ISOPTO ALKALINE

Hypromellose 1.0% w/v

Eye drops, solution.

Used topically to provide tear-like lubrication for the symptomatic relief of dry eyes and eye irritation associated with deficient tear production. (Usually in cases of rheumatoid arthritis, keratoconjunctivitis sicca and xerophthalmia).

Also used as an ocular lubricant for artificial eyes.

Adults, children and the elderly:

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

Hypersensitivity to any component of the product. The product contains benzalkonium chloride and should not be used when soft contact lenses are worn.

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

To preserve sterility do not allow the dropper to touch the eye or any other surface.

None known

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

May cause transient blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is clear.

May cause transient mild stinging or temporarily blurred vision.

Not applicable

OPHTHALMOLOGICALS: OTHER OPHTHALMOLOGICALS:

ATC CODE: SO1X A20

Hypromellose is an inert substance. It has no pharmacological activity.

Hypromellose is an inert substance. It has no pharmacological activity and, hence, the pharmacokinetic properties have not been studied.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Sodium citrate dihydrate , Disodium Phosphate anhydrous,

Sodium biphosphate , Sodium chloride , Benzalkonium chloride, Purified water.

None known

36 months (unopened), 1 month (after first opening).

Do not store above 25°C. Do not refrigerate.

Keep container tightly closed.

Discard 1 month after opening.

10 mL Drop-Tainer - Natural Low Density Polyethylene Bottle and Plug.

Polystyrene or Polypropylene cap.

Do not touch dropper tip to any surface as this may contaminate the contents.

If the drop of medication is not retained in the eye upon dosing for any reason, instil another drop.

Alcon Laboratories (UK) Ltd.,

Pentagon Park,

Boundary Way,

Hemel Hempstead,

HP2 7UD.

PL 0649/5900R

9^th October 1990/18^th December 2001

January 2002