Vidora Micro (drospirenone, ethinylestradiol) coated tablets 3 mg/0.02 mg. №28

Description

Vidora Micro (drospirenone, ethinylestradiol) coated tablets 3 mg/0.02 mg. №28

Composition

active substance: drospirenone, ethinylestradiol;

1 blister contains 28 tablets (21 active yellow tablets and 7 white placebo tablets);

1 yellow film-coated tablet contains drospirenone 3.0 mg and ethinyl estradiol 0.03 mg;

Excipients: lactose monohydrate, corn starch, pregelatinized starch, crospovidone Plasdone XL-10, crospovidone Plasdone XL, povidone K-30, polysorbate 80, magnesium stearate, Opadry yellow (polyethylene glycol, polyvinyl alcohol, polyvinyl alcohol, titanium 17) iron oxide yellow (E 172)).

1 white film-coated tablet (placebo) contains:

Excipients: lactose anhydrous, povidone K-30, magnesium stearate, Opadry II white (polyvinyl alcohol (hydrolyzed part), titanium dioxide (E 171), macrogol 3350, talc (E 553b)).

Dosage form

Film-coated tablets.

Main physical and chemical properties: Active tablets: round tablets, film-coated, yellow. Placebo tablets: round, film-coated tablets, white.

Pharmacotherapeutic group

Hormonal contraceptives for systemic use. Drospirenone and ethinyl estradiol.

ATX code G0ZA A12.

Pharmacological properties

This drug belongs to the group of oral contraceptives, includes hormones of the gonads, their estrogen-progestational fixed combinations.
It is a hormonal drug that contains ethinylestradiol and drospirenone (analogue of natural progestogen).
The contraceptive effect of this drug is based on the interaction of various properties of its constituent substances, the most important of which is the ability to inhibit ovulation and produce a qualitative effect on the endometrium of the uterus.
Drospirenone, when used in therapeutic doses, has antiandrogenic and mild antimineralocorticoid properties.
It lacks any estrogenic, glucocorticoid and antiglucocorticoid activity, which provides drospirenone with a pharmacological profile that is very similar to that of the naturally occurring hormone progesterone.
Weak anti-mineralocorticoid properties lead to a weak anti-mineralocorticoid effect.
It is produced in tablet form, in pink and white tablets. Pink tablets contain 3 mg drospirenone and 0.02 mg ethinylestradiol. White tablets do not contain active ingredient.

Indications

It is used as an oral hormonal contraceptive.
In addition to the properties of contraception, it has other properties. In particular, it produces an antiandrogenic effect, as a result, it has an effect on androgenic alopecia, acne, seborrhea, hormone-dependent fluid retention in the body.
Also has properties to treat the symptoms of premenstrual dysphoric disorder in women who use oral contraception.
Ethinylestradiol, which is part of the drug, is able to prevent the occurrence of osteoporosis by affecting osteoclasts. It also has a beneficial effect on the skin, slows down the formation of wrinkles on it, reduces the concentration of glucose and insulin in the blood.
Drospirenone is a progestogen. It counteracts water retention in the body, and as a result, the occurrence of arterial hypertension, weight gain, breast tenderness, edema.
The drug is also able to normalize lipid metabolism, lower blood cholesterol levels. This medicine can also prevent the appearance of malignant neoplasms.

Contraindications

Not applicable if the patient has hypersensitivity (allergy) to one of the components that make up the drug.
This medicinal product should not be used in patients who have:

•  vaginal bleeding;
•  oncological disease, benign tumor;
•  hepatic, renal failure;
•  arterial / venous thrombosis, thromboembolism;
•  acute violation of cerebral circulation;
•  severe arterial hypertension;
•  pancreatitis, liver tumors;
•  obesity;
•  diabetes;
•  migraine.

Application during pregnancy and lactation

This drug is contraindicated for use during pregnancy and lactation.

Method of administration and dosage

Vidora Micro is taken 1 tablet a day at the same time of the day. When taking, you should adhere to the sequence indicated on the back of the blister.
The tablets are taken in a row for 28 days. Each next package begins the next day after the previous one has ended.
Bleeding, similar to menstruation, begins on the 2-3rd day after you start taking the pills containing the placebo, and does not have to end before the next pack starts.
If the appointment is missed, then the next pill should be taken as soon as you remember about it. The next pill is taken the next day at the usual time. Moreover, if the break was less than 24 hours, then the contraceptive properties of the drug are not reduced. If the break is more than 24 hours, then the contraceptive effect may be reduced.
If an abortion is performed in the first trimester, then the drug is taken on the day of the operation.
If the abortion was performed in the second trimester of pregnancy, or the woman wants to start taking oral contraceptives after childbirth, then the reception begins on the 21-28th day.
The contraceptive effect is not guaranteed in the first week of admission. Therefore, these days, barrier methods of contraception should be used.
The break in admission can be less than 4, but not more than seven days.

Overdose

Overdose with this drug has not yet been observed and described.
Theoretically, an overdose of this drug can cause:

•  dyspepsia;
•  nausea;
•  vomiting;
•  vaginal bleeding.

Symptomatic treatment is recommended. No antidote has yet been identified.

Side effects

At the very beginning of replacement therapy with this drug, bleeding may occur, smearing vaginal discharge of a woman, pain in the mammary glands.
Adverse reactions have been observed with this drug:

•  anemia, anorexia, increased appetite, changes in body weight, constipation;
•  irritability, depression, emotional instability, tachycardia, phlebitis;
•  visual impairment, tinnitus, tremor, vertigo, candidal stomatitis;
•  thromboembolism, arterial hypertension, varicose veins, thrombophlebitis, venous thrombosis;
•  shortness of breath, abdominal pain, nausea, dyspepsia, vomiting, xerostomia;
•  stones in the gallbladder, cholecystitis;
•  hirsutism, alopecia, acne;
•  urinary tract infections, dysmenorrhea, uterine fibroids, benign tumors in the mammary glands, uterus, cervix;
•  swelling, chest pain, chills;
•  chloasma, purpura, erythema multiforme.

If you have any unusual side effects as a result of taking this drug, you should consult your doctor about possible changes in the treatment regimen.