VICOMBIL Coated tablet Ref.[50696] Active ingredients: Calcium Folic acid Nicotinic acid Pyridoxine Riboflavin Vitamin A Vitamin B1 Vitamin B12 Vitamin C Vitamin D2 Vitamin E

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: BIAL – Portela & Cª, S.A., À Av. da Siderurgia Nacional, 4745 457 S. Mamede do Coronado, Portugal

Product name and form

Vicombil, coated tablets.

Pharmaceutical Form

Coated tablets.

Qualitative and quantitative composition

Retinol 5000 I.U., Ergocalciferol 500 I.U., Tocopherol acetate 10 mg, Thiamine HCl 3 mg, Riboflavin 2 mg, Pyridoxine HCl 3 mg, Cyanocobalamin 1 mcg, Ascorbic acid 75 mg, Nicotinamide 20 mg, Folic acid 0,2 mg, Calcium pantothenate 5 mg (per coated tablet).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Calcium

Calcium plays a vital role in the anatomy, physiology and biochemistry of organisms and of the cell, particularly in signal transduction pathways. The skeleton acts as a major mineral storage site for the element and releases Ca2+ ions into the bloodstream under controlled conditions. Circulating calcium is either in the free, ionized form or bound to blood proteins such as serum albumin. Although calcium flow to and from the bone is neutral, about 5 mmol is turned over a day. Bone serves as an important storage point for calcium, as it contains 99% of the total body calcium.

Folic acid

Folic acid is a member of the vitamin B group which is reduced in the body to tetrahydrofolate, a co-enzyme active in several metabolic processes and produces a haemopoietic response in nutritional megaloblastic anaemias. Folic acid is rapidly absorbed and widely distributed in body tissues.

Nicotinic acid

Niacin (nicotinic acid) is an essential B complex Vitamin (B3), whose deficiency results in the clinical syndrome known as pellagra. Nicotinamide (niacinamide), the active ingredient, is the physiologically active form of niacin and is the chemical form of Vitamin B3 found in virtually all multivitamin products. Though nicotinic acid and nicotinamide are so closely related chemically, they differ somewhat in pharmacological properties.

Pyridoxine

Pyridoxine hydrochloride is Vitamin B6. It is converted to pyridoxal phosphate which is the co-enzyme for a variety of metabolic transformations. It is essential for human nutrition.

Riboflavin

Riboflavine is phosphorylated to flavine mononucleotide and flavine adenine dinucleotide which act as co-enzymes in the respiratory chain and in oxidative phosphorylation. Riboflavine deficiency presents with ocular symptoms, as well as lesions on the lips and at angles of the mouth.

Vitamin A

Vitamin A plays an important role in the visual process. It is isomerised to the 11-cis isomer and subsequently bound to the opsin to form the photoreceptor for vision under subdued light. Vitamin A also participates in the formation and maintenance of the integrity of epithelial tissues and mucous membranes.

Vitamin B1

Thiamine pyrophosphate (TPP), the coenzymatic form of thiamine, is involved in two main types of metabolic reactions: decarboxylation of α-ketoacids (e.g. pyruvate, α-ketoglutarate and branched-chain keto acids) and transketolation (e.g. among hexose and pentose phosphates). Therefore, the principal physiological role of thiamine is as a coenzyme in carbohydrate metabolism, where TPP is required for several stages in the breakdown of glucose to provide energy.

Vitamin B12

Hydroxocobalamin is used in the treatment and prevention of Vitamin B12 deficiency. For adults, the daily requirement of Vitamin B12 is probably about 1 to 2 micrograms and this amount is present in most normal diets. However, Vitamin B12 only occurs in animal products, not in vegetables, and therefore strict vegetarian or vegan diets that exclude dairy products may provide an inadequate amount, although a deficiency may not be apparent for many years.

Vitamin C

Ascorbic acid, coupled with dehydroascorbic acid to which it is reversibly oxidised, has a variety of functions in cellular oxidation processes. Ascorbic acid is required in several important hydroxylations, including the conversion of proline to hydroxyproline and appears to have an important role in metal ion metabolism, including the gastrointestinal absorption of iron and its transport between plasma and storage organs.

Vitamin D2

Vitamin D2 (ergocalciferol) is a fat soluble vitamin. In conjunction with parathyroid hormone and calcitonin, it regulates calcium haemostasis. Ergocalciferol metabolites promote active absorption of calcium and phosphorous by the small intestine, increase rate of excretion and resorption of minerals in bone and promote resorption of minerals in bone and promote resorption of phosphate by renal tubules.

Vitamin E

Vitamin E is known to exert an important physiological function as an antioxidant for fats, with a sparing action on vitamin A, carotenoids and on unsaturated fatty acids. Other work has demonstrated that vitamin E is connected with the maintenance of certain factors essential for the normal metabolic cycle.

List of Excipients

Calcium phosphate
Polyvinyl pirrolidone
Microcrystalline cellulose
Magnesium stearate
Talc
Methyl hydroxypropyl cellulose
Opaspray
Diethyl phthalate
Ethyl cellulose

Pack sizes and marketing

Carton box containing 60 tablets in blister Alu/Alu and a leaflet information.

Marketing authorization holder

BIAL – Portela & Cª, S.A., À Av. da Siderurgia Nacional, 4745 – 457 S. Mamede do Coronado, Portugal

Marketing authorization dates and numbers

18570

Date of first authorisation: 3 February 2000
Date of latest renewal: 27 May 2011

Drugs

Drug Countries
VICOMBIL Cyprus

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