1. Name of the medicinal product
ISOPTO PLAIN 0.5% eye drops, solution
2. Qualitative and quantitative composition
Hypromellose Ph.Eur. 0.5% w/v.
For excipients see 6.1.
3. Pharmaceutical form
Eye Drops, Solution
4. Clinical particulars
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
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.
4.4 Special warnings and precautions for use
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.
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
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.
4.7 Effects on ability to drive and use machines
May cause transient blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is clear.
4.8 Undesirable effects
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.