Allergan Ltd

Celluvisc^® 0.5% w/v, eye drops, solution, unit dose

1 ml contains 5mg carmellose sodium

For excipients, see section 6.1.

Eye drops, solution in single-dose container.

Clear, colourless to slightly yellow solution.

Tear substitute. Treatment of the symptoms of dry eye.

Instil 1-2 drops in the affected eye/s 4 times a day or 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.

If Celluvisc is concomitantly used with other ocular eye medications there must be an interval of at least 15 minutes between the two medications (as displacement of a medication may occur).

The eye drops may be used with contact lenses.

Hypersensitivity to carmellose sodium or to any of the excipients.

If irritation, pain, redness or changes in vision occur or if the patient's condition is worsened treatment discontinuation should be considered and a new assessment made.

None known.

For the use of concomitant ocular products, see section 4.2.

Due to the negligible systemic exposure and the lack of pharmacological activity Celluvisc can be used during pregnancy and lactation.

Celluvisc is not expected to cause blurred vision. If individual patients experience transient blurred vision they should be advised not to drive or operate machinery until vision has cleared.

The frequency of adverse reactions documented during clinical trials is given. The frequency 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:

Common: Eye Irritation

The following other adverse reactions have reported since Cellufluid has been marketed:

Eye pain, vision blurred, lacrimation increased, ocular hyperaemia.

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.

The excipients in Celluvisc were chosen to mimic the electrolyte constitution of tears.

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

There are no preclinical data considered relevant to clinical safety beyond data included in other sections of the SPC.

Sodium chloride

Sodium lactate

Potassium chloride

Calcium chloride dihydrate

Magnesium chloride hexahydrate

Sodium hydroxide or hydrochloric acid to adjust pH

Purified water

Not applicable.

18 months.

After first opening: Use immediately.

Do not store above 25ºC.

0.4 ml in LDPE single-dose container.

Pack sizes: 5, 30 or 90 single-dose containers.

Not all pack sizes may be marketed.

Discard any unused solution in opened container i.e. do not re-use container for subsequent doses.

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

County Mayo

Ireland

PA 148/59/2

10^th November 2006

17 DECEMBER 2010