SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Sodium Bicarbonate Tablets 600mg

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 600mg of Sodium Bicarbonate BP See Section 6.1. for Excipients

3    PHARMACEUTICAL FORM

White, biconvex, uncoated, odourless tablets

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Rapid relief dyspepsia. Relief of heartburn.

4.2    Posology and method of administration

Adults and children over 12 years:

1-3 tablets sucked when required.

Elderly:

A reduction in dosage is not thought necessary

Children under 12 years: Not recommended.

Route of administration For Oral Use

4.3 Contraindications

None stated.

4.4 Special warnings and precautions for use

Must be taken with care in patients with impaired renal function, cirrhosis of liver, congestive heart failure, hypertension, hepatic impairment, the elderly and avoided by those on a sodium-restricted diet. Although a reduction of normal adult dosage is not thought necessary for the elderly, sodium retention could result if there is a concomitant impaired cardiac or renal function.

Prolonged use should be avoided as it may lead to alkalosis.

4.5 Interaction with other medicinal products and other forms of interaction

Sodium bicarbonate may impair the oral absorption of the following drugs: fosinopril, azithromycin, cefpodoxime, ciprofloxacin, isoniazid, norfloxacin, ofloxacin, pivampicillin, rifampicin, tetracyclines, gabapentin, phenytoin, itraconazole, ketoconazole, chloroquine, hydroxychloroquine, phenothiazines, bisphosphonates (give at least 2 hours apart), penicillamine, diflunisal.

Sodium bicarbonate increases excretion of lithium (reduced plasma - lithium concentration).

It may accelerate the excretion of acidic drugs like salicylates by raising the urine pH; urinary excretion of basic drugs such as amphetamines or quinidine may be inhibited and may occasionally increase plasma concentrations.

Sodium bicarbonate may also damage enteric coatings designed to prevent dissolution in the stomach.

4.6 Fertility, Pregnancy and lactation

For Sodium Bicarbonate 600mg Tablets no clinical data on exposed pregnancies are available.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).

Caution should be exercised when prescribing sodium bicarbonate tablets to pregnant women.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

Sodium bicarbonate may cause rebound hyperacidity and with prolonged use alkalosis. Like other carbonate containing antacids it liberates carbon dioxide which causes belching.

May cause flatulence

Sodium supplements may increase blood pressure or cause fluid retention and pulmonary oedema in those at risk.

4.9 Overdose

Excessive doses may cause systemic alkalosis.

It is unlikely that “sodium excess” will occur, but this may take two forms; hypernatraemia and isotonic retention. Hypernatraemia requires the use of sodium-free fluids and the cessation of excessive sodium intake. Very occasionally dialysis has been needed in severe hypernatraemia. Iso-osmotic overload is managed by sodium and water restriction plus measures to increase renal sodium and water loss such as ‘loop diuretics’ or, in specific circumstances, antimineralocorticoid agents.

5.1 Pharmacodynamic properties

Sodium bicarbonate is a salt which on reaction with acid will raise the pH by lowering the concentration of hydrogen ions [H+]:

NaHCO3 + HCl = CO2 + NaCl + H2O

Thus sodium bicarbonate is used as an antacid in the stomach or as an agent to increase the pH of the urine or of the whole body.

5.2 Pharmacokinetic properties

There is little pharmacokinetic information available. The volume of distribution depends on the acid-base status of the individual.

Once it has entered the body, the action and fate of sodium bicarbonate is identical to that of endogenous sodium and bicarbonate ions. The kinetics are therefore determined by the physiological state of the patient at the time. A sodium depleted patient or one with

heart failure or renal failure will retain sodium. A replete patient with normal renal function will eliminate an excess in the urine.

5.3 Preclinical safety data

None available.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Syrup

Purified water Magnesium Stearate

6.2 Incompatibilities

None stated

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Polypropylene container with tamper evident polyethylene closure or polypropylene container with tamper evident, child resistant polyethylene closure or amber glass bottles with screw on cap in packs of 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120 and 500 tablets.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Teva UK Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG

8    MARKETING AUTHORISATION NUMBER(S)

PL 00289/1809

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

07/12/2005

DATE OF REVISION OF THE TEXT

20/02/2013