BEROCCA

BEROCCA® TABLETS Complete Information

A Prescription-Only Multivitamin Formulation For Nutritional Supplementation In Conditions Requiring Water-Soluble Vitamins

DESCRIPTION
Berocca is a oral multivitamin tablet specially formulated for prophylactic or therapeutic nutritional supplementation in conditions requiring water-soluble vitamins.Berocca tablets supply therapeutic levels of ascorbic acid, vitamins B1, B2, B6, niacin and pantothenic acid and a supplemental level of vitamin B12. Berocca tablets also supply a supplemental level of folic acid for pregnant or lactating women and a therapeutic level for adults and children four or more years of age.

CLINICAL PHARMACOLOGY
Vitamins are essential for normal metabolic functions including hematopoiesis. The B-complex vitamins are necessary for the conversion of carbohydrate, protein and fat into tissue and energy. Ascorbic acid (vitamin C) is involved in collagen formation and tissue repair. The water-soluble vitamins (B-complex and C) are not significantly stored by the body; excess quantities are excreted in the urine. They must be replenished regularly through diet or other means to maintain essential tissue levels. Thus, these vitamins are rapidly depleted in conditions interfering with their intake or absorption.

INDICATIONS AND USAGE
Berocca is indicated for supportive nutritional supplementation in conditions in which water-soluble vitamins are required prophylactically or therapeutically. These include: Conditions causing depletion, or reduced absorption or bioavailability of water-soluble vitamins - Gastrointestinal disorders, chronic alcoholism, febrile illnesses, prolonged or wasting diseases, hyperthyroidism or poorly-controlled diabetes. Conditions resulting in increased needs for water-soluble vitamins - Pregnancy, severe burns, recovery from surgery.

CONTRAINDICATIONS
Berocca is contraindicated in patients known to be hypersensitive to any of its components. CONTRAINDICATIONS: Berocca is contraindicated in patients known to be hypersensitive to any of its components. WARNINGS: Berocca is not intended for treatment of pernicious anemia or other megaloblastic anemias where vitamin B12 is deficient. Neurologic involvement may develop or progress, despite temporary remission of anemia, in patients with vitamin B12 deficiency who receive supplemental folic acid and who are inadequately treated with B12.

PRECAUTIONS
General: Certain conditions listed above may require additional nutritional supplementation. During pregnancy, for instance, supplementation with fat-soluble vitamins and minerals may be required according to the dietary habits of the individual. Berocca is not intended for treatment of severe specific deficiencies. Information for the Patient: Because toxic reactions have been reported with injudicious use of certain vitamins, urge patients to follow your specific instructions regarding dosage regimen. As with any medication, advise patients to keep Berocca out of reach of children. Drug and Treatment Interactions: As little as 5 mg pyridoxine daily can decrease the efficacy of levodopa in the treatment of parkinsonism. Therefore, Berocca is not recommended for patients undergoing such therapy. Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

DOSAGE AND ADMINISTRATION: Usual adult dosage: one tablet daily.

Each Berocca tablet contains:

Each tablet contains 285mg of sodium, which should be taken into account by those on a low sodium diet. Vitamins can only be of assistance if the dietary vitamin intake is inadequate.

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