Rigevidon tablets p / o, No. 84

- Contraception;

- Hormone-dependent functional disorders of the menstrual cycle (including
dysmenorrhea without an organic cause, menorrhagia without an organic cause,
premenstrual syndrome).

One tablet a day, preferably at the same time of day.

If the woman in the previous cycle did not take a contraceptive , and the doctor did not prescribe otherwise, the first pill should be taken on the first day of menstruation and the pills should be continued for 21 days. Then it is recommended to continue taking the drug with reddish-brown tablets for 7 days, during which menstrual bleeding occurs. After that, you should continue to take the next pack containing 21 white tablets, and then 7 reddish-brown tablets without interruption.

Thus, each intake cycle starts on the same day of the week.

In the event that a woman took a contraceptive in the previous

cycle , and in the previous package there were 21 tablets, the drug should be taken after a 7-day break, on the eighth day.

The composition of tablets of different colors is not the same. Therefore, the beginning and the correct sequence of administration - first 21 white tablets, then 7 reddish-brown tablets - are indicated on the package with numbers and arrows.

When switching to RigevidonЃ 21 + 7 from another contraceptive, you should use the above scheme.

Taking the drug after childbirth or after an abortion can be started not earlier than the first day of menstruation of the first two-phase cycle. The first biphasic cycle is usually shortened due to premature ovulation. If the drug is taken already at the first spontaneous bleeding, the drug cannot successfully prevent premature ovulation, therefore, contraception may be unreliable in the first two weeks of the cycle.

If the pill was missed on time , then the missed pill should be taken within the next 12 hours. In this case, there is no need to use additional methods of contraception. The rest of the tablets are recommended to be taken at the usual time. If more than 12 hours have passed, you should take the last missed pill (skipping the rest of the missed pills) and continue taking the drug as usual. In this case, in the next 7 days it is necessary to use additional methods of contraception (barrier methods, spermicides).

This does not apply to reddish-brown tablets, because they do not contain hormones.

For medicinal purposes, the dose of the drug and the regimen of administration are selected by the doctor for each patient individually.

for 1 coated tablet:

Tablets I:

Active ingredients:

Levonorgestrel - 0.150 mg Ethinylestradiol - 0.030 mg

Excipients:

- in the core of the tablet: colloidal silicon dioxide - 0.275 mg, magnesium stearate - 0.550 mg, talc - 1,100 mg, corn starch - 19.895 mg, lactose monohydrate - 33,000 mg;

- in the tablet shell: sucrose - 22.459 mg, talc - 6.826 mg, calcium carbonate - 3.006 mg, titanium dioxide - 1.706 mg, copovidone - 0.592 mg, macrogol 6000 - 0.148 mg, colloidal silicon dioxide - 0.146 mg, povidone - 0.088 mg, carmellose sodium - 0.029 mg.

Tablets II

Core :

iron fumarate 76.05 mg, colloidal silicon dioxide - 0.50 mg, croscarmellose sodium - 0.60 mg, magnesium stearate - 1.20 mg, povidone - 2.40 mg, talc - 2.40 mg, potato starch - 2 , 10 mg, corn starch - 10.20 mg, lactose monohydrate - 24.55 mg.

Sheath: sucrose - 38.295 mg, talc - 11.752 mg, calcium carbonate - 5.103 mg, titanium dioxide - 2.226 mg, copovidone - 1.124 mg, colloidal silicon dioxide - 0.240 mg, iron dye red oxide (color index 77491 / E172) - 0.787 mg, povidone - 0.144 mg, macrogol 6000 - 0.281 mg, carmellose sodium - 0.048 mg.

Increased individual sensitivity to the components of the drug, pregnancy; lactation period, liver failure, liver tumors; congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes); cholelithiasis; cholecystitis; chronic colitis; the presence or indication of a history of severe cardiovascular and cerebrovascular changes, thromboembolism and a predisposition to them, decompensated heart defects; hormone-dependent malignant neoplasms of the genitals and mammary glands (including suspicion of them), primarily breast or endometrial cancer; violation of fat metabolism; congenital hyperlipidemia; uncontrolled arterial hypertension of moderate and severe degree with arterial pressure 160/100 mm Hg. and higher; severe diabetes mellitus (accompanied by retinopathy and microangiopathy);sickle cell anemia; chronic hemolytic anemia; vaginal bleeding of unknown etiology; migraine; otosclerosis (which worsened during a previous pregnancy); idiopathic jaundice, severe pruritus, history of herpes of pregnant women; pancreatitis (including history), accompanied by severe hyperlipidemia; jaundice due to taking medicines containing steroids; smoking over the age of 35; age over 40.smoking over the age of 35; age over 40.smoking over the age of 35; age over 40.

CAREFULLY

Liver disease, epilepsy, depression, ulcerative colitis, uterine fibroids, mastopathy, tuberculosis, kidney disease, adolescence (without regular ovulatory cycles), diabetes mellitus, diseases of the cardiovascular system, arterial hypertension, renal dysfunction, varicose veins, phlebitis , otosclerosis, multiple sclerosis, chorea minor, intermittent porphyria, latent tetany, bronchial asthma.

Tradename:

Rigevidon Ѓ 21 + 7

International non-proprietary or grouping name (INN):

levonorgestrel + ethinyl estradiol

Dosage form:

film-coated tablets

Composition for 1 coated tablet:

Tablets I:

Active ingredients:

Levonorgestrel - 0.150 mg Ethinylestradiol - 0.030 mg

Excipients:

- in the core of the tablet: colloidal silicon dioxide - 0.275 mg, magnesium stearate - 0.550 mg, talc - 1,100 mg, corn starch - 19.895 mg, lactose monohydrate - 33,000 mg;

- in the tablet shell: sucrose - 22.459 mg, talc - 6.826 mg, calcium carbonate - 3.006 mg, titanium dioxide - 1.706 mg, copovidone - 0.592 mg, macrogol 6000 - 0.148 mg, colloidal silicon dioxide - 0.146 mg, povidone - 0.088 mg, carmellose sodium - 0.029 mg.

Tablets II

Core :

iron fumarate 76.05 mg, colloidal silicon dioxide - 0.50 mg, croscarmellose sodium - 0.60 mg, magnesium stearate - 1.20 mg, povidone - 2.40 mg, talc - 2.40 mg, potato starch - 2 , 10 mg, corn starch - 10.20 mg, lactose monohydrate - 24.55 mg.

Sheath: sucrose - 38.295 mg, talc - 11.752 mg, calcium carbonate - 5.103 mg, titanium dioxide - 2.226 mg, copovidone - 1.124 mg, colloidal silicon dioxide - 0.240 mg, iron dye red oxide (color index 77491 / E172) - 0.787 mg, povidone - 0.144 mg, macrogol 6000 - 0.281 mg, carmellose sodium - 0.048 mg.

DESCRIPTION

Pills

White, round biconvex film-coated tablets, the surface at the fracture is white.

Placebo pills

Reddish brown, glossy, round biconvex film-coated tablets. Light brown at the break.

Pharmacotherapeutic group:

combined contraceptive (estrogen + progestogen)

PHARMACHOLOGIC EFFECT

Oral monophasic combined estrogen-gestagenic contraceptive drug. When taken orally, it inhibits the pituitary secretion of gonadotropic hormones. The contraceptive effect is associated with several mechanisms. As a progestin component (progestin) it contains a 19-nortestosterone derivative - levonorgestrel, which is superior in activity to the corpus luteum hormone progesterone (and a synthetic analogue of the latter - pregnin), acts at the receptor level without preliminary metabolic transformations. The estrogenic component is ethinyl estradiol. Under the influence of levonorgestrel, there is a blockade of the release of releasing factors (luteinizing and follicle-stimulating hormones) of the hypothalamus, inhibition of the secretion of gonadotropic hormones by the pituitary gland, which leads to inhibition of maturation and the release of an egg ready for fertilization (ovulation).The contraceptive effect is enhanced by ethinyl estradiol. Maintains a high viscosity of cervical mucus (makes it difficult for sperm to enter the uterine cavity). Along with the contraceptive effect, when taken regularly, it normalizes the menstrual cycle and helps prevent the development of a number of gynecological diseases, incl. tumor nature.

Pharmacokinetics

Levonorgestrel

Levonorgestrel is rapidly absorbed (complete absorption time less than 4 hours). There is no effect of the first pass through the liver. Bioavailability is almost one hundred percent. Most of levonorgestrel binds to plasma proteins, mainly albumin and sex steroid binding globulins (SHBGs). The time to reach the maximum plasma concentration of levonorgestrel (TCmax) is 2 hours. The half-life of levonorgestrel (T1 / 2) varies from 8 to 30 hours (average 16 hours). Levonorgestrel is excreted through the kidneys - 60% and intestines - 40% in the form of metabolites (sulfate and glucuronide conjugates).

Ethinylestradiol

Ethinylestradiol is absorbed quickly and almost completely. Ethinylestradiol has an inherent effect of primary passage through the liver, TCmax is 1.5 hours. After oral administration, bioavailability is about 38-48%. Ethinylestradiol almost completely binds to plasma proteins, mainly albumin.

Ethinylestradiol undergoes first pass metabolism in the intestinal wall and liver. Active substances are metabolized in the liver. Both ethinyl estradiol and metabolites (2-OH-ethinylestradiol and 2-methoxy-ethinylestradiol) are released as conjugates (sulfates and glucuronides) into bile and undergo enterohepatic recirculation. The half-life is 26 ± 6.8 hours. About 40% is excreted through the kidneys and about 60% through the intestines.

Both components (levonorgestrel and ethinyl estradiol) are excreted in breast milk.

INDICATIONS FOR USE

- Contraception;

- Hormone-dependent functional disorders of the menstrual cycle (including
dysmenorrhea without an organic cause, menorrhagia without an organic cause,
premenstrual syndrome).

CONTRAINDICATIONS

Increased individual sensitivity to the components of the drug, pregnancy; lactation period, liver failure, liver tumors; congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes); cholelithiasis; cholecystitis; chronic colitis; the presence or indication of a history of severe cardiovascular and cerebrovascular changes, thromboembolism and a predisposition to them, decompensated heart defects; hormone-dependent malignant neoplasms of the genitals and mammary glands (including suspicion of them), primarily breast or endometrial cancer; violation of fat metabolism; congenital hyperlipidemia; uncontrolled arterial hypertension of moderate and severe degree with arterial pressure 160/100 mm Hg. and higher; severe diabetes mellitus (accompanied by retinopathy and microangiopathy);sickle cell anemia; chronic hemolytic anemia; vaginal bleeding of unknown etiology; migraine; otosclerosis (which worsened during a previous pregnancy); idiopathic jaundice, severe pruritus, history of herpes of pregnant women; pancreatitis (including history), accompanied by severe hyperlipidemia; jaundice due to taking medicines containing steroids; smoking over the age of 35; age over 40.smoking over the age of 35; age over 40.smoking over the age of 35; age over 40.

CAREFULLY

Liver disease, epilepsy, depression, ulcerative colitis, uterine fibroids, mastopathy, tuberculosis, kidney disease, adolescence (without regular ovulatory cycles), diabetes mellitus, diseases of the cardiovascular system, arterial hypertension, renal dysfunction, varicose veins, phlebitis , otosclerosis, multiple sclerosis, chorea minor, intermittent porphyria, latent tetany, bronchial asthma.

DOSAGE AND APPLICATION