Sodium Bicarbonate 500mg Capsules
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Bicarbonate 500 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Sodium Bicarbonate 500 mg.
For excipients, see 6.1.
3. PHARMACEUTICAL FORM Capsule, hard.
White, size 1, hard gelatin capsule printed with “NaB 500”.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Sodium Bicarbonate is used for the treatment of dyspepsia. It may also be used to treat metabolic acidosis arising from various disorders as well as severe respiratory acidosis.
4.2 Posology and method of administration
For oral administration. To be swallowed whole (do not chew) with a drink of water.
Adults
Dyspepsia: 1g - 5g when required.
Metabolic Acidosis: The dosage is dependent upon the acid-base balance and electrolyte status of the patient and must be calculated on an individual basis.
Children
No recommendation.
4.3 Contraindications
Hypersensitivity to any of the capsule ingredients.
4.4 Special warnings and precautions for use
Avoid in patients on salt restricted diets.
Administer with caution in patients suffering from heart failure, hypertension, hepatic or renal impairment.
Warning: Do not exceed the stated dose.
Prolonged use should be avoided.
Caution advised in elderly patients. Although a reduction of the normal adult dose is not considered necessary, sodium retention could occur if there is concomitant impaired cardiac or renal function
4.5 Interaction with other medicinal products and other forms of interaction
Sodium bicarbonate increases the excretion of lithium, resulting in reduced plasma lithium concentration.
Antacids reduce the absorption of antibacterials (eg. tetracycline, rifampicin) and antifungals (itraconazole and ketoconazole). They also reduce the absorption of dipyridamole, phenothiazines, chloroquine, hydroxychloroquine, phenytoin, gabapentin, bisphosphonates, penicillamine, captopril, enalapril and possibly other ACE inhibitors.
Antacids also increase the excretion of aspirin and methotrexate and reduce the excretion of ephedrine and quinidine in alkaline urine (occasionally plasma concentrations may increase).
4.6 Pregnancy and lactation
May be used if the usual precautions are followed and the anticipated benefits outweigh any risks, however as with all medicines best avoided unless considered essential.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Stomach pains and flatulence have 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.
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 at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Hypokalaemia and metabolic alkalosis may occur especially if renal function is impaired. In severe cases there have been reports of mood changes, shortness of breath, muscle weakness, tiredness, irregular heartbeat, convulsions and coma. Muscle hypertonicity, twitching and tetany may develop, especially in hypocalcaemic patients. Excessive doses of sodium salts may cause sodium overloading and hyperosmolality to occur. Treatment of metabolic alkalosis should be supportive with appropriate correction of fluid and electrolyte imbalance. Calcium gluconate may be given. An intravenous infusion of ammonium chloride can be used in severe alkalosis, except in patients with pre-existing hepatic disease.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
A02AH Antacids with Sodium Bicarbonate.
The normal concentration range of bicarbonate in plasma is 22 to 32 mmol per litre. The average intake of bicarbonate in the diet is negligible and very little is excreted in the urine under normal conditions; bicarbonate ions formed in the body are excreted in biliary, intestinal, pancreatic and salivary fluids. If bicarbonate is administered therapeutically thus increasing the plasma-bicarbonate in concentration above the normal range then compensatory renal mechanisms come to play and bicarbonate is excreted in the urine.
5.2 Pharmacokinetic properties
Oral administration of sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide. The remaining bicarbonate not involved in the above reaction is absorbed and, in the absence of a deficit of bicarbonate in the plasma, bicarbonate ions are excreted, along with sodium ions, in the urine which is rendered alkaline and there is an accompanying diuresis.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Microcrystalline Cellulose Magnesium Stearate
Capsule Shell:
Gelatin
Water
Titanium Dioxide (E171)
Printing ink: Opacode Black S-1-8152HV (containing Shellac, Black Iron Oxide E172, Soya Lecithin, Antifoam DC 1510).
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°c. Keep the container tightly closed. Store in the original container.
6.5 Nature and contents of container
PP tablet containers with PE caps containing 56 or 100 capsules.
6.6 Instructions for use and handling <and disposal>
No special requirements.
7. MARKETING AUTHORISATION HOLDER
Dalkeith Laboratories Ltd
2 Park Street
Woburn
Bedfordshire
MK17 9PG
8. MARKETING AUTHORISATION NUMBER(S)
PL 17946/0018
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12/12/2008
10 DATE OF REVISION OF THE TEXT
15/07/2015