Angélique Micro

Angélique Micro – estrogen-gestagennoye, anticlimacteric means.

Form of release and structure

Dosage form – tablets, film coated: yellow color, a round biconvex form, on one party in the correct hexagon the engraving of "EL" is put; on cross section – a yellow cover, a kernel from almost white till white color (on 28 pieces in the blister, in a cardboard pack 1 or 3 blisters complete with a pocket for their carrying).

Content of active agents is to 1 tablet:     

• oestradiol гемигидрат (micronized) in terms of oestradiol – 0,5 mg;
• дроспиренон (micronized) – 0,25 mg.

Auxiliary components: lactoses monohydrate, starch corn, starch corn prezhelatinizirovanny, povidone, magnesium stearate.    

Structure of a film cover: varnish yellow (macrogoal 6000, gipromelloza (5 Wednesday), dye ferrous oxide yellow, titanium dioxide, talc).

Indications to use

Use of tablets of Angélique Micro is shown as replacement hormonal therapy at women with an unextracted uterus for treatment of vasculomotor symptoms of average and heavy degree at a menopause.

Contraindications

• vulval bleeding of an unspecified etiology;
• hormonedependent malignant tumor or hormonedependent precancerous disease, or suspicion on them;
• breast cancer or suspicion on it (including the anamnesis);
• benign or malignant tumors of a liver (including the anamnesis);
• the expressed liver pathologies;
• adrenal insufficiency;
• acute renal failure, serious illness of kidneys (including the anamnesis);
• aggravation of a deep vein thrombosis, venous thromboembolisms, including a thromboembolism of a pulmonary artery (including in the anamnesis);
• stenocardia, acute arterial thrombosis, thromboembolism (myocardial infarction, stroke);
• existence of factors of high risk of arterial and venous thromboses: genetic predisposition (existence of a deep vein thrombosis or an embolism of a pulmonary artery at the immediate family (mother, the father, the sister) at young age), obesity (an index of body weight more than 30 kg on ^sq.m), age of the patient;
• gipergomotsisteinemiya, resistance to the activated protein of C, deficit of a protein of C, deficit of antithrombin III, an antibody to phospholipids (lupoid anticoagulant, antibodies to cardiolipin), deficit of a protein of S and other signs of predisposition to arterial and venous thrombosis;
• not treated hyperplasia;
• porphyria;
• lactose intolerance, inborn deficit of lactase, syndrome of glyukozo-galaktozny malabsorption;
• the expressed gipertriglitseridemiya;
• period of pregnancy and breastfeeding;
• age up to 18 years;
• hypersensitivity to drug components.

In case of detection of these diseases or states during Angélique Micro's use, treatment is required to be cancelled immediately.

With care women are recommended to appoint drug with a hysteromyoma, an inborn hyperbilirubinemia (syndromes the Cudgel Johnson, Gilbert and Rotor), a cholestatic itch during the previous pregnancy, cholestatic jaundice, endometriosis, a diabetes mellitus, with risk factors for development of estrogenzavisimy tumors (including a breast cancer at close relatives), an endometria hyperplasia in the anamnesis, existence of risk factors of development of a thromboembolism and thromboses in the family anamnesis (existence of tromboembolic episodes in young age at close relatives), smoking, obesity, a hypercholesterolemia, dementia, a system lupus erythematosus, diseases of a gall bladder, epilepsy, a moderate gipertriglitseridemiya, fibrinferment of vessels of a retina, a heavy hypocalcemia, hypostases against the background of chronic heart failure, endometriosis, bronchial asthma, hemangiomas of a liver, migraine, hyperpotassemia and states contributing to development of a hyperpotassemia, at administration of drugs of potassium, kaliysberegayushchy diuretics, inhibitors of an angiotensin-converting enzyme (APF), heparin, antagonists of receptors of angiotensin II (causing a means hyperpotassemia).

Route of administration and dosage

Pill is taken inside, without chewing, washing down with enough liquid, irrespective of meal.

Administration of drug of Angélique Micro can be begun in the absence of the previous therapy with estrogen and upon transition from other combined means for continuous reception at any time. If the woman accepted the combined drug of replacement hormonal therapy for the cyclic mode earlier, then reception should be begun after end of the current cycle of therapy.

Dosing mode: on 1 tablet a day within 28 days, after the termination of tablets in the previous blister begin reception of the first tablet from the new blister next day on the same day of week on which reception of the first tablet from the first blister, without interruption fell.

It is necessary to begin administration of drug in time of day, convenient for the patient, and to strictly adhere to it throughout the entire period of treatment. At accidental delay in reception of the next dose it should be accepted at once as soon as remembered. If time of delay made more than 24 hours, it is not necessary to take an additional pill. In case of the admission of several tablets in a row the woman can have a vulval bleeding.

Dose adjustment is not made at treatment of patients at advanced age, at patients with easy and moderate severity of abnormal liver functions and kidneys.

Side effects

The undesirable reactions revealed at clinical and post-market researches of drug of Angélique Micro:

• mammary gland and generative organs: often – pain, including uterine bleedings, painful discomfort in mammary glands; infrequently – a breast cancer, a polyp of a neck of uterus;
• nervous system: infrequently – migraine;
• disturbances of mentality: often – emotional lability;
• vascular system: infrequently – arterial and venous tromboembolic episodes (an embolism (occlusion) and thrombosis of pulmonary vessels, occlusion of peripheral deep veins, fibrinferments, an embolism, a heart attack (a myocardial infarction or a heart attack of a brain), a stroke (except a hemorrhagic stroke));
• digestive tract: often – an abdominal pain.

Besides, in isolated cases or after very prolonged use of tablets there can be following side effects of drug:

• benign and malignant tumors of a liver;
• hormonedependent malignant new growths or hormonedependent precancerous pathologies;
• cholelithiasis;
• endometrial cancer;
• dementia;
• arterial hypertension;
• gipertriglitseridemiya;
• abnormal liver functions;
• hloazma;
• increase in the sizes of a hysteromyoma;
• aggravation of symptoms of a hereditary Quincke's disease;
• change of insulin resistance or tolerance to glucose;
• prolaktinoma;
• reactivation of endometriosis;
• the itch and/or jaundice connected with a cholestasia;
• benign pathologies of mammary glands, epilepsy, system lupus erythematosus, bronchial asthma, hysterical chorea, otosclerosis, porphyria (development, deterioration in states or diseases with reception of tablets of Angélique Micro is not proved);
• rash, urticaria and other symptoms of hypersensitivity.

Special instructions

The doctor has to make purpose of drug on the basis of detailed studying of a case history of the patient, data of the all-medical and gynecologic inspections including measurement of the arterial pressure (AP), a condition of mammary glands, abdominal organs, a cytologic research of an epithelium of a neck of uterus.

Drug is not contraceptive means.

In case of suspicion on pregnancy the woman has to suspend administration of drug for the period, pregnancy will not be excluded yet.

Prior to Angélique Micro's use it is necessary to compare estimated advantage and all individual risk factors of therapy, to consider influence of sex hormones on growth of some hormonedependent tumors and fabrics.

The risk of a deep vein thrombosis or embolism of a pulmonary artery increases at a long immobilization, carrying out extensive planned and posttraumatic surgeries, severe injuries. Therefore administration of drug needs to be stopped in 4-6 weeks prior to planned operation, it is possible to resume the combined continuous replacement hormonal therapy after recovery of a physical activity.

Suspicion on development of trombotichesky disturbances or emergence of their symptoms is the basis for immediate cancellation of treatment.

The accompanying therapy by anticoagulants demands assessment of individual risk.

Presence of a drospirenon as a part of drug prevents risk of development of a hyperplasia of an endometria against the background of use of estrogen. Patients with an endometria hyperplasia in the anamnesis should apply estrogensoderzhashchy means with care.

The increased risk of a breast cancer decreases after the termination of therapy within several years to usual level.

At replacement hormonal therapy the mammography density of mammary glands increases, it can negatively affect radiological detection of a breast cancer.

There is a risk of development of ovarian cancer at long reception of the combined means for replacement hormonal therapy.

At the increased liver, differential diagnosis of pains in an upper part of a stomach or existence of symptoms of intra belly bleeding at the women taking Angélique Micro's pill should consider probability of existence of a tumor of a liver as drug can promote development of high-quality or malignant new growths of a liver.

Reception of estrogen increases risk of development of a zhelchekamenny disease by 2-4 times.

Reception of sex hormones can influence results of biochemical researches of a thyroid gland, function of a liver, kidneys and adrenal glands, concentration level in a blood plasma of transport proteins, indicators of coagulation, a fibrinolysis, carbohydrate metabolism. Drug does not influence tolerance of the patient to glucose.

At emergence of a severe frequent headache or for the first time the shown migrenepodobny pain, other symptoms which are harbingers of a trombotichesky stroke of a brain, reception of tablets should be stopped immediately.

Against the background of drug use perhaps slight increase of the ABP, at clinically significant steady arterial hypertension it is necessary to consider a question of drug withdrawal.

Treatment of patients with abnormal liver functions should be accompanied with periodic researches of function of a liver, at deterioration in indicators hormonal therapy should be cancelled.

Because of big risk of development of acute pancreatitis administration of drug should be stopped immediately in case of a recurrence of a cholestatic itch or cholestatic jaundice.

Frequency of irregular bleedings decreases in process of increase in duration of treatment and at long therapy of bleeding usually disappear.

At frequent or persistent pathological uterine bleedings carrying out a research of an endometria is required to exclude organic pathologies.

At increase in a hysteromyoma, an endometriosis recurrence against the background of reception of estrogen further therapy should be stopped.

At tendency to emergence of a hloazma the woman has to avoid long influence of direct sunshine and ultraviolet radiation.

Influence of tablets on ability of patients to manage vehicles and mechanisms is not established.

Medicinal interaction

At simultaneous use of drug of Angélique Micro with barbiturates, hydantoins, carbamazepine, Primidonum, rifampicin, topiramaty, felbamaty, okskarbazepiny, the griseofulvin and other medicines inducing liver enzymes it is necessary to consider that at prolonged treatment they can increase clearance of sex hormones and reduce their clinical performance. This property of the specified means is shown at women by irregular bleedings. The maximum induction of enzymes is reached in 2-3 weeks of use and remains within 4 and more weeks after their cancellation.

The combination to antibiotics of penicillinic and tetracycline group can cause decrease in level of concentration of oestradiol.

Ketokonazol, Cimetidinum and other CYP3A4 inhibitors can slow down oestradiol metabolism.

The concomitant use of drug with nonsteroid antiinflammatory and antihypertensives can lead to the insignificant increase in content of potassium in blood serum which was more expressed at patients with a diabetes mellitus.

The use of high doses of alcohol during hormonal therapy can cause increase in level of concentration of the circulating oestradiol.

Terms and storage conditions

To protect from children.

To store at a temperature up to 30 °C.

Period of validity – 3 years.