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

Logo MAGNESIT® Tablets
MAGNESIT® Granules

SCHEDULING STATUS:
Not Scheduled

PROPRIETARY NAME
(and dosage form):

MAGNESIT® Tablets
MAGNESIT
® Granules

COMPOSITION:
Each tablet contains:
Magnesium-l-aspartate hydrochloride ––                614,8 mg
Magnesium content: = 2,5 mmol (60,78 mg)

Each 5 g granules (one sachet) contains:
Magnesium-l-aspartate hydrochloride ––                1229,6 mg
Magnesium content: = 5 mmol (121,56 mg)
Digestible carbohydrates ––                3,1 g

PHARMACOLOGICAL CLASSIFICATION:
A24 (Mineral substitutes, electrolytes)

PHARMACOLOGICAL ACTION:
Magnesium is essential for the activity of many enzyme systems and plays an important role with regard to neuro-chemical transmission and muscular excitability.

INDICATIONS:
MAGNESIT is a magnesium supplement for the treatment of hypomagnesaemia and magnesium deficiency.

CONTRA-INDICATIONS:
Renal impairment and acute dehydration. Hypersensitivity to the ingredients.

DOSAGE AND DIRECTIONS FOR USE:
The dosage schedule should be adjusted according to the severity of the magnesium deficiency. In hypomagnesaemia the drug should be given daily over a period of 4 weeks.
The average daily dose is 4,5 mg of magnesium (0,185 mmol) per kg body weight.
The following guidelines should be observed:
ADULTS AND CHILDREN OVER 10 YEARS:
2 tablets with fluid, three times daily before meals.
The contents of one sachet (5g) three times daily before meals.
The granules should be dissolved in half a glass of water, mineral water, tea or fruit juice.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Diarrhoea and bowel discomfort may occur and in these cases the daily dose should be reduced.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Fatigue due to prolonged treatment or the administration of high doses may be indicative of abnormally high serum magnesium concentrations. In such cases, treatment should be temporarily withdrawn and the serum magnesium levels should be determined.
Toxic effects due to overdose of MAGNESIT by the oral route have not been reported.
However, serum levels over 5 mmol/litre could cause respiratory difficulty and absence of the deep tendon reflexes. At 6 to 7,5 mmol/litre the patient could be comatose and concentrations exceeding 8 mmol/litre would lead to respiratory paralysis and diastolic cardiac arrest.
Subjects with renal insufficiency might develop hypermagnesaemia characterized by nausea, vomiting, lethargy and blockage of the bladder when the serum concentration of magnesium ranges from 2,5 to 4,5 mmol/litre.

IDENTIFICATION:
MAGNESIT Tablets: White oblong tablet.
MAGNESIT Granules:
Almost white, free-flowing granules without lumps. Slight odour of lemons ––there should be no odour of isopropanol. Characteristic taste of lemons at first, followed by a sour and sweet taste.

PRESENTATION:
MAGNESIT Tablets are available in packs of 30 and 60 tablets
MAGNESIT Granules are available in packs of 20 and 50 sachets of 5 g.

STORAGE INSTRUCTIONS:
Store at room temperature (below 30°C). Keep all medicines out of reach of children.

REGISTRATION NUMBERS:
MAGNESIT Tablets: S/24/191
MAGNESIT Granules: S/24/192

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
BYK MADAUS (PTY) LTD.
2nd Road (Cnr. 16th Road)
Randjespark
1685 Midrand

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
11 January 1993

POSTAL ADDRESS:
BYK MADAUS (PTY) LTD.
P O Box 3435
1685 Halfway House

MPI 04/97/06
        Kreser

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