Videin forte

INSTRUCTION

for medical use of the medicinal product

VIDEYIN FORTE

(VIDEYIN FORTE)

Composition:

active substance: cholecalciferol;

1 capsule contains 500 µg of cholecalciferol (vitamin D₃ — 20000 IU);

excipients: α-tocopherol acetate, medium-chain triglycerides;

capsule shell: gelatin, glycerol.

Pharmaceutical form. Soft capsules.

Main physicochemical properties: soft gelatin capsules, oval, with a seam, light yellow in colour, filled with a colourless or slightly yellowish oily liquid.

Pharmacotherapeutic group. Vitamins. Vitamin D and analogues. Cholecalciferol. ATC code A11C C05.

Pharmacological properties.

Pharmacodynamics.

Cholecalciferol (vitamin D₃) is synthesised in the skin from 7-dehydrocholesterol under the action of ultraviolet radiation and is converted into its biologically active form (1,25-hydroxycholecalciferol) in two hydroxylation steps: first in the liver (position 25) and then in the renal tissues (position 1). Together with parathyroid hormone and calcitonin, 1,25-dihydroxycholecalciferol plays a significant role in regulating the balance of calcium and phosphate levels. In its biologically active form, vitamin D₃ stimulates the absorption of calcium in the intestine, the penetration of calcium into osteoid and the release of calcium from bone tissue. In the small intestine it promotes rapid and delayed calcium uptake. In addition, passive and active phosphate transport is stimulated. In the kidneys it inhibits the excretion of calcium and phosphates by stimulating tubular resorption. The biologically active form of cholecalciferol directly inhibits the production of parathyroid hormone in the parathyroid glands. Parathyroid hormone secretion is additionally suppressed as a result of increased calcium uptake in the small intestine under the action of biologically active vitamin D₃.

So-called vitamin D₃, in terms of its formation, physiological regulation and mechanism of action, can be regarded as a precursor of a steroid hormone. In addition to physiological production in the skin, cholecalciferol may enter the body with food or as a medicinal product. This latter route may cause overdose and intoxication, since in this case there is no inhibition of the physiological production of vitamin D as occurs with synthesis in the skin.

Occurrence in nature and meeting requirements

The reference amount of vitamin D for adults is 20 µg, which corresponds to 800 IU per day. Healthy adults can meet their vitamin D requirements through endogenous synthesis provided there is sufficient sunlight. Obtaining vitamin D from food is of only secondary importance, but may be significant under certain critical conditions (climate, lifestyle).

Fish liver oil and fish are particularly rich in vitamin D, although small amounts are also found in meat, eggs, yolks, milk, dairy products and avocado.

Signs of vitamin D deficiency

Signs of vitamin D deficiency may appear, for example, in preterm newborns, in infants exclusively breastfed for more than 6 months without calcium supplementation, or in children on a strict vegetarian diet. The rare vitamin D deficiency in adults may be caused by insufficient dietary intake, lack of adequate ultraviolet exposure, impaired absorption and digestion, liver cirrhosis and renal failure.

In the case of vitamin D deficiency, calcification of the skeleton does not occur (leading to the development of rickets) or decalcification of bone occurs (leading to the development of osteomalacia). Calcium and/or vitamin D deficiency causes a reversible increase in parathyroid hormone secretion. Such secondary hyperparathyroidism increases bone tissue metabolism, which may lead to bone fragility and fractures.

Pharmacokinetics.

Vitamin D, in the amount in which it is present in foodstuffs, is almost completely absorbed from food. It is absorbed together with alimentary lipids and bile acids, and therefore administration of vitamin D during the main meal of the day may promote its better absorption.

Distribution and biotransformation

The metabolic conversion of cholecalciferol takes place in the liver by means of microsomal hydroxylase with the formation of 25-hydroxycholecalciferol (25 (OH) D₃). It is then converted in the kidneys into 1,25-dihydroxycholecalciferol, which is the biologically active form.

After a single oral dose of cholecalciferol, the maximum serum concentration of 25 (OH) D₃, as the main storage form, is reached after approximately one week. Thereafter, 25 (OH) D₃ is eliminated slowly with an apparent serum half-life of approximately 50 days. After administration of vitamin D in high doses, the serum concentration of 25-hydroxycholecalciferol may remain elevated for several months. Hypercalcaemia caused by overdose may persist for several weeks (see section "Overdose").

Excretion

The metabolites bound to specific α-globin that circulate in the blood are excreted mainly with bile and faeces.

Special patient groups

In persons with impaired renal function, the metabolic clearance rate is reduced by 57 % compared with healthy volunteers.

In the case of malabsorption, the absorption of vitamin D₃ is reduced and its elimination is increased. Obese people show a lower ability to maintain vitamin D₃ levels on sun exposure, and higher oral doses of vitamin D₃ may be required to correct the deficiency.

Clinical particulars.

Indications.

• For the treatment of clinically confirmed vitamin D deficiency in adults.
• For the prevention of vitamin D deficiency in patients at high risk.
• As an adjunct to specific osteoporosis therapy in patients with vitamin D deficiency or at high risk of vitamin D insufficiency.

Contraindications.

• Hypersensitivity to the components of the medicinal product.
• Hypercalcaemia.
• Hypercalciuria.
• Hypervitaminosis D.
• Pseudohypoparathyroidism (the vitamin D requirement may be lower than during the period of normal sensitivity to the vitamin, with a risk of prolonged overdose).
• Nephrolithiasis (urolithiasis).
• Renal failure.
• Sarcoidosis.
• Tuberculosis.
• Additional intake of vitamin D (may lead to overdose).

Interaction with other medicinal products and other forms of interaction.

Concomitant use of anticonvulsants (such as phenytoin and phenobarbital) or barbiturates (as well as other medicines that induce hepatic enzymes) may lead to a reduced effect of vitamin D₃ due to metabolic inactivation.

Rifampicin may reduce the efficacy of cholecalciferol due to induction of hepatic enzymes.

Isoniazid may reduce the efficacy of cholecalciferol due to inhibition of the metabolic activation of cholecalciferol.

Ion-exchange resins, laxatives and orlistat may reduce the absorption of vitamin D in the gastrointestinal tract.

The cytotoxic agent actinomycin and imidazole antifungals reduce the activity of vitamin D₃ by inhibiting the conversion of 25-hydroxycholecalciferol into 1,25-dihydroxycholecalciferol by renal enzymes with the formation of 25-hydroxyvitamin D-1-hydrolase.

Glucocorticoids increase vitamin D metabolism, which may lead to reduced efficacy of vitamin D.

Concomitant administration of benzothiadiazine derivatives (thiazide diuretics) increases the risk of hypercalcaemia due to reduced renal calcium excretion. Therefore, calcium levels in plasma and urine must be monitored.

The combination of the medicinal product Videyin forte, 20000 IU, with vitamin D metabolites or analogues should be avoided. Concomitant administration of vitamin D₃ with vitamin D metabolites or analogues is possible only as an exception and only with monitoring of serum calcium levels (it increases the risk of toxic effects).

Oral administration of vitamin D together with cardiac glycosides may enhance the efficacy and toxicity of digitalis due to increased calcium levels (risk of cardiac arrhythmias). In such patients, ECG should be performed regularly and calcium levels in plasma and urine checked, and the concentration of digoxin or digitoxin determined where possible.

Concomitant use of the product with antacids containing aluminium or magnesium may provoke toxic effects of aluminium on bone and hypermagnesaemia in patients with renal failure.

Ketoconazole may reduce the biosynthesis and catabolism of 1,25(OH)₂-cholecalciferol.

Concomitant use with medicinal products containing high doses of calcium and phosphorus increases the risk of hyperphosphataemia.

Vitamin D may antagonise medicinal products prescribed for hypercalcaemia, such as calcitonin, etidronate, pamidronate.

Special warnings and precautions for use.

Videyin forte, 20000 IU, is not recommended for persons predisposed to the formation of calcium-containing kidney stones.

Videyin forte, 20000 IU, should be used with particular caution in patients with impaired renal function during treatment with benzothiadiazine derivatives, as well as in immobilised patients (because of the risk of hypercalcaemia and hypercalciuria). In such patients, calcium and phosphate levels must be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal failure, the normal metabolic conversion of cholecalciferol is impaired and therefore other forms of vitamin D must be used (see section "Contraindications").

Videyin forte, 20000 IU, should not be used in patients with sarcoidosis because of the risk of accelerated conversion of vitamin D into its active metabolites. In such patients, calcium levels in plasma and urine must be monitored.

When the medicinal product is used at an equivalent daily dose exceeding 1000 IU of vitamin D, serum and urinary calcium levels must be monitored and renal function checked by determining serum creatinine concentration. Such monitoring is especially important for elderly patients and during concomitant treatment with cardiac glycosides or diuretics (see section "Interaction with other medicinal products and other forms of interaction"). This also applies to patients predisposed to the formation of calcium-containing kidney stones.

For individual patients it is recommended to consider additional calcium supplementation. Food supplements containing calcium should be used under careful medical supervision to prevent hypercalcaemia.

Before starting treatment with vitamin D, a careful assessment of the patient's condition by a doctor is required, taking into account the additional amount of vitamin D that the patient consumes with certain foods.

Elderly patients (> 65 years)

According to published data, in elderly people with a history of falls, the risk of falling increased with the monthly administration of 60000 IU of vitamin D. Therefore, the use of the medicinal product Videyin forte, 20000 IU, in elderly patients is recommended only after a careful benefit–risk analysis and only where there are clear indications. The dose of 24000 IU per month (one capsule) should not be exceeded. For elderly patients with a history of falls, it is recommended to consider daily administration of additional vitamin D.

In persons aged > 70 years treated with vitamin D under a loading-dose protocol, serum 25(OH)D₃ levels must also be checked regularly. Treatment should be discontinued if the level is ≥ 50 ng/ml.

Use during pregnancy or breastfeeding.

Pregnancy

During pregnancy, the medicinal product Videyin forte, 20000 IU, may be prescribed only where there are clear indications, when it is absolutely necessary to correct vitamin D deficiency.

During pregnancy, overdose of vitamin D should be avoided, since prolonged hypercalcaemia may lead to delayed physical and mental development of the child and to the occurrence of supravalvular aortic stenosis and retinopathy in the child.

Breastfeeding

Vitamin D and its metabolites pass into breast milk. No cases of overdose have been observed in breastfed newborns. However, this should be taken into account if additional vitamin D is prescribed for the child. Breastfeeding women are not recommended to be prescribed treatment with vitamin D at a high dose, for example in capsules of 20000 IU.

Fertility

In studies of the effect of cholecalciferol on reproductive function and fertility in animals, no effects were observed. The potential benefit–risk ratio for humans remains unknown.

Effects on the ability to drive and operate machinery. Videyin forte, 20000 IU, has no or negligible influence on the ability to drive a car or operate other machinery. However, when driving or operating other machinery, particular caution is recommended in view of the possibility of adverse reactions of the nervous system.

Method of administration and dosage.

Method of administration

For oral use.

Adults should take the capsule swallowed whole with a sufficient amount of water, preferably during the main meal of the day.

Dosage

The dosage of vitamin D depends on the severity of the disease and on the patients' response to treatment. Depending on patients' needs, possibilities and preferences, daily, weekly or monthly regimens may be offered. Dosage forms with a lower strength (for example 400 IU, 500 IU, 800 IU and 1000 IU) are suitable for daily vitamin D supplementation, whereas forms with a higher strength, for example capsules of 20000 IU, contain an amount corresponding to weekly and monthly doses of vitamin D, which should be taken into account. The dose is prescribed by a doctor in each individual case.

Patients in certain groups have a higher risk of vitamin D deficiency and may require higher doses and monitoring of serum 25-hydroxycholecalciferol (25 (OH) D₃) concentration:

• persons residing in specialised institutions, or hospitalised persons;
• dark-skinned persons;
• persons with limited effective sun exposure due to wearing protective clothing or the constant use of sunscreens;
• patients with osteoporosis;
• obese persons;
• persons taking certain concomitant medicines (for example, anticonvulsants, glucocorticoids);
• persons recently treated for vitamin D deficiency who require maintenance therapy;
• patients with malabsorption, including inflammatory bowel disease and coeliac disease.

Dosage recommendations:

Initial treatment of vitamin D deficiency: 40000 IU per week for 6–12 weeks.

Treatment of vitamin D deficiency and maintenance of its level: from 60000 to 120000 IU per month for a period of up to 6 months.

Prevention of vitamin D deficiency: 20000 IU per week regardless of the baseline level, during the period from November to April.

Adjunct to specific osteoporosis therapy in patients with vitamin D deficiency or in patients at risk of vitamin D insufficiency:

Adults and elderly patients: from 20000 to 40000 IU per month in combination with a calcium product, if necessary.

Elderly people with a history of falls should avoid doses exceeding 24000 IU per month (see also section "Special warnings and precautions for use").

Patients with impaired renal function / hypercalcaemia: in the presence of hypercalcaemia or signs of reduced renal function, the dose must be reduced or treatment discontinued. If hypercalciuria occurs (more than 7.5 mmol, corresponding to 300 mg of calcium per 24 hours), the dose should be reduced or treatment discontinued.

Children. The medicinal product is not recommended for children and adolescents (under 18 years of age) due to the lack of data on the dosage regimen and the risk of choking when capsules are taken by children. Instead, it is appropriate to use drops or dispersible tablets.

Overdose.

Vitamin D₃ regulates calcium and phosphate metabolism — after an overdose, hypercalcaemia, hypercalciuria, renal calcium deposits and bone damage occur, as well as changes in the cardiovascular system. Hypercalcaemia occurs after administration of 50000–100000 IU of vitamin D₃ per day.

Symptoms of overdose. Acute and chronic overdose of vitamin D₃ may cause hypercalcaemia, which may become persistent and life-threatening. Symptoms may be non-specific and manifest as cardiac arrhythmia, thirst, dehydration, adynamia and impaired consciousness. In addition, chronic overdose may lead to calcium deposition in blood vessels and tissues.

In addition to increased phosphorus levels in serum and urine, overdose may also cause hypercalcaemic syndrome, which subsequently leads to calcium deposition in tissues and, in particular, in the kidneys (nephrolithiasis, nephrocalcinosis, renal failure), as well as in blood vessels.

Symptoms of intoxication are not very specific and manifest as muscle weakness, loss of appetite, nausea, vomiting, initial frequent diarrhoea followed by constipation, anorexia, dyspnoea, headache, myalgia, arthralgia, muscle weakness and persistent drowsiness, arrhythmia, azotaemia, polydipsia and polyuria, as well as (at the pre-terminal stage) dehydration of the body, photosensitivity, pancreatitis, rhinorrhoea, hyperthermia, decreased libido, conjunctivitis, hypercholesterolaemia, increased transaminase activity, arterial hypertension, uraemia. Muscle and joint pain are frequent symptoms.

Impaired renal function develops with albuminuria, erythrocyturia and polyuria, increased potassium loss, hyposthenuria, nocturia and a moderate increase in blood pressure.

In severe cases, corneal opacity is possible, more rarely — papilloedema of the optic nerve, inflammation of the iris up to the development of cataract.

Calculi may form in the kidneys, and calcification in soft tissues such as blood vessels, heart, lungs and skin.

Cholestatic jaundice develops rarely.

Characteristic biochemical abnormalities are hypercalcaemia, hypercalciuria and an increased serum concentration of 25-hydroxycalciferol.

Treatment. The appearance of symptoms of chronic vitamin D overdose may require forced diuresis, as well as the administration of glucocorticoids and calcitonin.

In case of overdose, measures should be taken to correct the often chronic and potentially life-threatening hypercalcaemia.

As the principal measure, vitamin D intake must be discontinued; normalisation of calcium levels in hypercalcaemia resulting from vitamin D intoxication takes several weeks.

Depending on the degree of hypercalcaemia, a calcium-free or low-calcium diet may be used, and intake of large amounts of fluid, forced diuresis with furosemide, and administration of glucocorticoids and calcitonin are recommended.

With normal renal function, calcium levels can in most cases be reduced by infusion of isotonic sodium chloride solution (3–6 litres over 24 hours) with the addition of furosemide; in some cases the administration of sodium edetate at a dose of 15 mg / kg body weight / h with constant monitoring of calcium levels and ECG is also recommended. However, in oligoanuria, haemodialysis must be performed (using a calcium-free dialysate).

No specific antidote is known.

Patients receiving long-term treatment with vitamin D at higher doses are recommended to be informed about the symptoms of possible overdose (nausea, vomiting, initial frequent diarrhoea followed by constipation, anorexia, dizziness, headache, myalgia, arthralgia, muscle weakness, drowsiness, azotaemia, polydipsia and polyuria).

Adverse reactions

As a rule, adverse reactions are not observed when taken at the recommended doses.

In the case of individual sensitivity to the medicinal product, which is noted rarely, or as a result of the use of very high doses over a long period, hypervitaminosis D may occur.

Adverse reactions are listed below by system organ class in accordance with MedDRA [Medical Dictionary for Regulatory Activities] by frequency of occurrence.

Cases of rhinorrhoea and hyperthermia have also been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is of great importance. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are asked to report any suspected adverse reactions and any lack of efficacy of the medicinal product via the automated information system for pharmacovigilance at: https://aisf.dec.gov.ua

Shelf life. 3 years.

Storage conditions. Store in the original package at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Package. 10 capsules in a blister; 2 blisters in a carton.

10 capsules in a blister; 6 blisters in a carton.

Dispensing category. On prescription.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Location of the manufacturer and address of its place of business. 38 Kopylivska Street, Kyiv, 04073, Ukraine.

Website: www.vitamin.com.ua

Date of last revision. 22.04.2026