Vidora micro tablets are covered.pl.ob. 3 mg + 0.02 mg 24 + 4 pcs. (Drospyrenon, ethinyl estradiol)

Release form

Film-coated tablets.

Pharmacological action

Contraceptive combined (estrogen + progestogen)

Indications

Contraception.

Contraception and treatment of moderate acne (acne vulgaris).

Contraception and treatment of severe premenstrual syndrome (PMS).

Contraindications

- Hypersensitivity to any component of the

preparation - current or history of thrombosis (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disease, cerebrovascular disease) thrombosis (including transient ischemic attacks, atrial fibrillation, angina pectoris) at present or in the history of

- the presence of multiple or pronounced risk factors for venous or arterial thrombosis, including: complicated lesions heart valve apparatus, atrial fibrillation, cerebrovascular or coronary artery disease

- uncontrolled arterial hypertension, prolonged immobilization, volumetric surgery, surgery on the lower extremities, lupus anticoagulant)

- a migraine with focal neurological symptoms at present or in the history of

- diabetes mellitus with diabetic angiopathy

- liver failure and severe liver disease (before normalization of liver function tests and within three months after returning to normal)

- liver tumors (benign or malignant) currently or in a history of

- severe or acute renal failure

- identified hormone-dependent malignancies diseases (including genitals or mammary glands) or suspected

- vaginal bleeding of unknown origin

- pregnancy or suspected

- breastfeeding

- pancreatitis with severe hypertriglyceridemia at present time 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, then you should immediately cancel it.

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 disease, and thrombosis history (thrombosis, myocardial infarction or cerebrovascular accident at a young age in any of the next of kin) age over 35 years in non-smoking women

- diseases, in which peripheral circulation disorders can 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

- hypertrigia mild and moderate liver disease

- diseases that first occurred or worsened during pregnancy or against the background of previous use of sex hormones (including jaundice and / or oud associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes during pregnancy, a history of Sydenham chorea, chloasma, the postpartum period).

Use during pregnancy and lactation

Pregnancy

Use of the drug VidoraВ® micro is contraindicated during pregnancy. If pregnancy is detected while taking the drug VidoraВ® micro, the drug should be immediately withdrawn. However, extensive epidemiological studies did not reveal an increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or teratogenicity when sex hormones were taken by negligence in the early stages of pregnancy.

At the same time, data on the results of taking drospirenone + ethinyl estradiol during pregnancy are limited, which does not allow us to draw any conclusions about the negative effect of the drug on pregnancy, fetal and newborn health. Currently, no significant epidemiological data are available.

Breastfeeding period

The use of the drug VidoraВ® micro is contraindicated in the period of breastfeeding. COCs can reduce the amount of breast milk and change its composition, so their use is not recommended until the termination of breastfeeding. A small amount of sex hormones and / or their metabolites can pass into breast milk.

Special instructions

Before using the drug, pregnancy should be excluded and it is recommended to undergo a thorough general medical and gynecological examination, including examination of the mammary glands and cytological examination of the cervix. In addition, a violation of the coagulation system should be excluded. In the case of prolonged use, prophylactic control examinations should be performed at least 1 time in 6 months.

A woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

A number of epidemiological studies have revealed an increase in the incidence of venous and arterial thrombosis and thromboembolism when taking COCs. The greatest risk of developing these complications exists in the first year of taking the drug (especially in the first 3 months) or the resumption of taking after a 4-week break. The use of any COC can be complicated by the development of venous thromboembolism (VTE), which manifests itself as deep vein thrombosis and pulmonary embolism. The approximate frequency of VTE in women, taking oral contraceptives with a low dose of estrogen (less than 50 micrograms of ethinyl estradiol), is up to 4 per 10,000 women per year, compared with 0.5-3 per 10,000 women not using oral contraceptives.

Medications containing levonorgestrel, norgestimate or norethindrone have a low risk of developing venous thromboembolism. For drugs that include drospirenone, the risk of developing thromboembolic complications is 2 times higher, and therefore, before a woman is recommended to use the drug Vidora® micro, she should be warned about this increased risk.

For 10,000 women taking COCs with drospirenone, VTE develops in about 9-12 over 1 year, and in women taking COCs with levonorgestrel, only 5-7.

However, the frequency of VTE, developing when taking COCs, is less than the frequency associated with pregnancy.

In women taking COCs, extremely rare cases of thrombosis of other blood vessels, such as the hepatic, mesenteric, renal arteries and veins, the central retinal vein and its branches, have been described. The connection with the use of COCs has not been proven.

A woman needs to stop taking the drug and consult a doctor if symptoms of venous or arterial thrombosis develop, which may include one-sided pain in the lower extremities and / or edema, sudden severe chest pain with or without radiation in the left arm, sudden shortness of breath, sudden cough, any unusual, severe , prolonged headache increased frequency and severity of migraine sudden partial or complete loss of vision diplopia slurred speech or aphasia dizziness loss of consciousness or fainting with or without an epileptic seizure weakness or very significant loss of sensation that suddenly appeared on one side or in one part of the body stomach.

The risk of thrombosis (venous and / or arterial) and thromboembolism increases: with age in smokers (with an increase in the number of cigarettes smoked or an increase in age. The risk further increases, especially in women over 35 years old) with a family history (i.e. venous or ever arterial thromboembolism in close relatives or parents at a relatively young age), obesity (body mass index more than 30 kg / m2), dyslipoproteinemia of arterial hypertension, diseases of the heart valves, atrial fibrillation, prolonged immobilization of temporary immobilization, including flights for more than 4 hours of serious surgery, any surgery on the lower extremities or extensive injury - in these situations, you must stop taking the drug in case of the planned surgical intervention - 4 weeks before him and do not resume taking within 2 weeks after the end of the immobilization.

An increased risk of postpartum thromboembolism should be considered.

Peripheral circulatory disorders can also occur 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 migraine during the use of COCs (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of these medications.

Biochemical parameters that may be a sign of a 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 anticoagulation).

When considering the risk / benefit ratio, the physician must take into account that adequate treatment of these diseases can reduce the risk of thrombosis associated with them and that the risk of thrombosis associated with pregnancy is higher than when using COCs.

An increased risk of developing cervical cancer with prolonged use of COCs has been reported in some epidemiological studies. His association with COC administration has not been proven.

A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk (RR = 1.24) of breast cancer diagnosed in women who were using COCs at the time of the study. His association with COC administration has not been proven. The observed increased risk may be due to an earlier diagnosis of breast cancer (women who use COCs have earlier stages of breast cancer than women who have never used them), biological effects of COCs, or a combination of both.

In rare cases, against the background of the use of COCs, the development of liver tumors was observed. In the case of severe pain in the abdomen, liver enlargement, or signs of intra-abdominal bleeding, this should be considered when making a differential diagnosis.

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

Recurrent cholestatic jaundice, which develops for the first time during pregnancy or during the previous intake of sex hormones, requires cessation of COCs.

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

K + excretion may be reduced in patients with renal failure. In a clinical study, drospirenone did not affect plasma concentrations in patients with mild or moderate severity of renal failure. Since, theoretically, the risk of developing hyperkalemia exists in cases where the concentration of K + in the blood plasma was at the upper limit of the norm before treatment and while taking potassium-sparing drugs, it is recommended to control the concentration of K + in the blood plasma in the first cycle of taking the drug in patients with mild renal failure and moderate severity and with a concentration of K + in blood plasma at the upper limit of the normal range before it is taken and, especially, with the concomitant use of potassium-saving drugs.

Women with hypertriglyceridemia or a family history have an increased risk of developing pancreatitis while taking COCs.

Although a slight increase in blood pressure (BP) has been described in many women taking COCs, clinically significant increases are rare. The relationship between taking COCs and a clinically significant increase in blood pressure has not been established. Nevertheless, if a persistent, clinically significant increase in blood pressure develops while taking COCs, drug withdrawal and treatment of arterial hypertension are necessary. Taking COCs can be continued after consulting a doctor if normal blood pressure values ​​are achieved with antihypertensive therapy.

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

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

The drug may affect the biochemical parameters of liver, thyroid, adrenal and renal function, as well as the amount of plasma transport proteins such as CSH and lipid / lipoprotein fractions, indicators of carbohydrate metabolism, blood coagulation and fibrinolysis. Changes usually do not go beyond the normal range.

Due to the antimineralocorticoid activity, drospirenone increases the concentration of renin and aldosterone in blood plasma.

While taking COCs, the course of endogenous depression and epilepsy may worsen.

The use of Vidora® micro as a COC may be especially useful for women with hormone-dependent fluid retention, as well as women with acne (acne) and seborrhea. The effectiveness of COCs may be reduced by skipping pills, vomiting and diarrhea, or as a result of drug interactions.

Irregular bleeding (spotting spotting or breakthrough bleeding) may occur with COCs, especially during the first months of use. Therefore, the assessment of any irregular bleeding is significant only after 3-4 months of contraception.

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

Some women may not develop withdrawal bleeding during a break in taking pills. If COC was administered as directed, then pregnancy is unlikely. Nevertheless, if prior to this, COCs were administered irregularly, or if two withdrawal bleedings were absent in a row, pregnancy should be excluded before continuing with the drug.

Impact on the ability to drive transp. Wed and fur .:

No effect on the ability to drive vehicles and mechanisms.

Composition

1 active film-coated tablet contains:

Core of the tablet:

Active ingredients: drospirenone - 3.00 mg, ethinyl estradiol - 0.02 mg

Excipients: lactose monohydrate - 44.00 mg corn starch - 38.40 mg, povidone-K30 - 6.00 mg, croscarmellose sodium - 1.20 mg, polysorbate-80 - 0.90 mg, magnesium stearate - 0.50 mg.

Tablet shell: Opadry II pink - 2.82 mg (partially hydrolyzed polyvinyl alcohol - 1.13 mg, titanium dioxide - 0.68 mg, macrogol-3350 - 0.57 mg, talc - 0.42 mg, iron dye oxide yellow - 0.01 mg, dye iron oxide red - 0.01 mg, dye iron oxide black - 0.001 mg).

1 placebo tablet contains:

core tablet: anhydrous lactose - 89.50 mg, povidone-K30 - 10.00 mg, magnesium stearate - 0.50 mg.

Shell of the tablet: Opadry II white - 4.00 mg (partially hydrolyzed polyvinyl alcohol - 1.600 mg, titanium dioxide - 1.000 mg, macrogol-3350 - 0.808 mg, talc - 0.592 mg).

Dosage and administration

Inside, without chewing, with a small amount of water, 1 tablet per day, in the order indicated on the blister, starting with active tablets (pink tablets), preferably at the same time of day, continuously for 28 days. For the drug Vidora® micro, containing 21 active tablets and 7 placebo tablets, the sequence of administration: 21 days - active tablets, then 7 days - placebo tablets. For the drug Vidora® micro, containing 24 active tablets and 4 placebo tablets, the sequence of administration: 24 days — active tablets, then 4 days — placebo tablets.

When taking inactive pills (placebo, white pills), menstrual bleeding is observed. It usually begins 2–3 days after taking the last active pill and may not end until you start taking pills from a new package. Acceptance of the drug from each subsequent package begins without interruption the next day, as soon as the tablets in the previous package end.

Vidora micro drug regimen, which includes 21 active tablets and 7 placebo tablets, and Vidora micro drug, which includes 24 active tablets and 4 placebo tablets, differ and are determined by the individual characteristics of the woman and the duration of the follicular phase of the menstrual cycle. Violation of the drug regimen increases the risk of an unwanted pregnancy.

If you are not taking any hormonal contraceptives in the previous month, you should start taking Vidora® micro on the first day of your menstrual cycle (on the first day of your menstrual bleeding). It is allowed to start taking on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use the barrier method of contraception during the first 7 days of taking tablets from the first package.

Transition from one regimen of using the drug Vidora® micro to another regimen

The drug Vidora® micro, which includes 21 active tablets and 7 tablets, placebo, and the drug Vidora® micro, which includes 24 active tablets and 4 tablets, placebo, are not therapeutically identical, t. to. when they are taken, the course (cyclic) dose of the active substances is different.

The rules for switching from one packaging of a Vidora® micro preparation to another packaging are similar to the rules for switching from another COC, described below.

It is imperative to adhere to the Vidora® micro regimen for optimal efficacy and safety.

Switching from another combined hormonal contraceptive (COC, vaginal ring or transdermal patch)

It is preferable to start taking the drug the day after taking the last active pill / dragee, but not too lateits next day after the usual 7-day break in taking (for drugs containing 21 tablets / dragees) or after taking the last inactive tablet / dragees (for drugs containing 28 tablets / dragees in a pack). Vidora® micro tablets should be taken on the day the vaginal ring or patch is removed, but no later than the day the new ring is inserted or a new patch is pasted.

Transition with hormonal contraceptives. containing only progestogens (mini-pills, injection forms, subcutaneous implants and intrauterine systems with controlled release of gestagen)

When switching from mini-pills, you can start taking the drug on any day (without interruption), from an implant or an intrauterine system with progestogen - on a day removal of the implant or intrauterine system, from the injection form - from the day when the next injection was to be made. In all cases, it is necessary to additionally use the barrier method of contraception during the first 7 days of taking Vidora® micro tablets.

After an abortion in the first trimester of pregnancy

You can start taking the drug immediately. If this condition is met, there is no need for additional contraceptive protection.

After childbirth or abortion in the second trimester of pregnancy

It is recommended to start taking the drug 21-28 days after the birth, in the absence of breastfeeding, or abortion. If the reception is started later, it is necessary to use the additional barrier method of contraception during the first 7 days of taking the Vidora® micro tablets. In the event of having sexual intercourse, pregnancy should be ruled out before the start of taking the drug or you must wait for the first menstruation.

Taking missed inactive tablets (placebo)

If you missed taking placebo tablets (white tablets from the last row of the blister pack), no action is required. Missed tablets should be discarded to avoid an unintended increase in the length of the placebo pill period.

Taking missed active pills

If you missed taking active (pink) pills and the delay in taking the next pill was less than 12 hours, contraceptive protection does not decrease. A missed tablet should be taken as soon as possible. Subsequent tablets should be taken at the usual time.

If the delay in taking the next pill was more than 12 hours (the interval since the last pill was taken was more than 36 hours), contraceptive protection may be reduced. The more pills missed in a row, and the closer this pass to the 7-day break in taking the drug, the higher the probability of pregnancy, since 7 days of continuous use of the drug are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system. The following recommendations may be made for such situations:

At 1 week of taking

, the missed pill should be taken as soon as possible (as soon as the woman remembers), even if it means taking two tablets at the same time. The following tablets should be taken at the usual time. Additionally, a barrier method of contraception should be used over the next 7 days. If sexual intercourse took place within a week before skipping the next pill, you must take into account the likelihood of pregnancy.

At week 2 of taking

, the missed pill should be taken as soon as possible (as soon as the woman remembers), even if this means taking two tablets at the same time. The following tablets should be taken at the usual time. If during the 7 days preceding the first pass in admission, all tablets were taken correctly, there is no need to use additional contraceptive measures. Otherwise, as well as in case of missing two or more tablets, it is necessary to use an additional barrier method of contraception for the next 7 days.

At 3 and 4 weeks of taking the drug

If you missed at 3 or 4 weeks of taking the drug, you must take the last missed tablet as soon as possible (even if it means taking 2 tablets at the same time).

If you miss a pill, you should not take more than two active tablets on the same day.

Next, the tablets should be taken as usual until the active tablets in the pack run out. Inactive tablets should be discarded and tablets should be taken immediately from the next package, i.e. nonstop. Additionally, a barrier method of contraception should be used over the next 7 days.

Most likely, there will be no withdrawal bleeding before the end of the second package, but spotting or uterine bleeding may be observed on the days of taking the drug from the second package. If a woman missed taking active pills, and there was no withdrawal bleeding while taking inactive pills, pregnancy must be excluded.

Recommendations for gastrointestinal upsets

In severe gastrointestinal upsets, absorption may not be complete, therefore additional contraceptive measures should be taken.

If vomiting occurs or diarrhea occurs within 4 hours after taking the active (pink) tablet, you should be guided by the recommendations when skipping tablets. If a woman does not want to change the usual regimen and transfer the onset of menstrual bleeding to another day of the week, an additional active pill should be taken from another package.

Change the day onset of menstrual bleeding

To delay the onset of menstrual bleeding, a woman should continue taking pills from the next package of Vidora® micro by skipping inactive tablets from the current package. Thus, the cycle of taking the drug can be extended, if desired, for any period until the active tablets from the second package end. Against the background of taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. Regular intake of the drug Vidora® micro resumes after the end of taking inactive tablets.

To postpone the onset of menstrual bleeding to another day of the week, a woman should reduce the duration of inactive tablets by the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and in the future there will be spotting and breakthrough bleeding while taking tablets from the second package.

Additional information about the use in special clinical groups

Use in children

The drug Vidora® micro is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this group of patients.

Use in old age

Not applicable. Vidora® micro is not indicated after menopause.

Use in case of impaired liver function

The drug Vidora® micro is contraindicated in women with severe liver diseases until the performance of liver function tests has returned to normal.

Use in case of impaired renal function

The drug Vidora® micro is contraindicated in women with severe renal failure.

Side effects of

The following adverse reactions have been reported in women using COCs with a very rare occurrence or with delayed symptoms that are thought to be associated with COC use:

- breast cancer (see Special instructions)

- liver tumors (benign and malignant)

- pancreatitis in women with hypertriglyceridemia

- the onset or worsening of conditions whose connection with COC has not been conclusively established: porphyria, epilepsy, uterine fibroids, SLE, herpes The burden of pregnancy, Sydenham's chorea, haemolytic uremic syndrome, cholestatic jaundice and / or pruritus cholestasis associated cholelithiasis

- impaired liver function

- change in glucose tolerance and the development of insulin resistance

- chloasma

- Crohn's disease, ulcerative colitis.

In women with hereditary angioedema, estrogen intake may cause or aggravate its symptoms.

Drug interactions

Long-term treatment with drugs, inducers of microsomal liver enzymes, which increases the clearance of sex hormones, can lead to a decrease in contraceptive effectiveness. Such drugs include: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, rifampicin, rifabutin, topiramate, felbamate, griseofulvin and perforated St. John's wort.

HIV protease inhibitors (ritonavir), non-nucleoside reverse transcriptase inhibitors (nevirapine) and their combinations can also potentially affect hepatic metabolism. The maximum induction of enzymes is usually achieved about 10 days after the start of taking these drugs, but can persist for at least 4 weeks after they are canceled. With the simultaneous administration of drugs that affect the induction of microsomal liver enzymes and within 28 days after their withdrawal, it is necessary to temporarily use the barrier method of contraception. If it is necessary to continue taking preparations of inducers of microsomal liver enzymes after taking the last active tablet from the current package of the drug Vidora® micro, you should skip the placebo tablet and start taking the tablets from the new package.

Contraceptive protection decreases with the use of antibiotics of the penicillin and tetracycline series due to their decrease in the intrahepatic circulation of estrogens and, as a result, a decrease in the concentration of ethinyl estradiol. While taking these antibiotics and within 7 days after their withdrawal, it is necessary to additionally use the barrier method of contraception.

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

Oral combined estrogen-progestogen contraceptives can affect the metabolism of other drugs, leading to an increase (cyclosporine) or a decrease (lamotrigine) in plasma and tissue concentrations. Despite, that taking COCs affects peripheral insulin resistance and glucose tolerance, correction of the dosage regimen of hypoglycemic drugs while taking COCs is not required.

Based on in vitro inhibition studies and the study of drug interactions in vivo with female volunteers, it was found that drospirenone at a dose of 3 mg does not affect the metabolism of omeprazole, simvastatin and midazolam.

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

Storage Conditions

At a temperature not exceeding 30 ° C.

Keep out of the reach and sight of children.

Term hodnosty

3 years

active substance

drospirenone, Ethinyl estradiol

Terms leave through pharmacies

In retseptu

Dosage form

tablet

Laboratios Leon Pharma S.A., Spain



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