VitUmnus diabetes (Capsules) Instructions for Use

Marketing Authorization Holder

Kron, LLC (Russia)

Manufactured By

VTF, LLC (Russia)

Dosage Form

VitUmnus diabetes

Capsules: 30 pcs.

Dosage Form, Packaging, and Product Composition

Capsules weighing 580 mg.

¹ % of the recommended level of daily consumption according to TR TS 022/2011 “Food products in terms of their labeling” (Appendix 2).
² % of the 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 the nutritional value of the product is determined by calculation based on the average content of the biologically active substance (BAS) in the product.

Composition magnesium oxide, gelatin capsule (gelatin, colorant (titanium dioxide)), Ascorbic acid, Taurine, zinc citrate, carrier (microcrystalline cellulose), Alpha-Tocopherol Acetate 50% (DL-Alpha-Tocopherol Acetate, modified starch, maltodextrin, silicon dioxide), Lipoic acid, Rutin, Niacinamide, ginkgo biloba leaf extract, Calcium pantothenate, anti-caking agent (magnesium stearate (magnesium salt of stearic acid)), Retinyl acetate 500000 IU/g, Pyridoxine hydrochloride, anti-caking agent (amorphous silicon dioxide), Thiamine hydrochloride, Riboflavin, chromium aspartate, Folic acid, sodium selenite, Cyanocobalamin.

Retinyl acetate 500000 IU/g (gelatin, corn starch, sucrose, Retinyl acetate, butylated hydroxytoluene) or Retinyl acetate 500000 IU/g (sucrose, gelatin, starch ester of aluminum salt of octenyl succinic acid, Retinyl acetate, butylated hydroxytoluene, sodium aluminosilicate).

Nutritional value (1 caps.): carbohydrates – 0.02 g.
Energy value (1 caps.): 2.04 kJ/0.48 kcal.

15 pcs. – blisters (2) – carton packs.

Therapeutic Category

Dietary supplement for correction of metabolism

Indications

• As a dietary supplement to food – an additional source of vitamins A, E, C, B1, B2, B3 (PP), B5, B6, B9, B12, magnesium, zinc, selenium, chromium, lipoic acid, taurine, rutin and flavonglycosides.
• To help compensate for the deficiency of essential micronutrients in individuals with impaired carbohydrate metabolism.
• For use as part of complex metabolic therapy to support the normal function of the nervous system, visual apparatus, and antioxidant protection of the body.
• To assist in maintaining normal blood glucose levels and improving insulin sensitivity in combination with a balanced diet and lifestyle modifications.

It is crucial to understand that this product is not a medicine and is not intended for the diagnosis, treatment, or cure of diabetes mellitus or any other disease. Its use should be complementary to, and not a replacement for, a comprehensive management plan prescribed by a healthcare professional.

Contraindications

• Individual intolerance to any of the components of the dietary supplement.
• Pregnancy and breastfeeding (lactation). The safety and efficacy of the product during these periods have not been established, and the high-potency vitamin and mineral composition may pose a risk.
• Children and adolescents under 18 years of age, due to the lack of data on safety and dosage appropriateness for this population group.
• Patients with severe impairment of liver or kidney function, as the product’s components are metabolized and excreted by these organs, and their compromised function could lead to accumulation and potential toxicity.
• Patients with urolithiasis (particularly oxalate stones) and conditions associated with increased iron accumulation (hemochromatosis, thalassemia), as certain vitamins can exacerbate these conditions.
• Concomitant use with levodopa without the cover of peripheral decarboxylase inhibitors, as high doses of vitamin B6 (pyridoxine) can reduce the effectiveness of levodopa.

Before starting the supplement, a consultation with a physician or pharmacist is mandatory to assess potential risks and ensure compatibility with the individual’s health status and concomitant therapy.

Dosage Regimen

For adults: take 1 capsule once daily with meals. The capsule should be swallowed whole with a sufficient amount of water (approximately 150-200 ml). Do not chew.

The duration of intake is 1 month. If necessary, the course can be repeated after a break of 1-2 months, or as recommended by a healthcare provider. Adherence to the recommended dosage is critical to avoid exceeding the upper tolerable intake levels for certain vitamins and minerals.

It is advisable to take the supplement at approximately the same time each day to maintain stable levels of micronutrients in the body. The product is intended for use as part of a balanced and varied diet; it is not a substitute for a healthy lifestyle.

Adverse Reactions

Adverse reactions are generally rare and mild when the product is used at the recommended dosage. However, in cases of individual hypersensitivity or pre-existing conditions, the following may occur:

Allergic reactions are possible, including skin rash, itching, urticaria, and redness of the skin. In isolated cases, more severe reactions such as angioedema may develop, requiring immediate discontinuation of the supplement and seeking medical attention.

From the gastrointestinal tract: dyspepsia, nausea, epigastric discomfort, diarrhea, or constipation may occur, especially when taken on an empty stomach. Taking the capsule with food usually mitigates these effects.

Due to the high content of B vitamins, a transient, harmless darkening or bright yellow coloration of urine may be observed, which is not a cause for concern. If any persistent or severe adverse effects occur, discontinue use immediately and consult a physician.

Drug Interactions

The components of VitUmnus diabetes can interact with certain medications, which may necessitate dosage adjustments or medical supervision.

Vitamin B6 (Pyridoxine) can antagonize the therapeutic effect of levodopa in Parkinson’s disease if taken without a peripheral decarboxylase inhibitor (e.g., carbidopa). Vitamin B9 (Folic acid) may reduce the plasma concentrations and effectiveness of phenytoin and other hydantoin anticonvulsants, potentially increasing the risk of seizures.

High doses of Vitamin E may enhance the effect of anticoagulant drugs (e.g., warfarin, acenocoumarol) and antiplatelet agents (e.g., clopidogrel, aspirin), increasing the risk of bleeding. Vitamin C in high doses can interfere with the anticoagulant effect of warfarin and may affect urine glucose tests, leading to false-negative results.

Zinc can reduce the absorption of tetracycline and fluoroquinolone antibiotics (e.g., ciprofloxacin, levofloxacin) and bisphosphonates (e.g., alendronate). It is recommended to take the supplement at least 2 hours before or 4-6 hours after taking these medications. Magnesium can form insoluble complexes with these same drug classes, similarly impairing their absorption.

Inform your doctor about all the medications, including over-the-counter drugs and other dietary supplements, you are taking before starting this product.

Overdose

Acute overdose with this dietary supplement is unlikely due to the packaging; however, chronic intake significantly exceeding the recommended dose can lead to hypervitaminosis and toxic effects, particularly for the fat-soluble vitamins A and E, as well as selenium and chromium.

Symptoms of acute or chronic Vitamin A overdose (hypervitaminosis A) may include severe headache, dizziness, blurred vision, nausea, vomiting, drowsiness, irritability, peeling of the skin, and in severe cases, increased intracranial pressure (pseudotumor cerebri) and liver damage.

Symptoms of Vitamin E overdose may include fatigue, weakness, blurred vision, and gastrointestinal disturbances. Due to its anticoagulant properties, excessive intake significantly increases the risk of hemorrhagic complications.

In case of suspected overdose, immediately discontinue the supplement and seek medical attention or contact a poison control center. Treatment is symptomatic and supportive. There is no specific antidote. Gastric lavage and administration of activated charcoal may be considered if the overdose is recent.

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.