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

Logo ALTACITE TABLETS
ALTACITE SUSPENSION
SCHEDULING STATUS :
Unscheduled

PROPRIETARY NAME :
(and dosage form)

ALTACITE TABLETS
ALTACITE SUSPENSION

COMPOSITION :
Tablets :
        Each tablet contains 500 mg hydrotalcite.
Suspension :
        Each 5 mL of suspension contains 500 mg hydrotalcite
        (preservative: bronopol 0,02% m/v).

PHARMACOLOGICAL CLASSIFICATION :
A.11.4 antacid/antipepsin.

PHARMACOLOGICAL ACTION :
Hydrotalcite adjusts stomach acidity to within the optimum range of pH 3,0 - 5,0 whilst at the same time inhibiting pepsin activity.

INDICATIONS:
Acid-pepsin disorders, peptic ulceration, gastritis, dyspepsia, hyper-acidity, 'heartburn' associated with reflux oesophagitis and hiatus hernia.

CONTRA-INDICATIONS :
Renal insufficiency.

DOSAGE AND DIRECTIONS FOR USE:
Adults:        1 to 2 tablets to be chewed slowly and swallowed, or 1 to 2 medicine measuresful to be taken between meals.
Children :        (Age 6 - 12 years) ½-1½ tablets or ½ -1½ medicine measuresful.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Occasional nausea and/or diarrhoea.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No acute or lasting effects of overdosage are to be expected.

IDENTIFICATION:
Tablets :        White 15 mm cylindrical, flat bevelled edge tablet flavoured with buttermint, marked ‘altacite’on one side and ‘roussel’on the reverse.

Suspension :        An aqueous suspension, slightly off-white, viscous and flavoured with buttermint.

PRESENTATION:
White buttermint flavoured tablets marked 'altacite’in packs of 30’s and 100’s, and a 200 mL bottle of white buttermint flavoured suspension.

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

REGISTRATION NUMBER :
Tablets:        E/11.4/165.
Suspension:        E/11.4/164.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Roussel Laboratories (Pty) Limited
REG. NO. 66/01057/07
5th Street, Marlboro Ext.1, Sandton 2199.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
26th March 1979

ALE 01211

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