Gr Babies Stomach Mixture 5 ml Suspension

GR BABIES STOMACH MIXTURE is indicated for use as an antacid.

Posology: Give three to four times a day. Paediatric population Under 1 month: 2,5 ml (u00bd medicine measure). 1 - 6 months: 2,5 u2013 5 ml (u00bd - 1 medicine measure). 6 - 12 months: 5 ml (1 medicine measure). 1 - 2 years: 5 - 7,5 ml (1 - 1u00bd medicine measures). 3 - 5 years: 7,5 - 10 ml (1u00bd u2013 2 medicine measures). 6 - 10 years 10 - 15 ml (2 - 3 medicine measures). Do not give this medicine to babies with a body mass less than 2,5 kg DO NOT USE THE MAXIMUM DOSAGE OF THIS PRODUCT FOR MORE THAN TWO WEEKS, EXCEPT ON THE ADVICE, AND UNDER THE SUPERVISION, OF A DOCTOR. SHAKE THE BOTTLE BEFORE USE.

Method of administration: For oral use only.

GR BABIES STOMACH MIXTURE is contraindicated in: u2022 patients who are hypersensitive to the active substances, magnesium carbonate light or sodium bicarbonate, or to any of the excipients listed in section 6.1. u2022 patients with metabolic or respiratory alkalosis, hypocalcaemia or hypochlorhydria.

GR BABIES STOMACH MIXTURE should be given extremely cautiously to patients with congestive heart failure, oedema, renal impairment, cirrhosis of the liver, hypertension, eclampsia, aldosteronism, or to patients receiving corticosteroids. Care should be taken to avoid excessive use in infants. Special care must be taken when administering GR BABIES STOMACH MIXTURE with other medicines, and in particular with salicylates, tetracyclines, barbiturates, bisphosphonates and lithium. Refer to section 4.5. This product contains a high percentage of alcohol. Refer to section 2

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. Magnesium salts may decrease the absorption of tetracyclines and bisphosphonates, and doses should be separated by a number of hours. Refer to section 4.4

GR BABIES STOMACH MIXTURE is not intended for administration to women of child-bearing age.

Not relevant as GR BABIES STOMACH MIXTURE is indicated for infants only.

Metabolism and nutrition disorders Frequency unknown : Hypermagnesaemia and metabolic alkalosis. Gastrointestinal disorders Frequency unknown: Stomach cramps, belching, flatulence, gastrointestinal irritation and watery diarrhoea. 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 u201c 6.04 Adverse Drug Reactions Reporting Form u201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Excessive use of GR BABIES STOMACH MIXTURE 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. Excessive doses of sodium salts may also lead to sodium overloading and hyperosmolality. Hypermagnesaemia may occur in patients with impaired renal function taking large amounts of magnesium. Symptoms include nausea, vomiting, CNS and respiratory depression, hyporeflexia, muscle weakness and cardiovascular effects including peripheral vasodilation, hypotension bradycardia and cardiac arrest.

Treatment of overdose 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. Treatment of mild hypermagnesaemia is usually limited to restricting magnesium intake.