As sodium cromoglycate is absorbed only to a very limited extent from eye drops, no action other than medical observation should be necessary.
Known hypersensitivity to benzalkonium chloride, sodium cromoglycate or other constituents.
Sodium cromoglycate forms insoluble complexes with metal ions resulting in solution turbidity.
Transient stinging and burning may occur after instillation, other symptoms of local irritation have been reported rarely.
The results of the studies do not add to the information needed by the prescriber, consequently, they are not repeated in the SPC.
Optiwell Eye Drops are for the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal kerato conjunctivitis.
Optiwell Hay Fever Eye Drops are for the treatment of acute seasonal allergic conjunctivitis.
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 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. Optiwell Eye Drops and Optiwell Hay Fever Eye Drops contain benzalkonium chloride. Do not wear soft contact lenses during the period of use.
Transient stinging or blurred vision may occur on instillation. Do not drive or operate machinery until proper vision is restored.
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.
The following instructions for use are included in the patient leaflet.
1. Before using your Optiwell Eye Drops (Optiwell 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 Optiwell Eye Drops (Optiwell 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.
