Excessive administration of bicarbonate may lead to hypokalaemia and metabolic alkalosis, especially in patients with impaired renal function. Symptoms include mood changes, tiredness, shortness of breath, muscle weakness and irregular heart beat. Muscle hypertonicity, twitching and tetany may develop, especially in hypocalcaemic patients. Excessive doses of sodium salts may lead to sodium overloading and hyperosmolality.
Treatment of metabolic alkalosis and hypernatraemia is by correction of fluid and electrolyte balance. Replacement of calcium, chloride, and potassium ions may be of particular importance.
Contraindicated in patients with metabolic or respiratory alkalosis, hypocalcaemia, or hypochlorhydria.
Not to be taken by children under 12 years old.
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 (> 10%), common (> 1% and < 10%); uncommon (> 0.1% and < 1%); rare (> 0.01% and < 0.1%), very rare (< 0.01%), not known (cannot be estimated from the available data).
| MedDRA System Organ Class | Adverse Reaction |
| Gastrointestinal disorders: | |
| Frequency not known | Wind, Nausea, Vomiting, Unpleasant taste |
| Metabolism and nutrition disorders: | |
| Frequency not known | Fluid retention, Loss of appetite (continuing) |
| Psychiatric disorders: | |
| Frequency not known | Mood or mental changes, Nervousness or restlessness |
| Vascular disorders: | |
| Frequency not known | Hypertension, Slow breathing, Breathing difficulties, Fluid on the lungs |
| Nervous system disorders: | |
| Frequency not known | Headache (continuing) |
| Skin and subcutaneous tissue disorders: | |
| Frequency not known | Swelling of feet of 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. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
No further relevant information.
Bicarbonato de Sodio EWE is used to treat hyperacidity, dyspepsia and symptomatic relief of heartburn and peptic ulceration.
ATC Code: A02A H, antacids with sodium bicarbonate.
Sodium bicarbonate is used as an antacid in relief of the symptoms of dyspepsia, heartburn and indigestion caused by excess gastrointestinal acid. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide.
Absorption
Sodium bicarbonate is readily absorbed from the gastro-intestinal tract.
Distribution
Sodium bicarbonate is present in all body fluids. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide.
Biotransformation
Sodium bicarbonate is not significantly metabolised.
Elimination
Any bicarbonate not involved in the gastric acid neutralisation reaction is absorbed and in the absence of a deficit of bicarbonate in the plasma, bicarbonate ions are excreted in the urine that is rendered alkaline and there is an accompanying diuresis.
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.
Keep all medicines away from children.
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.
None known.
Posology
For acid indigestion
Adults and children over 12 years:
Take 12ml (1g) to 60ml (5g) every 4 to 6 hours.
Not recommended for use in children under 12 years of age.
Method of administration
The required dose should be drawn from the container into the graduated syringe using the syringe adaptor.
The required dose should be drawn from the container into the graduated syringe provided using the syringe adaptor (see detailed instructions below). The syringe should be held into the mouth of the patient, and the contents of the syringe should then be ejected into the mouth and swallowed.
a) Open the bottle: press the cap and turn it anticlockwise (figure a).
b) Separate the adaptor from the syringe. Insert the adaptor into the bottle neck. Ensure it fits well (figure b). Take the syringe and put it in the adaptor opening. Turn the bottle upside down (figure c).
c) Fill the syringe with a small amount of solution by pulling the piston down, then push the piston up in order to remove any possible bubble. Pull the piston down to the graduation mark corresponding to the required dosage in millilitres (ml) (figure d).
d) Turn the bottle the right way up. Remove the syringe from the adaptor. Empty the contents of the syringe into the patient's mouth by pushing the piston to the bottom of the syringe (figure e). Close the bottle with the plastic screw cap.
Drain any remaining solution in the syringe and wash it with water after use. Store the syringe in a clean and dry place.
