Sodium Bicarbonate BP (Boots Company plc)

1. Name Of The Medicinal Product

Sodium Bicarbonate B.P.

2. Qualitative And Quantitative Composition

Sodium Bicaronate Ph Eur 100%

3. Pharmaceutical Form

Powder

4. Clinical Particulars

4.1 Therapeutic Indications

For use as an antacid, for the relief of indigestion.

4.2 Posology And Method Of Administration

For oral administration.

Adults and children over twelve years: A quarter to a half a teaspoonful dissolved in

water three to four times a day.

Children five to twelve years: A quarter of a teaspoonful dissolved in water three to four times a day.

Elderly: There is no need for dosage reduction in the elderly.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

Sodium bicarbonate should be used with caution by patients on low sodium diets or with congestive heart failure, hypertension, impaired renal function and cirrhosis of the liver.

Do not exceed the recommended dose as excess or prolonged use may lead to alkalosis.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions known.

4.6 Pregnancy And Lactation

The safety of sodium bicarbonate during pregnancy and lactation has not been established, but its use during these periods is not considered to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

May cause flatulence.

4.9 Overdose

Symptoms of overdosage include metabolic and electrolyte disturbances.

Treatment should consist of hydration using sodium-free fluids.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Sodium bicarbonate has antacid properties and neutralises excess gastric acid.

5.2 Pharmacokinetic Properties

Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide. Any bicarbonate not involved in that 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.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6. Pharmaceutical Particulars

6.1 List Of Excipients

None

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

A cardboard carton with a paper/polythene liner.

Pack size: 200, 500 gm.

or

A cardboard carton containing a metallised PET laminate bag.

Pack size: 200, 500 gm.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 0014/5584

9. Date Of First Authorisation/Renewal Of The Authorisation

First Authorisation: 4 April 1984

Last Renewal: 30 November 1994

10. Date Of Revision Of The Text

July 1999