Vividrin Eye Drops

Vividrin Hay Fever Eye Drops

Active

Sodium cromoglycate EP 2.00% w/v.

Sterile Preserved Multidose Eye Drops.

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.

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.

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

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.

None known.

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

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

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

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

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.

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.

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

Benzalkonium chloride EP

Edetic acid disodium salt 2H₂O EP

Polysorbate 80 EP

Sorbitol EP

Sodium hydroxide EP

Purified water EP

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

Unopened: 36 months.

Once opened for the first time: 1 month.

Store below 25ºC, out of direct sunlight.

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.

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

Pharma Global Limited

Hudson Road

Sandycove

Co Dublin

Ireland

PL 11185/0004

13^th December 1996

Not applicable