Expiration date: 02/2026

Structure and Composition:

Tablets complete 1 set.

Tablet I:

0.03 mg ethinylestradiol

0.05 mg levonorgestrel

Tablet II:

0.04 mg ethinylestradiol

0.075 mg of levonorgestrel

Tablet III:

0.03 mg ethinylestradiol

0.125 mg levonorgestrel

Placebo tablets:

76.05 mg ferrous fumarate

Other ingredients: colloidal anhydrous silica magnesium stearate, talc, corn starch, sucrose, lactose monohydrate, calcium carbonate, titanium dioxide, macrogol 6000 copovidone povidone, sodium carboxymethylcellulose, red iron oxide, yellow iron oxide, iron fumarate, sodium carmellose potato starch

in blister 28 pcs. (6 tablets of pink color, 5 - White 10 - dark yellow, 7 - reddish-brown color) in the paper cartons 1 or 3 blisters.

Description pharmaceutical form:

Tablets I: pink, glossy, biconvex tablet, disc-shaped, sugar-coated. On the surface, break the tablet is white, is visible along the edges of the shell coloring.

Tablets II: White glossy, biconvex tablet, disc-shaped, coated with a sugar coating. On the surface, break the tablet is white, is visible along the edges of the shell coloring.

Tablets III: Light yellow, glossy, biconvex tablet, disc-shaped, coated with a sugar coating. On the surface, break the tablet is white, is visible along the edges of the shell coloring.

Iron placebo tablets: Reddish-brown, glossy, round, biconvex tablets, sugar-coated.

Characteristic:

Combined, the three-phase oral hormonal contraceptives.

Tablets I: pink glossy biconvex tablets in the form of a disk coated with a sugar coating. On the surface, break the tablets are white, along the edges of the shell is visible coloration.

Tablets II: white, glossy, biconvex tablet, disc-shaped, covered with a sugar shell. On the surface, break the tablets are white, along the edges of the shell is visible coloration.

Tablets III: dark yellow, glossy, biconvex tablet in disc shape, covered with a sugar shell. On the surface, break the tablets are white, along the edges of the shell is visible coloration.

Iron placebo tablets are reddish brown, glossy, round, biconvex tablets, sugar-coated.

Pharmachologic effect:

It suppresses ovulation by blocking the secretion of FSH and LH from the pituitary gland, helps the secretory transformation of the endometrium, increases the viscosity of cervical mucus.

Pharmacokinetics:

Levonorgestrel is rapidly absorbed (less than 4 h). Levonorgestrel have no effect "first pass" through the liver. When combined with levonorgestrel ethinyl estradiol there is a relationship between dose and Cmax in the plasma.

T1 / 2 is 8-30 hours (mean 16 hours). Most levonorgestrel binds to albumin and globulin, sex hormone binding.

Ethinyl estradiol is rapidly and almost completely absorbed from the gut. Cmax in plasma is reached in the range of 1-1.5 h. T1 / 2 of approximately 26 hours. Ethinylestradiol inherent effect of "first pass" through the liver.

The metabolites of ethinyl estradiol, which are water-soluble products of the sulfate or glucuronide conjugation, enter the intestine with bile, where with the help of intestinal bacteria are exposed to disintegration.

Description of the pharmacological actions:

Serial drug pills containing different amounts of progestogen (levonorgestrel) and estrogen (ethinyl estradiol), allows you to fill in and provide the concentration of sex hormones in the blood, similar to physiological disorders with subsequent normalization of the menstrual cycle.

Indications:

Oral contraception, functional disorders of the menstrual cycle.

Contraindications:

Hypersensitivity to the drug Pregnancy lactation severe liver disease, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor), cholelithiasis presence or indication of a history of severe cardiovascular and cerebrovascular changes thromboembolism and predisposition to them tumor liver cancers, especially cancers breast or endometrial familial forms of hyperlipidemia, severe hypertension severe diabetes, and other diseases of the endocrine glands sickle cell anemia, chronic hemolytic anemia, vaginal bleeding of unknown cause migraine otosclerosis idiopathic jaundice of pregnant women in the history of severe itching pregnant pregnant herpes.

Application of pregnancy and breastfeeding:

Contraindicated in pregnancy and during breastfeeding.

Side effect:

Nausea, vomiting, headache, breast tension, change in body weight and libido, mood changes, bleeding intermenstrual discharge, in some cases, a feeling of discomfort while wearing contact lenses.

Rare: elevated triglycerides, blood glucose, impaired glucose tolerance, increased blood pressure, thrombosis and venous thromboembolism, jaundice, skin rashes, changes in vaginal secretion, vaginal candidiasis, fatigue, diarrhea.

Very rarely (at a long reception): chloasma.

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 use of tablets Three-Regola 21 + 7 requires caution when taken in conjunction with contraceptive following drugs:

• Ampicillin, rifampicin, chloramphenicol, neomycin, penicillin, sulfonamides, tetracyclines, dihydroergotamine, tranquilizers, phenylbutazone, because last may reduce the contraceptive effect, at the same time it is recommended to use an additional, non-hormonal contraceptive method
  
• Anticoagulants, coumarin derivatives or indandiona (possible need for an extraordinary determination of the prothrombin index and change the dose of anticoagulant)
  
• Tricyclic antidepressants, maprotiline, beta-blockers (possibly increasing their bioavailability and toxicity)
  
• Oral antidiabetics, insulin (may need to change their dose)
  
• Bromocriptine (decreased effectiveness of bromocriptine)
  
• Drugs with a potential hepatotoxic effect, such as dantrolene. hepatotoxicity Risk increases with age, especially in women over 35 years.
  

Dosage and administration:

Inside, with liquid squeezed small amount of liquid.

Starting with the first day of menstruation, for 28 days to take daily Table 1., Preferably at the same time. In menstrualnopodobnoe bleeding occurs while taking a reddish-brown tablets. For receiving pills from the next pack should be started without interruption, ie after 4 weeks after initiation of dosing, the same day of the week. It is important to observe the following sequence of taking the pills, first - pink 6, then - 5 white, then - 10 dark yellow at the end - 7 reddish-brown. In order to ensure the necessary priority on the package marked numbering and arrow. With good drug tolerance take as long as there is a need for contraception.

The transition to three-Regola 21 + 7 from another oral contraceptive is performed in the same way.

After an abortion, the drug is recommended to start in abortion the day or the next day after surgery.

After delivery, the drug can be recommended only for women not breastfeeding reception should begin no earlier than the first day of menstruation.

Missed tablets: missed tablet should be taken within the next 12 hours, if after taking the last tablet has passed 36 hours, contraception unreliable.. In such cases, to prevent possible intermenstrual bleeding must continue taking the drug out of the package that has already started, except skipped (s) tablet (s).

In the case of missing the timely reception of tablets it is recommended to use an additional, non-hormonal method of contraception (eg barrier).

This rule does not apply to tablets reddish-brown color, as they do not contain hormones.

Overdose:

Cases of toxic effects due to overdose are unknown.

Precautionary measures:

Before you assign a drug, it is necessary to exclude the presence of pregnancy, have a general medical check (blood pressure measurement, laboratory tests of liver function and blood sugar levels, and others.) And gynecological examination (state of the mammary glands, vaginal smear cytologic analysis).

While the drug is similar to medical and gynecological examination should be performed regularly every 6 months.

For women with thromboembolic disease at a young age or with elevated blood clotting in the family history of the use of tablets Three-Regola 21 + 7 is not recommended.

Caution is required in the presence of diabetes mellitus, diseases of the cardiovascular system, hypertension, renal dysfunction, varicose veins, phlebitis, otosclerosis, multiple sclerosis, epilepsy, chorea minor, intermittent porphyria, latent tetany, asthma. The use of oral contraceptives may be no earlier than 6 months after suffering a viral hepatitis, with the full normalization of liver function.

When the sharp pain in the upper abdomen, hepatomegaly or signs of intra-abdominal hemorrhage may be suspected on the presence of a liver tumor. If necessary, the drug should be discontinued. If abnormal liver function occurred during treatment, should consult a physician.

When the inter-menstrual bleeding receiving three-Regola 21 + 7 should be continued, because in most cases, the bleeding stops spontaneously. If intermenstrual bleeding persist or recur, require a medical examination to exclude organic pathology of the reproductive system.

In the case of vomiting or diarrhea should continue taking the drug at the same time using an additional, non-hormonal contraceptive method. Women over 35 years old receiving oral contraceptives should stop smoking because smoking while taking hormonal contraceptives increases the risk of diseases of the cardiovascular system.

During the 3 months before the planned pregnancy should stop taking the drug.

The drug should be discontinued:

• in the event of new or strengthening of existing migraine pain or unusual occurrence of severe headaches
  
• at acute worsening of visual acuity
  
• with suspected thrombosis or heart attack
  
• with a sharp increase in blood pressure
  
• with the appearance of jaundice or hepatitis without jaundice, generalized itching
  
• with frequent seizures
  
• before a planned surgery (for 6 weeks before surgery), during prolonged immobilization
  
• during pregnancy.
  

Special instructions:

Apply prescribed by a doctor to avoid complications.