Umthuthuzeli 5 ml Mixture

UMTHUTHUZELI is indicated for winds, gripes, colic and upset stomach associated with excess acid in infants.

Posology
SHAKE THE BOTTLE BEFORE USE.
Infants: 5 ml (one medicine measure) after meals or as required. UMTHUTHUZELI should not be taken for longer than a few days without medical advice.
Method of administration
For oral use only.

UMTHUTHUZELI is contraindicated in:
u2022 patients with metabolic or respiratory alkalosis, hypocalcaemia or hypochlorhydria.
u2022 patients who are hypersensitive to sodium bicarbonate or to any of the excipients listed in section 6.1.

UMTHUTHUZELI should be used extremely cautiously in patients with cardiac failure, hypertension, impaired renal function, peripheral or pulmonary oedema, or aldosteronism. Care should be taken to avoid excessive use in infants. Special care must be taken when administering UMTHUTHUZELI with other medicines, and in particular with salicylates, tetracyclines, barbiturates and lithium. (Refer to section 4.5). UMTHUTHUZELI contains a high percentage of alcohol.

Bicarbonate may reduce or increase the rate and/or extent of absorption of a number of medicines due to raising intra-gastric pH. Alkalinisation of the urine leads to increased renal clearance of acidic medicine such as salicylates, tetracyclines and barbiturates. Conversely, it may prolong the half-life of alkaline medicines and result in toxicity. Sodium bicarbonate enhances the excretion of lithium. (Refer to section 4.4).

Not applicable. UMTHUTHUZELI is not intended for administration to women of child-bearing age.

Not applicable. UMTHUTHUZELI is intended for use by infants only.

The following side effects may occur:
Gastrointestinal disorders
Frequency unknown: Stomach cramps, flatulence, belching, flatulence
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Excessive use of UMTHUTHUZELI may lead to hypokalaemia and metabolic alkalosis, especially in patients with impaired renal function. Symptoms include mood changes, tiredness, slow breathing, muscle weakness, and irregular heartbeat. Muscle hypertonicity, twitching, and tetany may develop, especially in hypocalcaemic patients. 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. Excessive doses of sodium salts may also lead to sodium overloading and hyperosmolality. Sodium u201cexcessu201d may take two forms. The first is a rise in extracellular concentration (hypernatraemia) and the second form is too much sodium and water in the body without change in extracellular concentration. Symptoms of hypernatraemia may include restlessness, weakness, thirst, reduced salivation and lachrymation, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypotension, tachycardia, delirium, hyperpnoea and respiratory arrest. Symptoms of hyponatraemia may include anorexia, fatigue, muscle weakness, diarrhoea, abdominal cramps, confusion, hypotension, tachycardia, weakened pulse, cyanosis, hypothermia, pitting oedema, oliguria and convulsions. Treat symptomatically.