This information is intended for use by health professionals
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.
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.
The product contains benzalkonium chloride and should not be used when soft contact lenses are worn.
Studies have not been performed to evaluate the effect of topical ocular administration of hypromellose on fertility. Hypromellose is a pharmacologically inert compound and it would not be expected to have any effect on fertility.
There are no or limited amount of data from the use of ophthalmic hypromellose in pregnant women. Systemic exposure to hypromellose following topical ocular administration is negligible and the product has no pharmacological properties.
It is unknown whether topical hypromellose/metabolites are excreted in human milk. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to hypromellose is negligible. In addition to this, hypromellose is pharmacologically inert.
May cause transient blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is clear.
The following adverse reactions have been reported following administration of ISOPTO PLAIN. Frequency cannot be estimated from the available data.
System Organ Classification
Vision blurred, eye pain, foreign body sensation in eyes, eye irritation, ocular hyperaemia
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of benefit/risk balance of the medicinal product. Health care professionals are asked to report any suspected adverse reactions via their national reporting system:
Yellow Card Scheme
Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, nor in the event of accidental ingestion of the contents of one bottle.
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.
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 Eye Care UK Limited
Park View, Riverside Way
Watchmoor Park, Camberley
Surrey, GU15 3YL
14 May 2002