Vidora Micro, 3 mg+0.02 mg 24+4 pcs.

Contraception

Contraception.

Contraception and treatment of moderate acne (acne vulgaris).

Contraception and treatment of severe premenstrual syndrome (PMS).

Active ingredient

Drospirenone, Ethinylestradiol

Composition

drospirenone – 3.00 mg,

How to take, the dosage

Intentionally, whole, without chewing, with a little water, 1 tablet daily, in the order indicated on the blister, starting with the active tablets (pink tablets), preferably at the same time of day, continuously for 28 days. For the preparation Vidora® micro containing 21 active tablets and 7 placebo tablets the sequence of taking: 21 days – active tablets and then 7 days – placebo tablets. For Vidor® Micro containing 24 active tablets and 4 placebo tablets, the order of administration is 24 days of active tablets followed by 4 days of placebo tablets.

When inactive pills (placebo, white tablets) are taken, menstrual bleeding occurs. It usually begins 2 to 3 days after taking the last active pill and may not end until the pills from the new pack are taken. Each successive package of pills begins without interruption the day after the pills in the previous package are finished.

The regimen of taking the product Vidora Micro, which includes 21 active pills and 7 placebo tablets, and the product Vidora Micro, which includes 24 active pills and 4 placebo tablets, are different and are determined by the individual characteristics of women and the duration of the follicular phase of the menstrual cycle. Violation of the scheme of taking the drug increases the risk of unwanted pregnancy.

In case of absence of taking any hormonal contraceptives in previous month the use of Vidor® Micro should be started on the first day of menstrual cycle (the first day of menstrual bleeding). It is allowed to start taking the preparation on days 2-5 of menstrual cycle, but in this case it is recommended to use additional barrier method of contraception during first 7 days of taking tablets from the first package.

Transitioning from one Vidora® Micro regimen to another

Vidora® Micro with 21 active tablets and 7 placebo tablets and Vidora® Micro with 24 active tablets and 4 placebo tablets are not therapeutically identical.Because they have different daily (cycle) doses of the active ingredients.

The rules for switching from one package of Vidor® Micro to another are similar to the rules for switching from another OC below.

It is extremely important to follow the Vidora® Micro dosing schedule to ensure optimal efficacy and safety.

Transitioning from another combined hormonal contraceptive (OC, vaginal ring, or transdermal patch)

Prefer to start with Vidor® Micro. It is preferable to start the product the day after taking the last active pill/juice but no later than the day after the usual 7-day interval (for products with 21 pills/juice) or after taking the last inactive pill/juice (for products with 28 pills/juice in a package). Vidora® Micro should be started on the day the vaginal ring or patch is removed, but no later than the day the new ring or patch is to be inserted.

Transitioning from hormonal contraceptives containing only gestagens (“mini-pills,” injectable forms, subcutaneous implants, and intrauterine systems with controlled release of gestagen)

Switching to a gestagen-only hormonal contraceptive. When switching from the “mini-pili” you can start taking the drug on any day (without a break), from the implant or intrauterine system with gestagen – on the day of removal of the implant or intrauterine system, from the injectable form – from the day when the next injection should have been made. In all cases it is necessary to use an additional barrier method of contraception during the first 7 days of taking Vidor® micro tablets.

After an abortion in the first trimester of pregnancy

It is possible to start taking the drug immediately. No additional contraceptive protection is necessary if this condition is met.

After delivery or abortion in the second trimester of pregnancy

It is recommended that the drug be started 21-28 days after delivery, in the absence of breastfeeding, or abortion. If started later, an additional barrier method of contraception should be used during the first 7 days of taking Vidor® Micro tablets. If there is sexual intercourse before taking the drug, pregnancy should be excluded or the first menstrual period should be waited.

Missed inactive pills (placebo pills)

If you miss taking placebo pills (white pills from the last row of the blister pack), no action is needed. Unaccepted pills should be discarded to avoid inadvertently increasing the length of time the placebo pills are taken.

Missed active pills

If active (pink) pills are missed and the next pill is less than 12 hours late, contraceptive protection is not reduced. The missed pill should be taken as soon as possible. Subsequent pills should be taken at the usual time.

If the next pill is missed for more than 12 hours (the interval since the last pill was taken is more than 36 hours), contraceptive protection may be reduced. The more pills missed in a row, and the closer this missing is to a 7-day interval in taking the drug, the greater the likelihood of pregnancy, as 7 days of continuous taking the drug is required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system. The following recommendations may be given for these situations:

In the 1st week of taking the drug

The missed pill should be taken as soon as possible (as soon as the woman remembers), even if it means taking two pills at the same time. The next pills should be taken at the usual time. Additionally, a barrier method of contraception should be used for the next 7 days. If sexual intercourse took place during the week before skipping the next pill, it is necessary to consider the possibility of pregnancy.

In the 2nd week of taking the drug

The missed pill should be taken as soon as possible (as soon as the woman remembers), even if this means taking two pills at the same time. The next pills should be taken at the usual time. If all pills have been taken correctly in the 7 days preceding the first omission, no additional contraceptive measures are necessary. Otherwise, and if two or more pills are missed, an additional barrier method of contraception should be used for the next 7 days.

In weeks 3 and 4 of taking the drug

If you miss 3 or 4 weeks of taking the drug, you should take the last missed pill as soon as possible (even if this means taking 2 pills at once).

If you miss a pill, you should not take more than two active pills in one day.

The pills should then be taken as usual until the active pills in the pack run out. Inactive pills should be discarded and the pills from the next package should be started immediately, i.e., without interruption. Additionally, a barrier method of contraception should be used for the next 7 days.

There will probably not be any bleeding “cancellation” until the end of the second package, but there may be “smeary” bleeding or uterine bleeding “cancellation” on the days of taking the second package. If a woman skips active pills and does not have bleeding “cancellation” while taking inactive pills, pregnancy must be ruled out.

Recommendations for gastrointestinal disorders

In severe gastrointestinal disorders, absorption may be incomplete, so additional contraceptive measures should be taken.

If vomiting or diarrhea has occurred within 4 h of taking the active (pink) pill, the recommendations for skipping the pill should be followed. If a woman does not want to change her usual regimen and postpone the start of menstrual bleeding to another day of the week, an additional active pill should be taken from a different package.

Changing the day menstrual bleeding starts

In order to delay menstrual bleeding, women should continue taking pills from the next Vidor® Micro product package, skipping the inactive pills in the current package. Thus, the cycle of taking the drug may be prolonged, if desired, for any period of time until the active pills of the second package are finished. While taking the drug from the second package, a woman may have “masticatory” discharge or “breakthrough” uterine bleeding. Regular use of Vidora® Micro is resumed when the inactive pills are finished.

In order to postpone the onset of menstrual bleeding to another day of the week, a woman should shorten the duration of inactive pills by the desired number of days. The shorter the interval, the greater the risk that she won’t have “cancellation” bleeding, and there will be “smeary” discharge and “breakthrough” bleeding while taking pills from the second pack.

Further information on use in special clinical groups

Use in children

Vidora® Micro is indicated only after the onset of menarche. The data suggest no dose adjustment in this group of patients.

Application in the elderly

It is not applicable. Vidora® Micro is not indicated after the onset of menopause.

Hypatic disorders

Vidora® Micro is contraindicated in women with severe liver disease until liver function tests return to normal.

The use in renal dysfunction

Vidora® Micro is contraindicated in women with severe renal impairment.

Interaction

Long-term treatment with drugs that induce microsomal liver enzymes and increase the clearance of sex hormones may lead to a decrease in contraceptive efficacy. These drugs include phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, rifampicin, rifabutin, topiramate, felbamate, griseofulvin, and drugs containing St. John’s wort.

HIV protease inhibitors (ritonavir), non-nucleoside reverse transcriptase inhibitors (nevirapine) and their combinations, can also potentially affect hepatic metabolism. Maximum induction of enzymes is usually achieved about 10 days after the start of these drugs, but may persist for at least 4 weeks after their withdrawal. If concomitant administration of drugs affecting induction of microsomal liver enzymes and for 28 days after their withdrawal, a barrier method of contraception should be used temporarily. If it is necessary to continue taking drugs inducible of microsomal liver enzymes after taking the last active tablet from the current package of Vidor® micro medicine, skip taking placebo tablets and start taking tablets from a new package.

Contraceptive protection is decreased while taking penicillin- and tetracycline-type antibiotics because of the decrease in intrahepatic circulation of estrogens and the resulting decrease in ethinyl estradiol concentrations. While taking these antibiotics and for 7 days after their withdrawal, an additional barrier method of contraception should be used.

Since the main metabolites of drospirenone in human plasma are formed without the participation of the cytochrome P450 system, inhibitors of this enzyme system do not affect the metabolism of drospirenone.

The oral combined estrogen-gestogen contraceptives may affect the metabolism of other drugs, resulting in increased (cyclosporine) or decreased (lamotrigine) plasma and tissue concentrations. Despite the fact that taking OCs affects peripheral insulin resistance and glucose tolerance, the dosing regimen of hypoglycemic drugs with OCs does not need to be adjusted.

Based on in vitro inhibition studies and in-vivo drug interaction studies with female volunteers, drospirenone 3 mg does not affect the metabolism of omeprazole, simvastatin, and midazolam.

There is a theoretical possibility of increased plasma potassium (K+) concentrations in women receiving oral contraceptives simultaneously with drugs that increase plasma K+ concentrations: angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, some nonsteroidal anti-inflammatory drugs (such as indomethacin), potassium-saving diuretics, and aldosterone antagonists. However, in a study evaluating the interaction of an ACE inhibitor with a drospirenone+estradiol combination in women with moderate arterial hypertension receiving enalapril and placebo, no significant difference was found between serum K+ concentrations.

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Special Instructions

Before starting to use the drug, pregnancy should be excluded and a thorough general medical and gynecological examination, including examination of the breast and cervical cytology, is recommended. In addition, a disorder of the blood clotting system should be excluded. Prophylactic controls should be performed at least once every 6 months if prolonged use is indicated.

Warn women that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

A number of epidemiological studies have found an increased incidence of venous and arterial thrombosis and thromboembolism when taking OCs. The risk of these complications is greatest in the first year of use (especially in the first 3 months) or after a 4-week break. The use of any OC can be complicated by venous thromboembolism (VTE) manifested as deep vein thrombosis and pulmonary embolism. The estimated incidence of VTE in women taking low-dose oral contraceptives with estrogen (less than 50 mcg ethinyl estradiol) is up to 4 per 10,000 women per year, compared with 0.5 to 3 per 10,000 women not using oral contraceptives.

Drugs containing levonorgestrel, norgestimat, or norethindrone have a low risk of venous thromboembolism. Drugs containing drospirenone have twice the risk of thromboembolic complications, so a woman should be advised of this increased risk before Vidora® Micro is recommended.

In 10,000 women taking drospirenone OCs, about 9-12 develop VTE within 1 year, while women taking levonorgestrel OCs develop VTE in only 5-7.

The incidence of VTE developing while taking OCs, however, is lower than the incidence associated with pregnancy.

In women taking OC, extremely rare cases of thrombosis of other blood vessels, such as hepatic, mesenteric, renal arteries and veins, and central retinal vein and its branches, have been described. There is no proven association with the intake of OCs.

A woman should stop taking the drug and consult a physician if she develops symptoms of venous or arterial thrombosis, which may include unilateral pain in the lower extremities and/or swelling; sudden severe chest pain; with or without irradiation into the left arm; sudden shortness of breath; sudden cough; any unusual, severe, prolonged headache; increased frequency and severity of migraines; sudden partial or total loss of vision; diplopia; slurred speech or aphasia; dizziness; loss of consciousness or fainting, with or without an epileptic seizure; weakness or very marked loss of sensation, suddenly on one side or in one part of the body; motor disturbances; “acute” abdomen.

The risk of thrombosis (venous and/or arterial) and thromboembolism increases: with age; in smokers (with increasing number of cigarettes smoked or increasing age. The risk subsequently increases, especially in women over the age of 35); with a family history (i.e. venous or arterial thromboembolism ever in a close relative or parent at a relatively young age), obesity (body mass index greater than 30 kg/m2), dyslipoproteinemia; arterial hypertension; heart valve disease; atrial fibrillation; prolonged immobilization; temporary immobility, including flying for more than 4 hours; major surgery, any lower extremity surgery or extensive trauma – in these situations the drug must be stopped; if surgical intervention is planned

The increased risk of thromboembolism in the postpartum period should be considered.

Peripheral circulatory disorders may also be seen in diabetes mellitus, SLE, hemolytic-uremic syndrome, chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) and sickle cell anemia.

An increase in the frequency and severity of migraines during the use of OCs (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of these medications.

Biochemical parameters that may be a sign of hereditary or acquired predisposition to venous or arterial thrombosis include: resistance to APS, hyperhomocysteinemia, antithrombin III deficiency, protein C and S deficiency, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant).

When considering the risk/benefit ratio, the physician should consider that adequate treatment of these conditions may reduce the associated risk of thrombosis and that the risk of thrombosis associated with pregnancy is higher than with OCs.

An increased risk of cervical cancer with long-term use of OC has been reported in some epidemiological studies. Its association with OC use has not been proven.

A meta-analysis of 54 epidemiological studies demonstrated that there was a slightly increased relative risk (RR=1.24) of developing breast cancer diagnosed in women who were using OC at the time of the study. The association with taking OC has not been proven. The observed increase in risk may be a consequence of earlier diagnosis of breast cancer (women who use OC are diagnosed with earlier stages of breast cancer than women who have never used them), biological effects of OC, or a combination of both.

In rare cases the development of liver tumors has been observed with the use of OCs. If severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding occur, this should be considered in the differential diagnosis.

Drospirenone is well tolerated in patients with mild to moderate hepatic impairment (Child-Pugh class B).

Recurrent cholestatic jaundice that develops for the first time during pregnancy or during previous use of sex hormones requires discontinuation of OCs.

Drospirenone is well tolerated in women with mild to moderate renal impairment.

K+ excretion may be reduced in patients with renal insufficiency. In a clinical study, drospirenone administration had no effect on plasma concentrations in patients with mild to moderate renal impairment. Since in theory the risk of hyperkalemia exists in cases where plasma K+ concentrations were at the upper limit of normal before treatment and concomitant use of potassium-saving drugs, it is recommended to monitor the plasma K+ concentration in the first cycle of the drug in patients with mild to moderate renal failure and with a plasma K+ concentration at the upper limit of normal range before starting its administration and especially when concomitant use of potassium-saving drugs.

Women with hypertriglyceridemia or a family history of pancreatitis are at increased risk of developing pancreatitis while taking OC.

While small increases in blood pressure (BP) have been described in many women taking OCs, clinically significant increases have rarely been reported. The relationship between taking OCs and clinically significant increases in BP has not been established. However, if a persistent, clinically significant increase in BP develops during OC use, discontinuation and treatment of hypertension is necessary. OCs may be continued after physician consultation if normal BP has been achieved with hypotensive therapy.

While OCs may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using OCs. However, women with diabetes should be monitored closely while taking OCs.

Women with a tendency to chloasma should avoid prolonged sun exposure and exposure to ultraviolet radiation while taking OCs.

The drug may affect biochemical parameters of liver, thyroid, adrenal, and kidney function, as well as the amount of plasma transport proteins such as CRP and lipid/lipoprotein fractions, carbohydrate metabolism, blood clotting, and fibrinolysis. Changes are usually within normal limits.

Drospirenone increases plasma renin and aldosterone concentrations due to its anti-mineralocorticoid activity.

Drospirenone may worsen the course of endogenous depression and epilepsy while taking OCs.

The use of Vidor® micro as OCs may be especially useful for women with hormone-dependent fluid retention and for women with acne and seborrhea. The effectiveness of OCs may be reduced by skipping pills, vomiting and diarrhea, or by drug interactions.

An irregular bleeding (“smeary” bleeding or “breakthrough” bleeding) may occur while taking OCs, especially during the first months of use. Therefore, evaluation of any irregular bleeding is meaningful only after 3-4 months of contraception.

If irregular bleeding recurs or develops after previous regular cycles, a thorough evaluation should be performed to rule out malignancy or pregnancy.

Some women may not develop “withdrawal” bleeding during a break in the pill. If the OCs were taken as directed, pregnancy is unlikely. However, if prior OC use has been irregular, or if there are no two consecutive “withdrawal” bleeding events, pregnancy should be ruled out before continuing to take the medication.

The effect on the ability to drive:

No effect on ability to operate vehicles and machinery has been identified.

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Contraindications

– Hypersensitivity to any of the ingredients of the drug;

– Thrombosis (venous and arterial), current or history (including deep vein thromboembolism, pulmonary embolism, myocardial infarction, cerebrovascular disorders.

– Thrombosis (venous or arterial), current or past history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular events).transient ischemic attacks, atrial fibrillation, angina pectoris), current or history of thrombosis;

– the presence of multiple or significant risk factors for venous or arterial thrombosis, including.: complicated cardiac valve disease, atrial fibrillation, cerebral vascular disease, or coronary artery disease;

– Uncontrolled arterial hypertension, prolonged immobilization, major surgery, lower extremity surgery, major trauma, >35 years old smoking, obesity with a BMI greater than 30 kg/m2;

– Hereditary or acquired predisposition to venous or arterial thrombosis, such as activated protein C (APC) resistance, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, and presence of antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);

– migraine with focal neurological symptoms currently or in the history;

– Diabetes mellitus with diabetic angiopathy;

– Liver failure and severe liver disease (until normalization of liver function tests and within three months after returning to normal values);

– current or history of liver tumors (benign or malignant);

– severe or acute renal failure;

– any known or suspected hormone-dependent malignancies (including those of the genital or mammary glands);

– vaginal bleeding of unclear genesis;

– pregnancy or suspected pregnancy;

p> – breastfeeding period;

– pancreatitis with significant hypertriglyceridemia, current or history;

– hereditary lactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

If any of the above diseases or conditions develop for the first time while taking the drug, it should be stopped immediately.

With caution:

– Risk factors for thrombosis and thromboembolism: Smoking, obesity with a body mass index less than 30 kg/m2, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart defects, presence of thrombosis and thromboembolism in a family history (thrombosis, myocardial infarction or stroke in young age in any of the immediate family members) age over 35 years in non-smoking women;

– diseases in which peripheral circulatory disorders may be noted: diabetes mellitus without vascular disorders, systemic lupus erythematosus (SLE), hemolytic-uremic syndrome, Crohn’s disease, ulcerative colitis, sickle cell anemia, superficial vein phlebitis;

– Hereditary angioedema;

Hypertriglyceridemia;

Mild to moderate liver disease;

Diseases first developed or exacerbated during pregnancy or from previous use of sex hormones (including jaundice and/ or pruritus.including jaundice and/or pruritus associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, a history of herpes during pregnancy, Sydengam’s chorea, chloasma, postpartum).

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Side effects

The following adverse reactions have been reported in women using OCs, with very rare occurrence or delayed symptoms believed to be related to taking OCs:

– breast cancer (see Special Instructions.

– liver tumors (benign and malignant);

– pancreatitis in women with hypertriglyceridemia;

– occurrence or worsening of conditions whose association with taking OC is not conclusively established: porphyria, epilepsy, uterine myoma, SLE, herpes in pregnancy, Sydenham’s chorea, hemolytic-uremic syndrome, cholestatic jaundice and/or pruritus associated with cholestasis; cholithiasis;

– liver dysfunction;

– change in glucose tolerance and development of insulin resistance;

– chloasma;

– Crohn’s disease, ulcerative colitis.

In women with hereditary angioedema, taking estrogen may cause or exacerbate its symptoms.

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Overdose

Symptoms may include nausea, vomiting, “smeary” bloody vaginal discharge or metrorrhagia.

Treatment: there is no specific antidote, symptomatic therapy is carried out.

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Similarities

Midiana, Ges, Dimia, Vidora, Leia, Delsia, Anabella