Detrimax^® 2000 (Tablets) Instructions for Use

Marketing Authorization Holder

UNIPHARM, LLC (Russia)

Manufactured By

Grokam GBL, sp. z o.o. (Poland)

Groups

MASTER PHARM, S.A. (Poland)

For

UNIPHARM LABORATORIES, Limited (Ireland)

Dosage Form

Detrimax® 2000

Coated tablets, 2000 IU (50 mcg): 30, 60, 90, or 120 pcs.

Dosage Form, Packaging, and Product Composition

Coated tablets, with a break line, weighing 240 mg.

Excipients: dicalcium phosphate (anti-caking agent), microcrystalline cellulose (filler).

Coating composition: hypromellose (stabilizer), titanium dioxide (colorant), polydextrose (stabilizer), talc (anti-caking agent), maltodextrin, medium-chain triglycerides, magnesium stearate (anti-caking agent).

15 pcs. – blisters (2) – cardboard packs.
15 pcs. – blisters (4) – cardboard packs.
15 pcs. – blisters (6) – cardboard packs.
15 pcs. – blisters (8) – cardboard packs.

Therapeutic Category

Dietary supplement – source of vitamin D

Properties

Dietary supplement to food. The product contains vitamin D₃ (Colecalciferol) – an essential fat-soluble vitamin necessary for the functioning of almost all organs and systems of the human body.

The role of vitamin D in the functioning of organs and systems

Musculoskeletal system. It participates in the regulation of calcium-phosphorus metabolism: it helps calcium absorption in the intestines, maintains the necessary levels of calcium and phosphorus in the blood, and activates bone metabolism.

It helps to ensure bone strength and reduce the risk of developing rickets and osteomalacia. Maintaining a normal level of vitamin D is extremely necessary at any age, but especially in old age, when the risk of falls and bone fractures increases. Vitamin D strengthens teeth by activating the production of dentin, the main component of hard tooth tissue. A sufficient level of vitamin D in the body reduces the risk of developing caries.

It helps maintain muscle strength and neuromuscular conduction. Vitamin D deficiency is associated with muscle weakness, which is why, especially elderly people, may experience difficulty walking.

Endocrine system. Vitamin D is involved in the regulation of the function of almost all endocrine glands. It stimulates the synthesis of female and male sex hormones: estrogens, progesterone, testosterone.

It helps maintain the normal function of the thyroid and parathyroid glands, adrenal cortex, as well as the β-cells of the pancreas that secrete insulin.

Reproductive function. Vitamin D has a positive effect on reproductive function in both women and men, including couples planning pregnancy or experiencing difficulties conceiving a child.

In women with sufficient levels of vitamin D, fertilization of eggs occurs more often. The absence of vitamin D deficiency can improve IVF outcomes. Vitamin D can have a positive effect on the endometrium, preventing proliferative processes, improves ovarian folliculogenesis and promotes egg maturation.

Carbohydrate and fat metabolism. Vitamin D helps improve carbohydrate and fat metabolism, positively affects the metabolism of glucose and insulin, and vitamin D deficiency is a risk factor for the development of insulin resistance and impaired glucose tolerance.

Vitamin D can stimulate insulin secretion by pancreatic β-cells, and also indirectly activates calcium-dependent endopeptidase of β-cells, which converts proinsulin into active insulin. Vitamin D can affect tissue sensitivity to insulin by stimulating the expression of insulin receptors in cells.

Vitamin D can help reduce the blood levels of total cholesterol, triglycerides, and low-density lipids. Due to these properties, vitamin D plays a significant role in the correction of obesity and metabolic disorders. It inhibits lipid peroxidation processes.

Cardiovascular system. Vitamin D plays an important role in maintaining the function of the cardiovascular system: it positively affects the inner layer and muscular wall of blood vessels, as well as blood clotting processes.

It has a positive effect on the activity of the renin-angiotensin system, which is involved in the regulation of blood pressure, contributing to the normalization of arterial vascular tone and preventing an increase in blood pressure.

Immune system. It helps maintain healthy immune function, positively affecting both innate and acquired immunity.

It triggers the synthesis of its own antimicrobial substances in the cells of the skin, epithelium of the respiratory and gastrointestinal tract: the proteins cathelicidin and defensin, which destroy viruses, bacteria, and fungi, thereby helping to reduce the risk of developing colds.

Vitamin D regulates the synthesis of substances (anti-inflammatory mediators) by immune cells that help suppress inflammatory reactions in the body, and also suppresses autoimmune reactions, preventing the development of immune-inflammatory conditions.

Nervous system. Vitamin D is involved in the processes of regulating the activity of the nervous system, positively affecting cognitive functions: memory, attention, the ability to assimilate information, and performance.

Vitamin D plays an important role in the mechanisms of protecting the brain from damage – neuroprotection. It helps improve mood by participating in the process of converting tryptophan (an amino acid that enters the body with food) into serotonin – a neurotransmitter that is of great importance for a person’s psycho-emotional state.

Vitamin D can have a positive effect on pain sensitivity by suppressing the synthesis of inflammatory mediators by immune cells.

Bronchopulmonary system. Vitamin D is a necessary factor for maintaining normal lung function. It is involved in maintaining the function of the respiratory tract muscles, regulating the activity of immune cells, and a healthy inflammatory response.

Vitamin D helps improve the respiratory function of the lungs and increase the body’s protection against a wide range of infections, including tuberculosis and acute respiratory infections.

Skin. Vitamin D helps improve metabolic processes in the skin, increase its protective properties, and initiate programs for restoring the function of skin cells.

Vitamin D is a protective factor for the skin against photoaging (in which the barrier function of the skin and collagen production decrease, the skin loses elasticity, becomes dry and flabby, prone to the development of inflammatory changes).

Digestive system. Vitamin D affects the homeostasis of the gastrointestinal mucosa, contributing to the protection and preservation of the integrity of the epithelial barrier and its healing ability.

Due to its influence on the function of immune cells, vitamin D helps suppress autoimmune inflammatory processes in the intestine. Vitamin D has a positive effect on the function of the gastrointestinal tract.

Regulation of energy metabolism. Vitamin D helps relieve fatigue and increase body tone by regulating the energy potential of cells: as a result of the influence of vitamin D, the production of ATP (adenosine triphosphate) increases in the mitochondria of cells, which is its own universal source of energy for all biochemical processes occurring in the body.

Regulation of cell growth. Vitamin D has a regulatory effect on the growth, development, and renewal of cells.

Epidemiological studies conducted in Russia have established that a reduced concentration of vitamin D in the blood is observed in 50-92% of the adult working-age population and children, regardless of the season.

The reasons for vitamin D deficiency in most of the Russian population are both its insufficient intake with food and the low level of its synthesis in the skin due to the geographical location of the Russian Federation (low insolation).

Health disorders associated with vitamin D deficiency

• The main manifestation of vitamin D deficiency in childhood is rickets, in adults – osteomalacia;
• In elderly people, vitamin D deficiency is primarily associated with muscle weakness, poor physical function and impaired balance, and increased bone fragility.

The Panel on Dietetic Products, Nutrition and Allergies of the European Food Safety Authority has established a link between the intake of vitamin D from food and its contribution to the normal functioning of the immune system.

Vitamin D₃ (Colecalciferol), when taken orally, is almost completely absorbed (up to 80%) in the distal part of the small intestine due to the formation of micellar compounds in the small intestine environment. C_max in tissues is reached in 4-5 hours, after which the concentration decreases somewhat, remaining at a constant level for a long time.

* TR CU 022/2011, “Food products regarding their labeling”;
** Does not exceed the upper permissible level of intake, “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)” of the Customs Union of the EAEU.

Scope of Application

• As a dietary supplement to food – an additional source of vitamin D for: strengthening bones and teeth, maintaining immunity, relieving fatigue and increasing tone, maintaining muscle strength, assimilating information, concentrating attention and developing memory, maintaining reproductive function, replenishing deficiency and maintaining normal levels of vitamin D.

ICD codes

Dosage Regimen

Adults – 1/4 tab./day.

Duration of intake – 6 months.

Intake of vitamin D is especially recommended during the cold season from September to April.

Contraindications

• Individual intolerance to the components of the dietary supplement.

Use during pregnancy and lactation

This product should be taken by pregnant and breastfeeding women on the recommendation of a doctor.

Special instructions

A dietary supplement to food, not a medicine.

It is recommended to consult a doctor before use.

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

Over-the-Counter

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.