SODIUM BICARBONATE

Posology 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 – 60ml (approximately 1 – 5g) 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. 6).

General adverse effects of sodium bicarbonate are as follows. 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 Metabolic alkalosis Loss of appetite (continuing) Psychiatric disorders Frequency not known Mood or mental changes Nervousness or restlessness Nervous system disorders Frequency not known Headache (continuing) Dizziness Vascular disorders Frequency not known Hypertension Slow breathing Breathing difficulties Fluid on the lungs Respiratory, thoracic and mediastinal disorders Frequency not known Pulmonary oedema Gastrointestinal disorders Frequency not known Abdominal discomfort Abdominal distention 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 Promotion of renal urolithiasis (formation of calcium or magnesium phosphate calculi) upon prolonged use.

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.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Overtreatment with bicarbonate must be avoided. Frequent monitoring of serum electrolytes and acid-base status is essential. In patients with moderate and advanced chronic renal disease, the association between serum bicarbonate concentration and all-cause mortality is U-shaped.

The lowest mortality rate is seen in patients with serum bicarbonate concentration in the range of 26-29 mmol/l. The highest mortality rate is observed among patients with serum bicarbonate levels of < 22 mmol/l but an increase in mortality is also seen in patients with serum bicarbonate levels of > 29 mmol/l.

Sodium bicarbonate should be given extremely cautiously to patients with heart failure, oedema, renal impairment, hypertension, eclampsia, aldosteronism, or other conditions associated with sodium retention. Do not take if you are hypersensitive to sodium bicarbonate.

Consult your doctor or pharmacist if symptoms persist after 7 days. This medicine can mask the symptoms of stomach cancer or ulcer. 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.

15% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 414% of the WHO recommended maximum daily intake for sodium. Sodium bicarbonate 84mg/ml oral solution is considered high in sodium.

This should be particularly taken into account for those on a low salt diet.

1 • Metabolic or respiratory alkalosis • Hypokalaemia • Hypernatraemia • Hypocalcaemia • Hypochlorhydria • Patients on a low sodium diet