SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Vividrin Eye Drops Vividrin Hay Fever Eye Drops

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active

Sodium cromoglycate EP 2.00 %w/v

3    PHARMACEUTICAL FORM

Sterile Preserved Multidose Eye Drops

4    CLINICAL PARTICULARS

4.1 Therapeutic indications

Vividrin Eye Drops are for the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal kerato conjunctivitis.

Vividrin Hay Fever Eye Drops are for the treatment of acute seasonal allergic conjunctivitis.

Posology and method of administration

Route of Administration:

For topical administration to the eye.

Adults, Children and the Elderly

One or two drops into each eye up to four times daily.

4.3 Contraindications

Known hypersensitivity to benzalkonium chloride, sodium cromoglycate or other constituents.

4.4 Special warnings and precautions for use

The solution should be discarded 1 month after first opening the bottle or if any turbidity develops. Do not use if the bottle has been opened prior to receipt. Vividrin Eye Drops and Vividrin Hay Fever Eye Drops contain benzalkonium chloride. Do not wear soft contact lenses during the period of use.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

Use in Pregnancy: Vividrin Eye Drops and Vividrin Hay Fever Eye Drops should be used cautiously during pregnancy and lactation. The widespread use of sodium cromoglycate has yet to reveal any adverse effects to mother or child during pregnancy.

Use in Lactation: It is not known whether sodium cromoglycate is excreted in human breast milk, but on the basis of its physicochemical properties, this is considered unlikely. There is no information to suggest that the use of sodium cromoglycate has any undesirable effects on the baby.

4.7 Effects on ability to drive and use machines

Transient stinging or blurred vision may occur on instillation. Do not drive or operate machinery until proper vision is restored.

4.8 Undesirable effects

Transient stinging and burning may occur after instillation, other symptoms of local irritation have been reported rarely.

4.9 Overdose

As sodium cromoglycate is absorbed only to a very limited extent from eye drops, no action other than medical observation shouldbe necessary.

5 PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Sodium cromoglycate has neither anti-histaminic or anti-inflammatory activity. Evidence suggests that sodium cromoglycate inhibits the release of mediators of the allergic reaction by stabilising the membranes of sensitised mast cells.

5.2 Pharmacokinetic properties

Due to lipid insolubility, sodium cromoglycate is poorly absorbed following administration to the eye. In normal volunteers approximately 0.03% is systemically absorbed. Absorbed sodium cromoglycate is excreted unchanged in the bile and urine.

Trace amounts of sodium cromoglycate have been detected in the aqueous humor of rabbits for up to 24 hours after treatment.

5.3 Preclinical safety data

The results of the studies do not add to the information needed by the prescriber, consequently, they are not repeated in the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzalkonium chloride EP Edetic acid disodium salt 2H₂0 EP Polysorbate 80 EP Sorbitol EP Sodium hydroxide BP Purified water EP

6.2 Incompatibilities

Sodium cromoglycate forms insoluble complexes with metal ions resulting in solution turbidity.

6.3 Shelf life

Unopened : 36 months

Once opened for the first time : 1 month

6.4 Special precautions for storage

Store below 25°C, out of direct sunlight

6.5 Nature and contents of container

Vividrin Eye Drops - 13.5ml polyethylene multidose eye dropper bottle with polyethylene cap. Vividrin Hay Fever Eye Drops - 10.0ml polyethylene multidose eye dropper bottle with polyethylene cap.

6.6 Special precautions for disposal

The following instructions for use are included in the patient leaflet.

1.    Before using your Vividrin Eye Drops (Vividrin Hay Fever Eye Drops) you should wash your hands.

2.    You may find it helps to sit in front of a mirror, so that you can see what you are doing. Gently pull down your lower eyelid and carefully place one or two Vividrin Eye Drops (Vividrin Hay Fever Eye Drops) in the space between the eyelid and the eye. Take care not to touch the dropper with your eye or fingers.

3.    Release the eyelid and blink a few times to make sure the liquid covers the whole surface of the eye.

4.    Repeatthe procedure with the other eye and then replace the cap on the bottle.

7 MARKETING AUTHORISATION HOLDER

Bausch & Lomb (UK) Ltd

Bausch &Lomb House 106 London Road Kingston-Upon-Thames Surrey KT2 6TN

UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 03468/0035

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13 December 1996

DATE OF REVISION OF THE TEXT

28/03/2011