Progynova 2mg 21 tablets — Made in France — Free Delivery

Indications

For the treatment of signs and symptoms of estrogen deficiency after natural menopause or oophorectomy.

Prevention of postmenopausal osteoporosis.

Application

Adult women, including older women.

If the patient has not had her uterus removed and is still menstruating, within the first 5 days of the menstrual cycle, a combination therapy regimen with Proginova and a progestogen should be started. In the event that menstruation occurs very rarely or for postmenopausal patients, taking Proginov dragees can be started at any time, subject to the exclusion of pregnancy.

Doses

Daily 1 tablet of Proginov.

Taking pills

Each blister pack is designed for a 21-day course of treatment. After use for 21 days, you can take a break in treatment, usually 7 days or less (cyclic HRT), or continue taking pills daily (continuous HRT). When choosing the last mode of therapy, dragees from a new package are taken immediately after the end of the previous package.

Combination Therapy

For women with an unremoved uterus, the use of an appropriate progestogen for 10-14 days every 4 weeks (cyclically combined HRT) or simultaneous administration of a progestogen with each estrogen tablet (continuously combined HRT) is recommended.

It is necessary to provide for and ensure patient compliance with the recommended regimen of combination therapy.

Swallow the dragee whole with a small amount of water, it is advisable to take the dragee at the same time every day. Missed pills should be taken in the next 12-24 hours. If you miss taking several pills, sudden bleeding may begin.

Contraindications

HRT should not be started in any of the following conditions. if any of these conditions occurs during HRT, the preparation should be discontinued immediately.

During pregnancy and breastfeeding.

Vaginal bleeding of unknown etiology.

Diagnosed or suspected breast cancer.

Diagnosed or suspected precancerous conditions or malignant tumors dependent on sex steroids.

Liver tumors at the current time or in history (benign or malignant).

Severe liver disease.

Arterial thromboembolism in the acute stage (for example, myocardial infarction, stroke).

Exacerbation of deep vein thrombosis, thromboembolic disorders at a given time or information about such diseases in history.

Severe form of hypertriglyceridemia.

Hypersensitivity to active substances or to any of the auxiliary components of the preparation.

Side effects

The following side effects have been reported in women who have used oral HRT preparations:

Reproductive organs and mammary glands: changes in the nature of vaginal bleeding - abnormal or severe bleeding, breakthrough bleeding, spotting (these disorders usually normalize with continued treatment); dysmenorrhea, changes in vaginal secretion, premenstrual-like syndrome, pain in the mammary glands, feeling of tightness or enlargement of the mammary glands.

Gastrointestinal: dyspepsia, bloating, nausea, vomiting, abdominal pain.

Skin and subcutaneous tissues: skin rashes, itching, eczema, urticaria, acne, hirsutism, hair loss, erythema nodosum.

Nervous system: headache, migraine, dizziness, anxiety, depressed mood, fatigue.

Other disorders: palpitations, edema, muscle cramps, changes in body weight, increased appetite, changes in libido, visual disturbances, contact lens intolerance, hypersensitivity reactions.

special instructions

In the presence or exacerbation of any of the following diseases / risk factors, it is recommended to conduct an individual analysis of the benefit-risk ratio of the preparation before starting or continuing HRT.

Venous thromboembolism

The results of epidemiological and randomized controlled trials suggest the likelihood of an increased risk of developing venous thromboembolism (VTE), that is, deep vein thrombosis or pulmonary embolism. Therefore, when prescribing HRT to women with a risk factor for developing VTE, the risk-benefit ratio of treatment should be carefully weighed.

Commonly recognized risk factors for the development of VTE include: personal and family history (a case of VTE in a close relative at a relatively early age may indicate a genetic predisposition) and severe obesity. The risk of VTE also increases with age. The question of the possible role of varicose veins in the development of VTE remains controversial.

The risk of VTE may temporarily increase with prolonged immobilization, after major elective or major surgery, or after severe trauma. The issue of temporary cessation of HRT should be decided depending on the nature of the surgical intervention and the duration of immobilization.

Arterial thromboembolism

The results of clinical studies using a combination of conjugated equine estrogens and medroxyprogesterone acetate (MPA) in a continuous mode indicate a possible increase in the risk of developing coronary artery disease during 1 year of use, with continued treatment, the risk remained stable. Another negative consequence identified during therapy is an increase in the risk of stroke by 30-40% with estrogen monotherapy or in combination with MPA.

Tumors

endometrial cancer

Long-term estrogen monotherapy increases the risk of endometrial hyperplasia or carcinoma. Based on the results of studies, it is believed that the proper inclusion of progestogens in the treatment regimen eliminates this increased risk.

Mammary cancer

Based on clinical studies and observations, an increase in the risk of developing breast cancer in women using HRT for several years has been shown. These facts may be associated with earlier diagnosis, the stimulating effect of HRT on pre-existing tumors, and the combined influence of these factors.

The overall relative risk of diagnosing breast cancer in more than 50 epidemiological studies conducted in most cases ranged from 1 to 2.

The relative risk increases with duration of treatment and may be lower or more likely unchanged with estrogen monotherapy.

A similar increase in the incidence of breast cancer is observed, for example, in women with a delay in the onset of natural menopause or with alcohol consumption or obesity. A few years after the start of HRT therapy, the increased risk is leveled.

It is noted that tumors detected in women who use or recently used HRT are characterized by a higher degree of differentiation than tumors detected in women who do not use HRT. When using HRT, the density of images in mammographic studies increases, which in some cases can complicate the diagnosis of breast diseases.

ovarian cancer

According to the results of studies, a slight increase in the risk of developing ovarian cancer in women receiving HRT with estrogens for a long time (more than 10 years) was revealed, the results of other studies of the increased risk are denied.

Tumors of the liver

After the use of hormonal preparations, including HRT, benign, and even less often, malignant liver tumors were observed in isolated cases. In isolated cases, these tumors have caused life-threatening intra-abdominal bleeding. With pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding, differential diagnosis should take into account the likelihood of a liver tumor.

Cholelithiasis

Estrogens are known to increase the lithogenicity of bile. Some women are prone to gallbladder disease during estrogen treatment.

Dementia

Based on clinical studies with preparations containing conjugated equine estrogens, it has not been proven that taking hormones can increase the risk of developing dementia when treatment is started in women aged 65 years and older. The risk may be reduced if treatment is started early in the menopause.

Other states

Treatment should be stopped immediately if a migraine-like or frequent and unusually severe headache or other symptoms appear for the first time, which are likely prodromal signs of cerebral vascular occlusion.

A general relationship between the use of HRT and the development of clinical hypertension has not been established. A slight increase in blood pressure has been reported in women receiving HRT, a clinically significant increase in pressure was rarely observed. However, if, in some cases, persistent clinically significant hypertension develops during HRT, consideration should be given to the advisability of abandoning HRT.

In mild hepatic impairment, including various forms of hyperbilirubinemia such as Dubin-Johnson syndrome or Rotor syndrome, patients should be under close medical supervision with periodic determination of liver function. With a deterioration in liver function, the use of HRT should be discontinued.

Women with moderately elevated triglyceride levels need special monitoring. In such cases, the use of HRT can cause a further increase in the level of triglycerides, which leads to the risk of developing acute pancreatitis.

Although HRT may affect peripheral insulin resistance and glucose tolerance, as a rule, there is no need to change the therapeutic regimen for diabetic patients using HRT. However, women with diabetes during HRT should be under close medical supervision.

Some patients during HRT may develop undesirable manifestations of estrogen stimulation, such as abnormal uterine bleeding. Frequent or persistent spotting during treatment is an indication for examining the condition of the endometrium.

Under the influence of estrogens, the size of uterine fibroids can increase. In this case, treatment should be stopped.

It is recommended to stop treatment if a recurrence of endometriosis occurs during therapy.

If a prolactinoma is suspected, the possibility of this disease should be excluded before starting HRT.

In some cases, chloasma may occur, especially in women with a history of chloasma of pregnancy. When taking a course of HRT, women who are predisposed to developing chloasma should avoid exposure to the sun or ultraviolet radiation.

It has been found that the use of HRT may cause or exacerbate the following conditions and diseases. Although it cannot be confidently stated that these changes are associated with HRT, patients taking HRT should be closely monitored and in whom the following diseases have been identified: epilepsy; benign diseases of the breast; BA; migraine; porphyria; otosclerosis; systemic lupus erythematosus; chorea.

Medical examination/consultation. Before starting or resuming HRT, it is necessary to study in detail the anamnesis of the patient's life and illness and conduct a physical examination, taking into account contraindications (see CONTRAINDICATIONS) and warnings (see SPECIAL INSTRUCTIONS), and periodically repeat such examinations. The frequency and nature of examinations should be based on existing standards of medical practice, taking into account the individual characteristics of the patient. As a rule, the pelvic organs are subject to examination, including a standard cytological analysis of the cervix, examination of the abdominal cavity, mammary glands, measurement of blood pressure.

During pregnancy and breastfeeding. Proginova should not be administered during pregnancy and lactation. If pregnancy occurs while taking Proginova, treatment should be stopped immediately.

Clinical data, based on a limited number of cases of use of the preparation during pregnancy, do not indicate a negative effect of estradiol valerate on the fetus. According to the results of most epidemiological studies, no teratogenic or fetotoxic effects of preparations for HRT were detected when they were accidentally taken during pregnancy.

A small amount of sex hormones can be excreted in breast milk.

Influence on the ability to drive vehicles and work with mechanisms: not noted.

Interactions

The use of hormonal contraceptives should be discontinued by the beginning of HRT, if necessary, the recommendation of non-hormonal methods of contraception.

Interaction of the preparation with other preparations

Treatment with preparations that affect the activity of liver enzymes (for example, some anticonvulsants and antimicrobials) for a long time can increase the clearance of sex hormones and reduce their clinical effectiveness. Such properties to induce liver enzymes have been identified in hydantoins, barbiturates, primidone, carbamazepine and rifampicin, the presence of these features can also be expected in oxcarbazepine, topiramate, felbamate and griseofulvin. The maximum induction of enzymes, as a rule, is noted no earlier than 2–3 weeks from the start of use and persists for 4 weeks after stopping the preparation.

In isolated cases, during the concomitant use of certain types of antibiotics (for example, penicillin and tetracycline groups), a decrease in the level of estradiol was observed.

Substances that form conjugates (for example, paracetamol) can increase the bioavailability of estradiol by competitive inhibition of conjugation systems during adsorption.

In some cases, the need for oral antidiabetic agents or insulin may change due to the effect on glucose tolerance.

Interaction with alcohol

Excessive alcohol consumption during HRT can lead to an increase in plasma estradiol levels.

Impact on laboratory results. The use of sex steroids may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, levels of transport proteins such as corticosteroid-binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, and parameters coagulation and fibrinolysis.

Overdose

The results of studies on acute toxicity of the preparation do not indicate the existence of a risk of acute side effects even with an accidental dose that is several times higher than the therapeutic one.

Storage conditions

At a temperature not higher than 30 °C.