INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BEMINAL* 500 Tablets
SCHEDULING STATUS:
Unscheduled.

PROPRIETARY NAME
(and dosage form):

BEMINAL* 500 Tablets

COMPOSITION:
Each tablet contains:
Vitamin C
500,0 mg
Vitamin B1 25,0 mg
Vitamin B2 12,5 mg
Vitamin B6 10,0 mg
Vitamin B12 5,0 micrograms
Niacinamide 100,0 mg
Calcium pantothenate 20,0 mg
Does not contain saccharin or other sweeteners.

PHARMACOLOGICAL CLASSIFICATION:
Category A,22.1.5 Vitamins (Vitamin B-complex with Vitamin C).

PHARMACOLOGICAL ACTION:
A dietary supplement.

INDICATIONS:
BEMINAL* 500 Tablet is indicated as a dietary supplement where a deficiency of the relevant vitamins exists.

CONTRA-INDICATIONS:
Hypersensitivity to any of the active ingredients.

DOSAGE AND DIRECTIONS FOR USE:
Children aged 12 years and older, and Adults:
One tablet daily, or as directed by the physician.
Do not exceed the recommended dosage.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Niacinamide:
Flushing, a sensation of heat, faintness, pounding in the head, urticaria, pruritus, furunculosis, other skin lesions, abdominal cramps, diarrhoea, nausea and vomiting, malaise, anorexia, activiation of peptic ulcer, amblyopia, jaundice and impairment of liver function, decrease in glucose tolerance, mild diabetes, and hyperuricaemia may occur. Most of these effects subside on withdrawal of the niacinamide. Niacinamide should be given cautiously to patients with a history of peptic ulceration.
Vitamin C:
Large doses may cause diarrhoea and the formation renal calcium oxalate calculi. Doses of 600 mg or more daily have a diuretic action. Ascorbic acid should be administered with care to patients with hyperoxaluria. Tolerance may be induced in patients taking high doses.
Vitamin B6:
Long term administration of large doses of Vitamin B6 (pyridoxine) is associated with the development of severe peripheral neuropathies. Pyridoxine reduces the effects of levodopa, but this does not occur if a dopa decarboxylase inhibitor is also given.
Vitamin B12
It can mask symptoms of subacute degeneration of the spinal cord. Allergic hypersensitivity reactions have been reported following the administration of Vitamin B12 compounds, cyanocobalamin and hydrocobalamin. Cyanocobalamin and hydrocobalamin should, if possible, not be given to patients without first confirming the diagnosis, and should not be used to treat megaloblastic anemia of pregnancy. Administration of doses greater than 10 micrograms may produce a hematological response in patients with a folate deficiency; indiscriminate use may mask the precise diagnosis. Serum concentrations may be decreased by the concurrent administration of oral contraceptives.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Generally:
Treatment is symptomatic and supportive.

IDENTIFICATION:
BEMINAL* 500 is an oval, orange film-coated tablet.

PRESENTATION:
BEMINAL* 500 Tablets are presented in securitainers of 30 tablets

STORAGE INSTRUCTIONS:
To be kept tightly dosed, and stored in a cool (below 25°C), dry place.
Keep out of reach of children.

REFERENCE NUMBER:
H2380 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
AKROMED PRODUCTS (PTY) LTD.
(Co. Reg. no. 05/13586/07)
Electron Avenue, ISANDO, 1600

*Registered Trademark.
*Under licence from WYETH-AYERST LABORATORIES. U.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23 November 1989

        260-9033
        Davbar Dbn.

Current: January 2005
Source: Pharmaceutical Industry

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