Active agent: oestradiol valerate – 2 mg;
Auxiliary components: montanglikolevy wax – 0,075 mg, monohydrate of lactose – 46,25 mg, talc – 2,4 mg, corn starch – 26,2 mg, povidone of 25 000 - 3 mg, magnesium stearate – 0,15 mg, a macrogoal of 6000 - 3,719 mg, crystal sucrose – 33,54 mg, povidone of 700 000 - 0,323 mg, talc – 7,104 mg, the besieged calcium carbonate – 14,572 mg, глицерол 85% – 0,205 mg, indigo carmine (E132) – 0,051 mg, titanium dioxide (E171) – 0,411 mg.

Indications to use

The Replacement Hormonal Therapy (RHT) against the background of the following diseases / states: climacteric disorders, involute changes of skin and an urinogenital path, depressions in a climacteric, symptoms of deficit of estrogen because of sterilization or a natural menopause;
Post-menopausal osteoporosis (prevention).

Contraindications

The breast cancer (confirmed or assumed);
Bleeding from a vagina of not clear etiology;
Liver tumors (high-quality/malignant) now or in the presence of anamnestic data;
The hormonedependent precancerous diseases or hormonedependent malignant tumors (confirmed or assumed);
The expressed gipertriglitseridemiya;
Acute arterial thrombosis or thromboembolism (stroke, myocardial infarction);
Serious illnesses of a liver;
High probability of development of thromboses (venous and arterial);
Deep vein thrombosis (at an aggravation), thromboembolisms now or in the presence of anamnestic data;
Lactose intolerance, inborn deficit of lactase, isomaltase/invertase, glyukozo-galaktozny malabsorption;
Pregnancy and period of a lactation;
Age up to 18 years;
Hypersensitivity to drug components.

If any of the described states/diseases for the first time develop against the background of Proginova's reception, it is necessary to interrupt immediately therapy and to consult with the specialist.

Route of administration and dosage

Proginova should be accepted inside, washing down with a small amount of liquid.

If the uterus is not removed, and at the woman periods still proceed, begin therapy in a combination with any gestagen in the first 5 days of a menstrual cycle. At very rare periods, and also in the period of a postmenopause it is possible to begin Proginova's reception at any time after a pregnancy exception.

The recommended dosing mode – 1 dragee a day. At cyclic ZGT in 21 days (upon termination of packaging) it is possible to take a break in administration of drug (as a rule, for 7 days or it is less), at continuous replacement hormonal therapy Proginova is accepted daily without interruption.

At the cyclic combined ZGT гестаген it is recommended to accept every 4 week for 10-14 days, at the continuous combined ZGT – along with each tablet of estrogen.

Proginova is recommended to be accepted at the same time, however time of day does not render on efficiency of drug of influence. At the admission of reception of a single dose, dragee it is necessary to accept in the closest 12-24 h. If therapy was interrupted for more long term, bleeding can develop.

Side effects

Probable side reactions (≥1/10 – it is frequent; ≥1/10 00 and <1/10 – infrequently; <1/1000 – seldom):

Central nervous system: often – a headache; infrequently – dizziness; seldom – migraine;
Reproductive system: often – uterine, vulval bleedings, including the smearing bleedings; infrequently – mammary gland pain, increase in sensitivity of mammary glands; seldom – a symptom complex of a premenstrual syndrome, a dysmenorrhea, increase in mammary glands, vaginal allocations;
Cardiovascular system: infrequently – heartbeat;
Immune system: infrequently – hypersensitivity reactions;
Skeletal and muscular system: seldom – muscular spasms;
Alimentary system: often – an abdominal pain, nausea; infrequently – dyspepsia; seldom – abdominal distention, vomiting;
Integuments: often – rash, an itch; infrequently – a knotty erythema, a small tortoiseshell; seldom – a hirsutism, an acne;
Metabolism: often – change (decrease or increase) of body weight;
Organ of sight: infrequently – vision disorders; seldom – intolerance of contact lenses (unpleasant feelings at their carrying);
Mentality: infrequently – decrease in mood; seldom – alarm, change (increase or decrease) a libido;
The general: infrequently – hypostases; seldom – weakness.

In rare instances at Proginova's reception development of a thromboembolism and a deep vein thrombosis, and also high-quality is possible, and is even more rare – malignant tumors of a liver (in some cases it led to the intra belly bleeding posing a threat for life).

At long monotherapy the probability of developing of cancer or hyperplasia of an endometria increases. At administration of drug within several years increase in relative risk of developing of a breast cancer is established.

At some women administration of drug can lead to development of cholelithiasis.

There are limited data indicating increase in probability of developing of dementia at the patients beginning Proginova's reception aged from 65 years.

Development of a hloazma, in particular at women with hloazmy pregnant women in the anamnesis is in certain cases possible. In the presence of hereditary forms of a Quincke's disease of Proginov can cause or worsen signs of a Quincke's disease.

Special instructions

With several risk factors of development of thrombosis or high degree of manifestation of one of risk factors it is necessary to consider probability of mutual strengthening of action of these factors and the appointed therapy on development of thrombosis. Total value of the available risk factors in such cases increases. With high probability of risk Proginova should not be accepted.

Before purpose of a medical course, and also regularly in the course of therapy (at least 1 times in half a year) it is necessary to conduct the necessary researches including survey of mammary glands, gynecologic inspections, measurement of arterial pressure and others in the presence of a prolaktinoma – medical examination (including periodic definition of concentration of prolactin).

Women in the presence of the following states / diseases need careful medical observation:

Endometriosis (now or in the presence of instructions in the anamnesis);
Uterus fibromyoma;
Jaundice during the previous pregnancy or the previous reception of sex hormones;
Epilepsy;
Diseases of a liver or gall bladder (purpose of drug after the postponed hepatitis is possible not earlier, than in half a year (after normalization of indicators of function of a liver));
Arterial hypertension;
Diabetes mellitus;
Hloazma now or in the past (it is necessary to avoid long stay in the sun or ultraviolet radiation);
Hysterical chorea;
System lupus erythematosus;
Benign diseases of mammary glands (mastopathy);
Migraine;
Bronchial asthma;
Porphyria;
The increased content of triglycerides in blood;
Otosclerosis;
The increased risk of a vein thrombosis (the risk increases with age, and also at the excess body weight, a varicosity, instructions in the family anamnesis by thrombosis).

The risk of emergence of a deep vein thrombosis can quickly increase because of operations, a long immovability or serious injuries. When planning surgical interventions or operations it is necessary to report to the doctor about administration of drug in advance (in 4-6 weeks).

It is not necessary to apply Proginova to prevention of a heart attack or a stroke.

During therapy it is necessary to consider probability of development of the following diseases:

Endometrial cancer: the risk increases at long monotherapy. At the kept uterus the combined use of Proginova from gestagena is necessary. At frequent irregular or breakthrough bleedings it is necessary to consult with the specialist;
Breast Cancer (BC): the relative risk increases with increase in duration of monotherapy by estrogen. Within the first several years after the termination of ZGT the increased risk gradually decreases to usual level. ZGT can increase the mammography density of mammary glands that in some cases can negatively influence radiological detection of a breast cancer (possibly use of other methods of a research for screening regarding RMZh);
Ovarian cancer: at long (longer than 10 years) replacement therapy by estrogen (EZT) the risk of development of ovarian cancer slightly increases;
Liver tumors: communication with the carried-out ZGT is not proved. At development of the unusual feelings in an upper part of a stomach which are not passing during a short period it is necessary to consult with the specialist.

At emergence of one of the following states it is necessary to interrupt therapy and to see a doctor:

Exacerbation of the available migraine;
The migraine attack which arose for the first time (it is characterized by nausea and the pulsing headache which are preceded a vision disorder);
Sudden hearing disorder or sight;
Any unusually frequent or unusually heavy headaches;
Inflammation of veins (phlebitis).

Also thrombosis or suspicion on it is the reason of the termination of reception of Proginova. Cough with blood, a loss of consciousness, unusual pain in legs or hands or their puffiness, sudden shortage of air belongs to symptoms of possible thrombosis.

In case of development of jaundice or approach of pregnancy therapy needs to be stopped.

Before carrying out laboratory researches it is necessary to warn the doctor about Proginova's reception as therapy can exert impact on results of some of them.

With the contraceptive purpose to accept Proginova does not follow (use of non-hormonal methods, except temperature and calendar is recommended). In case of suspicion on pregnancy administration of drug needs to be suspended (to its exception).

Women aged from 65 years before Proginova's reception need to consult with the specialist (because of the data indicating increase in probability of development of dementia).

Medicinal interaction

Before ZGT it is necessary to interrupt use of hormonal contraceptives. In case of need to the woman appoint non-hormonal contraceptives.

At simultaneous use of Proginova with some medicinal means / substances there can be following effects:

Alcohol: increase in level of the circulating oestradiol;
Some types of antibiotics (tetracycline and penicillinic groups): decrease in level of oestradiol;
The drugs inducing liver enzymes (some anticonvulsant and antimicrobic medicines): increase in clearance of sex hormones and reduction of their clinical performance;
Peroral antidiabetic means, insulin: change of need for them (because of influence of ZGT on tolerance to glucose);
Substances which substantially are exposed to conjugation (paracetamol): increase in bioavailability of oestradiol.