SODIUM BICARBONATE

Adults (including elderly):

Metabolic acidosis: dosage is calculated on an individual basis and is dependent on acid-base balance and electrolyte status.

Dyspepsia:

Doses of 12–60 mL (approximately 1–5 g sodium bicarbonate) every 4–6 hours as required.

Paediatric population:

The efficacy of sodium bicarbonate in children under 18 years of age has not been established. No data are available. Method of administration For oral use. The required dose should be drawn from the container into the graduated syringe using the syringe adaptor

Stomach pains and flatulence has been reported. Alkalosis on prolonged use. Sodium supplements may increase blood pressure or cause fluid retention and pulmonary oedema in those at risk. Hypokalaemia may be exacerbated. The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

MedDRA System Organ Class Adverse reaction Metabolism and nutrition disorders Frequency not known Alkalosis on prolonged use, Fluid retention, Hypokalaemia may be exacerbated, Loss of appetite (continuing) Psychiatric disorders Frequency not known Mood or mental changes, Nervousness or restlessness Nervous system disorders Frequency not known Headache (continuing) Vascular disorders Frequency not known Hypertension, Slow breathing, Breathing difficulties, Fluid on the lungs Respiratory, thoracic and mediastinal disorders Frequency not know Pulmonary oedema Gastrointestinal disorders Frequency not known Pain in the stomach Flatulence Spontaneous stomach rupture Nausea Vomiting Unpleasant taste Skin and subcutaneous tissue disorders Frequency not known Swelling of feet or lower legs Renal and urinary disorders Frequency not known Frequent urge to urinate General disorders and administration site conditions Frequency not known Extreme irritability, unusual tiredness or weakness, muscle spasms or cramps Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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Sodium bicarbonate should be used with caution in patients with cirrhosis of the liver and patients on low sodium diets. Administer with caution to patients suffering from congestive heart failure, hepatic and renal impairment or hypertension.

This medicine can mask the symptoms of stomach cancer or ulcer Sodium bicarbonate should be given extremely cautiously to patients with eclampsia, aldosteronism or other conditions associated with sodium retention. Do not exceed the recommended dose as excess or prolonged use may lead to alkalosis.

If symptoms persist consult your doctor. Caution is recommended in elderly patients (aged from 65 years). Keep all medicines out of the sight and reach of children. Since the efficacy of sodium bicarbonate in children under 18 years of age has not been established Sodium bicarbonate 84mg/ml oral solution is not recommended in children.

• Hypersensitivity to the active substance • Metabolic or respiratory alkalosis • Hypocalcaemia • Hypochlorhydria