DlyaJens^® diol (Gel) Instructions for Use

Marketing Authorization Holder

Pharmasintez-Tyumen, LLC (Russia)

ATC Code

G03CA03 (Estradiol)

Active Substance

Estradiol (Rec.INN registered by WHO)

Dosage Form

DlyaJens® diol

Transdermal gel 0.1%: pkg. 0.5 g, 1 g or 1.5 g 28 pcs.

Dosage Form, Packaging, and Composition

Transdermal gel

0.5 g – sachets (28 pcs.) – cardboard packs – By prescription
1 g – sachets (28 pcs.) – cardboard packs – By prescription
1.5 g – sachets (40 pcs.) – cardboard packs – By prescription

Clinical-Pharmacological Group

Anticlimacteric estrogenic drug

Pharmacotherapeutic Group

Sex hormones and modulators of the genital system; estrogens; natural and semisynthetic estrogens

Pharmacological Action

Estrogen. A follicular hormone necessary for the development of the female body and the reproductive system.

Exogenous Estradiol has the same physiological action as natural hormones: it stimulates the development of the uterus, fallopian tubes, the development of secondary sexual characteristics in cases of their underdevelopment, causes proliferative changes in the endometrium, increases the excitability of the uterus, and in large doses suppresses lactation.

Estradiol regulates nitrogen metabolism, reduces the level of lipids and cholesterol in the blood, and has a weak anabolic effect.

It helps maintain the balance between osteoblasts and osteoclasts, reduces bone resorption and promotes its formation.

Pharmacokinetics

After oral administration, it is absorbed from the gastrointestinal tract.

It undergoes the “first-pass” effect through the liver.

It is metabolized to less active metabolites – estriol and estrone.

Metabolites are excreted by the kidneys, a small part – through the intestines.

Indications

Primary and secondary amenorrhea; hypoplasia of the reproductive system and secondary sexual characteristics; hormone replacement therapy for disorders observed during natural or surgically induced menopause (including vasomotor disorders, hot flashes, increased sweating, sleep disorders, atrophic processes of the vagina and lower urinary tract), the cause of which is a deficiency in the production of endogenous estrogens; prevention of recurrent infectious and inflammatory diseases of the vagina and lower urinary tract; prevention and treatment of postmenopausal osteoporosis.

ICD codes

Dosage Regimen

Apply the gel once daily to clean, dry, intact skin.

Use the lowest effective dose for the shortest duration necessary to treat symptoms.

Apply the entire contents of one sachet (0.5 g, 1 g, or 1.5 g) as prescribed.

Spread the gel thinly over a large area (e.g., lower abdomen, thighs, or buttocks).

Avoid application to the breasts, face, or irritated skin.

Allow the application site to dry completely before covering with clothing.

Rotate application sites daily to minimize potential skin irritation.

Wash hands thoroughly after application to prevent accidental transfer to others.

For hormone replacement therapy in menopausal women, initiate treatment with a 1 mg dose (1 g of 0.1% gel).

Adjust the dose based on clinical response and tolerability.

For primary or secondary amenorrhea, follow the specific dosing regimen determined by the physician.

For the prevention of postmenopausal osteoporosis, use a maintenance dose of 0.5 mg to 1 mg daily.

Supplement estrogen therapy with a progestogen for at least 10-12 days per month in women with an intact uterus.

This progestogen supplementation is required to reduce the risk of endometrial hyperplasia.

Re-evaluate the need for continued therapy at regular intervals, typically every 6 to 12 months.

Adverse Reactions

From the central nervous system headache, dizziness, depression are possible.

From the digestive system nausea, vomiting, cholestatic jaundice, impaired liver function, gallstone formation are possible.

From the endocrine system uterine and vaginal bleeding, breast tenderness and enlargement, changes in libido, endometrial proliferation, development of endometrial carcinoma (in women with an intact uterus after menopause), edema, weight gain are possible.

Allergic reactions urticaria, skin rash are possible.

Dermatological reactions erythema multiforme, chloasma, melanoderma are possible.

Contraindications

Breast cancer and endometrial cancer, uterine fibroids, endometriosis, uterine bleeding of unknown etiology; severe liver damage, severe cardiovascular diseases, collagenoses, porphyria, pituitary tumors, otosclerosis, thrombophlebitis, thromboembolism; history of hepatitis, jaundice, prolonged itching, herpes during previous pregnancy; pregnancy, lactation period (breastfeeding).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during the lactation period (breastfeeding).

Use in Hepatic Impairment

Contraindicated in severe liver damage, history of hepatitis, jaundice. Should be used with caution in patients with impaired liver function.

Use in Renal Impairment

Should be used with caution in patients with impaired renal function.

Special Precautions

Before starting treatment, a gynecological examination is necessary; during long-term therapy, it should be performed at least once a year.

It is advisable to combine estradiol treatment with progestogenic drugs.

Should be used with caution in patients with coronary artery disease, circulatory failure, migraine, bronchial asthma, epilepsy, severe arterial hypertension, impaired liver and/or kidney function.

Estradiol may cause an increase in existing uterine fibroids.

During the use of estradiol, liver function and blood pressure parameters should be systematically monitored; in patients with diabetes mellitus, blood glucose concentration should be monitored.

Drug Interactions

With simultaneous use, estrogens may reduce the effects of anticoagulants, antihypertensive and hypoglycemic drugs.

With simultaneous use of estradiol and drugs that induce hepatic enzymes (barbiturates, carbamazepine, griseofulvin and rifampicin), a decrease in the level of estradiol in the blood plasma is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.