VitUmnus 55+ (Tablets) Instructions for Use

Marketing Authorization Holder

Kron, LLC (Russia)

Manufactured By

VTF, LLC (Russia)

Dosage Form

VitUmnus 55+

Tablets: 60 pcs.

Dosage Form, Packaging, and Product Composition

Tablets mass of 760 mg.

^# in conversion to tocopherol equivalent.
¹ % from recommended daily consumption level according to TR TS 022/2011 “Food products in part of its labeling” (Appendix 2).
² % from adequate consumption level according to “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)” (Appendix 5).
* does not exceed the upper permissible consumption level according to “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)”.
Information on nutritional value of product is determined by calculation method by average value of content of biologically active substance (BAS) in product.

Composition calcium carbonate, magnesium oxide, Chondroitin sulfate sodium, Ascorbic acid, carrier (microcrystalline cellulose), zinc citrate, carrier (maltodextrin), Alpha-Tocopherol Acetate 50% (DL-Alpha-Tocopherol Acetate, modified starch, maltodextrin, amorphous silicon dioxide), carriers (hydroxypropylmethylcellulose, polyvinylpyrrolidone), Beta-carotene 20%, ginkgo biloba extract, Niacinamide, Iron electrolytic, colorant (titanium dioxide), anti-caking agent (talc), carrier (sodium croscarmellose), anti-caking agent (amorphous silicon dioxide), vitamin A acetate 500000 IU/g, Calcium pantothenate, manganese sulfate, carriers (magnesium stearate (magnesium salt of stearic acid), sodium carboxymethylcellulose), humectant (propylene glycol), Colecalciferol 100 IU/mg, Pyridoxine hydrochloride, copper citrate, Thiamine hydrochloride, Riboflavin, colorant (ponceau 4R), Folic acid, sodium iodate, sodium selenite, Cyanocobalamin.

Beta-carotene 20% (modified starch, corn starch, Beta-carotene, glucose syrup, sodium ascorbate, alpha-tocopherol)
Or Beta-carotene 20% (gelatin, corn starch, Beta-carotene, maltodextrin, sucrose, corn oil, alpha-tocopherol, ascorbyl palmitate),
Or Beta-carotene 20% (starch ester of sodium octenyl succinate, isomalt, Beta-carotene, corn starch, sodium ascorbate, Ascorbic acid, calcium phosphate).
vitamin A acetate 500000 IU/g (gelatin, corn starch, sucrose, vitamin A acetate, butylated hydroxytoluene)
Or vitamin A acetate 500000 IU/g (sucrose, gelatin, starch ester of aluminum octenyl succinate, vitamin A acetate, butylated hydroxytoluene, sodium aluminosilicate).
Colecalciferol 100 IU/mg (modified starch, sucrose, sodium ascorbate, medium-chain triglycerides, silicon dioxide, DL-alpha-tocopherol, Colecalciferol)
Or Colecalciferol 100 IU/mg (modified starch, sucrose, coconut oil, DL-alpha-tocopherol, silicon dioxide, Colecalciferol),
Or Colecalciferol 100 IU/mg (sucrose, gum arabic, corn starch, medium-chain triglycerides, tricalcium phosphate, Colecalciferol, DL-alpha-tocopherol).

Nutritional value (1 tab.): carbohydrates – 0.06 g.
Energy value (1 tab.): 0.54 kJ/0.13 kcal.

15 pcs. – blisters (4) – carton packs.

Therapeutic Category

Dietary supplement – source of vitamins, macro- and microelements for persons over 55 years

Indications

• To compensate for vitamin and mineral deficiencies commonly associated with aging, including reduced dietary intake and impaired nutrient absorption.
• As an adjunctive nutritional support for individuals over 55 years to help maintain overall health and metabolic functions.
• To support bone health and help reduce the risk of osteoporosis through the provision of calcium, vitamin D, and other bone-supportive minerals.
• To contribute to the maintenance of normal cognitive function and joint mobility via components like B vitamins, ginkgo biloba extract, and chondroitin sulfate.
• To assist in the normal functioning of the immune system and provide antioxidant protection against oxidative stress with vitamins C, E, selenium, and beta-carotene.

This dietary supplement is intended to fill nutritional gaps in the diet and is not intended to diagnose, treat, cure, or prevent any disease. The product should be used as part of a balanced and varied diet and a healthy lifestyle.

Contraindications

• Hypersensitivity or individual intolerance to any of the components of the dietary supplement. Careful review of the composition is necessary prior to use.
• Pregnancy and breastfeeding. The safety and necessity of use during these periods should be determined exclusively by a physician, as the requirements for vitamins and minerals differ and excessive intake can be harmful.
• Patients with severe renal impairment or renal failure, due to the potential for accumulation of minerals and fat-soluble vitamins which could exacerbate the condition.
• Conditions associated with impaired iron metabolism, such as hemochromatosis, hemosiderosis, or thalassemia, due to the iron content in the formulation.
• Hypercalcemia (elevated blood calcium levels) or hypercalciuria (elevated calcium in urine), as the supplement contains a significant amount of calcium and vitamin D.
• Patients with active peptic ulcer disease or gastritis in the acute phase, as certain components may irritate the gastrointestinal mucosa.

It is critically important to consult with a healthcare professional before starting use if you have any pre-existing chronic medical conditions or are taking any other medications or dietary supplements.

Dosage Regimen

The recommended dosage for adults, specifically persons over 55 years of age, is two tablets once daily with meals. The tablets should be swallowed whole with a sufficient amount of water (approximately 150-200 ml).

Do not chew the tablets. The duration of continuous use is one month. If necessary, the course may be repeated after a consultation with a physician. It is important to adhere to the recommended dosage to avoid potential adverse effects from excessive intake.

The supplement is intended for use as part of a balanced diet and is not a substitute for a varied and healthy lifestyle. The maximum beneficial effect is achieved with regular use as directed.

Drug Interactions

Concomitant use of VitUmnus 55+ with other products containing vitamins, minerals, or other dietary supplements may lead to excessive cumulative doses of certain nutrients, particularly fat-soluble vitamins (A, D, E, K) and minerals like iron, selenium, and zinc. This can increase the risk of toxicity.

Tetracycline and fluoroquinolone antibiotics: The calcium, magnesium, and iron in this supplement can form insoluble complexes with these antibiotics in the gastrointestinal tract, significantly reducing their absorption and efficacy. A minimum interval of 2-3 hours between taking the antibiotic and the supplement is strongly recommended.

Levothyroxine: Calcium carbonate can impair the absorption of levothyroxine. These medications should be taken at least 4 hours apart to ensure adequate absorption of the thyroid hormone.

Bisphosphonates (e.g., alendronate): Divalent and trivalent cations (calcium, magnesium, iron) can drastically reduce the absorption of bisphosphonates. A dosing interval of at least 2 hours is necessary.

Warfarin and other coumarin-derived anticoagulants: Vitamin K (not listed but potentially present in trace amounts or from other sources) can antagonize the effect of warfarin. Furthermore, high doses of vitamin E may potentially enhance anticoagulant activity and increase the risk of bleeding. Patients on such therapy should have their INR monitored closely if taking this supplement.

Diuretics: Certain diuretics, particularly thiazides, can reduce calcium excretion, which, when combined with calcium supplementation, could lead to hypercalcemia. Potassium-sparing diuretics can increase the risk of hyperkalemia when taken with supplements containing potassium (though not a primary component here, it may be present in excipients).

It is imperative to inform your doctor about all the medications and supplements you are taking to prevent potential interactions and ensure safe and effective therapy.

Adverse Reactions

When taken at the recommended dosage, adverse reactions are uncommon. However, in cases of individual sensitivity or exceeding the recommended dose, the following reactions are possible.

Allergic reactions are possible and may manifest as skin rash, itching, urticaria, and in rare cases, more severe reactions such as angioedema. If any signs of an allergic reaction appear, discontinue use immediately and seek medical attention.

Gastrointestinal disturbances may occur, including nausea, epigastric discomfort, constipation, or diarrhea. These effects are often dose-related and may be minimized by taking the supplement with food.

Due to the iron content, stool may darken, which is a harmless and expected effect. High doses of certain components, particularly fat-soluble vitamins (A, D) and minerals like selenium, if consumed chronically above recommended levels, can lead to hypervitaminosis and toxicity.

Symptoms of vitamin A excess (hypervitaminosis A) may include dizziness, headache, nausea, skin changes, and in severe cases, increased intracranial pressure. Excess vitamin D can lead to hypercalcemia, manifested by weakness, fatigue, nausea, vomiting, and renal impairment.

If you experience any adverse effects, whether listed here or not, it is recommended to stop taking the supplement and consult a healthcare professional for advice.

Overdose

Acute overdose with a single, very large dose of multivitamin-mineral supplements is rare but can lead to severe gastrointestinal upset, including nausea, vomiting, abdominal pain, and diarrhea.

Of greater concern is chronic overdose, which occurs from prolonged intake of doses significantly exceeding the recommended daily amount. This can lead to the accumulation of fat-soluble vitamins (A, D, E, K) and certain minerals, resulting in toxic effects.

Symptoms of chronic overdose may include persistent headache, bone and joint pain, generalized itching, dry skin, hair loss, lethargy, irritability, and signs of hypercalcemia (from excess vitamin D and calcium) such as thirst, polyuria, anorexia, and in severe cases, renal calcification and impaired kidney function.

In case of suspected overdose, immediately discontinue use of the supplement. Symptomatic and supportive treatment is indicated. Gastric lavage or administration of activated charcoal may be considered if a massive acute overdose has occurred recently. It is crucial to seek immediate medical attention or contact a poison control center, bringing the product packaging with you to assist healthcare providers.

Storage Conditions

Store at 2°C (36°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.