Estrimax (Tablets) Instructions for Use

Marketing Authorization Holder

Gedeon Richter, Ltd. (Hungary)

ATC Code

G03CA03 (Estradiol)

Active Substance

Estradiol (Rec.INN registered by WHO)

Dosage Form

Estrimax

Film-coated tablets, 2 mg: 28 or 84 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets light gray in color, convex.

28 pcs. – blisters (1) – cardboard packs.
28 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Anticlimacteric estrogenic drug

Pharmacotherapeutic Group

Estrogen

Pharmacological Action

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

Take one 2 mg tablet orally once daily.

Initiate therapy at the lowest effective dose for the shortest duration consistent with treatment goals and risks.

For continuous hormone replacement therapy in postmenopausal women, take tablets daily without interruption.

For cyclical regimens, take tablets daily for the first 21-25 days of each calendar month, followed by a treatment-free interval.

Administer the tablet at approximately the same time each day, with water, with or without food.

For women with an intact uterus, add a progestogen for at least 10-14 days per month to reduce the risk of endometrial hyperplasia.

Adjust the dosage based on clinical response, tolerability, and the specific indication being treated.

Regularly re-evaluate the need for continued therapy. Do not discontinue or adjust dosage without consulting a physician.

Adverse Reactions

From the CNS 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 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 a 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. It should be used with caution in patients with impaired liver function.

Use in Renal Impairment

It 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.

Treatment with estradiol is advisable to combine with progestogenic drugs.

It 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 liver enzymes (barbiturates, carbamazepine, griseofulvin and rifampicin), a decrease in the plasma level of estradiol is possible.

Storage Conditions

Store at 15°C (59°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.