SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Sodium Bicarbonate BP Numark Sodium Bicarbonate BP Boots Sodium Bicarbonate BP

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium Bicarbonate 100%

3.    PHARMACEUTICAL FORM

Oral Powder

4    CLINICAL PARTICULARS

4.1    Therapeutic Indications

For use as an antacid for the symptomatic relief of dyspepsia.

4.2    Posology and Method of Administration

Adults, the elderly and children aged 12 years and over :-

Take 1 to 5g in water 4 to 6 hourly as required.

Not recommended for children under 12 years of age.

4.3 Contra-indications

Congestive cardiac failure

4.4 Special Warnings and Special Precautions for Use

Caution should be exercised in patients who are on Sodium restricted diets and those with cardiac disease, hypertension, renal or hepatic impairment. A physician should be consulted if the patient is receiving other medications before taking this product. If symptoms persist consult your doctor.

4.5 Interactions with other Medicinal Products and other Forms of Interaction

This product may cause alkalisation of plasma and urine and, as such, may affect the renal clearance of several drugs.

4.6 Pregnancy and Lactation

Data on a large number of exposed pregnancies indicate no adverse effects of Bicarbonate of Soda (Sodium Bicarbonate BP) on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available.

Caution should be exercised, when prescribing to pregnant women.

4.7 Effects on Ability to Drive and Use Machines

None known

4.8 Undesirable effects

This medicine may cause abdominal cramps and flatulence. Excessive administration may lead to metabolic alkalosis, especially in patients with impaired renal function.

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

Excessive amounts of this medicine may cause metabolic alkalosis. Dyspepsia and muscle weakness may occur owing to potassium depletion. Twitching tetany may occur in hypercalcaemic patients. Severe overdosages may lead to convulsions and coma. Treatment consists of appropriate correction of fluid and electrolyte balance and is otherwise supportive and symptomatic. Anti-convulsant therapy may be needed in severe overdosage.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

Not applicable

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

None

6.2 Incompatibilities

None 6.3 Shelf life

As packaged for sale: Three years As reconstituted for use: Thirty minutes After first opening the container: One month

6.4 Special precautions for storage

Do not store above 25°C.

6.5    Nature and contents of container

A spirally wound, varnished, cardboard tub with a press-fit lid or polypropylene jar and cap containing 100g, 150g, 200g, 250g, 300g or 500g of sodium bicarbonate.

6.6    Instruction for use and handling

Take 1 to 5g in water.

7. MARKETING AUTHORISATION HOLDER

Bell Sons & Co (Druggists) Ltd

Gifford House

Slaidburn Crescent

Southport

Merseyside

PR9 9AL

UK

8. MARKETING AUTHORISATION NUMBER

PL 03105/0067

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

12^th February 1999

10 DATE OF REVISION OF THE TEXT

01/04/2015