ISOPTO PLAIN 0.5% eye drops, solution

Hypromellose Ph.Eur. 0.5% w/v

For excipients see 6.1.

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.

Hypromellose is an inert substance and is not expected to be absorbed systemically. Hence, although no systemic toxicity studies have been conducted it is not expected to demonstrate any systemic toxicity or to have any effect on reproductive processes.

Similarly no specific local ocular toxicity or irritation studies have been conducted, however, no adverse effects are anticipated. Indeed, hypromellose ophthalmic solution is used as a control in some ophthalmic drug studies because of the acknowledged low level of toxicity.

Sodium citrate dihydrate Ph.Eur., Disodium hydrogen phosphate anhydrous BP, Sodium dihydrogen phosphate monohydrate BP, Sodium chloride Ph.Eur., Benzalkonium chloride Ph.Eur, Purified water Ph.Eur.

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, instill another drop.

Alcon Laboratories (UK) Ltd.,

Pentagon Park,

Boundary Way,

Hemel Hempstead,

HP2 7UD.

PL 0649/5920R

14 May 2002

April 2005