Ultra-D Vitamin D3 25 mcg 1000 IU (Tablets) Instructions for Use

Marketing Authorization Holder

Orion Pharma, LLC (Russia)

Manufactured By

Pharmia, Oy (Finland)

For

ORION CORPORATION (Finland)

Contact Information

ORION CORPORATION ORION PHARMA (Finland)

Dosage Form

Ultra-D Vitamin D3 25 mcg (1000 IU)

Chewable tablets 25 mcg (1000 IU): 30, 60, 90, 120, 180, 240, 360 or 720 pcs.

Dosage Form, Packaging, and Product Composition

Chewable tablets weighing 425 mg.

* cholecalciferol.

Excipients: sweetener xylitol (E967), sweetener sorbitol (E420), thickener hydroxypropyl cellulose (E463), anticaking agent magnesium salts of fatty acids, antioxidant alpha-tocopherol (E307), palm oil, carrier modified starch (E1450), sucrose, antioxidant sodium ascorbate (E301), anticaking agent amorphous silicon dioxide (E551), raspberry flavor, peach flavor.

Nutritional value of 1 tablet: sugar alcohols – 0.4 g, energy value – 0.9 kcal (4.9 kJ).

30 pcs. – plastic bottles (1) with a label.
60 pcs. – plastic bottles (1) with a label.
90 pcs. – plastic bottles (1) with a label.
120 pcs. – plastic bottles (1) with a label.
180 pcs. – plastic bottles (1) with a label.
240 pcs. – plastic bottles (1) with a label.
360 pcs. – plastic bottles (1) with a label.
720 pcs. – plastic bottles (1) with a label.
30 pcs. – plastic bottles (1) with a label – cardboard packs.
60 pcs. – plastic bottles (1) with a label – cardboard packs.
90 pcs. – plastic bottles (1) with a label – cardboard packs.
120 pcs. – plastic bottles (1) with a label – cardboard packs.
180 pcs. – plastic bottles (1) with a label – cardboard packs.
240 pcs. – plastic bottles (1) with a label – cardboard packs.
360 pcs. – plastic bottles (1) with a label – cardboard packs.
720 pcs. – plastic bottles (1) with a label – cardboard packs.

Therapeutic Category

Dietary supplement – source of vitamin D

Properties

Vitamin D₃ (Cholecalciferol) is a biologically active substance, a fat-soluble vitamin. It enters the human body with food, but its content in foods is low, and absorption is only possible in a healthy intestine. Most of the vitamin D should be synthesized in the skin under the influence of ultraviolet light, but only with sufficient time spent in the sun and sufficient intensity of UV radiation. According to epidemiological studies¹, more than 80% of the adult population in Russia has insufficiency or deficiency of vitamin D, and such insufficiency is noted both in summer and winter. Only 3.5% of Russian women have normal vitamin D levels².

The biological role of vitamin D is explained by the presence of specific receptors in more than 40 organs and tissues and the control of more than 200 genes³.

Classical effects are associated with the regulation of calcium-phosphorus metabolism: vitamin D increases the absorption of calcium and phosphorus in the intestine, increases their reabsorption in the kidneys, promotes increased mineralization and elasticity of bone tissue, normalizes neuromuscular transmission, and prevents myopathies against the background of mineral metabolism disorders (manifested by muscle weakness, difficulty walking, maintaining balance, and a tendency to falls). An adequate level of vitamin D in children prevents the development of rickets, and in adults – osteomalacia (decreased bone strength)³.

Non-classical (non-skeletal effects)

Reproductive functions Vitamin D may positively influence the production of sex hormones (estradiol and progesterone). Vitamin D deficiency is observed in 67-85% of women with polycystic ovary syndrome². Restoring the recommended concentrations of vitamin D in the blood in these women helps correct metabolic disorders, improve the quality of the endometrium, and restore the menstrual cycle⁴. In IVF programs, pregnancy occurs 1.5 times more often in women with sufficient levels of vitamin D⁵. The likelihood of having a child after ART/IVF is significantly higher in women without vitamin D deficiency⁶. Low levels of vitamin D are associated with an increased risk of developing endometriosis². During menopause, the need for vitamin D increases due to the increased risk of developing osteoporosis⁷.

Pregnancy During this period, vitamin D is especially important for both the mother and the unborn child. As studies show, low levels of vitamin D are associated with an increased risk of developing gestational diabetes, preterm birth², preeclampsia, and cesarean section⁵. Hypovitaminosis D in the mother leads to rickets in children, including congenital rickets, an increased risk of intrauterine infection, and impaired immune regulation⁸. Children born to mothers with normal vitamin D levels are less likely to suffer from respiratory viral infections and bronchiolitis³.

Lactation The period of breastfeeding is a time of increased need for vitamin D for the mother⁷.

Male fertility Vitamin D deficiency in men can lead to the development of secondary hypogonadism (deficiency of sex hormones), decreased testosterone production, impaired spermogram parameters (decrease in the total number of spermatozoa, the number of spermatozoa with normal morphology, and a decrease in their motility and linear velocity), as well as an increased risk of developing type 2 diabetes, which is a factor in the development of male infertility^9,10.

Nervous system By participating in the production of neurotransmitters (substances that transmit impulses between neurons), vitamin D has a positive effect on cognitive functions, the psychoemotional sphere, and performance, improves mood, and helps combat stress^3,11.

Immune system The immunomodulatory effect is associated with the activation of all parts of the immune system. Vitamin D stimulates the activity of immune system cells in the bone marrow and has anti-inflammatory properties¹².

Metabolism Normal levels of vitamin D contribute to the normalization of fat metabolism, have a positive effect on the course of metabolic syndrome, and reduce the level of total cholesterol, triglycerides, and low-density lipids. Normalization of energy production in cells leads to increased vitality¹³.

Endocrine system Vitamin D insufficiency plays a role in the formation of insulin resistance and the manifestation of glucose tolerance. According to research, against the background of vitamin D deficiency, insulin production by pancreatic cells decreases³, and the function of the parathyroid gland and adrenal glands is impaired¹⁴.

Scope of Application

Of the product Ultra-D Vitamin D3 25 mcg (1000 IU)

• As a dietary supplement – an additional source of vitamin D.

ICD codes

Dosage Regimen

Adults 1/2 tab. once/day, with meals.

The recommended daily dose (1/2 tab.) contains

* TR TS 022/2011 “Food products regarding their labeling”.
** MR 2.3.1.2432-08. Norms of physiological requirements for energy and nutrients for various groups of the population of the Russian Federation. M., 2008.
*** Does not exceed the upper permissible level of intake, Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control).

Duration of administration – 2 weeks.

Side effects

The manifestation of side effects of vitamin D directly depends on the dose consumed; side effects occur in case of a significant excess of the recommended doses.

Contraindications

• Individual intolerance to the components.

Use during pregnancy and lactation

At the planning stage and during pregnancy, vitamin D is especially necessary for both the mother and the unborn child. At the preparation stage for pregnancy, the intake of preventive or deficiency-correcting doses (if vitamin deficiency is detected) is recommended. Hypovitaminosis D in these situations is subject to mandatory correction^18,19. During pregnancy, the dosage of vitamin D intake is determined by the doctor.

Special instructions

Dietary supplement, not a medicinal product.

Consult a physician before use.

The determination of the daily dose and duration of vitamin D intake can be made by the doctor individually, depending on the results of laboratory tests and anamnestic data, and may differ from that recommended in this leaflet. Do not exceed the dose recommended by your doctor.

Due to solubilization (interaction with saliva components), the absorption of the vitamin from the chewable tablets Ultra-D Vitamin D3 25 mcg (1000 IU) begins in the oral cavity. The oral mucosa is abundantly supplied with blood, due to which vitamin D quickly enters the bloodstream. After swallowing, the absorption of vitamin D continues in the small intestine due to the formation of micelles (multilayered colloidal particles)^15,16. The dual mechanism of cholecalciferol absorption from the chewable tablet ensures a high rate of absorption and the achievement of an adequate level of vitamin D in the blood serum¹⁷.

Contains a sweetener. May have a laxative effect if consumed in excess.

Nutritional value of 1 tablet: sugar alcohols – 0.4 g, energy value – 0.9 kcal (4.9 kJ).

Dispensing Status

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

Storage Conditions

Ultra-D Vitamin D3 25 mcg (1000 IU) should be stored in the original packaging in a dry place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date stated 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.