Angelik Micro - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Angelique Micro

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 1222 rub.

Buy

Angelique Micro is an estrogen-progestogenic, anti-climacteric agent.

Release form and composition

Dosage form - film-coated tablets: yellow, round biconvex, engraved "EL" on one side in a regular hexagon; cross-section - a yellow shell, the core is from almost white to white (28 pcs. in a blister, in a cardboard box 1 or 3 blisters complete with a pocket for carrying them).

Content of active substances in 1 tablet:

• estradiol hemihydrate (micronized) in terms of estradiol - 0.5 mg;
• drospirenone (micronized) - 0.25 mg.

Auxiliary components: lactose monohydrate, corn starch, pregelatinized corn starch, povidone, magnesium stearate.

The composition of the film shell: yellow varnish (macrogol 6000, hypromellose (5cP), iron dye yellow oxide, titanium dioxide, talc).

Indications for use

The use of Angelik Micro tablets is indicated as hormone replacement therapy in women with an unremoved uterus for the treatment of moderate to severe vasomotor symptoms during menopause.

Contraindications

• vaginal bleeding of unknown etiology;
• hormone-dependent malignant tumor or hormone-dependent precancerous disease, or suspicion of them;
• breast cancer or suspicion of it (including history);
• benign or malignant liver tumors (including history);
• severe liver pathologies;
• adrenal insufficiency;
• acute renal failure, severe kidney disease (including history);
• exacerbation of deep vein thrombosis, venous thromboembolism, including pulmonary thromboembolism (including a history);
• angina pectoris, acute arterial thrombosis, thromboembolism (myocardial infarction, stroke);
• the presence of high-risk factors for arterial and venous thrombosis: a genetic predisposition (presence of deep vein thrombosis or pulmonary embolism in the immediate family (mother, father, sister) at a young age), obesity (body mass index over 30 kg per m ²), age of the patient;
• hyperhomocysteinemia, resistance to activated protein C, protein C deficiency, antithrombin III deficiency, antibodies to phospholipids (lupus anticoagulant, antibodies to cardiolipin), protein S deficiency and other signs of predisposition to arterial and venous thrombosis;
• untreated hyperplasia;
• porphyria;
• lactose intolerance, congenital lactase deficiency, glucose-galactose malabsorption syndrome;
• severe hypertriglyceridemia;
• the period of pregnancy and breastfeeding;
• age up to 18 years;
• hypersensitivity to the components of the drug.

In case of detection of these diseases or conditions during the period of application of Angelique Micro, treatment must be canceled immediately.

It is recommended to prescribe the drug with caution to women with uterine myoma, congenital hyperbilirubinemia (Dubin-Johnson, Gilbert and Rotor syndromes), cholestatic pruritus during a previous pregnancy, cholestatic jaundice, endometriosis, diabetes mellitus, in the presence of risk factors for the development of estrogen-dependent tumors (including breast cancer) glands in close relatives), a history of endometrial hyperplasia, the presence of risk factors for the development of thromboembolism and thrombosis in the family history (the presence of thromboembolic complications at a young age in close relatives), smoking, obesity, hypercholesterolemia, dementia, systemic lupus erythematosus, gallbladder disease, moderate hypertriglyceridemia, retinal vascular thrombosis, severe hypocalcemia, edema against the background of chronic heart failure, endometriosis,bronchial asthma, hepatic hemangiomas, migraine, hyperkalemia and conditions predisposing to the development of hyperkalemia, when taking potassium preparations, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, heparin, angiotensin II receptor antagonists (drugs).

Method of administration and dosage

The tablets are taken orally, without chewing, with a sufficient amount of liquid, regardless of the meal.

Taking the drug Angelique Micro can be started at any time in the absence of previous estrogen therapy and when switching from another combined agent for continuous administration. If a woman has previously taken a combined hormone replacement therapy for a cyclic regimen, then the reception should be started after the end of the current cycle of therapy.

Dosage regimen: 1 tablet per day for 28 days, after the end of the tablets in the previous blister, the next day, they start taking the first tablet from the new blister on the same day of the week, on which the first tablet from the first blister was taken, without interruption.

You should start taking the drug at a time of day convenient for the patient and strictly adhere to it throughout the entire period of treatment. If you are accidentally late in taking the next dose, it should be taken as soon as you remember. If you are more than 24 hours late, you should not take an extra pill. If several tablets are missed in a row, a woman may experience vaginal bleeding.

Dose adjustment is not performed in the treatment of elderly patients, in patients with mild and moderate hepatic and renal dysfunction.

Side effects

Adverse reactions identified in clinical and post-marketing studies of Angelik Micro:

• mammary gland and genitals: often - pain, including uterine bleeding, painful discomfort in the mammary glands; infrequently - breast cancer, cervical polyp;
• nervous system: infrequently - migraine;
• mental disorders: often - emotional lability;
• vascular system: infrequently - arterial and venous thromboembolic complications (embolism (occlusion) and thrombosis of pulmonary vessels, occlusion of peripheral deep veins, thrombosis, embolism, heart attack (myocardial infarction or cerebral infarction), stroke (except for hemorrhagic stroke));
• gastrointestinal tract: often - abdominal pain.

In addition, in isolated cases or after very long-term use of tablets, the following side effects of the drug may occur:

• benign and malignant liver tumors;
• hormone-dependent malignant neoplasms or hormone-dependent precancerous pathologies;
• cholelithiasis;
• endometrial cancer;
• dementia;
• arterial hypertension;
• hypertriglyceridemia;
• liver dysfunction;
• chloasma;
• an increase in the size of uterine fibroids;
• exacerbation of symptoms of hereditary angioedema;
• changes in insulin resistance or glucose tolerance;
• prolactinoma;
• reactivation of endometriosis;
• itching and / or jaundice associated with cholestasis;
• benign pathologies of the mammary glands, epilepsy, systemic lupus erythematosus, bronchial asthma, chorea minor, otosclerosis, porphyria (development, worsening of conditions or diseases with taking Angelik Micro tablets has not been proven);
• rash, hives and other symptoms of hypersensitivity.

special instructions

The doctor should prescribe the drug on the basis of a detailed study of the patient's medical history, data from general medical and gynecological examinations, including measuring blood pressure (BP), the state of the mammary glands, abdominal organs, cytological examination of the epithelium of the cervix.

The drug is not a contraceptive.

In case of suspicion of pregnancy, the woman should stop taking the drug for a period until pregnancy is ruled out.

Before starting to use Angelique Micro, it is necessary to compare the intended benefits and all individual risk factors from therapy, take into account the effect of sex hormones on the growth of some hormone-dependent tumors and tissues.

The risk of deep vein thrombosis or pulmonary embolism increases with prolonged immobilization, extensive elective and post-traumatic surgery, and severe trauma. Therefore, taking the drug must be discontinued 4-6 weeks before the planned operation, the combined continuous hormone replacement therapy can be resumed after the restoration of physical activity.

Suspicion of the development of thrombotic disorders or the appearance of their symptoms is the basis for immediate discontinuation of treatment.

Concomitant anticoagulant therapy requires an individual risk assessment.

The presence of drospirenone in the composition of the drug prevents the risk of developing endometrial hyperplasia against the background of the use of estrogens. Patients with a history of endometrial hyperplasia should use estrogen-containing agents with caution.

The increased risk of breast cancer decreases after discontinuation of therapy for several years to normal levels.

With hormone replacement therapy, the mammographic density of the mammary glands increases, this can adversely affect the radiographic detection of breast cancer.

There is a risk of ovarian cancer with long-term use of combination hormone replacement therapy.

With an enlarged liver, differential diagnosis of pain in the upper abdomen, or the presence of signs of intra-abdominal bleeding in women taking Angelik Micro tablets, the likelihood of a liver tumor should be taken into account, since the drug can contribute to the development of benign or malignant liver neoplasms.

Taking estrogens increases the risk of developing gallstone disease by 2-4 times.

The intake of sex hormones can affect the results of biochemical studies of the thyroid gland, liver, kidney and adrenal gland function, the level of concentration of transport proteins in the blood plasma, indicators of coagulation, fibrinolysis, carbohydrate metabolism. The drug does not affect the patient's glucose tolerance.

If a severe frequent headache or migraine-like pain appears for the first time, other symptoms that are precursors of a thrombotic cerebral stroke, the pills should be stopped immediately.

Against the background of the use of the drug, a slight increase in blood pressure is possible; with clinically significant persistent arterial hypertension, the question of discontinuing the drug should be considered.

Treatment of patients with impaired liver function should be accompanied by periodic studies of liver function; if the indicators deteriorate, hormonal therapy should be canceled.

Due to the high risk of developing acute pancreatitis, the drug should be stopped immediately in case of recurrence of cholestatic pruritus or cholestatic jaundice.

The incidence of irregular bleeding decreases with increasing duration of treatment, and with prolonged therapy, bleeding usually disappears.

With frequent or persistent pathological uterine bleeding, a study of the endometrium is required to exclude organic pathologies.

With an increase in uterine fibroids, recurrence of endometriosis while taking estrogens, further therapy should be discontinued.

With a tendency to develop chloasma, a woman should avoid prolonged exposure to direct sunlight and ultraviolet radiation.

The effect of tablets on the ability of patients to drive vehicles and mechanisms has not been established.

Drug interactions

With the simultaneous use of the drug Angelik Micro with barbiturates, hydantoins, carbamazepine, primidone, rifampicin, topiramate, felbamate, oxcarbazepine, griseofulvin and other drugs that induce liver enzymes, it should be borne in mind that during long-term treatment they can increase the clearance and increase the clearance of their sex hormones efficiency. This property of these funds is manifested in women by irregular bleeding. The maximum induction of enzymes is achieved after 2-3 weeks of use and persists for 4 or more weeks after their cancellation.

The combination with antibiotics of the penicillin and tetracycline groups can cause a decrease in the concentration of estradiol.

Ketoconazole, cimetidine and other inhibitors of CYP3A4 can slow down the metabolism of estradiol.

Simultaneous administration of the drug with non-steroidal anti-inflammatory and antihypertensive drugs can lead to a slight increase in serum potassium, which is more pronounced in patients with diabetes mellitus.

Drinking large doses of alcohol during hormone therapy can cause an increase in circulating estradiol levels.

Analogs

Angelik is an analogue of the drug Angelik Micro.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 30 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Angelique Micro: prices in online pharmacies

Drug name Price Pharmacy

Angelique Micro 0.25 mg + 0.5 mg film-coated tablets 28 pcs. 1222 RUB Buy

Angelik Micro tablets p.p. 28 pcs. 1282 RUB Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!