D3 Forte (Capsules) Instructions for Use

Marketing Authorization Holder

Besin Healthcare Rus, LLC (Russia)

Manufactured By

Besins Healthcare Brasil Comercial e Distribuidora de Medicamentos, Ltda (Brazil)

Contact Information

BESINS HEALTHCARE RUS LLC (Russia)

Dosage Form

D3 Forte

Capsules 50 mcg (2000 IU): 60 pcs.

Dosage Form, Packaging, and Product Composition

Capsules soft gelatin, oval in shape, bright orange in color, weighing 0.23 g.

* “Unified Sanitary-Epidemiological and Hygienic Requirements for Goods Subject to Sanitary-Epidemiological Surveillance (Control)” of the EurAsEC Customs Union;
** Does not exceed the upper permissible intake level according to MR 2.3.1.24320-08 “Norms of Physiological Requirements for Energy and Nutrients for Various Groups of the Population of the Russian Federation”; M., 2008.

Excipients: caprylic acid triglyceride (Miglyol 812), tocopherol (vitamin E), gelatin, glycerol (glycerin), purified water, colors: titanium dioxide, yellow pigment, red pigment, red iron oxide.

Energy value (1 caps.): 4 kcal (16.74 kJ).

10 pcs. – blisters (6) – cardboard packs.

Therapeutic Category

Dietary supplement – additional source of vitamin D₃

Properties

D3 Forte contains vitamin D₃ (Colecalciferol) – a biologically active substance, a fat-soluble vitamin, necessary for the functioning of almost all organs and systems of the human body.

Vitamin D is naturally present only in a very limited number of food products, and synthesis in the human body is only possible under certain conditions, when ultraviolet rays from sunlight hit the skin.

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 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, as a result of which, especially elderly people, may experience difficulties when 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 pancreatic β-cells 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.

Vitamin D affects reproductive processes in women and men due to the presence of receptors for this vitamin in the organs of the reproductive system.

In women with a sufficient level of vitamin D in the blood (30 ng/ml and above), fertilization of eggs occurs more often.

A sufficient level of vitamin D can improve IVF outcomes.

Vitamin D can have a positive effect on the endometrium, preventing proliferative processes, improves ovarian folliculogenesis and promotes egg maturation.

Taking vitamin D can increase endometrial thickness in women with polycystic ovary syndrome.

In addition, in women with polycystic ovary syndrome, vitamin D plays a significant role in correcting obesity and the course of metabolic syndrome.

Taking vitamin D has a positive effect on menstrual cycle disorders.

In late reproductive age, the probability of pregnancy in women with high levels of vitamin D in the blood is higher.

In women during the menopausal transition and after menopause, the need for vitamin D is higher, due to the increased risk of developing osteoporosis.

Vitamin D supplementation in men is positively associated with sperm quality and motility, and normalization of gonadotropin hormone levels.

Carbohydrate and fat metabolism. Vitamin D helps improve carbohydrate-fat metabolism, positively affects glucose and insulin metabolism, and vitamin D deficiency is a risk factor for the development of insulin resistance, 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 influence tissue sensitivity to insulin by stimulating the expression of insulin receptors in cells.

Vitamin D can help reduce the levels of total cholesterol, triglycerides, and low-density lipids in the blood.

Due to these properties, vitamin D plays a significant role in correcting 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 vessel tone and preventing an increase in blood pressure.

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

It triggers the synthesis of its own antimicrobial substances in skin cells, respiratory epithelium, and gastrointestinal tract epithelium: cathelicidin and defensin proteins, 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 respiratory tract muscles, regulating the activity of immune cells, and a healthy inflammatory response.

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

Studies have established that maternal intake of vitamin D was associated with a lower risk of developing obstructive lung diseases in children.

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

Vitamin D is a protective factor for the skin against photoaging (which reduces the skin’s barrier function and collagen production, 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 positively affects 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, which is the body’s own universal source of energy for all biochemical processes occurring in the body, increases in the mitochondria of cells.

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

Dementia. Vitamin D deficiency in adults may be associated with the risk of developing dementia, including Alzheimer’s disease.

As research shows, vitamin D may provide protection for elderly patients against neurodegenerative diseases.

Vitamin D receptors and 1α-hydroxylase are widely distributed in all parts of the brain, affecting the cognitive functions of the hippocampus.

Vitamin D promotes the phagocytosis of amyloid plaques, regulation of neurotrophins; with low levels of vitamin D, the risk of decreased cognitive function and dementia increases.

Malignant neoplasms. There is data on the influence of vitamin D on the proliferation of epithelial cells.

The results of observational studies show the greatest association between reduced vitamin D levels and the development of colorectal cancer; data regarding cancers of other locations, including breast, prostate, and overall cancer incidence, have less evidence.

Research in this area continues.

Thus, adequate intake of vitamin D and its concentration in serum are important for bone health and calcium-phosphorus metabolism, as well as for the optimal functioning of many organs and tissues.

Epidemiological studies conducted in Russia have established that 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 causes of vitamin D deficiency in the majority 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).

Scope of Application

Of the product D3 Forte

As a dietary supplement – 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

Take orally, with meals.

Adults – 1 caps. once/day.

Side effects

The occurrence of side effects of vitamin D directly depends on the dose consumed; side effects occur when taking doses significantly exceeding the recommended ones.

Contraindications

• Individual intolerance to the components.

Use during pregnancy and breastfeeding

Published research data to date in humans show that antenatal use of vitamin D (during pregnancy) is safe at doses recommended for pregnant women. To date, not a single case of teratogenic effect of vitamin D in humans has been registered. Women planning pregnancy and pregnant women are advised to additionally receive vitamin D, since the entire territory of the Russian Federation is located in an area endemic for vitamin D deficiency.

Special instructions

Dietary supplement, not a medicinal product.

Determination of the daily dose and duration of vitamin D intake can be done individually by a doctor and, depending on the results of laboratory tests, may differ from the dose recommended by the manufacturer. The dose recommended by the doctor should not be exceeded.

According to the “Clinical Guidelines of the Russian Association of Endocrinologists for the Diagnosis, Treatment and Prevention of Vitamin D Deficiency in Adults”

• Broad population screening for vitamin D deficiency is not recommended. Screening for vitamin D deficiency is indicated only for patients with risk factors for its development;
• Vitamin D deficiency is defined as a concentration of 25(OH)D <20 ng/ ml (50 nmol/l), insufficiency - a concentration of 25(OH)D from 20 to 30 ng/ml (from 50 to 75 nmol/l), adequate levels - more than 30 ng/ml (75 nmol/l). Recommended target values for 25(OH)D when correcting vitamin D deficiency are 30-60 ng/ml (75-150 nmol/l);
• The recommended drugs for the prevention of vitamin D deficiency are Colecalciferol (D3) and ergocalciferol (D2);
• Pregnant and breastfeeding women are recommended to receive at least 800-1200 IU of vitamin D per day for the prevention of vitamin D deficiency;
• To maintain a level of 25(OH)D above 30 ng/ml, an intake of at least 1500-2000 IU of vitamin D per day may be required;
• In diseases/conditions accompanied by impaired absorption/metabolism of vitamin D, it is recommended to take vitamin D in doses 2-3 times higher than the daily requirement of the age group;
• Without medical supervision and control of the level of 25(OH)D in the blood, it is not recommended to prescribe doses of vitamin D exceeding 10,000 IU per day for a long period (> 6 months).

If it is impossible to control the level of 25(OH)D during long-term (> 6 months) treatment, it is recommended to adhere to doses not exceeding 4000 IU/day for persons without risk factors for vitamin D insufficiency and not more than 10000 IU/day for persons at risk of vitamin D deficiency.

When determining the individual dose of vitamin D, it is necessary to take into account its amount coming from food.

In case of impaired renal function, vitamin D should be used with caution; prior consultation with a doctor is necessary.

Dispensing Status

Places of sale are determined by the national legislation of the member states of the Eurasian Economic Union.

Storage Conditions

The product should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 24 months. Do not use after the expiration date printed on the packaging.

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.