Pausogest (Tablets) Instructions for Use

Marketing Authorization Holder

Gedeon Richter, Ltd. (Hungary)

ATC Code

G03FA01 (Norethisterone and estrogens)

Active Substances

Estradiol (Rec.INN registered by WHO)

Norethisterone (Rec.INN registered by WHO)

Dosage Form

Pausogest

Film-coated tablets, 2 mg+1 mg: 28 or 84 pcs.

Dosage Form, Packaging, and Composition

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

Clinical-Pharmacological Group

Anticlimacteric drug

Pharmacotherapeutic Group

Antimenopausal agent (estrogen + progestogen)

Pharmacological Action

Monophasic drug for hormone replacement therapy. Pausogest is a combination of an estrogen and a progestogen.

The drug replenishes the deficiency of female sex hormones during the postmenopausal period.

Pausogest relieves vasomotor, psychoemotional, and other estrogen-dependent climacteric symptoms in the postmenopausal period, prevents the development of endometrial hyperplastic processes, and prevents bone loss and osteoporosis.

Pharmacokinetics

Absorption

Estradiol and norethisterone acetate are absorbed from the gastrointestinal tract.

Metabolism

They are metabolized in the liver.

Excretion

They are excreted in the urine as metabolites and in small amounts – unchanged in the feces.

Indications

• Hormone replacement therapy in the postclimacteric period;
• Prevention of postmenopausal osteoporosis.

ICD codes

Dosage Regimen

Each package is designed for 28 days of administration.

Treatment is carried out continuously, starting the next package immediately after the previous one is finished.

1 tablet/day is prescribed.

The duration of therapy with Pausogest is determined by the attending physician depending on the clinical situation.

Therapy should be started no earlier than one year after the onset of menopause.

Adverse Reactions

From the endocrine and reproductive systems during the first few months of treatment – menstrual-like bleeding; breast tenderness, nausea, headache, peripheral edema.

From the cardiovascular system rarely – thromboses, thromboembolisms (with long-term use).

Others visual impairment, skin reactions, breast diseases.

Contraindications

• Pregnancy or suspected pregnancy;
• Malignant tumors of the breast (or suspicion of them) or their presence in history;
• Estrogen-dependent tumor (e.g., endometrial carcinoma) or suspicion of it;
• Acute or chronic liver diseases or a history of liver diseases;
• Kidney diseases;
• Deep vein thrombosis of the lower extremities, thromboembolic diseases;
• Cerebrovascular disorders or a history of these diseases;
• Abnormal vaginal bleeding of unknown etiology;
• Hemoglobinopathies;
• Porphyria;
• Hypersensitivity to the drug components.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy.

Use in Hepatic Impairment

Contraindicated in acute or chronic liver diseases or a history of liver diseases.

Use in Renal Impairment

Contraindicated in kidney diseases.

Special Precautions

Before starting treatment, it is necessary to collect a family history and conduct a thorough medical examination, including blood pressure measurement, examination of the breasts and abdomen, and a gynecological examination.

Patients who have previously received estrogen therapy should be carefully examined to detect endometrial hyperplasia.

With long-term use of the drug, examination should be carried out at least once a year.

In the first months of taking the drug, transient menstrual-like bleeding may occur.

If this bleeding continues for a long time, it is necessary to perform diagnostic curettage or aspiration biopsy to exclude a possible malignant process of the endometrium.

Therapy should be immediately discontinued if the following side effects appear

• Deep vein thrombosis, including thromboembolic complications;
• Development of jaundice;
• Appearance of migraine-like headache;
• Sudden deterioration or impairment of vision;
• Significant increase in blood pressure.

Long-term therapy for the prevention of osteoporosis should be carried out in those women who have a high risk of bone fracture.

In patients receiving antihypertensive therapy in combination with hormonal therapy, blood pressure should be regularly monitored.

Patients with epilepsy, migraine, diabetes mellitus, bronchial asthma, or cardiovascular diseases should be monitored with particular care, as estrogens may worsen the course of these diseases.

Therapy with the drug should be discontinued 4-6 weeks before surgery.

Overdose

With proper use of the drug, overdose is impossible.

Symptoms nausea, vomiting, uterine bleeding are possible.

Treatment there is no specific antidote. If necessary, symptomatic therapy is carried out.

Drug Interactions

With simultaneous use with inducers of liver enzymes, the metabolism of estrogen is enhanced and the effectiveness of Pausogest is reduced.

Anesthetics, opioid analgesics, some antihypertensive agents, and ethanol reduce the effectiveness of the drug.

When co-administered, dose adjustment of hypoglycemic drugs may be required.

Drug interaction has been proven with the combined use of Pausogest with barbiturates, phenytoin, rifampicin, and carbamazepine.

Storage Conditions

The drug should be stored at a temperature from 15°C (59°F) to 30°C (86°F) in a place inaccessible to children.

Shelf Life

Shelf life – 3 years.

Dispensing Conditions

The drug is dispensed by prescription.

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.