PHARMACOLOGICAL CLASSIFICATION: Category A 11.4.1 Antacid - Acid neutralisers.
PHARMACOLOGICAL ACTION: Antacid, with the capability to neutralise the acid in the stomach.
INDICATIONS: Hyper-acidity and acid indigestion.
CONTRA-INDICATIONS: Hypersensitivy to any of the ingredients. It should not be administered to patients with metabolic or respiratory alkalosis, hypocalcaemia, or hypochlorhydria. The safety of this medicine during pregnancy has not yet been established.
WARNINGS: Do not use this product if you are on a sodium restriction diet, or suffer from hypertension, or heart failure, except under the advice and supervision of a doctor. Do not use this product if you have kidney disease except under the advice and supervision of a doctor.
DOSAGE AND DIRECTIONS FOR USE: Note: 1 medicine measure = 5 mL. To be taken one hour after meals and at bedtime. Children:
older than 1 month to 6 months:
1/4 medicine measure (1,25 mL)
6 months to 5 years:
½ medicine measure (2,5 mL)
6 years to 10 years:
1 medicine measure (5 mL)
Adults: Up to 2 medicine measures (10 mL) Do not use the maximum daily dosage of this product for more than two weeks, except under the advice and supervision of a doctor. Not to be used in children under the age of 1 month.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Magnesium carbonate may cause diarrhoea. The release of carbon dioxide in the stomach may cause discomfort. If renal function is impaired, hypermagnesaemia may result. The symptoms of which 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. Sodium bicarbonate may 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. Symptoms include nausea, vomiting, diarrhoea, abdominal cramps, thirst, reduced salivation and lachrymation, sweating, fever, hypotension, tachycardia, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma, and death. Infants may appear not to be severely dehydrated, but coma and convulsions may persist due to vascular injury. They may show respiratory distress with tachypnoea and flaring nostrils. Sodium bicarbonate should be administered with extreme caution to patients with congestive heart failure, renal impairment, cirrhosis of the liver, or hypertension, and to patients receiving corticosteroids. Alkalinization of the urine by sodium bicarbonate leads to increased renal clearance of acidic drugs. Magnesium carbonate may interfere with the absorption of other drugs when these are taken concomitantly.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Refer to "Side-Effects and Special Precautions" above. Treatment consists of appropriate correction of fluid and electrolyte balance. Further treatment is symptomatic and supportive.
IDENTIFICATION: Pink, homogenous suspension.
PRESENTATION: 100mL and 2,5 L bottles
STORAGE INSTRUCTIONS: Store in a cool, dry place (below 30°C). In airtight containers.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: E/11.4.1/1712
NAME AND BUSINESS ADDRESS OF THE APPLICANT: Adcock Ingram Limited.
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77
Private Bag X69, Bryanston, 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 08/02/1994
New addition to this site: April 2004
Source: Pharmaceutical Industry