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.

Paediatric population

The safety and efficacy of Celluvisc in Paediatric population have not been established. No data are available.

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

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 or possible eye injury, do not touch the tip to the bottle or vial to any surface and avoid contact with the eye. 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.

Pregnancy and Breast-feeding

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 which may impair the ability to drive or operate machines. 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).

The following adverse reactions have been identified during clinical studies of 0.5% w/v and 1.0% w/v Celluvisc Eye drops, solution, unit dose.

Eye disorders:

Common: Eye irritation (including burning and discomfort), eye pain, eye pruritus, visual disturbance.

Postmarketing Experience

The following additional adverse reactions have been identified during postmarketing use of Celluvisc 1.0% in clinical practice.

Immune System Disorders

Uncommon: Hypersensitivity including eye allergy with symptoms of eye swelling or eyelid edema.

Eye Disorders

Uncommon: Lacrimation increased, vision blurred, eye discharge, eyelid margin crusting and/or medication residue, foreign body sensation in eye, ocular hyperemia, visual impairment.

Injury, Poisons and Procedural Complications

Uncommon: Superficial injury of eye (from the vial tip touching the eye during administration) and/or corneal abrasion

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; Website: www.mhra.gov.uk/yellowcard.

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 25° C.

Keep the single dose containers in the pouch and place the pouch back in the outer carton. Pouch is required to prevent moisture loss.

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:

Carton containing 10, 20, 30, 40, 60 or 90 foil pouched single-dose containers. Each foil pouch contains 10 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).