SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Hypromellose Eye Drops BPC 0.3%

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Hypromellose BP (4500)

3    PHARMACEUTICAL FORM

Eye drops

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

To provide tear-like lubrication for the symptomatic relief of dry eyes and eye irritation associated with deficient tear production.

As an ocular lubricant for artificial eyes.

4.2.    Posology and Method of Administration

Adults, children and the elderly

The dose depends on the need for lubrication. Usually one or two drops to each eye three times daily or as prescribed.

4.3    Contraindications

Hypersensitivity to any component.

Contains benzalkonium chloride, soft contact should not be worn.

4.4    Special warnings and special precautions for use

If irritation persists or worsens, or headache, eye pain, vision changes or continuous redness occur, discontinue use and consult a physician.

Pharmacogenetic problems None known.

4.5.    Interactions with other Medicinal Products and other Forms of Interaction

None known.

4.6.    Pregnancy and Lactation

There is insufficient evidence of safety in pregnancy and this product should, therefore, only be used in pregnancy if it is considered essential by the physician.

4.7.    Effects on Ability to Drive and Use Machines

May cause transient mild stinging or temporary blurring of vision. Do not drive or operate machinery unless vision is clear.

4.8.    Undesirable Effects

May cause transient mild stinging or temporary blurring of vision.

4.9 Overdose

Not applicable.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

This product is a sterile, isotonic, buffered solution of Hypromellose. It is used as a substitute for natural tears.

5.2. Pharmacokinetic Properties

Not appropriate.

5.3 Preclinical safety data

None stated.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Purified water, Sodium Chloride, Potassium Chloride, Borax, Boric Acid, Benzalkonium Chloride solution and may contain sodium hydroxide or hydrochloric acid.

6.2.    Incompatibilities

None known.

6.3.    Shelf-Life

36 months unopened.

28 days after opening.

6.4.    Special Precautions for Storage

Store below 25°C.

6.5.    Nature and Content of Container

Plastic tamper evident eye drop assembly. Fill volume 10ml.

6.6.    Instructions for Use, Handling and Disposal

None stated.

ADMINISTRATION DETAILS

7    MARKETING AUTHORISATION HOLDER

Martindale Pharmaceuticals Ltd

Bampton Road

Romford

RM3 8UG

England.

8    MARKETING AUTHORISATION NUMBER(S)

PL 00156/0069

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

06/06/1997

10 DATE OF REVISION OF THE TEXT

27/03/2002