Description
Trade name:
Cyclo-Progynova
Compound:
Each tablet contains:
11 white tablets contain:
Estradiol valerate 2 mg
10 light brown tablets contain:
norgestrel 0.5 mg
estradiol valerate 2 mg
Auxiliary components:
lactose monohydrate, corn starch, povidone, talc, magnesium stearate, sucrose, povidone, macrogol 6000, calcium carbonate, talc, glycerol 85%, glycol wax, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).
Properties:
A combined hormonal drug containing estrogen and gestagen.
Estradiol valerate is an estrogen that is converted in the human body into natural 17-estradiol.
Norgestrel is a progesterone derivative.
The addition of norgestrel for 10 days of each cycle prevents the development of endometrial hyperplasia and cancer.
Due to the composition and cyclical regimen of taking this combination (taking only estrogen for 11 days, then a combination of estrogen and gestagen for 10 days, and finally a 7-day break), women with an intact uterus are able to establish a menstrual cycle with regular use of the drug.
When taking this combination, ovulation is not suppressed, and the production of hormones in the body itself is practically unchanged.
Estradiol replenishes the estrogen deficiency in the female body after menopause and provides effective treatment of psycho-emotional and vegetative climacteric symptoms (such as hot flashes, increased sweating, sleep disturbances, increased nervous excitability, irritability, palpitations, cardialgia, dizziness, headache, decreased libido, muscle and joint pain); involution of the skin and mucous membranes, especially the mucous membranes of the genitourinary system (urinary incontinence, dryness and irritation of the vaginal mucosa, pain during intercourse).
Indications:
Hormone replacement therapy for climacteric disorders, involutional changes in the skin and urinary and genital tracts, depressive states in the climacteric period, as well as symptoms of estrogen deficiency due to natural menopause or hypogonadism, sterilization or primary ovarian dysfunction in women with an intact uterus; prevention of postmenopausal osteoporosis; normalization of irregular menstrual cycles; treatment of primary or secondary amenorrhea.
Method of administration and dosage:
The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a specific drug with the indications for use and dosage regimen.
Taken orally.
The application scheme depends on the indications and the state of the menstrual cycle.
Contraindications:
Hypersensitivity to the components of the combination; pregnancy, breast-feeding; vaginal bleeding of unknown origin; confirmed or suspected diagnosis of breast cancer; confirmed or suspected diagnosis of hormone-dependent precancerous disease or hormone-dependent malignant tumors; liver tumors at present or in anamnesis (benign or malignant); severe liver disease; acute arterial thrombosis or thromboembolism (such as myocardial infarction, stroke); deep vein thrombosis in the acute stage, thromboembolism at present or in anamnesis; severe hypertriglyceridemia.
Precautions:
This combination is not used for contraceptive purposes.
If any of the conditions or risk factors listed below is present or worsens, the individual risk/benefit ratio of treatment should be assessed before starting or continuing HRT.
A number of controlled randomised studies as well as epidemiological studies have shown an increased relative risk of developing venous thromboembolism (VTE) during HRT, i.e. deep vein thrombosis or pulmonary embolism. Therefore, when prescribing HRT to women with risk factors for VTE, the risk/benefit ratio of treatment should be carefully weighed and discussed with the patient.
Side effects:
From the reproductive system and mammary glands: changes in the frequency and intensity of uterine bleeding, breakthrough bleeding.
From the digestive system: dyspepsia, bloating, nausea, vomiting, abdominal pain, relapse of cholestatic jaundice.
From the skin and subcutaneous tissue: skin rash, skin itching, chloasma, erythema nodosum.
From the nervous system: headache, migraine, dizziness, anxiety or depressive symptoms, increased fatigue.
From the cardiovascular system: tachycardia, increased blood pressure.
From the blood coagulation system: venous thrombosis and thromboembolism.
Others: swelling, muscle cramps, changes in body weight, changes in libido.
Storage method:
Store at temperatures not exceeding 30 degrees.
