Substitution of tear fluid in the management of dry eye conditions, including keratoconjunctivitis sicca and unstable tear film.

• Adults (including the elderly) and children:

• One drop to be instilled into the conjunctival fold of each affected eye 3 - 4 times daily or as required, depending on the degree of discomfort.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Blurred vision can occur if too much gel is instilled at one time, or if the gel is used too frequently. This effect can last for up to an hour. Recovery can be aided by blinking vigorously for a few seconds. If this fails, the lower eyelid should be manipulated until the gel returns to the lower fornix and normal vision is restored.

Contact lenses should be removed during treatment with GelTears.

No significant interactions have been reported.

Safety for use in pregnancy and lactation has not been established, therefore, Geltears should not be used in these circumstances.

As with other ophthalmic preparations, transient blurring of vision may occur on instillation. If affected, the patient should be advised not to drive or operate hazardous machinery until normal vision is restored.

Corneal irritation due to benzalkonium chloride could possibly occur with prolonged use.

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 the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard

Not applicable.

Pharmacotherapeutic group: Artificial tears and other indifferent preparations, ATC code: S01XA20

GelTears contains Carbomer 980, a hydrophilic, high molecular weight polymer of carboxyvinylic acid. The gel forms a transparent lubricating and moistening film on the surface of the eye. The preparation has a pH similar to that found in the normal tear film and is slightly hypotonic with respect to tears. GelTears relieves the symptoms of irritation linked with dry eye syndromes and protects the cornea against drying out.

The use of vital stains has provided objective evidence that the corneal and conjunctival epithelial lesions associated with dry eye syndromes show improvement on treatment with GelTears. The gel remains on the surface of the eye for longer than low viscosity artificial tears and hence, less frequent application is required.

No human pharmacokinetic studies are available, however, absorption or accumulation in ocular tissues is likely to be negligible due to the high molecular weight of the active ingredient.

No adverse safety issues were detected during the development of this formulation. The ingredients are well established in clinical ophthalmology.

Benzalkonium chloride 0.01% w/w (as a preservative)

Water for Injection

Sorbitol

Sodium hydroxide for pH adjustment

Not applicable.

The shelf life expiry date shall not exceed 3 years from the date of its manufacture when stored below 25° C. Any remaining gel should be discarded 28 days after first opening the tube.

The product should be transported in the original packaging. It should be stored below 25° C.

Sterile ophthalmic gel presented in 5g and 10g plasticised, lacquered aluminium tubes, closed with a tamper evident polyethylene cap. Each tube is individually cartonned with a patient information leaflet.

Not applicable.