Allergan Ltd

Celluvisc 1% w/v Eye drops, solution, unit dose

1 ml contains 10 mg carmellose sodium.

One drop (≈ 0.05 ml) contains 0.5 mg of carmellose sodium.

For a full list of excipients, see section 6.1.

Eye drops, solution

A clear, colourless to slightly yellow viscous solution.

Treatment of the symptoms of dry eye.

Instil one or two drops in the affected eye/s as needed.

Ensure that the single-dose container is intact before use. The eye drop solution should be used immediately after opening.

To avoid contamination do not touch the tip to the eye or any other surface.

Hypersensitivity to the active substance or to any of the excipients.

If irritation, pain, redness and changes in vision occur or worsen, treatment should be discontinued and a new assessment considered.

Contact lenses should be removed before each application and may be inserted after 15 minutes.

Concomitant ocular medication should be administered 15 minutes prior to the instillation of Celluvisc.

To avoid contamination, do not touch the tip to the eye or any surface. Discard open single dose container after use.

No interaction studies have been performed

1. No interactions have been observed with Celluvisc. Given the formulation of Celluvisc, no interactions are anticipated.

2. If this product is used concomitantly with other topical eye medications there must be an interval of at least 15 minutes between the two medications.

The constituents of Celluvisc have been used as pharmaceutical agents for many years with no untoward effects. No special precautions are necessary for the use of Celluvisc in pregnancy and lactation.

Celluvisc has minor or moderate influence on the ability to drive and use machines as it may cause transient blurring of vision. Do not drive or use machinery unless vision is clear.

The frequency of undesirable effects is defined as follows: Very Common ( 1/10) Common (1/100, <1/10) Uncommon (1/1,000, <1/100) Rare (1/10,000, <1/1,000) Very Rare (<1/10,000), not known (cannot be estimated from the available data).

Eye disorders:

Not known: eye irritation, eye pain, vision blurred, lacrimation increased.

Accidental overdose will present no hazard.

Pharmacotherapeutic group: Other ophthalmologicals

ATC code: S01XA20

Carmellose sodium has no pharmacological effect. Carmellose sodium has a high viscosity resulting in an increased retention time on the eye.

Due to the high molecular weight (approx. 90,000 Daltons) carmellose sodium is unlikely to penetrate the cornea.

No additional information of relevance for the doctor has been obtained from the preclinical testing.

Sodium chloride

Sodium lactate

Potassium chloride

Calcium chloride

Purified water

Not applicable.

2 years.

The eye drop solution should be used immediately after opening. Any unused solution should be discarded.

Do not store above 25ºC.

Clear, single-dose containers made from low density polyethylene formed with a twist-off tab.

Each unit is filled with 0.4 ml of solution.

Pack sizes: 5, 10, 20, 30, 40, 60 or 90 single-dose containers.

Not all pack sizes may be marketed.

Ensure that the single dose container is intact before use. Discard any unused solution (i.e. once opened do not re-use container for subsequent doses).

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

PA 148/59/1

Date of first authorisation: 23^rd April 1997

Date of last renewal: 3^rd October 2008

13th February 2009