Composition, form of production and packaging
Tablets, coated with a shell, are of two kinds.
Tablets I, coated with a white coating, round, biconvex; on a break of white color (21 pieces in a blister).
ethinylestradiol 30 Ојg
levonorgestrel 150 Ојg
[PRING] silicon dioxide colloid - 0.275 mg, magnesium stearate - 0.55 mg, talc - 1.1 mg, corn starch - 19.895 mg, lactose monohydrate - 33 mg.
Sheath composition: 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, silicon dioxide colloid - 0.146 mg, povidone - 0.088 mg, carmellose sodium - 0.029 mg.
Tablets II (placebo), coated with a coat of reddish-brown color, glossy, round, biconvex; On a break of light brown color (7 pieces in a blister).
[PRING] iron fumarate - 76.05 mg, silicon dioxide colloid - 0.5 mg, croscarmellose sodium - 0.6 mg, magnesium stearate - 1.2 mg, povidone - 2.4 mg, talc - 2.4 mg, potato starch - 2.1 mg, starch corn - 10.2 mg, lactose monohydrate - 24.55 mg.
The composition of the shell: sucrose 38.295 mg, talc 11.752 mg, calcium carbonate 5.103 mg, titanium dioxide 2.226 mg, kopividone 1.124 mg, silicon dioxide colloid 0.24 mg, iron oxide red oxide 77491 / E172 iron oxide, - 0.787 mg, povidone - 0.144 mg, macrogol 6000 - 0.281 mg, carmellose sodium - 0.048 mg.
28 pcs. (tablets I, II) - blisters (1) - packs of cardboard.
28 pcs. (tablets I, II) - blisters (3) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
Combined monophasic oral hormonal contraceptive. Oppresses pituitary secretion of gonadotropic hormones. The contraceptive effect is associated with several mechanisms. As progestin, the progestin derivative contains a derivative of 19-nortestosterone, levonorgestrel, which is progesterone, which is superior in activity to the hormone of the yellow body, and acts on the level of receptors without preliminary metabolic transformations. The estrogen component is ethinyl estradiol.
Under the influence of levonorgestrel comes the blockade of the release of LH and FSH from the hypothalamus, oppression of the pituitary gland by gonadotropic hormones, which leads to inhibition of maturation and release of the ovum ready for fertilization (ovulation). The contraceptive effect is enhanced by ethinyl estradiol.Preserves high viscosity of the cervical mucus (making it difficult for sperm to enter the uterine cavity).
Along with the contraceptive effect with regular admission, it normalizes the menstrual cycle and helps prevent the development of gynecological diseases, incl.tumors.
Ethinyl estradiol is rapidly and almost completely absorbed from the intestine. T max is 1-1.5 hours. Ethinyl estradiol is subjected to the effect of "first passage" through the liver. Bioavailability is 38-48%.
Ethinyl estradiol almost completely binds to plasma proteins, mainly with albumins.
Ethinyl estradiol undergoes presystemic metabolism in the wall of the intestine and liver. Active metabolites undergo further metabolism in the liver. Both ethinylestradiol and its metabolites (2-OH-ethynyl-estradiol and 2-methoxyethyne-estradiol) are isolated as conjugates (sulfates and glucuronides) in bile and are subjected to intestinal hepatic recirculation.
T 1/2 is 26 В± 6.8 hours. About 40% is excreted by the kidneys and about 60% by the intestine.
Excreted in breast milk.
After ingestion, levonorgestrel is rapidly absorbed (less than 4 hours). Levonorgestrel is not exposed to the effect of "first passage" through the liver. Bioavailability is almost 100%. T max in plasma is 2 hours.
T 1/2 of levonorgestrel is 8-30 hours (an average of 16 hours). Most of the levonorgestrel binds in the blood with albumin and SHBG (globulin, binding sex hormones).
Levonorgestrel is excreted by the kidneys - 60% and through the intestine - 40% in the form of metabolites (sulfate and glucuronide conjugates).
Excreted in breast milk.
- hormone-dependent functional disorders of the menstrual cycle (including dysmenorrhea of вЂ‹вЂ‹inorganic genesis, menorrhagia of inorganic genesis, syndrome of pre-domestinal stress).
Take inside 1 tablet / day.
If the woman in the previous cycle did not take the contraceptive and the doctor did not appoint otherwise, the first white pill should take the 1st day of the menstrual cycle and continue the procedure for 21 days. Then, taking the drug is recommended to continue the tablets of a reddish-brown color for 7 days, during which menstrual bleeding occurs. After that, the next package takes white tablets from within 21 days, and then without interruption, 7 tablets of a reddish-brown color. Thus, each reception 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 had 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 Rigevidon В® 21 + 7 from another contraceptive, the above scheme should be used.
Taking the drug after childbirth or after an abortion can begin no earlier than the first day of menstruation of the first two-phase cycle. The first two-phase cycle is usually shortened because of premature ovulation. If the drug is taken with the first spontaneous bleeding, the drug can not successfully prevent premature ovulation, so in the first two weeks of the cycle, contraception may not be reliable.
If the tablet was missed within the prescribed period , the missed tablet should be taken within the next 12 hours. In this case, there is no need for additional methods of contraception. The remaining tablets are recommended at the usual time. If more than 12 hours have passed, the last missed tablet should be taken (bypassing the remaining unacceptable tablets) and continue taking the drug in normal mode. In this case, additional methods of contraception (barrier methods, spermicides) should be used in the next 7 days.
This does not apply to tablets of a reddish-brown color, t. they do not contain hormones.
For medicinal purposes, the dose of the drug and the scheme of application are selected by the doctor for each patient individually.
On the part of the reproductive system: possibly - engorgement of the mammary glands, increased libido, intermenstrual bleeding; rarely - increased vaginal discharge, candidiasis of the vagina.
From the side of the digestive system: perhaps - nausea, vomiting; rarely - hepatitis, jaundice, diarrhea. Iron fumarate, which is part of the reddish-brown tablets, can cause irritation of the mucous membrane of the digestive tract, nausea, vomiting, diarrhea, constipation and stain the feces black.
From the nervous system: perhaps - headache, depressed mood; with long-term admission very rarely - an increase in the frequency of epileptic seizures.
From the senses: in some cases - eyelid edema, conjunctivitis, visual impairment, discomfort when wearing contact lenses (these phenomena are temporary and disappear after withdrawal without prescribing any therapy); at long reception very seldom - a hearing loss.
From the cardiovascular system: rarely - increased blood pressure, pulmonary embolism, thromboembolism, myocardial infarction, cardiovascular disorders (eg, cerebral vascular embolism, stroke, retinal thrombosis, mesenteric thrombosis, thrombosis of pelvic organs, lower extremities, thrombophlebitis deep veins of the lower extremities).
From the side of metabolism: it is possible - an increase in body weight; rarely - an increase in the level of triglycerides, glucose in the blood, a decrease in glucose tolerance.
From the skin: rarely - skin rashes, hair loss; with long-term admission very rarely - chloasma, generalized itching.
Other: rarely - increased fatigue; with long-term admission very rarely - cramps calf muscles.
- liver failure;
- Liver tumors;
- congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome, Rotor syndrome);
- chronic colitis;
- severe cardiovascular diseases now or in the anamnesis;
- cerebrovascular diseases at present or in the anamnesis;
Decompensated heart diseases;
- thromboembolism and predisposition to them;
- hormone-dependent malignant neoplasms of genital organs (including suspicion of them), especially breast cancer or endometrium;
- violations of lipid metabolism;
- congenital hyperlipidemia;
- uncontrolled arterial hypertension of medium and severe degree (BP 160/100 mm Hg and above);
- pancreatitis (including in the anamnesis), accompanied by severe hyperlipidemia;
- jaundice due to taking steroids;
- Diabetes mellitus of severe course (accompanied by retinopathy and microangiopathy);
sickle cell anemia;
- chronic hemolytic anemia;
vaginal bleeding of unclear etiology;
otosclerosis (aggravated during the previous pregnancy);
- Idiopathic jaundice during pregnancy in anamnesis;
- severe skin itching during pregnancy in anamnesis;
- herpetic infection during pregnancy in the anamnesis;
- smoking over the age of 35;
- age over 40 years;
- the period of lactation (breastfeeding);
- Hypersensitivity to the components of the drug.
With caution , the drug should be prescribed for liver diseases, diabetes, cardiovascular diseases, arterial hypertension, renal dysfunction, varicose veins, phlebitis, otosclerosis, multiple sclerosis, epilepsy, small chorea, intermittent porphyria, latent tetany, bronchial asthma, depression, ulcerative colitis, uterine myoma, mastopathy, tuberculosis, adolescent patients (without regular ovulatory cycles).
PREGNANCY AND LACTATION
The drug is contraindicated in pregnancy and lactation (breastfeeding).
APPLICATION FOR FUNCTIONS OF THE LIVER
Care should be taken when administering the drug to patients with impaired renal function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe liver diseases (including congenital hyperbilirubinemia - syndromes Gilbert, Dubin-Johnson and Rotor, liver tumors).
APPLICATION IN ELDERLY PATIENTS
Before the beginning of the course of taking the drug and, subsequently, every 6 months, a general medical and gynecological examination is recommended to exclude diseases that are contraindicated to the use of oral contraceptives, as well as pregnancy. The studies should include a cytological analysis of the vaginal smear, assessment of the mammary glands condition, determination of blood glucose, cholesterol, control of liver function indicators, blood pressure, urinalysis.
The use of any combination oral contraceptive increases the risk of venous thromboembolic disease. The risk of these diseases reaches a maximum in the first year of taking medications.
The appointment of Regividone 21 + 7 to women with thromboembolic disease at a young age and increased blood coagulability in a family history is not recommended.
The use of oral contraception is allowed no earlier than 6 months after the transferred viral hepatitis in the normalization of liver function.
After long-term use of hormonal contraceptives, in rare cases, benign, in very rare cases, a malignant liver tumor, which in some cases can lead to life-threatening bleeding in the abdominal cavity. When there are sharp pains in the upper abdominal areas, hepatomegaly and signs of intra-abdominal bleeding, there may be a suspicion of a liver tumor. If necessary, the drug should be discontinued.
If there is a violation of the liver, it is necessary to undergo medical supervision every 2-3 months.
If the liver function indicators worsen during the reception of Regvidon 21 + 7, consultation of the therapist is necessary.
With the appearance of mild acyclic (intermenstrual) bleeding, the drug should be taken, in most cases these bleedings spontaneously cease. If acyclic (intermenstrual) bleeding does not disappear or recur, a medical examination should be performed to exclude the organic pathology of the reproductive system.
In the case of vomiting or diarrhea, the drug should be continued, additionally applying another, non-hormonal method of contraception.
Smoking women taking 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 older than 35 years).
A large number of epidemiological studies have investigated the incidence of ovarian, endometrial, cervical and breast cancer in women taking combined oral contraceptives. Studies have shown that these drugs protect women from ovarian and endometrial cancer. Some studies have found an increase in the incidence of cervical cancer among women who have been taking combined oral contraceptives for a long time, but the results are mixed. Sexual behavior, the presence of human papillomavirus and other factors occur in the formation of cervical cancer, and therefore the relationship between cervical cancer and the use of combined oral contraceptives is not proven.
The relative risk of developing breast cancer is slightly higher among women taking combined oral contraceptives. In the next 10 years after discontinuation of combined oral contraceptives, the risk level is gradually reduced. Because Breast cancer is rare in women younger than 40, an increase in the number of diagnosed breast cancers in women who are currently taking or taking previously combined oral contraceptives is low compared to the risk of developing breast cancer throughout life.
In the absence of bleeding cancellation, pregnancy should be excluded.
After discontinuation of the drug fertility is restored quickly enough, during 1-3 menstrual cycles.
The drug should be discontinued immediately in the following cases:
- when a migraine headache occurs for the first time or if it is worse (if it was not previously), or if there is an unusually strong headache;
- with the appearance of early signs of phlebitis or phlebothrombosis (unusual pain or swelling of the veins on the legs);
- if there is jaundice or hepatitis without jaundice;
- with acute deterioration of visual acuity;
- with cerebrovascular disorders;
- with the appearance of stitching pains of unclear etiology during breathing or coughing, pain and tightness in the chest, with a sharp increase in blood pressure;
- with suspected thrombosis or heart attack;
- when generalized itching occurs;
- with increased epileptic seizures;
- 3 months before the planned pregnancy;
- before the planned operation (for 6 weeks before the operation);
- during prolonged immobilization (for example, after injuries);
- in the presence of pregnancy.
Impact on the ability to drive vehicles and manage mechanisms
Does not affect the ability to drive and work with machinery.
Reception of oral contraceptives in high doses is not accompanied by the development of serious symptoms.
Symptoms: nausea, in young girls - nevilnye vaginal bleeding.
Treatment: there is no specific antidote, symptomatic therapy is performed.
Care should be taken when using the drug concurrently with other medicines.
With simultaneous use with barbiturates, certain antiepileptic drugs (carbamazepine, phenytoin), derivatives of pyrazolone, it is possible to increase the metabolism of steroids included in the preparation.
With simultaneous use with ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines, dihydroergotamine, tranquilizers, phenylbutazone, a reduction in the contraceptive effect is possible, therefore it is necessary to additionally apply another, non-hormonal method of contraception.
When used simultaneously with anticoagulants, coumarin or indanedione derivatives, it is necessary to monitor prothrombin time and, if necessary, change the dose of anticoagulant.
With simultaneous use with tricyclic antidepressants, maprotilinom, beta-adrenoblockers may increase their bioavailability and toxicity.
When used simultaneously with oral hypoglycemic agents, insulin may require a change in their dose.
With simultaneous application with bromocriptine, a decrease in the effectiveness of bromocriptine is possible.
When used simultaneously with hepatotoxic drugs, especially dantrolene, the risk of hepatotoxicity increases, especially in women over 35 years of age.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.