HYPROMELLOSE Eye Drops Ref.[8855] Active ingredients: Hypromellose

May cause transient mild stinging or temporary blurred vision. If irritation persists or worsens, or headache, eye pain, vision changes or continuous redness occur, patients should discontinue use and consult a physician or pharmacist.

In order to preserve the sterility, the dropper should not be allowed to touch any part of the eye or any other surface.

The product contains benzalkonium chloride and should not be used if soft contact lenses are being worn.

Remove contact lenses prior to application and wait at least 15 minutes before reinserting. Benzalkonium chloride is known to discolour soft contact lenses.

Hypromellose prolongs the contact time of topically applied drugs commonly used in ophthalmology.

Fertility

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.

Pregnancy

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.

Breast-feeding

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 women to hypromellose is negligible. In addition to this, hypromellose is pharmacologically inert.

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

Adverse events which have been associated with Hypromellose are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

Eye disorders

Not known: transient mild stinging or vision blurred, eye pain, foreign body sensation in eyes, eye irritation, ocular hyperaemi

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.