INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
BISODOL® TABLETS
BISODOL® POWDER

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

BISODOL^® TABLETS
BISODOL^® POWDER

COMPOSITION:
Each tablet contains:

	Magnesium Carbonate, Light	67,60 mg
	Sodium Bicarbonate	62,01 mg
	Chalk (Calcium Carbonate)	521,52 mg

Each 5 mL of powder contains:

	Magnesium Carbonate, Heavy	18,36 mg
	Magnesium Carbonate, Light	345,51 mg
	Sodium Bicarbonate	532,08 mg

PHARMACOLOGICAL CLASSIFICATION:
A.11.4.1 Antacids - acid neutralizers.

PHARMACOLOGICAL ACTION:
Acid-neutralizing; diminishes activity of pepsin in gastric secretion.

INDICATIONS:
For the relief of acid indigestion, heartburn, hyperacidity, dyspepsia, gastritis, oesophageal reflux with heartburn/reflux oesophagitis.

CONTRA-INDICATIONS:
Do not use BISODOL if you have kidney disease, except under the advice and supervision of a doctor.

WARNINGS:
Do not use BISODOL if you are on a sodium restricted diet, or suffer from hypertension or heart failure, except under the supervision of a doctor.

Use with care in patients with renal failure. May enhance the cardiac effects of digitalis glycosides. May interfere with the absorption of other medicines given concomitantly. Do not take more than the recommended dosage in a 24 hour period. Do not use the maximum dosage of BISODOL for more than 2 weeks, except under the advice and supervision of a doctor.
KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:

TABLETS:	Allow one tablet to dissolve slowly in the mouth when required or as directed by a doctor. Do not take more than 10 tablets per day.
POWDER:	Take 5 mL (medicine measure) mixed in one-third of a glass of water, after meals or when required or as directed by a doctor. Do not take more than 20 mL of powder per day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Calcium Carbonate may cause constipation. Flatulence from released carbon dioxide is usually not serious, eructations may occur in some patients. Hypercalcemia and alkalosis can occur following regular use of calcium carbonate.

Milk Alkali Syndrome has occurred, usually in patients taking higher doses.

Magnesium Carbonate may cause diarrhoea. Release of carbon dioxide may cause discomfort. Hypermagneseamia may occur if renal function is impaired

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
If the recommended dosage is followed, BISODOL should have no untoward effects. If heavy overdosage is suspected or distressing symptoms occur, cease medication and consult your doctor immediately.

IDENTIFICATION:

TABLETS:	White, smooth tablets with bevelled edges, free from specks and blemishes with a breakline on one side.
POWDER:	Fine, white powder with peppermint flavour.

PRESENTATION:

TABLETS:	Strip-pack of 24 tablets and blister packs.
POWDER:	Securitainer of 100 g.

STORAGE INSTRUCTIONS:
Store in a cool, dry place (below 25 °C), well-sealed.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:

TABLETS:	E/11.4.1/916
POWDER:	E/11.4.1/914

NAME AND BUSINESS ADDRESS OF APPLICANT:
S.A.D. SELF MEDICATION [PTY] LIMITED
(Co. Reg. No. 92/04769/07)
Robbie de Lange Road, Wilsonia, EAST LONDON 5201

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
December 1993
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