Expiration date: 03/2025

Structure and Composition:

Film-coated tablets. 1 tablet contains active substance:

0.03 mg ethinylestradiol

0.15 mg levonorgestrel

Other ingredients: colloidal silicon dioxide, magnesium stearate, talc, corn starch, lactose monohydrate

shell: sucrose, talc, calcium carbonate, titanium dioxide, macrogol 6000 copovidone colloidal silica povidone sodium carmellose

Film-coated tablets (II) of Table 1.

active substance:

76.05 mg ferrous fumarate

Other ingredients: colloidal silicon dioxide, croscarmellose sodium magnesium stearate, povidone, talc, corn starch, potato starch, lactose monohydrate

shell: sucrose, talc, calcium carbonate, titanium dioxide kopolividon colloidal silicon dioxide ferric oxide red - E172 Macrogol 6000 Povidone Sodium carmellose

in blister Al / PVC 28 pcs. (Tablets (I) - 21 pcs, tablets (I) I -. 7 pcs.) In the paper cartons 1 or 3 blisters.

Description pharmaceutical form:

Tablets (I): biconvex circular shape, coated on the surface of white white fracture.

Tablets (II): biconvex round shape, glossy coated cover of red-brown color on the fracture surface of a light brown color.

Pharmacokinetics:

levonorgestrel

Rapidly absorbed (time for complete absorption of less than 4 hours). No first-pass effect through the liver.

Bioavailability is almost 100%. Most of levonorgestrel is bound to plasma proteins, mainly albumin and binding globulin sex steroids.

Tmax is levonorgestrel plasma 2 h T1 / 2 levonorgestrel ranges from 8 to 30 hours (average - 16 h).. Levonorgestrel is excreted through the kidneys - 60% and intestine - 40% as metabolites (glucuronide and sulfate conjugates).

Ethinylestradiol

It absorbed quickly and almost completely. Ethinylestradiol inherent effect of first pass through the liver, Tmax was 1.5 hours after oral bioavailability -. Approximately 38-48%. Ethinylestradiol almost completely bound to plasma proteins, mainly albumin.

Ethinylestradiol undergoes first-pass metabolism in the gut wall and liver. Active substances are metabolized in the liver. As ethinyl estradiol and metabolites (OH-2 and 2-ethinyl-methoxy-ethinyl estradiol) are allocated as conjugates (glucuronides and sulfates) in the bile and undergo enterohepatic recirculation. . T1 / 2 (26 ± 6,8) h about 40% excreted through the kidneys and about 60% - in the intestine.

Description of the pharmacological actions:

Monophasic oral combined estrogen-progestin contraceptive drug. If ingestion inhibits the secretion of pituitary gonadotropins. The contraceptive effect is due to several mechanisms. As a progestin component (progestin) contains a derivative of 19-nortestosterone - levonorgestrel, surpassing the activity of the corpus luteum hormone progesterone (and a synthetic analogue of the latter - pregnin), it acts on the receptor level without prior metabolic transformations.

Estrogen component is ethinyl estradiol. Under the influence of levonorgestrel comes blockade release releasing factors (luteinizing and follicle stimulating hormones) of the hypothalamus, the pituitary gland secretion inhibiting gonadotropin-releasing hormone, which leads to inhibition of maturation and release ready to fertilize an egg (ovulation). The contraceptive effect is enhanced ethinylestradiol. Retains high viscosity of cervical mucus (makes it difficult penetration of sperm into the uterus). Along with the contraceptive effect when taken regularly normalizes the menstrual cycle and helps prevent the development of a number of gynecological diseases, including tumoral nature.

Indications:

contraception

hormone-dependent functional menstrual disorders (including dysmenorrhea without organic cause, menorrhagia without organic cause, premenstrual syndrome).

Contraindications:

• Increased individual sensitivity to the drug
  
• pregnancy, lactation
  
• liver failure, liver cancer
  
• congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor)
  
• cholelithiasis, cholecystitis
  
• chronic colitis
  
• the presence or indication of a history of severe cardiovascular and cerebrovascular changes, thromboembolism and predisposition to them, decompensated heart diseases
  
• hormone-dependent cancers and genital mammary glands (including suspected them), especially breast cancer or endometrial
  
• violation of fat metabolism, congenital hyperlipidemia
  
• uncontrolled hypertension moderate and severe with BP 160/100 mm Hg and higher
  
• diabetes mellitus, severe course, accompanied by retinopathy and microangiopathy
  
• sickle cell anemia and chronic hemolytic
  
• vaginal bleeding of unknown etiology
  
• migraine
  
• otosclerosis (which worsened during previous pregnancy)
  
• idiopathic jaundice, severe pruritus, herpes, pregnancy history
  
• pancreatitis (including history), accompanied by severe hyperlipidemia
  
• jaundice due to taking drugs containing steroids
  
• smoking at the age of 35 years
  
• age over 40 years.
  

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

Side effect:

Nausea, vomiting, headache, breast tenderness, weight gain, and libido, depressed mood, intermenstrual bleeding in some cases - swelling of the eyelids, conjunctivitis, blurred vision, discomfort while wearing contact lenses (these effects are temporary and disappear after drug withdrawal purpose without any treatment).

Chronic administration very rarely can occur chloasma, hearing loss, generalized itching, jaundice, leg cramps, increase in the frequency of epileptic seizures.

Rarely - elevated triglycerides, blood glucose, impaired glucose tolerance, increased blood pressure, pulmonary embolism, thromboembolism, myocardial infarction, cardiovascular disorders (including cerebral vascular embolism, stroke, thrombosis of the retina, mesenteric thrombosis, vessels pelvic, lower extremities, thrombophlebitis of the lower limbs deep veins), hepatitis, jaundice, skin rashes, hair loss, increased vaginal discharge, vaginal candidiasis, fatigue, diarrhea.

Fumarate iron, part of the reddish-brown tablets, sugar-coated, can cause irritation to the gastrointestinal mucosa, nausea, vomiting, diarrhea, constipation and stool painted in black.

Drug Interactions:

The drug is used with caution at the same time:

• With barbiturates, some antiepileptic drugs (carbamazepine, phenytoin), pyrazolone derivatives (may increase metabolism members of the steroid drug)
  
• Ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines, dihydroergotamine, tranquilizers, phenylbutazone (contraceptive effect may decrease, so other non-hormonal contraceptive method should be used in addition)
  
• With anticoagulants, coumarin derivatives or indandiona (need to redefine the prothrombin time, and, if necessary, change the dose of anticoagulant)
  
• Tricyclic antidepressants, maprotiline, & beta-blockers (may increase their bioavailability and toxicity)
  
• With oral antidiabetics, insulin (you may need to change the dose of these funds)
  
• With bromocriptine (decreased effectiveness of bromocriptine)
  
• With hepatotoxic drugs, especially dantrolenom (increases the risk of hepatotoxicity, especially in women older than 35 years).
  

Dosage and administration:

Inside.

Table 1. per day, preferably in the same time.

If the woman in the previous cycle did not take contraceptive and a doctor has not appointed otherwise, the first pill to be taken in the first day of menstruation and continue taking the tablets for 21 days. Then treatment is recommended to continue taking a red-brown tablets for 7 days, during which there is menstrualnopodobnoe bleeding. After that you should continue taking the next pack containing 21 Table. white, and then Table 7. red-brown color - without interruption. Each cycle starts reception in the same day of the week.

In that case, if a woman takes contraceptives in the previous cycle and the previous package was 21 tab., The drug should be started after a 7-day break, on the 8th day.

The composition of the tablets of different colors vary. Therefore, the beginning and the correct sequence of reception - first 21 white tablet, then 7 red-brown tablets - numbers are indicated on the packaging and arrows.

When you go to Rigevidon 21 + 7 with another contraceptive, you should use the above scheme.

Taking the drug after birth or after an abortion can begin no earlier than the 1st day of menstruation the first two-phase cycle. 1st biphasic cycle due to premature ovulation usually shortened. If the drug begins at the 1st spontaneous bleeding, the drug can not successfully prevent premature ovulation, so the 1st 2 week cycle contraception can be unreliable.

If a pill is missed within the prescribed period, the missed tablet should be taken within the next 12 hours. In this case, there is no need to use additional contraceptive methods. The rest are advised to take the tablets at the usual time. If more than 12 hours, you should take the last missed tablet (omitting the other missed pills) and continue taking the drug normally. In this case, in the next 7 days is necessary to use additional methods of contraception (barrier methods, spermicides).

This does not apply to the tablets of red-brown color, as they do not contain hormones.

For therapeutic purposes, the dose and application of the scheme chosen doctor for each patient individually.

Overdose:

Taking large doses of oral contraceptives is not accompanied by the development of severe symptoms.

Symptoms: Nausea, young girls - not abundant vaginal bleeding.

Treatment: symptomatic (the drug has no specific antidote).

Precautionary measures:

Before you start taking this medication and then every 6 months is recommended to general medical and gynecological examination to exclude disease is a contraindication to the use of oral contraceptives and pregnancy, including a cytological analysis of the vaginal smear, evaluation of the breast, the determination of blood glucose, cholesterol , monitoring of liver function, blood pressure, urinalysis.

The use of any combined oral contraceptives increases the risk of venous thromboembolic disease. The risk of these diseases reaches a maximum during the first year of treatment.

Appointment Regividona 21 + 7 women with thromboembolic disease at a young age and increased blood clotting in the family history is not recommended.

The use of oral contraceptives may be no earlier than 6 months after suffering a viral hepatitis in the normalization of liver function.

After prolonged use of hormonal contraceptives, in rare cases it may be benign, in rare cases - malignant tumor of the liver, which in some cases can lead to life-threatening bleeding in the abdominal cavity. When the sharp pain in the upper abdomen, hepatomegaly or signs of intra-abdominal bleeding may occur suspicion of liver tumors. If necessary, the drug should be discontinued.

In the presence of impaired liver function, you must pass medical control every 2-3 months.

If deterioration in liver function while taking Regividona 21 + 7 should consult a physician.

When moderate acyclic (intermenstrual) bleeding, the drug should be continued, t. To. In most cases, the bleeding stops spontaneously. If acyclic (intermenstrual) bleeding persist or recur, it should carry out a medical examination to exclude organic pathology of the reproductive system.

In the case of vomiting or diarrhea should continue taking the drug further using other non-hormonal method of contraception.

Smoking women taking hormonal contraceptives have an increased risk of developing cardiovascular disease with serious consequences (myocardial infarction, stroke). The risk increases with age, and depending on the number of cigarettes (especially in women> 35 years).

In a large number of epidemiological studies have investigated the frequency of ovarian, endometrial, cervical and breast cancer in women taking combined oral contraceptives. Studies have shown that these drugs protect women against ovarian and endometrial cancer.

Some studies have found increased incidence of cervical cancer among women who took a long time combined oral contraceptives, but the results are mixed. In the formation of cervical cancer occurs sexual behavior, the presence of human papilloma virus and other factors, so the link between cervical cancer and the use of combined oral contraceptives has not been proved.

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. Breast cancer is rare in women younger than 40 years, so the increase in the number of diagnosed cases of breast cancer in women taking currently or previously treated with combined oral contraceptives, is low compared with the risk of breast cancer throughout their lives cancer.

In the absence of withdrawal bleeding is necessary to exclude pregnancy.

After discontinuation of the drug quickly enough fertility restored within 1-3 menstrual cycles.

The drug should be discontinued immediately in the following cases:

• The appearance of new or strengthening of migraine headaches (if it was not previously) or the appearance of unusually severe headache
  
• The appearance of early signs of phlebitis or phlebothrombosis (unusual pain or swelling of veins)
  
• Occurrence of jaundice or hepatitis without jaundice
  
• A sharp deterioration in visual acuity
  
• Cerebrovascular disorders
  
• The appearance of stabbing pain of unknown etiology when breathing or coughing, pain and tightness in the chest, with a sharp increase in blood pressure
  
• Suspected thrombosis or heart attack
  
• Occurrence of generalized itching
  
• Quickening of epileptic seizures
  
• 3 months before planned pregnancy
  
• Before a planned surgery (for 6 weeks before surgery), during prolonged immobilization (eg after injuries)
  
• In the presence of pregnancy.
  

Effects on ability to drive or to perform work requiring higher rate of physical and mental reactions. No effect on driving ability and work with mechanisms.