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

Logo SURGE STRONG LAXATIVE GRANULES [EFFERVESCENT GRANULES]

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

SURGE STRONG LAXATIVE GRANULES [EFFERVESCENT GRANULES]

COMPOSITION:
Contains per 10 g of the granules:
        Yellow
Phenolphthalein        300 mg

PHARMACOLOGICAL CLASSIFICATION:
A 11.5 Laxatives.

PHARMACOLOGICAL ACTION:
Surge Strong Laxative Granules have laxative properties.

INDICATIONS:
Surge Strong Laxative Granules are indicated for the relief of constipation in adults.

CONTRA-INDICATIONS:
Surge Strong Laxative Granules should not be taken by persons with intestinal obstruction, abdominal pain, nausea or vomiting. Not to be administered to patients sensitive to phenolphthalein.

WARNINGS:
This medicine should not be used in the presence of abdominal pain, nausea or vomiting. Frequent or prolonged use of this preparation may result in dependence on laxatives. If you have noticed a sudden change in bowel habits that persist over a period of 2 weeks, consult a doctor before using a laxative. If the recommended use of this product for 1 week has had no effect, discontinue use and consult a doctor. Toxic epidermal necrolysis, which may be life-threatening, may occur on chronic administration.

If a skin rash appears or if a patient is known to be sensitive in any regard to phenolphthalein, this medicine should be discontinued immediately and this or any other preparation containing phenolphthalein should not be used in the future.

DOSAGE AND DIRECTIONS FOR USE:
Daily Adult Dose:
        Empty the entire contents into half a glass of warm water and drink immediately while bubbling. Do not take this product for longer than one week without consulting a doctor.

Children:
        The use of this product in children is not recommended.

DO NOT EXCEED THE STATED DOSE.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side Effects:
Abdominal cramps may occur. Cardiac and respiratory distress have been reported. Phenolphthalein has caused albuminuria and the presence of free haemoglobin in the urine. Constant use may decrease the sensitivity of the intestinal mucous membranes so that the bowel may fail to respond to normal stimuli and the redevelopment of a normal habit is prevented. The prolonged use or the administration of high doses of phenolphthalein may result in excessive laxation or electrolyte depletion, muscular weakness or mass loss. Skin reactions, including non-specific rashes and pigmentation, and toxic epidermal necrolysis which may be life-threatening may occur. Changes in the intestinal musculature associated with malabsorption, and dilation of the bowel, similar to ulcerative colitis and to megacolon, may also occur.

Special precautions:
If a skin rash appears, or if the patient is known to be sensitive in any other regard to phenolphthalein, this other medicine should be discontinued immediately, and this or any other preparation containing phenolphthalein should not be used in the future.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The symptoms of overdosage include derangement of fluids and electrolytes, shock, intense metabolic acidosis, convulsions acute renal failure and a possible fatal outcome.

The treatment of overdosage is symptomatic and supportive.

IDENTIFICATION:
An odourless mixture of red, orange and yellow granules with a saline taste.

PRESENTATION:
A plastic vial containing 10 g of granules and sachets each containing 10 g of the granules.

STORAGE INSTRUCTIONS:
Store below 25 °C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
K/11.5/141

NAME AND BUSINESS ADDRESS OF THE 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:
{undated}

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