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Doppelherz® Aktiv Vitamin D 1000 IU (Tablets) Instructions for Use

Marketing Authorization Holder

Quisser Pharma LLC (Russia)

Manufactured By

Queisser Pharma, GmbH & Co. KG (Germany)

Dosage Form

Bottle OTC Icon Doppelherz® aktiv Vitamin D 1000 IU Tablets: 30 pcs.

Dosage Form, Packaging, and Product Composition

Tablets weighing 278 mg

1/2 tab. (1 dose) % of RULP#
Colecalciferol (vit. D3) 12.5 mcg 250%*

# % of the recommended daily intake level.
* does not exceed the upper permissible level of recommended daily intake according to the “Unified Sanitary-Epidemiological and Hygienic Requirements for Goods Subject to Sanitary-Epidemiological Surveillance (Control)” of the EurAsEC Customs Union, approved by the CTC Decision No. 299 dated 28.05.2010, appendix 5.

Excipients: microcrystalline cellulose (anti-caking agent), hypromellose (thickener), croscarmellose sodium (stabilizer), titanium dioxide (colorant), magnesium salts of fatty acids (anti-caking agent), polyethylene glycol (glazing agent), amorphous silicon dioxide (anti-caking agent), talc (anti-caking agent).

Nutritional value (1/2 tab.): protein – 0 g, fat – 0 g, carbohydrates – 0 g.
Energy value (1/2 tab.): 1 kJ/1 kcal.

10 pcs. – blisters (3) – cardboard packs.

Therapeutic Category

Dietary supplement – additional source of vitamin D3

Properties

Biologically active food supplement.

Replenishes the daily requirement for vitamin D.

The precursor of vitamin D is synthesized in human skin under the influence of ultraviolet rays from sunlight. A certain amount of vitamin D enters the body with food (fish oil, butter, eggs, milk, mushrooms).

Vitamin D deficiency can manifest as muscle weakness, discomfort in bones and muscles, difficulty walking, frequent colds, and constant fatigue.

This product can be used if adequate intake of vitamin D cannot be guaranteed, for example, due to unbalanced food consumption or lack of sunlight. Moreover, with age, vitamin D levels decrease even in people living in regions with sufficient insolation. Causes of vitamin D deficiency can include the geographical location of the area of residence, which causes scattering of solar rays in the atmosphere or a small number of sunny days per year, as well as the use of sunscreens. Furthermore, impaired absorption of nutrients in gastrointestinal diseases, excess body weight, and the use of certain medications can play a role in the development of vitamin D deficiency.

This product can be taken to maintain normal levels of vitamin D3 (colecalciferol) regardless of the season, insolation, food preferences, or diet.

Vitamin D is necessary for maintaining: the body’s energy potential – helps reduce feelings of fatigue and improve well-being; immune system activity, which may help reduce the risk of developing colds; levels of calcium and phosphorus in the body, which helps ensure the strength of bones and teeth; normal cell division; healthy functioning of the nervous system, including the psycho-emotional sphere and cognitive functions; normal reproductive function in women and men.

Some products may contain vitamin E.

Vitamin E has an antioxidant effect, participates in heme and protein biosynthesis, cell proliferation, tissue respiration, other important processes of tissue metabolism, prevents hemolysis of erythrocytes, and prevents increased permeability and fragility of capillaries.

Scope of Application

As a biologically active food supplement – an additional source of vitamin D3.

ICD codes

ICD-10 code Indication
E55 Vitamin D deficiency
ICD-11 code Indication
5B57.Z Vitamin D deficiency, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Used in accordance with the recommendations for the specific product used.

Side effects

Possible allergic reactions.

Contraindications

Hypersensitivity to the components of the product used.

Use during pregnancy and breastfeeding

Pregnant and breastfeeding women should take products intended for this category of consumers on the recommendation and under the supervision of a doctor.

Special instructions

Biologically active food supplement; not a medicinal product.

Consultation with a doctor is recommended before use.

In children, dietary supplements intended for this category of patients should be used after consultation with a pediatrician.

Drug Interactions

Concomitant use of other dietary supplements and medicinal products containing Colecalciferol is not recommended.

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.

Medical Disclaimer

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