Celluvisc 1.0% w / v, Eye drops, solution

1. Name Of The Medicinal Product

Celluvisc 1.0% w/v Eye drops, solution, unit dose

2. Qualitative And Quantitative Composition

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.

3. Pharmaceutical Form

Eye drops, solution

A clear, colourless to slightly yellow viscous solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of the symptoms of dry eye.

4.2 Posology And Method Of Administration

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

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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.

4.6 Pregnancy And Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

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.

4.8 Undesirable Effects

The frequency of undesirable effects is defined as follows:

• Very Common (

• Common (

• Uncommon (

• Rare (

• 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.

4.9 Overdose

Accidental overdose will present no hazard.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

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

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium chloride

Sodium lactate

Potassium chloride

Calcium chloride

Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years.

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

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

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.

6.6 Special Precautions For Disposal And Other Handling

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).

7. Marketing Authorisation Holder

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

County Mayo

IRELAND

8. Marketing Authorisation Number(S)

PL 05179/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

23 April 1997 / 29 September 2003 / 03 October 2008

10. Date Of Revision Of The Text

03 October 2008