PHARMACOLOGICAL CLASSIFICATION: A 11.4.1 Antacids: Acid neutralizers
PHARMACOLOGICAL ACTION: Acid neutralizing.
INDICATIONS: To comfort infants with Gripes.
CONTRA-INDICATIONS: Hypersensitivity to any of the ingredients.
Sodium bicarbonate should not be administered to patients with metabolic or respiratory alkalosis, hypocalcaemia or hypochlorhydria.
WARNINGS: Consult your doctor if there is no improvement after 24 hours.
Do not use this product if you are on a sodium restricted diet or suffer from hypertension or heart failure, except under the supervision of a doctor.
Do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.
Babies up to 12 months old: Do not take more than 4 medicine measures in a 24 hour period.
DOSAGE AND DIRECTIONS FOR USE:
Babies up to 12 months old:
1 Medicine measure (5 mL) not more than three to four times per 24 hour period.
Do not give this medicine to babies with a bodymass less than 2,5 kg.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Do not exceed the stated dose.
Sodium bicarbonate should be administered extremely cautiously to patients with congestive heart failure, renal impairment, cirrhosis of the liver or hypertension and to patients receiving corticosteroids. Sodium bicarbonate can also cause stomach cramps and flatulence.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Excessive administration of sodium bicarbonate may lead to metabolic alkalosis, especially in patients with impaired renal function. Symptoms may include shortness of breath, weakness and mental disturbances, such as restlessness, convulsions and coma. Muscle hypertonicity, twitching and tetany may develop, especially in hypocalcemic patients due to increased protein binding and renal reabsorption of calcium. Excessive doses may, also lead to sodium overloading and hyperosmolality. Treatment of metabolic alkalosis and hypernatraemia associated with sodium bicarbonate overdose consists mainly of appropriate correction of fluid and electrolyte balance. Replacement of calcium, chloride and potassium ions may be of particular importance.
IDENTIFICATION: Clear, pale yellow solution.
Odour, pleasant, of dill.
PRESENTATION: 100 mL Clear, glass bottle with a black screwcap.
STORAGE INSTRUCTIONS: Store in a cool, dry place below 25°C, and away from light. Keep out of reach of children.
REGISTRATION NUMBER: E/11.4.1/719
NAME AND BUSINESS ADDRESS OF APPLICANT: Universal Pharmaceuticals (Pty) Ltd
7 Browning Street, Jeppe, Johannesburg.
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 21 August, 1972