SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Sodium Chloride (Normal Saline) Eye Drops 0.9% w/v

2.    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Sodium Chloride BP 9mg/ml

3.    PHARMACEUTICAL FORM

Eye Drops

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

The product should be used when irrigation    of the eye    is required.

4.2    Posology and method of administration

Eye drops for topical administration Adults (including the elderly) and children

One or two drops to be instilled into the eye as required, or as directed by the Physician or Pharmacist

4.3    Contraindications

The product should not be used by patients with known hypersensitivity to any component of the preparation.

4.4    Special warnings and precautions for use

The product contains benzalkonium chloride and soft contact lenses must not be worn during the period of use. The drops should be discarded 28 days after first opening. During use care should be taken not to contaminate the dropper nozzle by contact with the eyelid or other surface. The product is for external use only and should be stored out of the reach of children.

4.5    Interactions with other medicinal products and other forms of interaction

None known relevant to topical ocular use

4.6    Pregnancy and lactation

The product should only be used after consultation with a doctor or pharmacist.

4.7    Effects on ability to drive and use machines

Transient blurring of vision may occur on instillation of eye drops. Users should not drive or operate any hazardous machinery unless vision is clear.

4.8    Undesirable effects

None known

4.9    Overdose

Not relevant to topical ocular use

5.    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

The product is an isotonic solution of sodium chloride used for irrigation of the eye

5.2    Pharmacokinetic properties

Not applicable

5.3    Preclinical safety data

No additional data of relevance to the prescriber

6.    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Benzalkonium chloride Purified water

May contain sodium hydroxide or hydrochloric acid

6.2    Incompatibilities

None known

6.3    Shelf life

3 years (36 month) unopened 28 days after first opening

6.4    Special precautions for storage

Store upright in a dry place below 25°C Protect from light

6.5    Nature and contents of container

Instructions for use, handling and disposal

Sterile until opened.

Discard 28 days after opening

7    MARKETING AUTHORISATION HOLDER

Martindale Pharmaceuticals Ltd

Bampton Road

Romford

RM3 8UG

England

8. MARKETING AUTHORISATION NUMBER

PL 00156/0082

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

First authorised: 6^th June 1997 Last renewed: 21^st October 1999

10. DATE OF (PARTIAL) REVISION OF TEXT

October 1999