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

Active ingredients

Each capsule of the medicinal product contains the following: white 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 white 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.

Therapeutic indications

• Euthyroid nodular/multinodular goitre
• Subclinical hypothyroidism
• Autoimmune thyroiditis (Hashimoto thyroiditis)
• Prophylaxis of thyroid diseases

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.

Attention!
ENDONORM^® may be used by patients with thyroid diseases associated with abnormal thyroid function (clinically relevant change in thyroid hormone levels) only when prescribed by the attending physician and under the doctor’s careful monitoring!
Discontinuation of / switching from an ongoing treatment should also be done only by the attending physician!