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

Logo SB LAXATIVE MIXTURE

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME:
(and dosage form)

SB LAXATIVE MIXTURE

COMPOSITION:
Each 5 mL contains.
Magnesium sulphate   1,875 g
Preservative: 
Sodium methylparaben   0,1% m/v
Availability of Magnesium in the maximum daily dose:
2,27 g per 30 mL

PHARMACOLOGICAL CLASSIFICATION:
A 11.5 Laxatives

PHARMACOLOGICAL ACTION:
Magnesium sulphate acts by its osmotic properties thus increasing stimulation of fluid secretion, thereby promoting bowel movement.

INDICATIONS:
For the relief of occasional constipation.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
Should not be used in patients with impaired renal function as it may lead to hypermagnesaemia which may result in flushing of the skin, thirst, hypotension due to peripheral vasodilation drowsiness, confusion, loss or tendon reflexes respiratory depression, cardiac arrythmias, coma and cardiac arrest.

WARNINGS:
1. This medicine should not be used in the presence of abdominal pain, nausea or vomiting.
2. Frequent or prolonged use of this preparation may result in dependance on laxatives and loss of normal bowel function.
3. This product should not be used for a period longer than one week, unless directed by a doctor.
4. If you have noticed a sudden change in bowel habits that has persisted for a period greater than 2 weeks, consult a doctor before using a laxative.
5. Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a serious condition. Discontinue use and consult a doctor.
6. Magnesium sulphate should be used with caution in patients receiving digitalis glycosides.

DOSAGE AND DIRECTIONS FOR USE:
This product generally produces bowel movement in a half hour to six hours.
To be taken once in the morning and once at night, when needed for constipation.
Adults and children 12 years and over: 3 Medicine measures (15 mL): Children 6 to under 12 years: 2 Medicine measures - (10 mL); 2 to under 6 years: 1 Medicine measure (5 mL). Not recommended for use in children under 2 years of age.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Do not exceed the stated dose.
Magnesium salts should be used with care by those with impaired renal function and those receiving Digitalis glycosides. Acute ingestion may cause gastro-intestinal irritation and watery diarrhoea.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Excessive use of Magnesium leads to the development of hypermagnesaemia (See warnings)
See side-effects and special precautions.
Treatment is supportive and symptomatic.

IDENTIFICATION:
Dark brown mixture with a bitter, liquorice taste.

PRESENTATION:
200 mL Glass bottle with a plastic screwcap.

STORAGE INSTRUCTIONS:
Store in a cool, dry place below 25°C.
Keep out of reach of children.

REGISTRATION NUMBER:
E/11.5/715

NAME AND BUSINESS ADDRESS OF APPLICANT:
Universal Pharmaceuticals (Pty) Ltd
7 Browning Street, Jeppe, Johannesburg.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13 November, 1996

Code: SB11I

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