VICOMBIL Coated tablet (2020)

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Περιεχόμενα

1. Name of the medicinal product

Vicombil, coated tablets.

2. 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 ...

3. Pharmaceutical form

Coated tablets.

4.1. Therapeutic indications

Prophylaxis and treatment of multivitamin deficiencies.

4.2. Posology and method of administration

Posology Adults and adolescents Prophylaxis: 1 tablet daily. Treatment: 1 tablet, 2 to 4 times daily.

4.3. Contraindications

VICOMBIL is contraindicated in situations of hypervitaminosis and hypersensitivity to one or more vitamins included in its composition.

4.4. Special warnings and precautions for use

Allergic hypersensitivity to one or more vitamins included in VICOMBIL.

4.5. Interaction with other medicinal products and other forms of interaction

Some of the vitamins included in VICOMBIL may have interactions with other drugs. However, if therapeutically adequate, usually the doses of vitamins included in VICOMBIL are not too high to develop such ...

4.6. Pregnancy and lactation

Vicombil may be used during pregnancy and lactation. However, the use of large doses of vitamin A should be avoided generally during normal pregnancy. The use of large doses of pyridoxine during pregnancy ...

4.7. Effects on ability to drive and use machines

Vicombil has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

If the recommended doses are not exceeded side effects will not be observed. Overdosage may develop signs of hypervitaminosis A and D. Reporting of suspected adverse reactions Reporting suspected adverse ...

4.9. Overdose

Some vitamins included in VICOMBIL (e.g. vitamins A and D) may develop symptoms of hypervitaminosis, if large doses are administered, for long term periods. Therefore the recommended dose should not be ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: 11.3.1.3 Association of vitamins ATC code: A11BA Vitamins are a group of substances with several chemical compositions which may be defined as organic substances ...

5.2. Pharmacokinetic properties

All vitamins in VICOMBIL are well absorbed by digestive tract. Once absorbed they are more or less stored and metabolized. However vitamin B12 is rapidly absorbed if there does not exist deficiency ...

5.3. Preclinical safety data

The safety of use of the different vitamins in VICOMBIL is well established: The hydrosoluble ones are practically nontoxic, except for the cases of susceptibility to vitamins B1 and B ...

6.1. List of excipients

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

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25ºC.

6.5. Nature and contents of container

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

6.6. Special precautions for disposal and other handling

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

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

8. Marketing authorization number(s)

18570

9. Date of first authorization / renewal of the authorization

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

10. Date of revision of the text

12/11/2020

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