Summary of Product Characteristics for ENDONORM® (field of application and dosages)

Active ingredients
Therapeutic group
Description
Mechanism of action
Therapeutic indications
Method of administration and posology
Contraindications
Adverse effects
Overdose
Interactions with other medicinal products
Nature and contents of container
Shelf-life
Special warnings and precautions for use
Therapeutic activity range

Active ingredients

Each capsule of the medicinal product contains the following: cinquefoil roots and rootstocks extract – 200 mg, beggars-ticks herb extract – 80 mg, liquorice roots extract – 50 mg, brown algae (devil’s apron) thalluses powder – 70 mg.

Therapeutic group

Plant-derived thyrotropic and gonadotropic agent.

Description

The broad spectrum of the supplement’s pharmacological activity is due to the summarized effects of the biologically active substances included in its composition: Albinin®, the triterpene glycosides and the phenol compounds of cinquefoil, the iridoids and phenylpropanoids of beggars-ticks, and the glycyrrhetinic acids of Glycyrrhiza glabra.

Mechanism of action

Administration of ENDONORM® in hypothyroidism (1 capsule three times per day) increases thyroid function by activation of proliferation in the interfollicular islets and increased rate of synthesis. The therapeutic effect of ENDONORM® in autoimmune thyroiditis and nodular goitre forms is achieved indirectly, by relieving the thyroid functional overload and change in the rate of humoral regulation of this organ.
The therapeutic effect of ENDONORM® in climacteric syndrome is achieved thanks to normalized levels of the gonadotropic hormones (indirect influence on the hypothalamus – pituitary system) and increased functional activity of the adrenal cortex.
The therapeutic effect of the drug in the complex treatment of hyperplastic conditions of the female reproductive system (mastopathy, endometriosis, endometrial hyperplasia) is due to its pronounced anti-inflammatory properties and gonadotropic activity.
The therapeutic effect of the drug in the complex treatment of the metabolic syndrome is attained through recovery of thyroid function and increased intensity of metabolism in the body’s tissues.

Therapeutic indications

• Hypothyroidism
• Autoimmune thyroiditis
• Euthyroid goitre (diffuse, nodular, multinodular)
• Endemic goitre
• Prophylaxis of thyroid diseases
• Climacteric syndrome
• Complex treatment of hyperplastic conditions of the female reproductive system (mastopathy, endometriosis, endometrial hyperplasia, etc.)
• Complex treatment of the metabolic syndrome

Method of administration and posology

For all therapeutic indications, ENDONORM® should be taken 10 minutes before a meal.

Contraindications

Individual intolerance of any of the drug’s components, acute inflammatory diseases of the gastrointestinal tract, pregnancy and lactation, age under 12 years (due to a lack of clinical data).

Adverse effects

Dyspeptic reactions may develop.

Overdose

No cases of overdosage have been described to date.

Interactions with other medicinal products

Concomitant administration of ENDONORM® with thyroid hormones and thyrostatics is allowed only under the treating physician’s supervision, because of possible perversion of pharmacological effects.

Nature and contents of container

Solid gelatin capsules of 400 mg. 60 and 90 capsules in a polymeric box.

Shelf-life

2 years. Store in a dry place protected from light, at temperatures not exceeding 25 °C. Keep out of the reach of children.

Special warnings and precautions for use

To achieve the maximum therapeutic effect, treatment with ENDONORM® should be combined with special diet. Daily intake of foods rich in selenium (Se), zinc (Zn), and vitamin С is recommended, or a multivitamin – mineral complex should be taken.
Selenium concentrators include: sea fish (herring, hake, cod, etc.), crabs, shrimp, coconut, pistachios, garlic, and brewer’s yeast.
Zinc concentrators include: red meat, liver, heart, chicken eggs, pumpkin seeds, oat flakes, and legumes. 
Vitamin С concentrators are: fresh juices, canker berries, canker-berry syrup, red sweet pepper, blackcurrant, sea-buckthorn.
The patient should also limit or avoid consumption of foods containing goitre-inducing substances (substances causing thyroid dysfunction). Such substances include: cabbage, Brussels sprout, cauliflower, broccoli, turnip, turnip rape, colza, and millet.

Therapeutic activity range

Gynaecology: menopause and ENDONORM®

In the course of ENDONORM® development, an important drug-induced effect was revealed. Thus, the preparation showed high therapeutic activity in women during menopause (in the climacteric period). ENDONORM® showed its efficiency not only for normalization of thyroid gland hormonal function, but for the entire endocrine system.
Up to 60% of women at the age of 45 to 55 years suffer from some thyroid gland disorders and (удалено) resulting endocrine disorders, which first of all have the most negative effect on the menopause.
Due to the unique biochemical composition, cinquefoil normalizes thyroid gland function and levels negative effects of hormonal imbalance.
In the dosage applied in ENDONORM®, bur beggar-ticks herb has a soft tranquilizing (soothing) effect.
Glycyrrhizic acids contained in the common licorice normalize the hormonal balance of the organism, restore the function of adrenal glands and ovaries. Moreover, common licorice components possess a pronounced estrogenic activity, preventing age-dependent reduction in the estrogen level.

Immunology: immunomodulatory effect of ENDONORM®

Tests carried out in the course of ENDONORM®development showed that complex combination of the three components, common licorice, cinquefoil and bur beggar-ticks herb, provides for a pronounced immunomodulatory effect, which allows neutralizing the destructive effect of the organism’s immunity in case of deep-rooted autoimmune thyroiditis (Hashimoto's thyroiditis). Therapy revealed steady reduction in antiserum capacity to thyroglobulin (Anti-Tg) and to thyroid peroxydase (Anti-TPO), in some cases, Blood Sedimentation Rate reduction.
Clinical studies of ENDONORM®