reduces the amount of milk produced and changes its composition. Small amounts of hormones that are part of the contraceptive and / or their metabolites are excreted in breast milk and can affect the fed baby.

Special instructions

Smoking increases the risk of severe cardiovascular side effects of PDA, the risk increases with age and depending on the number of cigarettes smoked and more pronounced in women over the age of 35, smoking women over the age of 35 should use other methods of contraception.
With the use of PDA increases the risk of serious diseases: myocardial infarction, thrombosis / thromboembolism, stroke and liver tumors.
Other risk factors such as hypertension, hyperlipidemia, obesity and diabetes mellitus clearly increase the risk of morbidity and mortality.
If one of the above listed diseases / risk factors is present, it is necessary to weigh the possible benefits of taking Belar.^® against risks, and this should be discussed with a woman before taking her medication. If these diseases or risk factors begin to manifest or progress while taking the drug, you should consult a doctor.
The doctor must decide whether to stop taking this drug.
Thromboembolism and other vascular diseases
It is noted that there is a relationship between taking CPC and an increased risk of diseases caused by venous or arterial thromboembolism, for example, myocardial infarction, brain stroke, deep vein thrombosis or pulmonary embolism. These complications are rare.
Admission of PDA leads to an increased risk of venous thromboembolism (VTE). The risk of VTE is greatest during the first year of administration. The degree of this risk is less than during pregnancy, when the incidence of VTE is 60 cases per 100,000 pregnancies. VTE is fatal in 1–2% of cases. There is no data on the assessment of the development of risk of VTE when taking Belara^® in comparison with other PDAs.
The risk of developing venous thromboembolic complications when taking CPC increases:

with age
in the presence of thromboembolism in relatives (venous thromboembolism in one of the siblings or parents at a relatively young age). If it is assumed that hereditary predisposition is present, it is recommended to send a woman to consult a specialist before making a decision on the appointment of CPC
with prolonged reduced mobility
for obesity (body mass index> 30 kg / m²).
The risk of developing arterial thromboembolic complications when taking CPC increases:
with age
for smokers
with dyslipoproteinemia
for obesity (body mass index> 30 kg / m²)
with hypertension
with heart defects
with atrial fibrillation
in the presence of thromboembolism in relatives (arterial thromboembolism in one of the siblings or parents at a relatively young age). If chronic intestinal inflammation (Crohn's disease and ulcerative colitis), sickle-shaped anemia. When assessing the risk / benefit, it should be remembered that adequate treatment of the above diseases can reduce the risk of thrombosis. It is necessary to take into account the increased risk of thromboembolic complications in the postpartum period.
There is no consensus about whether there is a relationship between superficial vein thrombophlebitis and / or varicose veins and the etiology of venous thromboembolism.
With the development of venous or arterial thrombosis, the following symptoms may occur:
leg pain and / or swelling
sudden severe chest pain, with or without irradiation to the left arm
sudden dyspnea, cough for no apparent reason
unexpected severe long headache
partial or complete loss of vision, diplopia / speech disorders or aphasia
dizziness, collapse, in some cases accompanied by a focal epileptic seizure
sudden weakness or dysesthesia (distortion of sensitivity) on one side or in one part of the body
movement disorders
acute abdominal pain.

Women taking PDA should be informed that when symptoms appear that resemble thrombosis symptoms, they should contact their doctor. Belara^® should be canceled if you suspect or confirm the diagnosis of thrombosis.
Increasing or increasing the severity of migraine attacks while taking CPC (which may be a precursor to the development or a symptom of cerebrovascular disease) may be the reason for their cancellation.

Tumors
It is noted that the use of PDA is: a risk factor for developing cervical cancer in women infected with the human papillomavirus (HPV). However, the question of the degree of influence on the results of this observation of other related factors (for example, the number of sexual partners or the use of mechanical contraceptives) remains controversial (see also "Medical examination").
There is evidence that the relative risk (RR = 1.24) of breast cancer in women who take PDA is slightly higher. Within 10 years after the discontinuation of PDA, the risk level gradually decreases and returns to the age level. Since breast cancer is rarely seen in women under the age of 40, the difference between the risk of breast cancer in currently receiving and newly treated CCP women and the overall risk of developing the disease is small.

There are reports of the development in rare cases of benign, even more rare cases of malignant liver tumors during the intake of PDA. In some cases, these tumors are the causes of life-threatening intraperitoneal bleeding. In the case of severe abdominal pain that does not go away on its own, hepatomegaly or signs of intra-abdominal bleeding, it is necessary to take into account the possibility of a liver tumor, and to cancel Belar^®.

Other diseases
Many women taking oral contraceptives have a slight increase in blood pressure; however, a clinically significant increase is rare. The relationship between the appointment of oral contraceptives and the clinical manifestation of hypertension has not yet been confirmed. If while taking Belara^® a clinically significant increase in blood pressure appears, the drug should be discontinued and hypertension should be treated. As soon as blood pressure indicators return to normal on the background of antihypertensive therapy, taking Belara^® can continue.
In women, with a herpes pregnancy in history, while taking a PDA, there may be a relapse of the disease. In women with a history of hypertriglyceridemia or those with a family history, the risk of pancreatitis increases while taking CPC. Acute or chronic abnormal liver function may require the abolition of the PDA to normalize the indicators of liver function. Relapse of cholestatic jaundice, which first appeared during pregnancy, or the previous administration of sex hormones, requires the abolition of the CCP.

KPC may have effects on peripheral insulin resistance or glucose tolerance.
Therefore, patients with diabetes while taking oral contraceptives should be under constant surveillance.
In rare cases, chloasma may develop, especially in women who have had a chloasma during pregnancy. Women at risk of developing chloasma should avoid exposure to the sun and ultraviolet radiation while taking oral contraceptives.
Patients with rare congenital abnormalities - galactose intolerance, Lappa-deficient lactase, or glucose-galactose malabsorption syndrome - should not take this medication.

Medical examination
Before prescribing oral contraceptives, it is necessary to collect complete data on the health of the woman and her relatives in order to identify contraindications (see section “Contraindications”) and risk factors (see section “With caution”). A woman must undergo a medical examination.
Medical examination should be conducted annually while taking Belara^®. Regular medical examinations are also necessary due to the fact that diseases that are contraindications (for example, transient ischemic attacks) or risk factors (for example, venous or arterial thrombosis in relatives) may occur for the first time while taking oral contraceptives. Medical examination should include measuring blood pressure, examining the mammary glands, abdomen, internal and external genital organs, taking a smear from the cervix, and carrying out appropriate laboratory tests.
A woman should be warned that the appointment of oral contraceptives, including the drug Belara^®, does not protect it from infection with HIV infection (AIDS) or other sexually transmitted diseases.

Lack of effectiveness
Skip taking pills (see section "Dosage and administration", "Missing the drug"), nausea or symptoms of indigestion, including diarrhea, long-term simultaneous use of certain drugs (see the section “Use in case of diarrhea, vomiting”, “Interaction with other drugs”) or, in very rare cases, metabolic disorders may reduce the effectiveness of contraception.

Effect on the menstrual cycle
Bleeding or bleeding "breakthrough" (intermenstrual)
All oral contraceptives can cause irregular vaginal bleeding (bleeding / bleeding "breakthrough"), especially during the first few cycles while taking the drug. Therefore, a medical examination for irregular cycles should be carried out only after a period of adaptation, which usually lasts for 3 cycles. If while taking Belara^® the appearance of extraordinary bleeding continues or appeared for the first time in a woman with a regular cycle, it is necessary to conduct an examination to exclude pregnancy or organic pathology; After exclusion of pregnancy and organic pathology, taking Belara^® You can continue or go to the reception of another drug.
Bleeding between cycles can be a sign of insufficient contraceptive effectiveness.

No menstrual bleeding (withdrawal bleeding)
21 days after taking the drug, withdrawal bleeding usually occurs. Sometimes, especially in the first few months of taking the drug, withdrawal bleeding may be absent. However, this is not evidence of insufficient contraceptive effect. If bleeding does not occur after taking the drug for one cycle, provided that not a single pill with a film coating was missed, the period after the completion of taking the drug did not exceed 7 days, other drugs were not taken at the same time, there was no nausea or diarrhea, fertilization is unlikely whether or not the reception of Belara^® pregnancy or organic pathology. After exclusion of pregnancy and organic pathology, taking Belara^® can be continued. If when taking Belara^® instructions were not executed before the first absence of withdrawal bleeding, or withdrawal bleeding was absent for two consecutive cycles, it is necessary to exclude the presence of pregnancy in order to decide whether to continue taking the drug.
Along with taking the drug Belara should not take herbal medicines containing St. John's wort (Hypericum perforatum).

Laboratory values
Changes in some laboratory parameters, including the functional activity of the liver, adrenal glands and the thyroid gland, the level of plasma bound proteins (for example, SHBG (SHBG), lipoproteins), carbohydrate metabolism, coagulation, and fibrinolysis may occur while taking KPC.
The nature and extent of changes is partly determined by the nature and dose of the hormones taken.

INFLUENCE ON THE ABILITY TO MANAGE THE VEHICLE OR WORK ON EXACT INSTRUMENTS
Does not affect.

Overdosage

With an overdose of the drug is not observed any serious toxic reactions. If you accidentally take a large number of pills may develop nausea, vomiting, bleeding / bleeding from the vagina.
There is no specific antidote. Symptomatic treatment. In rare cases, it is necessary to monitor indicators of water and electrolyte metabolism and liver function.