Tablets "Regulon ^® " are applied to oral contraception. Before prescribing of medicine "Regulon ^® " should estimate the individual risk factors which are available for the woman, especially those that concern risk of a venous thrombembolia (VTE) and also to compare risk of venous tromboembolic episodes at administration of medicament "Regulon ^® " to risk at reception of other the combined hormonal contraceptives (CHC).

Structure

One tablet, coated, contains (active ingredients):

• - 0.15 mg;
• ethinylestradiol - 0.03 mg.

Excipients: alpha tocopherol (all-rac-α-токоферол), magnesium stearate, silicon dioxide colloidal waterless, stearic acid, povidone, potato starch, lactoses monohydrate; structure of a cover: propylene glycol, macrogoal 6000, gipromelloza.

Contraindication

Combined Hormonal Contraceptives (CHC) should not be applied at the states provided below. At emergence of such state for the first time during reception of KGK its application should be stopped immediately.

pregnancy.

Existence or risk of developing of a venous thrombembolia (VTE):

• a venous thrombembolia now, in particular owing to therapy by anticoagulants or in the anamnesis (for example the deep vein thrombosis (DVT) or a pulmonary embolism (TELA);
• known hereditary or acquired tendency to a venous thrombembolia, such as resistance to the activated protein With (including a mutation of a factor of the V Leiden), insufficiency of antithrombin III, insufficiency of a protein With, insufficiency of a protein of S;
• big surgery with a long immobilization;
• high risk of a venous thrombembolia owing to existence of multiple factors of risk.

Existence or risk of developing arterial thrombembolia (ATE):

• presence of an arterial thrombembolia now or in the anamnesis (for example a myocardial infarction) or a prodromal state (for example stenocardia);
• cerebrovascular diseases - a stroke now or in the anamnesis, or a prodromal state (for example the tranzitorny ischemic attack (TIA));
• hereditary or acquired tendency to an arterial thrombembolia established, such as gipergomotsisteinemiya and existence of anti-phospholipidic antibodies (anti-cardiolipin antibodies, lupoid anticoagulant);
• existence in the anamnesis of migraine with focal neurologic symptoms;
• high risk of development of ATE owing to existence of multiple factors of risk or existence of one of the following serious risk factors:
  • diabetes with vascular complications;
  • heavy arterial hypertension;
  • heavy dislipoproteinemiya.

Presence of pancreatitis now or in the anamnesis, connected with a heavy gipertriglitseridemiya.

Presence of a serious illness of a liver now or in the anamnesis until indicators of function of a liver return to norm.

Presence of tumors of a liver now or in the anamnesis (benign or malignant).

Known or expected malignant tumors (for example genitals or mammary glands) which are dependent on sex hormones.

endometrium Hyperplasia.

Vaginal bleeding of an unspecified etiology.

Hypersensitivity to active ingredients or to any of medicine excipients.

for simultaneous application with the medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir.

with

from the first day of a menstrual cycle and to accept on one tablet a day within 21 day without interruption, whenever possible - at the same time day. Then it is necessary to take a 7-day break during which there is cancellation bleeding. Next day after a 7-day break (in 4 weeks after reception of the first tablet, on the same day weeks) resume administration of medicament from the following blister packing which also contains 21 tablets even if bleeding did not stop. It is necessary to adhere to such scheme of reception while there is a need for contraception. At observance of instructions of the doctor the contraceptive effect remains also for the period of a 7-day break in reception of tablets.

to take the Pill inside in the order specified on the blister packing.

Children

Safety and efficiency of a dezogestrel at teenagers aged up to 18 years is not established to

Feature of application

. There are no data.

by

Drivers

Influence of the CPC on ability to steer motor transport or other mechanisms it is not revealed.

Overdose

About the serious side reactions developing at overdose of oral contraceptives it was not reported. In this case can be possible symptoms: nausea, vomiting and also insignificant vaginal bleeding at young girls. Thus, the overdose of medicine of treatment does not demand. However at identification of overdose within 2-3 hours or at reception of a large number of tablets the gastric lavage can be carried out. Specific antidote does not exist, it is necessary to carry out symptomatic therapy.

Side effects

Mental violations: often (≥ 1/100 - <1/10) - suppressed mood, change of mood.

Disorder of nervous system: often (≥ 1/100 - <1/10) - a headache.

Disorder of digestive tract: often (≥ 1/100 - <1/10) - nausea, an abdominal pain.

Disorder of a reproductive system and mammary glands: often (≥ 1/100 - <1/10) - morbidity of mammary glands, mammary gland pain.

to Store

at a temperature not above 30 °C, out of children's reach.

Expiration date - 3 years.