(and dosage form):
Yellow Phenolphthalein 120 mg
Sodium Benzoate 0,03 % m/m
A 11.5 Laxatives.
Phenolphthalein stimulated the bowel causing peristalsis and laxative action.
Relief of constipation.
Nausea and vomiting. Pregnancy. Phenolphthalein should not be taken by patients with symptoms of appendicitis, intestinal obstruction or abdominal pain of unknown cause, or with known sensitivity to phenolphthalein. Should prolonged use of laxatives become necessary, consult your doctor.
Should not be taken when patient is pregnant.
If a skin rash appears or if a patient is known to be sensitive in any other regard to phenolphthalein this medicine should be discontinued immediately, and this or any other preparation containing phenolphthalein should not be used in future. Continued usage in these circumstances could lead to toxic epidermal necrolysis which may be life threatening.
If a sudden change in bowel habits that persist over a period of two weeks have been noticed consult your doctor before using a laxative.
If the recommended use of this product for 1 week has had no effect, discontinue and consult your doctor.
Frequent or prolonged use of this preparation may result in dependence on laxatives.
DOSAGE AND DIRECTIONS FOR USE:
Do not exceed stated dose.
ADULT DOSE: One tablet with water at night.
This preparation is not recommended for children.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The constant use of purgatives may decrease the sensitivity of the intestinal mucous membranes. The use of purgatives may be associated with abdominal colic and flatulence and abdominal cramps may occur. Prolonged use may produce watery diarrhoea with excessive loss of water and electrolytes, particularly potassium, muscular weakness and mass loss. Paralyses of the intestinal musculature followed by dilation of the bowel and megacolon may also occur. Cardiac and renal symptoms have been reported. In susceptible persons phenolphthalein may give rise to drug eruption or to an urticarial rash. Allergic skin reactions, including fixed drug eruption and Stevens-Johnson syndrome have been reported. In such individuals further exposure to the drug must be avoided.
It has caused albuminuria and the presence of free haemoglobin in the urine.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The major danger of overdosage is fluid and electrolyte deficits resulting from excessive cathartic effect. The loss of alkaline fluid from the intestine leads to metabolic acidosis. Sodium Chloride loss of extracellular fluid could be sufficiently severe to effect circulation and renal function. Symptoms of hyponatremia may lead to convulsions. Features of iso-osmotic fluid loss include thirst, postural hypotension and ultimately shock. Acute renal failure and the possible fatal outcome. Treatment is symptomatic and supportive.
Pinkish biconvex tablets with a break line on the one side.
In cartons of 10 and 25 tablets.
Store below 25 °C protected from light and moisture.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Co. Reg. No. 05/25041/06
Robbie de Lange Road, Wilsonia, EAST LONDON 5201
P O Box 422, EAST LONDON 5200
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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