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

Logo GENTRISIL SUSPENSION

SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

GENTRISIL SUSPENSION

COMPOSITION:
Each 10 mL contains:
Magnesium trisilicate         500 mg
Light
magnesium carbonate         500 mg
Sodium bicarbonate         500 mg
Preservatives:
Methylhydroxybenzoate        0,1% (m/v)
Propyl hydroxybenzoate        0,02% (m/v)
Chloroform spirit        1,7% (v/v)

PHARMACOLOGICAL CLASSIFICATION:
A 11.4.1 Antacids - Acid neutralisers

PHARMACOLOGICAL ACTION:
GENTRISIL has acid neutralising properties.

INDICATIONS:
For relief of symptoms due to hyperacidity.

CONTRA-INDICATIONS:
Sensitivity to any of the ingredients; patients with renal impairment and acute dehydration.

WARNINGS:
1. GENTRISIL should not be administered to patients with congestive heart failure, renal impairment, cirrhosis of the liver, or hypertension, and to patients receiving corticosteroids, except under the advice and supervision of a doctor.
2. Do not use this product if you have kidney disease except under the advice and supervision of a doctor.
3. GENTRISIL should not be taken by patients on sodium restricted diets.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 10 mL to 15 mL (2 - 3 medicine measures) every four hours as required. Do not take more than 90 mL (18 medicine measures) in a 24 hour period and do not use the daily maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor. SHAKE THE BOTTLE BEFORE USE.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Diarrhoea and bowel discomfort, due to the release of carbon dioxide caused by both magnesium carbonate and sodium bicarbonate.
Excessive administration of magnesium leads to the development of hypermagnesaemia, especially in renal insufficiency. Symptoms of hypermagnesaemia may include flushing of the skin, thirst, hypotension due to peripheral vasodilation, drowsiness, confusion, loss of tendon reflexes due to neuromuscular blockade, muscle weakness, respiratory depression, cardiac arrhythmias, coma, and cardiac arrest. Magnesium carbonate and magnesium trisilicate may interfere with the absorption of other medicines when taken concomitantly. Administration of sodium bicarbonate by mouth can cause stomach cramps and flatulence.
Excessive administration of sodium bicarbonate may lead to metabolic alkalosis, especially in patients with impaired renal function. Symptoms may include shortness of breath, muscle weakness (associated with potassium depletion), and mental disturbances such as restlessness, convulsions, and coma. Muscle hypertonicity, twitching, and tetany may develop especially in hypocalcaemic patients due to increased protein binding and renal reabsorption of calcium. Excessive doses may also lead to sodium overloading and hyperosmolality. Sodium excess may result in hypernatraemia, a rise in extracellular concentration or in too much sodium and water in the body without change in extracellular concentration.
Retention of sodium leads to the accumulation of extracellular fluid (oedema) which may affect the cerebral, pulmonary or peripheral circulations.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Fatigue due to prolonged treatment or the administration of high doses may be indicative of abnormally high serum magnesium concentrations. In such cases, treatment should be withdrawn and the serum magnesium levels should be determined.
Refer to side-effects for additional symptoms which may occur with overdosage. Treatment is symptomatic and supportive.

IDENTIFICATION:
A white suspension with a taste and odour of peppermint.

PRESENTATION:
100 mL, 200 mL bottle.
2,5 L polycan.

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

REGISTRATION NUMBER:
28/11.4.1/0235

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ALLIANCE PHARMA (PTY) LTD
17 Faraday Street
Village Main
JOHANNESBURG
2001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
24 September 1993

        PM 0527-07/2004

Updated on this site: April 2005
Source: Hospital Pharmacy

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