Rigevidon tablets 0.15 + 0.03mg, No. 21

• Oral contraception,

• functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, dysfunctional metrorrhagia, premenstrual syndrome).

Use orally without chewing and drinking a small amount of liquid.
If during the previous menstrual cycle hormonal contraception was not carried out , contraception with Rigevidon is started from the first day of menstruation, taking 1 tablet daily for 21 days, at the same time of day.
This is followed by a 7-day break, during which menstrual bleeding occurs. The next 21-day cycle of taking pills from a new package containing 21 pills must be started the next day after the 7-day break, that is, on the eighth day, even if the bleeding has not stopped. Thus, the beginning of taking the drug from each new package falls on the same day of the week.
When switching to taking Rigevidon from another oral contraceptive , a similar scheme is used. The drug is taken as long as there is a need for contraception.
After an abortion , it is recommended to start taking the drug on the day of the abortion or the next day after the operation.
After childbirth, the drug can be prescribed only to women who are not breastfeeding; you should start taking a contraceptive no earlier than the first day of your period. During lactation, the use of the drug is contraindicated.
Missed pills;the missed pill should be taken within the next 12 hours. If 36 hours have passed since the last pill was taken, contraception is not reliable. In order to avoid intermenstrual bleeding, the drug should be taken from the already started package, with the exception of the missed tablet (s). In cases of missing pills, it is recommended to additionally use another, non-hormonal method of contraception (eg, barrier).
For medicinal purposes; the dose of Rigevidon and the regimen of use are selected by the doctor in each case individually.

Active substances:
Ethinylestradiol: 0.03 mg
Levonorgestrel; 0.15 mg
Excipients:
- in the core of the tablet: colloidal silicon dioxide, magnesium stearate, talc, corn starch, lactose monohydrate;
- in the tablet shell: sucrose, talc, calcium carbonate, titanium dioxide, copovidone, macrogol 6000, colloidal silicon dioxide, povidone, sodium carmellose.

• Hypersensitivity to the components of the drug,

• pregnancy,

• breastfeeding period,

• severe liver disease,

• congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes),

• cholecystitis,

• the presence or indication of a history of severe cardiovascular and cerebrovascular changes,

• thromboembolism and predisposition to them,

• liver tumors

• malignant tumors,

• primarily breast or endometrial cancer;

• familial forms of hyperlipidemia,

• severe forms of arterial hypertension,

• severe forms of diabetes mellitus and other diseases of the endocrine glands,

• sickle cell anemia,

• chronic hemolytic anemia, cystic drift,

• age over 40,

• vaginal bleeding of unknown etiology,

• migraine,

• otosclerosis;

• a history of idiopathic jaundice of pregnant women,

• severe itching of pregnant women,

• herpes of pregnant women.

CAREFULLY

Diseases of the liver and gallbladder, epilepsy, depression, ulcerative colitis, uterine fibroids, mastopathy, tuberculosis, kidney disease, adolescence (without regular ovulatory cycles).
In the presence of diabetes mellitus, diseases of the cardiovascular system, arterial hypertension, impaired renal function, varicose veins, phlebitis, otosclerosis, multiple sclerosis, epilepsy, small chorea, intermittent porphyria, latent tetany, bronchial asthma, the administration of the drug also requires caution.

Tradename:

RIGEVIDONЃ

International non-proprietary name or group name:

Ethinylestradiol + Levonorgestrel

Dosage form:

coated tablets

COMPOSITION

Active substances:
Ethinylestradiol: 0.03 mg
Levonorgestrel; 0.15 mg
Excipients:
- in the core of the tablet: colloidal silicon dioxide, magnesium stearate, talc, corn starch, lactose monohydrate;
- in the tablet shell: sucrose, talc, calcium carbonate, titanium dioxide, copovidone, macrogol 6000, colloidal silicon dioxide, povidone, sodium carmellose.

Description

White, round, biconvex film-coated tablets.

Pharmacotherapeutic group:

contraceptive (estrogen + progestogen)

ATX code: G03AA07.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Rigevidon is an 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 derivative of 19-nortestosterone - 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 hormones (LH and FSH) 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 is rapidly absorbed (in less than 4 hours). Levonorgestrel has no hepatic first pass effect. When levonorgestrel is coadministered with ethinyl estradiol, there is a relationship between the dose and the maximum plasma concentration. TCmax (time to reach maximum concentration) of levonorgestrel is 2 hours, T1 / 2 (half-life) is 8-30 hours. (on average 16 hours). Most of the levonorgestrel is bound in the blood to albumin and SHBG (sex hormone binding globulin).
Ethinylestradiol is rapidly and almost completely absorbed from the intestines. Ethinylestradiol has an inherent effect of primary passage through the liver, TCmax is 1.5 hours, the half-life is about 26 hours.
When taken orally, ethinyl estradiol is excreted from the blood plasma within 12 hours, the half-life is 5.8 hours.
Ethinyl estradiol is metabolized in the liver and intestines. Ethinyl estradiol metabolites - water-soluble products of sulfate or glucuronide conjugation, enter the intestine with bile, where they undergo disintegration with the help of intestinal bacteria.
Both components (levonorgestrel and ethinyl estradiol) are excreted in breast milk. Active substances are metabolized in the liver, T1 / 2 is 2-7 hours.
Levonorgestrel is excreted by the kidneys (60%) and through the intestines (40%); ethinylestradiol - by the kidneys (40%) and through the intestines (60%).

INDICATIONS FOR USE

• Oral contraception,

• functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, dysfunctional metrorrhagia, premenstrual syndrome).

CONTRAINDICATIONS

• Hypersensitivity to the components of the drug,

• pregnancy,

• breastfeeding period,

• severe liver disease,

• congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes),

• cholecystitis,

• the presence or indication of a history of severe cardiovascular and cerebrovascular changes,

• thromboembolism and predisposition to them,

• liver tumors

• malignant tumors,

• primarily breast or endometrial cancer;

• familial forms of hyperlipidemia,

• severe forms of arterial hypertension,

• severe forms of diabetes mellitus and other diseases of the endocrine glands,

• sickle cell anemia,

• chronic hemolytic anemia, cystic drift,

• age over 40,

• vaginal bleeding of unknown etiology,

• migraine,

• otosclerosis;

• a history of idiopathic jaundice of pregnant women,

• severe itching of pregnant women,

• herpes of pregnant women.

CAREFULLY

Diseases of the liver and gallbladder, epilepsy, depression, ulcerative colitis, uterine fibroids, mastopathy, tuberculosis, kidney disease, adolescence (without regular ovulatory cycles).
In the presence of diabetes mellitus, diseases of the cardiovascular system, arterial hypertension, impaired renal function, varicose veins, phlebitis, otosclerosis, multiple sclerosis, epilepsy, small chorea, intermittent porphyria, latent tetany, bronchial asthma, the administration of the drug also requires caution.

PREGNANCY AND LACTATION

During pregnancy and lactation, the drug is contraindicated.

DOSAGE AND APPLICATION

Use orally without chewing and drinking a small amount of liquid.
If during the previous menstrual cycle hormonal contraception was not carried out , contraception with Rigevidon is started from the first day of menstruation, taking 1 tablet daily for 21 days, at the same time of day.
This is followed by a 7-day break, during which menstrual bleeding occurs. The next 21-day cycle of taking pills from a new package containing 21 pills must be started the next day after the 7-day break, that is, on the eighth day, even if the bleeding has not stopped. Thus, the beginning of taking the drug from each new package falls on the same day of the week.
When switching to taking Rigevidon from another oral contraceptive , a similar scheme is used. The drug is taken as long as there is a need for contraception.
After an abortion , it is recommended to start taking the drug on the day of the abortion or the next day after the operation.
After childbirth, the drug can be prescribed only to women who are not breastfeeding; you should start taking a contraceptive no earlier than the first day of your period. During lactation, the use of the drug is contraindicated.
Missed pills;the missed pill should be taken within the next 12 hours. If 36 hours have passed since the last pill was taken, contraception is not reliable. In order to avoid intermenstrual bleeding, the drug should be taken from the already started package, with the exception of the missed tablet (s). In cases of missing pills, it is recommended to additionally use another, non-hormonal method of contraception (eg, barrier).
For medicinal purposes; the dose of Rigevidon and the regimen of use are selected by the doctor in each case individually.

SIDE EFFECT

The drug is usually well tolerated.
Possible transient side effects that pass spontaneously: nausea, vomiting, headache, breast engorgement, changes in body weight and libido, mood changes, acyclic spotting, in some cases - eyelid edema, conjunctivitis, blurred vision, discomfort when wearing contact lenses (these phenomena are temporary and disappear after discontinuation without prescribing any therapy).
Chloasma, hearing loss, generalized itching, jaundice, calf muscle cramps, and an increase in the frequency of epileptic seizures can very rarely occur with prolonged use. Rarely, hypertriglyceridemia, hyperglycemia, decreased glucose tolerance, increased blood pressure (BP), thrombosis and venous thromboembolism, jaundice, skin rashes, changes in the nature of vaginal secretion, vaginal candidiasis, increased fatigue, diarrhea are noted.

OVERDOSE

Cases of development of toxic effects due to overdose are unknown.

INTERACTION WITH OTHER DRUGS

Barbiturates, some antiepileptic drugs (carbamazepine, phenytoin), sulfonamides, pyrazolone derivatives can increase the metabolism of the steroid hormones that make up the drug.
A decrease in contraceptive efficacy can also be observed with simultaneous administration with some antimicrobial drugs (ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines), which is associated with a change in the microflora in the intestine.
When using anticoagulants, coumarin or indandione derivatives, it may be necessary to additionally determine the prothrombin index and change the dose of the anticoagulant.
When using tricyclic antidepressants, maprotiline, beta-blockers, their bioavailability and toxicity may increase.
When using oral hypoglycemic drugs and insulin, it may be necessary to change their dose.
When combined with bromocriptine, the effectiveness of bromocriptine decreases.
When combined with drugs with a potential hepatotoxic effect, for example, with the drug dantrolene, an increase in hepatotoxicity is observed, especially in women over 35 years old.

SPECIAL INSTRUCTIONS

Before starting contraception and, thereafter, every 6 months. a general medical and gynecological examination is recommended, including a cytological analysis of a smear from the cervix, an assessment of the state of the mammary glands, determination of blood glucose, cholesterol and other indicators of liver function, blood pressure control, urinalysis).
The appointment of Rigevidon to women with thromboembolic diseases at a young age and increased blood clotting in a family history is not recommended.
The use of oral contraception is allowed no earlier than 6 months after the transferred viral hepatitis, subject to the normalization of hepatic functions.
With the appearance of sharp pain in the upper abdomen, hepatomegaly and signs of intra-abdominal bleeding, a suspicion of a liver tumor may arise. If necessary, the drug should be discontinued.
In case of deterioration of hepatic functions while taking Rigevidon, a therapist's consultation is necessary.
If acyclic (intermenstrual) bleeding occurs, Rigevidon should be continued, since in most cases these bleeding will stop spontaneously. If acyclic (intermenstrual) bleeding does not disappear or recur, a medical examination should be carried out to exclude organic pathology of the reproductive system.
In case of vomiting or diarrhea, the drug should be continued, additionally using another, non-hormonal method of contraception.
Women who smoke and take hormonal contraceptives have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk increases with age and depending on the number of cigarettes smoked (especially in women over 35).
The drug should be discontinued in the following cases:
- when a migraine-like headache develops for the first time or worsens, or an unusually severe headache appears;
- with the appearance of early signs of phlebitis or phlebothrombosis (unusual pain or swelling of the veins in the legs);
- if jaundice or hepatitis occurs without jaundice;
- with cerebrovascular disorders;
- with the appearance of stabbing pains of unclear etiology when breathing or coughing, pain and tightness in the chest;
- with an acute deterioration in visual acuity;
- if you suspect a thrombosis or heart attack;
- with a sharp increase in blood pressure;
- when generalized itching occurs;
- with an increase in epileptic seizures;
- 3 months before the planned pregnancy, approximately 6 weeks before the planned surgical intervention, with prolonged immobilization.
- if you are pregnant.

INFLUENCE OF THE PREPARATION ON THE ABILITY TO DRIVE A CAR AND OTHER MECHANISMS

Taking the drug does not affect the ability to drive a car and other mechanisms, work with which is associated with an increased risk of injury.

RELEASE FORM

Pills;
21 tablets in a blister of PVC / PVDC film and aluminum foil;
1 or 3 blisters in a cardboard box with instructions for use.

STORAGE CONDITIONS

At a temperature of 15-30 ? C.
It is necessary to store the drug out of the reach of children!

SHELF LIFE

5 years. Do not use after the expiration date.

TERMS OF RELEASE FROM PHARMACIES

On prescription.