SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Sodium Citrate 0.3M Oral Solution

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium Citrate

2.647g of Sodium Citrate in 30ml of Oral Solution For excipients see 6.1 below

3.    PHARMACEUTICAL FORM

Oral Solution

The product is a clear and colourless solution.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic indications

Non-particulate antacid for use by mouth to prior to general anaesthesia for caesarean section.

4.2. Posology and method of administration

30ml of a 0.3M solution orally immediately prior to anaesthesia.

4.3. Contraindications

Hypersensitivity to the active ingredient or to other ingredients of the product.

4.4. Special warnings and precautions for use

Sodium Citrate should not be administered to patients with metabolic or respiratory alkalosis, hypocalcaemia, or hypochlorhydria. Sodium containing salts should be administered extremely cautiously to patients with heart failure, oedema, renal impairment, hypertension, or aldosteronism. (During

treatment of acidosis, frequent monitoring of serum-electrolyte concentrations and acid-base status is essential. Alkalinisation of the urine by bicarbonates or bicarbonate precursors

leads to increased renal clearance of acidic drugs.) However, urinary alkalinisation prolongs the half-life of basic drugs and may result in toxicity.

Citrates and Citric Acid enhance intestinal aluminium absorption in renal patients which may lead to increased, harmful serum aluminium levels. It has therefore been suggested that patients with renal failure taking aluminium compounds to control phosphate absorption should not be prescribed citrate or citric acid containing products.

4.5.    Interactions with other medicinal products and other forms of interaction

As with all antacids, sodium citrate may affect the absorption of many drugs.

4.6.    Pregnancy and lactation

Use as indicated above

4.7.    Effects on ability to drive and use machines

Not applicable

4.8.    Undesirable effects

There are no further effects other than those mentioned in Sections 4.3, 4.4,

4.5 and 4.9 of the Summary of Product Characteristics.

4.9.    Overdose

As with all antacids, overdose may produce metabolic alkalosis. The product contains 27mmol of Sodium ions per 30ml and this should be considered. Management of overdose should include monitoring of plasma electrolytes and acid-base status, and general supportive measures.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Sodium citrate has no relevant pharmacodynamic activity other than that caused by its alkalinity (e.g. its gastric acid neutralising capacity).

5.2.    Pharmacokinetic properties

Sodium citrate is systemically absorbed and renally eliminated, causing metabolic alkalosis and urine alkalisation in sufficient doses.

5.3.    Preclinical safety data

No further data is provided.

6. PHARMACEUTICAL PARTICULARS

6.1.    List of excipients

Purified water Glycerol

6.2.    Incompatibilities

Not applicable

6.3.    Shelf life

2 years

6.4.    Special precautions for storage

Do not store above 25°C. Store in the original container. Keep the container tightly closed.

For single use only. Discard any remaining solution.

6.5.    Nature and contents of container

Amber PET bottle with LDPE-lined closure.

6.6.    Instruction for use and handling

None

7.    MARKETING AUTHORISATION HOLDER

Viridian Pharma Ltd

Yew Tree House, Hendrew Lane, Llandevaud, Newport, Gwent NP18 2AB

8.    MARKETING AUTHORISATION NUMBER

PL 20346/0001

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

25/08/2005

10    DATE OF REVISION OF THE TEXT

07/02/2008