LlQUlVISC 2.5 mg/g, eye gel

Carbomer 974P 2.5 mg/g.

Excipient: benzalkonium chloride (0.06 mg/g).

For a full list of excipients, see section 6.1.

Eye gel

Slightly yellow and opalescent gel.

Symptomatic treatment of dry eye syndrome.

Ocular use.

Adults (including the elderly):

Instil one drop of the gel into the inferior conjunctival cul-de-sac 1 to 4 times daily according to the degree of ocular trouble.

Children:

No specific studies with LIQUIVISC 2.5 mg/g, eye gel have been performed in children. It is recommended that LlQUlVISC 2.5 mg/g, eye gel should not be used in children until further data becomes available.

After instillation, the bottle should be stored vertically with the dropper downwards to facilitate the formation of drops when next used.

Do not touch the eye with the dropper tip. Replace the cap after use.

Hypersensitivity to any of the components of the product.

Benzalkonium chloride is commonly used as a preservative in ophthalmic products and has been reported rarely to cause punctate keratopathy and/or ulcerative keratopathy.

Contact lenses :

Benzalkonium chloride may be absorbed by and discolour contact lenses and therefore the patients should be instructed to wait until 30 minutes after instillation of LIQUIVISC 2.5 mg/g, eye gel before inserting contact lenses.

If symptoms continue or worsen, the patient should be reviewed by a physician.

In case of concomitant use with other eye drops, wait for 15 minutes between instillations.

LIQUIVISC 2.5 mg/g, eye gel should be the last medication instilled.

LIQUIVISC 2.5 mg/g, eye gel was not studied in pregnant and breast-feeding women.

Caution should be exercised when prescribing to pregnant or breast-feeding women.

Vision may be blurred for a few minutes after the instillation.

If affected, the patient should be advised not to drive or operate hazardous machinery until normal vision is restored.

As for other eye drops, possibility of mild transient stinging or burning upon instillation.

Blurred vision may occur briefly after instillation until the gel is evenly distributed over the eye surface.

Any ocular overdose or oral intake that could occur is of no clinical relevance.

TEAR SUBSTITUTE

(S : Sensory organ (eye))

- Fluid eye gel based on a high molecular weight hydrophilic polymer (carbomer 974P).

- Due to its physical properties, this gel forms a transparent lubricating and wetting film on the surface of the eye, temporarily compensating for tear insufficiency.

- Its pH (7.3) and osmolality are similar to those of the normal tear film.

- Its viscosity (700 mPas) is greater than that of artificial tears, allowing less frequent administration.

Because of the relatively large size of the carbomer molecule, penetration through the cornea is unlikely.

The persistence time of the gel on the eye surface is about 30 minutes.

Data from subacute toxicity and local tolerance studies do not show any relevant findings.

Benzalkonium chloride

Sorbitol

Lysine monohydrate

Sodium acetate

Polyvinyl alcohol

Water for injections

Not applicable.

Shelf life prior to opening:

30 months.

In-use shelf life:

4 weeks.

Do not store above 25°C. Store container in the outer carton, in order to protect from light.

10 g in 10 m1 bottle (PE) with dropper (PE).

No special requirements.

Laboratoires Thea

12 rue Louis Blériot

Z.I.du Brézet

63017 Clermont-Ferrand Cedex 2

France

PL 20162/0009

10/06/2008

10/06/2008