Rigevidon pills №21

Dosage form

Pills

Composition

1 coated pill contains: Ethinyl Estradiol 30 mcg, Levonorgestrel 150 mcg

Auxiliary substances: colloidal silicon dioxide, Magnesium stearate, talc, corn starch, lactose monohydrate

Shell composition: Sucrose, talc, Calcium carbonate, titanium dioxide, copovidone, macrogol 6000, colloidal silicon dioxide, povidone, carmellose sodium

Packing

In 1 blister 21 tablets.

Mechanism of action

Rigevidon - combined monophasic oral hormonal contraceptive drug.

When ingestion inhibits pituitary secretion of gonadotropic hormones. The contraceptive effect is associated with several mechanisms. As a gestagen component (progestin) contains a derivative of 19-nortestosterone - levonorgestrel, surpassing the activity of the corpus luteum hormone Progesterone (and the synthetic analogue of the latter - pregnin), acts at the receptor level without prior metabolic transformations. The estrogen component is ethinyl estradiol.

Under the influence of levonorgestrel, a blockade of release of LH and FSH from the hypothalamus occurs, the pituitary secretion of gonadotropic hormones is inhibited, which leads to inhibition of maturation and release of the ovum ready for fertilization. Contraceptive action is enhanced by ethinyl estradiol. Retains a high viscosity of the cervical mucus (makes it difficult for sperm to enter the uterus). Along with the contraceptive effect with regular use, it normalizes the menstrual cycle and helps prevent the development of a number of gynecological diseases, including neoplastic nature.

Indications and usage

- Oral contraception.
- Functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, dysfunctional metrorrhagia).
- Premenstrual tension syndrome.

Contraindications

- Severe liver diseases (including congenital hyperbilirubinemia - Gilbert, Dubin-Johnson and Rotor syndromes).
- Cholecystitis.
- The presence or indication in the history of severe cardiovascular and cerebrovascular diseases.
- Thromboembolism and predisposition to them.
- Malignant tumors (primarily breast or endometrial cancer).
- Liver tumors.
- Family forms of hyperlipidemia.
- Severe forms of arterial hypertension.
- Endocrine diseases (including severe diabetes).
- Sickle cell anemia.
- Chronic hemolytic anemia.
- Vaginal bleeding of unknown etiology.
- Bubble skid.
- Migraine.
- Otosclerosis.
- Idiopathic jaundice of pregnant women in the anamnesis.
- Severe pruritus during pregnancy.
- Herpes pregnant.
- Age over 40 years.
- Pregnancy.
- Lactation period (breastfeeding).
- Hypersensitivity to the drug.

With caution should use the drug for:

- Diseases of the liver and gallbladder.
- Epilepsy.
- Depressed.
- Ulcerative colitis.
- Myome uterus.
- Mastopathy.
- Tuberculosis.
- Kidney disease.
- With diabetes.
- Diseases of the cardiovascular system.
- Hypertension.
- Impaired renal function.
- Varicose veins.
- Phlebite.
- Multiple sclerosis.
- Little chorea.
- In adolescence (without regular ovulatory cycles).

Pregnancy and Breastfeeding

The drug is contraindicated in pregnancy and lactation (breastfeeding).

Dosage and administration

The drug is taken orally at the same time of day, without chewing and washing it down with a small amount of liquid.

For the purpose of contraception, if during the previous menstrual cycle hormonal contraception was not performed. Ripevidon is prescribed 1 pill daily for 21 days from the first day of menstruation. This is followed by a 7-day break, during which menstrual-like bleeding occurs. The next 21-day cycle of taking pills from a new package containing 21 pills should be started the next day after a 7-day break, i.e. on the 8th day, even if the bleeding has not stopped. Thus, the start of taking the drug from each new package falls on the same day of the week.

When switching to the reception of Rigevidon from another oral contraceptive, a similar scheme is used. The drug is taken as long as the need for contraception remains.

After an abortion, it is recommended to start taking the drug on the day of the abortion or the day after surgery.

After birth, the drug can be prescribed only to women who are not breastfeeding; To receive contraceptive should begin no earlier than the first day of menstruation. During lactation, the use of the drug is contraindicated.

If you miss a dose, the missed pill should be taken within the next 12 hours. If 36 hours have passed since taking the last pill, then contraception is unreliable. In order to avoid intermenstrual bleeding, taking the drug should be continued from the already started packaging, with the exception of the missed pill (s). In the case of missed pills, it is recommended to additionally use another, non-hormonal method of contraception (for example, a barrier method).

For therapeutic purposes, the doctor sets the dose of Rigevidon and the scheme of use in each case individually.

Special notes

Before starting hormonal contraception and every 6 months thereafter, a general medical and gynecological examination is recommended, including a cytological analysis of a smear from the cervix, assessment of the mammary glands, determination of blood glucose, cholesterol and other indicators of liver function, blood pressure control, urinalysis).

Appointment of Rigevidon to women with thromboembolic diseases at a young age and an increase in blood clotting in the family history is not recommended.

The use of oral contraception is allowed no earlier than 6 months after the transferred viral hepatitis provided normalization of hepatic functions.

With the appearance of sharp pain in the upper abdomen, hepatomegaly and signs of intra-abdominal bleeding, a liver tumor may be suspected. If necessary, the drug should be discontinued.

In case of abnormal liver function while taking Rigevidon, consultation of the therapist is necessary.

With the appearance of acyclic (intermenstrual) bleeding, the reception of Rigevidon should be continued, since in most cases, these bleedings spontaneously stop. If the acyclic (intermenstrual) bleeding does not disappear or recur, a medical examination should be conducted to exclude organic pathology of the reproductive system.

In the case of vomiting or diarrhea, the drug should be continued, using a different, non-hormonal method of contraception.

Smoking women who take hormonal contraceptives have an increased risk of developing cardiovascular diseases with serious consequences (myocardial infarction, stroke). The risk increases with age and depending on the number of cigarettes smoked (especially in women older than 35 years).

The drug should be stopped in the following cases:

- When you first appear or increase migraine headache.
- The appearance of an unusually strong headache.
- With the appearance of early signs of phlebitis or phlebothrombosis (unusual pain or distended veins in the legs).
- If jaundice or hepatitis occurs without jaundice.
- In cerebrovascular disorders.
- With the appearance of stabbing pains of unclear etiology when breathing or coughing, pain and chest tightness.
- With acute deterioration of visual acuity.
- If you suspect a thrombosis or heart attack.
- With a sharp increase in blood pressure.
- When a 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.
- With the onset of pregnancy.

- Application for violations of the liver: Contraindicated for severe liver disease (including congenital hyperbilirubinemia - Gilbert, Dubin-Johnson and Rotor syndromes; liver tumors).

- Application for violations of kidney function: Care must be taken when it is necessary to administer the drug to patients with impaired renal function.

- Impact on the ability to drive vehicles and control mechanisms: Taking the drug does not affect the ability to drive vehicles and to control other mechanisms, work with which is associated with an increased risk of injury.

Barbiturates, some antiepileptic drugs (carbamazepine, phenytoin), sulfonamides, pyrazolone derivatives can increase the metabolism of steroid hormones that make up the drug.

A decrease in contraceptive efficacy can also be observed when administered concomitantly with certain antimicrobial agents (includingwith ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines), which is associated with changes in the intestinal microflora.

When applied simultaneously with anticoagulants, coumarin or indanedione derivatives, an additional determination of the prothrombin index and a change in the dose of the anticoagulant may be required.

With the use of tricyclic antidepressants, maprotiline, beta-blockers may increase their bioavailability and toxicity.

With the use of oral hypoglycemic drugs and insulin , it may be necessary to change their dose.

When combined with Bromocriptine , its effectiveness is reduced.

When combined with drugs with a potential hepatotoxic effect, for example, with the drug dantrolen, there is an increase in hepatotoxicity, especially in women over 35 years of age.

Caution should be taken Rigewedon in combination with the above drugs.

The drug should be stored at a temperature of 15 ° to 30 ° C.

5 years.