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Instructions

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Instructions / Instruction for use: Oestrogel

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Active substance: Estradiol

ŔŇŐ Code: G03CA03 Estradiol

Pharmacological groups

Oestrogels [Oestrogels, gestagens; their homologs and antagonists]

Oestrogels [Antitumor hormonal agents and hormone antagonists]

Nosological classification (ICD-10)

E28 Ovarian dysfunction

Dysfunction of the sex glands, Abnormal ovarian function, Non-functioning ovaries, Primary dysfunction of the ovaries, Decreased function of the sex glands, Oestrogel insufficiency

M81.0 Postmenopausal osteoporosis

Menopause osteoporosis, Osteoporosis in menopause, Osteoporosis in menopause, Osteoporosis in postmenopausal women, Osteoporosis in the postmenopausal period, Postmenopausal osteoporosis, Osteoporosis in postmenopausal women, Perimenopausal osteoporosis, Postmenopausal osteoporosis, Post-menopausal osteoporosis, Postmenopausal osteoporosis, Postmenopausal demineralization of bones, Osteoporosis with Oestrogel deficiency, Osteoporosis in postmenopausal women, Osteoporosis in postmenopausal women and after hysterectomy

N95.1 menopausal and menopausal status of women

Atrophy of the mucosa of the lower genital tract, caused by Oestrogel deficiency; Vaginal dryness; Autonomic dysfunction in women; gipoOestrogeliya state; Deficiency of Oestrogel in menopausal women; Degenerative changes of the mucous membrane in the menopause; Natural menopause; an intact uterus; climacteric; Menopause women; Menopause in women; menopausal depression; Climacteric ovarian dysfunction; Menopause; Climacteric neurosis; Menopause; Menopausal symptoms complicated psychovegetative; Climacteric syndrome; Climacteric vegetative disorders; Climacteric psychosomatic disorder; menopausal disorders; Menopausal disorders in women; menopausal condition; Climacteric vascular disorders; Menopause; Menopausal vasomotor symptoms; menopausal period; Lack of Oestrogel; Feeling the heat; Pathological menopause; perimenopause; menopause; postmenopausal; Premature menopause; premenopauznom period; tides; hot flashes; flushing in the Meno and postmenopausal; Hot flashes / hot flashes in menopause; Heart attack during menopause; Early menopause in women; Disorders of menopause; climacteric syndrome; Vascular complications of menopause; Physiological menopause; Oestrogeldefitsitnye state; premature Menopause

N95.9 Menopausal and perimenopausal disorders, unspecified

Postmenopause, Atrophy of the vulva, Climacteric syndrome, Postmenopausal period, Premenopausal period, Menopausal Symptom

Composition

Gel transdermal 1 g

active substance:

Estradiol hemihydrate (in terms of estradiol) 0.6 mg

auxiliary substances: carbomer (carbopol 980) - 5 mg; trolamine (triethanolamine) - 5 mg; ethanol 400 mg; purified water - q.s. up to 1 g

Description of dosage form

Gel: colorless transparent, with the smell of ethanol.

pharmachologic effect

The pharmacological action is Oestrogelic.

Pharmacodynamics

The active substance of the preparation, Oestrogel®-17β-estradiol, is chemically and biologically identical to endogenous human estradiol.

Has an Oestrogelic effect on the main target organs: ovaries, endometrium, vaginal epithelium, mammary glands, urethra, hypothalamus, pituitary gland, liver - similar to the action of endogenous Oestrogels in the follicular phase of the menstrual cycle.

Replenishes the deficiency of Oestrogel in a woman during menopause and reduces the severity of menopausal disorders, including hot flashes, increased sweating at night, atrophic changes in the urinary tract (atrophic vulvovaginitis, dyspareunia, urinary incontinence), and psychoemotional disorders.

The clinical efficacy of the drug Oestrogel® in the treatment of the symptoms of menopause is comparable to that of Oestrogel ingestion.

Estradiol helps to reduce the concentration of total XC without changing the ratio of Xc / HDL (high-density lipoproteins).

It has a procoagulant effect, increases the synthesis in the liver of vitamin K-dependent coagulation factors (II, VII, IX, X), reduces the concentration of antithrombin III.

Estradiol prevents loss of bone mass associated with natural menopause or ovariectomy.

Oestrogel deficiency in the postmenopausal period is associated with a decrease in BMD. The effect of Oestrogel on BMD is dose-dependent and continues, apparently, as long as HRT is performed. After the abolition of HRT, the BMD begins to decrease at the same rate as before the beginning of the procedure. Data from the randomized placebo-controlled study "Women's Health Initiative" (WHI) and a meta-analysis of clinical studies showed that HRT alone with Oestrogels or Oestrogels combined with gestagens in healthy women during postmenopausal women reduces the risk of fractures of the hip, spine and other osteoporotic fractures. There is also limited evidence that HRT can prevent bone fractures in women with low BMD and / or established osteoporosis.

Pharmacokinetics

Absorption and distribution. When the gel is applied locally on a large surface of the skin, the alcohol evaporates and approximately 10% of estradiol is absorbed through the skin into the vascular system, regardless of the patient's age. Daily use of 2,5 or 5 g of the drug ESTROGEL® on an area of 400-750 cm2 leads to a gradual increase in the concentration of estradiol and estrone and provides their Css (equilibrium concentration) in the blood plasma after about 3-5 days in a ratio characteristic of the beginning of the middle of the follicular phases of the menstrual cycle. With the use of the drug ESTROGEL® in 17 postmenopausal women 1 time per day by applying on the back surface of one hand from the wrist to the shoulder for 14 days Cmax estradiol and estrone in blood plasma on the 12th day of application was 117 and 128 pg / ml, respectively . The average concentration of estradiol and estrone in the blood plasma over a 24-hour time interval after the application of 2.5 g of the drug ESTROGEL® on the 12th day of administration was 76.8 and 95.7 pg / ml, respectively.

Metabolism and excretion. Estradiol is metabolized, mainly, in the liver to estriol, estrone and their conjugated metabolites (glucuronides, sulfates). These metabolites are subjected to intestinal hepatic recirculation. After discontinuation of treatment, the concentration of estradiol returns to the baseline level after approximately 76 hours.

Indications

hormone replacement therapy with symptoms of Oestrogel deficiency; treatment of climacteric syndrome associated with natural or surgical menopause;

prevention of osteoporosis in the postmenopausal period in women with a high risk of fractures with intolerance or the presence of contraindications to other drugs for the prevention of osteoporosis.

Contraindications

hypersensitivity to estradiol and / or any of the excipients of the drug;

breast cancer (diagnosed, suspected or in history);

diagnosed, suspected Oestrogel-dependent malignant tumors of the genital organs (eg, endometrial cancer) or their presence in the anamnesis;

bleeding from the genital tract of unclear etiology;

untreated endometrial hyperplasia;

identified acquired or hereditary predisposition to venous or arterial thrombosis, including antithrombin III deficiency, protein C deficiency, protein S deficiency);

venous thrombosis and thromboembolism now or in history (including thrombosis and thrombophlebitis of deep veins, thromboembolism of the pulmonary artery);

active or recently transferred arterial thromboembolic diseases (including angina pectoris, myocardial infarction);

congenital hyperbilirubinemia (syndromes Gilbert, Dubin-Johnson, Rotor);

benign or malignant liver tumors at present or in the anamnesis;

Cholestatic jaundice or severe cholestatic itching (including during previous pregnancy or on the background of taking sex hormones);

acute liver disease or a history of liver disease, if the results of functional liver tests did not return to normal;

porphyria;

pregnancy;

the period of breastfeeding (see "Application in pregnancy and lactation").

With caution: should use the drug Oestrogel ® in such diseases and conditions as: myoma of the uterus; endometriosis; endometrial hyperplasia in the anamnesis; the presence of risk factors for Oestrogel-dependent tumors (breast cancer in relatives of the first line of kinship); presence of risk factors for thromboembolic disorders; arterial hypertension; liver diseases (including liver adenoma) with normal liver function tests; diseases of the gallbladder (including cholelithiasis); diabetes mellitus with or without diabetic angiopathy; migraine or severe headache; systemic lupus erythematosus; epilepsy; bronchial asthma; otosclerosis, chronic heart failure; kidney failure; cardiac ischemia; sickle-cell anemia; a history of chloasma; hypertriglyceridemia in history; pancreatitis; hereditary angioedema.

The experience of treating women over 65 is limited.

Application in pregnancy and lactation

The drug Oestrogel® is contraindicated for use during pregnancy.

If pregnancy occurs during the use of the drug, treatment should be stopped immediately.

The results of most epidemiological studies on the random effects of Oestrogel on the fetus do not indicate a teratogenic or fetotoxic effect.

The drug Oestrogel® is contraindicated in the period of breastfeeding.

Side effects

Possible side effects of HRT.

diseases of the gallbladder;

- from the skin and subcutaneous tissues: chloasma, erythema multiforme, erythema nodosum, thrombocytopenic purpura;

- increased risk of developing dementia over the age of 65.

The risk of breast cancer

- In women using combined Oestrogel-progestogen drugs for more than 5 years, there is an increased risk of diagnosing breast cancer by 2 times;

- when carrying out HRT only Oestrogel, the risk of developing breast cancer is much lower than with combined Oestrogel-progestogen preparations;

- the magnitude of the risk of developing breast cancer depends on the duration of HRT.

Risk of endometrial cancer

In postmenopausal women with an intact uterus. The incidence of endometrial cancer is about 5 cases for every 1000 women with an intact uterus who are not receiving HRT. In women with an intact uterus, HRT is not recommended for Oestrogel alone, as this increases the risk of endometrial cancer.

Depending on the duration of application of only Oestrogel and its dose, the increased risk of endometrial cancer in epidemiological studies ranged from 5 to 55 additional cases diagnosed in every 1000 women aged 50 to 65 years. Addition of a progestogen for at least 12 days to an Oestrogel-only therapy can prevent this increased risk. In the WHI study, when carrying out HRT (sequential or continuous) with combined Oestrogel-progestational drugs for 5 years, there was no increase in the risk of endometrial cancer (PP 1 (0.8-1.2).

Ovarian Cancer

Prolonged use of HRT alone with Oestrogels and combined Oestrogel-progestational medications was associated with a small increase in the risk of developing ovarian cancer. In the WHI study, a 1 additional case of ovarian cancer in 2500 women was detected during 5 years of HRT.

Risk of venous thromboembolism

In women receiving HRT, there is an increased risk of developing VTE (venous thromboembolism), in particular, deep vein thrombosis or pulmonary embolism, compared with women who did not receive HRT - in 1,3-3 times. The probability of VTE development is higher in the first year of HRT than in subsequent years.

Interaction

The use of the drug Oestrogel® together with surfactants (eg, sodium lauryl sulfate) or other substances that alter the structure or barrier function of the skin can reduce its effectiveness. Therefore, joint application of the preparation with strong detergents and detergents (for example containing benzalkonium or benzethonium chloride), skin care products with a high alcohol content (astringent, sunscreen) and keratolytic agents (for example, salicylic or lactic acid) should be avoided. It should avoid the use of any concomitant drugs (drug) that have a damaging effect on the skin (for example, cytotoxic). Metabolism of estradiol is accelerated by the simultaneous use with inductors of microsomal liver enzymes, such as antiepileptic drugs (phenobarbital, phenytoin, carbamazepine); some antibiotics and antiviral drugs (rifampicin, rifabutin, nevirapine, efavirenz); herbal preparations containing St. John's Wort.

Ritonavir and nelfinavir, also known as potent inhibitors, on the contrary, exhibit induction properties when combined with sex hormones.

In transdermal application, the effect of primary passage through the liver can be avoided, that is, the effect of preparations for HRT with transdermal application of Oestrogels, possibly to a lesser extent than with oral administration, depends on the action of inducers of microsomal liver enzymes.

Metabolism of estradiol is accelerated with simultaneous use with tranquilizers (anxiolytics), narcotic analgesics, means for anesthesia.

The concentration of estradiol in blood plasma also decreases with simultaneous use with certain antibiotics (penicillins and tetracyclines).

The effect of estradiol is enhanced by the intake of folic acid and thyroid hormone preparations.

In clinical practice, increased Oestrogel metabolism can lead to a weakening of the effect and changes in the character of uterine bleeding.

Estradiol:

- increases the effectiveness of lipid-lowering drugs;

- Weaken the effect of drugs of male sex hormones, hypoglycemic, diuretic, antihypertensive drugs and anticoagulants.

Dosing and Administration

Outer, continuous or cycles. The doses and duration of therapy are set individually.

Usually, the initial dose of the drug is 2.5 g of gel once a day, which corresponds to 1.5 mg of estradiol. In most patients, this dose is effective to alleviate the symptoms of menopause. If after one month of therapy the efficacy is not achieved, an increase in the daily dose of the drug to a maximum of 5 g of gel is possible, which corresponds to 3 mg of estradiol. To start and continue therapy for menopausal symptoms, the minimum effective dose should be used for a minimum period of time.

Prevention of osteoporosis in postmenopausal women

The minimum effective dose for most patients is 2.5 g of Oestrogel® once a day.

When using the drug in the form of a "tube", a plastic dose applicator is used to determine the daily dose: 1 dose of the applicator corresponds to 2.5 g of gel (corresponding to 1.5 mg of estradiol).

When the drug is used in the form of a "vial", when one presses the dosage pump, 1.25 g of gel is released (corresponding to 0.75 mg of estradiol) equal to half the daily dose. The average daily dose of the drug is 2.5 g of gel (2 clicks on the dosage pump).

Use of the drug in the form of a tube release: open the tube and pierce the metal membrane of the tube using a small punch that is located in the upper part of the tube cover. The required dose is extracted from the tube by the applicator's ruler.

1 dose corresponds to the column of the extracted gel with a diameter equal to the diameter of the tube outlet, the length of which coincides with the depression in the applicator ruler. The groove has a dash, which allows you to divide the daily dose in half. One tube with gel is designed for 30 doses.

Application of the drug in the form of a "bottle": you need to remove the cap from the vial and strongly press the pump-dispenser, substituting another hand to collect the gel. The dose that is released by the first pressing may be inaccurate. It is recommended to discard it. The bottle is designed for 64 clicks. After 64 clicks, the amount of gel that is released by one press can be less than necessary. Therefore, it is not recommended to use the bottle after 64 clicks on the dispensing pump.

The use of the drug Oestrogel® without the addition of progestogen is possible only in patients with a deleted uterus.

Patients with an intact (unremoved) uterus during treatment with the drug Oestrogel® are recommended to be prescribed gestagen.

During the menopausal transition, treatment should be performed for at least 3 weeks in a row, followed by a one-week break, and at the same time, orally administered progestogen for the 12-14 last days of the month.

During the period of perimenopause treatment can be carried out from 1 to 25 of the month simultaneously with oral administration of progestogen. During the week-long break, menstrual bleeding may occur, due to a decrease in the content of sex hormones. It is recommended to use only those progestogens, the use of which is allowed simultaneously with Oestrogels.

During the postmenopausal period, treatment with Oestrogels in combination with gestagens is carried out in a constant mode.

Prolonged monotherapy with Oestrogels is indicated in women after hysterectomy. In women who underwent hysterectomy, the addition of progestogen in the absence of an anamnesis of endometriosis is not recommended.

Depending on the clinical symptomatology after 2-3 cycles of treatment, dose adjustment is carried out, namely:

- with the appearance of symptoms of hyperOestrogelism, such as a feeling of tension in the mammary glands, a feeling of overflow in the abdomen and pelvis, feelings of anxiety, nervousness, aggressiveness, a dose reduction is necessary;

- with symptoms of hypoOestrogelism, such as persistent hot flushes, dryness of the vaginal mucosa, headache, sleep disorders, asthenia, a tendency to depression, the dose should be increased.

In women who have not previously used drugs for HRT, and women who switch to the preparation of Oestrogel® from a combined drug for HRT with a continuous regimen, treatment with the drug Oestrogel® can begin in any patient-friendly day. For women who switch to Oestrogel® with a continuous sequential HRT regimen, treatment should be started after the completion of the previous regimen.

If the patient has forgotten to apply the gel, you should do this as soon as possible, however no later than within 12 hours from the time of application. If more than 12 hours have passed, the application of the drug Oestrogel® should be postponed until the next time. With irregular use of the drug (missed doses), breakthrough bleeding and spotting bleeding may occur.

The gel is applied by the patients themselves on a thin, thin layer to clean, dry skin of the abdomen, lumbar region, shoulders or forearms until full absorption.

The area of application should be at least 2 palms.

Do not massage the place of application of the gel. It is necessary to avoid getting the gel on the mammary glands and mucous membrane of the vulva and vagina.

Application is considered correct and effective if the gel is absorbed completely within 2-3 minutes.

If the sticky consistency persists for more than 5 minutes after application, the gel is covered with a too small skin surface.

Wash hands immediately after applying the gel.

Overdose

Symptoms: pain in the mammary glands or excess production of the secretion of the cervix can indicate a too high dose of the drug.

No symptoms of acute overdose were reported.

Symptoms of an overdose of Oestrogels can be nausea and withdrawal bleeding.

Treatment: there is no specific antidote; it is necessary to cancel the drug, symptomatic therapy.

special instructions

In the treatment of postmenopausal symptoms, HRT should be started only if they are present, adversely affecting the quality of life. It should be at least once a year to conduct a detailed assessment of the risks and benefits and appoint HRT only if the benefit exceeds the risk.

Data on the risks associated with HRT for the treatment of premature menopause are limited. However, given the low absolute risk of HRT in young women, the ratio of benefits and risks in these patients may be more favorable than in older women.

Before starting or re-appointing HRT, you must collect a complete personal and family history. A medical examination should be conducted to identify possible contraindications and to observe the necessary precautions when taking the drug (including examination of pelvic organs and mammary glands). During the treatment it is recommended to conduct a periodic examination.

The frequency and methods included in it are determined for each individual case individually. Studies, including mammography, should be conducted in accordance with accepted norms and adapt to the individual clinical needs of each individual case. During the patient's admission of drugs for HRT, a thorough evaluation of all the benefits and risks of therapy should be conducted.

Conditions that require observation

If any of the following conditions are present, previously seen and / or aggravated during pregnancy or previous hormonal therapy, the patient should be under constant medical supervision. It should be taken into account that these conditions can rarely recur or worsen during treatment with the drug Oestrogel®, in particular:

uterine myoma or endometriosis;

- risk factors for thromboembolic disease;

- risk factors for Oestrogel-dependent tumors (presence of relatives of the first line of kinship with breast cancer);

- arterial hypertension;

- liver disease (eg, liver adenoma);

- diabetes mellitus with or without diabetic angiopathy;

- cholelithiasis;

- migraine and / or severe headache;

- systemic lupus erythematosus;

- Endometrial hyperplasia in the anamnesis;

- epilepsy;

- bronchial asthma;

-otosclerosis;

hereditary angioedema.

Reasons for immediate cessation of therapy

Therapy should be discontinued if contraindications and / or in the following situations are detected:

- jaundice or worsening of liver function;

- marked increase in blood pressure (arterial pressure);

- newly emerged seizures of migraine-like headache;

- Pregnancy.

Hyperplasia and endometrial cancer

In women with an intact uterus, the risk of hyperplasia and endometrial cancer increases with Oestrogel for a long time. According to available data, the risk of developing endometrial cancer in women using only Oestrogels increases 2-12 times compared to women who do not use Oestrogels, depending on the duration of treatment and the dose of Oestrogels. After cessation of treatment, the increased risk may persist for at least 10 years.

The addition of progestogen in the last 12 days of the month / 28 days of the cycle or continuous combined Oestrogel-progestational therapy in women with an unrefined uterus reduces the increased risk of hyperplasia and endometrial cancer associated with HRT with Oestrogel alone.

During the first months of treatment, breakthrough bleeding and spotting bleeding can occur. If breakthrough bleeding or spotting bleeding occurs after a certain period of treatment or continues after the treatment has been withdrawn, a check should be performed to determine the cause of their occurrence, including an endometrial biopsy to exclude the malignant neoplasm of the endometrium.

The use of drugs for HRT containing only Oestrogel can lead to precancerous or malignant transformation of residual foci of endometriosis.

Thus, women who underwent a hysterectomy due to endometriosis should be provided with the addition of progestogen to Oestrogel replacement therapy in order to prevent endometrial cancer if it is known that they have residual foci of endometriosis.

Mammary cancer

The available data indicate an increased risk of breast cancer in women receiving combined Oestrogel-progestational medications and, possibly, also Oestrogel-only preparations for HRT; this risk depends on the duration of HRT use.

Use of drugs for HRT that contain only Oestrogel. The WHI study found no increased risk of developing breast cancer in women who underwent a hysterectomy and used hormone-eluting drugs containing only Oestrogel.

In observational studies, in most cases, there is a slight increase in the risk of diagnosing breast cancer, which is significantly lower than that of women using combined Oestrogel-progestational drugs.

The use of combined Oestrogel-progestogen drugs for HRT. In the WHI study and in epidemiological studies, coincident data have been obtained on the increased risk of breast cancer in women receiving combined Oestrogel-progestational medications for HRT; increased risk was detected after about 3 years of treatment. Additional risk begins to appear after several years of treatment, but returns to baseline within a few (not more than 5) years after discontinuation of treatment.

HRT, in particular combined Oestrogel-progestogen, leads to an increase in the density of mammographic images, which can prevent radiographic detection of breast cancer.

Ovarian Cancer

Ovarian cancer is much less common than breast cancer. Long-term (no less than 5-10 years) use of drugs for HRT that contain only Oestrogel is associated with an increased risk of ovarian cancer. Some studies, including the WHI study, have found that prolonged use of combination drugs for HRT may give rise to a similar or even less significant risk.

Venous thromboembolism

In women receiving HRT, there is an increased risk of developing VTE (venous thromboembolism), in particular, deep vein thrombosis or pulmonary embolism, compared with women who did not receive HRT 1.3-3 times. The probability of VTE development is higher in the first year of HRT than in subsequent years. Patients with known thrombophilic disorders may have an increased risk of developing VTE, and HRT may further increase it. Therefore, HRT in such patients is contraindicated.

The main risk factors for VTE development are: individual or family history, use of Oestrogel, old age, serious surgery, prolonged immobilization, severe obesity (BMI over 30 kg / m2), pregnancy and the postpartum period, systemic lupus erythematosus, malignant neoplasms.

There is no consensus on the possible role of varicose veins in the development of VTE.

The risk of VTE increases with prolonged immobilization, extensive injuries or extensive surgical interventions. Admission of drugs for HRT should be discontinued 4-6 weeks before planned surgery on the abdominal organs or orthopedic operations on the lower limbs. Treatment can be resumed after a complete recovery of motor ability.

Women who do not have a history of VTE, but who have first-degree relatives who have survived thrombosis at a young age, can be screened after a detailed discussion of its limitations (screening reveals only a few thrombophilic disorders).

If a patient exhibits a thrombophilic disorder manifested by thrombosis in family members, as well as in the presence of severe defects (such as deficiency of antithrombin, protein S or protein C, or combination of defects), HRT is contraindicated.

Women who are already receiving continuous treatment with anticoagulants require a thorough evaluation of the ratio of the benefits and risks of HRT.

If VTE develops after the start of treatment, the drug should be discontinued.

Patients should be advised to immediately contact a physician if there are potential symptoms of thromboembolism (soreness and / or swelling of the lower limb, sudden chest pains, shortness of breath).

CHD

In the randomized controlled trials, no data were obtained on the prophylactic effect of myocardial infarction in women with or without IHD receiving HRT with combined Oestrogel-progestational medications or Oestrogels alone.

Use of drugs for HRT that contain only Oestrogel. In randomized controlled trials, there was no evidence of an increased risk of coronary heart disease in patients who underwent hysterectomy and who received Oestrogel-only preparations for HRT.

The use of combined Oestrogel-progestogen drugs for HRT. When combined Oestrogel-progestational drugs for HRT are used, there is a slight increase in the relative risk of coronary heart disease. Since the initial absolute risk of CHD depends largely on age, the number of additional cases of IHD caused by the use of Oestrogels in combination with gestagens in healthy women approaching menopause is extremely small, but increases with age.

Ischemic stroke

HRT combined Oestrogel-progestogen and Oestrogel alone is associated with an increased risk of ischemic stroke by almost 1.5 times. Relative risk does not change with age and depending on the time that has passed since the onset of menopause. However, since the baseline risk of stroke largely depends on age, the overall risk of stroke in women receiving HRT will increase with age.

Other states

- Oestrogels cause fluid retention in the body. Patients with cardiac or renal failure should be under constant medical supervision;

- careful observation is necessary for HRT in women with hypertriglyceridemia in the anamnesis, since in this condition, when compared with Oestrogel therapy, rare cases of a sharp increase in the concentration of triglycerides in the blood plasma, leading to the development of pancreatitis;

- Oestrogels increase the concentration of thyroxine-binding globulin, leading to an increase in the total concentration of circulating thyroid hormones.

Concentrations of free T3 and T4 do not change.

It may increase the content of other proteins, for example, corticosteroid-binding globulin and globulin, binding sex hormones, which can lead, respectively, to an increase in the total concentration of circulating glucocorticosteroids and sex hormones. Concentrations of free or biological active hormones do not change. It is also possible to increase the content of other blood plasma proteins (angiotensinogen (renin substrate), α-1-antitrypsin, ceruloplasmin).

Chloasma

In some cases, chloasma may develop, especially in women who have a history of chloasma during pregnancy. Women with a tendency to develop chloasma, when using HRT, should minimize exposure to sunlight or UV irradiation.

influence on cognitive function

HRT does not affect the improvement of cognitive function. The WHI study showed a trend towards a possible increase in the risk of developing dementia in women who started long-term HRT with combined Oestrogel-progestational medications or Oestrogels only over the age of 65 years.

The use of the drug Oestrogel® should be done:

- the very woman;

- in the morning or evening, on clean skin.

The drug Oestrogel® does not leave stains.

Influence on the ability to drive vehicles, mechanisms. The effect of Oestrogel on the ability to drive vehicles and mechanisms has not been studied.

Form of issue

Gel transdermal, 0.6 mg / g.

To 80 g of gel in a plastic bottle with a dispensing pump, equipped with a protective cap. 1 f. put in a pack of cardboard.

80 g of gel in an aluminum tube, sealed with a screw cap. The tube with the applicator-dispenser is placed in a pack of cardboard.

Conditions of leave from pharmacies

On prescription.

storage Conditions

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiry date printed on the package.