Section Number

Subject

Change

1

Name of the medicinal product

Amended from Celluvisc 1.0% to read Celluvisc 1%

4.5

Interaction with other medicinal products and other forms of interaction

Section title amended to read:

Interaction with other medicinal products and other forms of interactions

7

Marketing Authorisation Holder

Amendment to address (format only):

County Mayo changed to read Co. Mayo

Word Ireland deleted.

9

Date of first authorisation /renewal of authorisation

Date of last renewal amended from 29^th September 2003 to 3^rd October 2008.

10

Date of revision of text

New Text:  13^th February 2009.

Replaces:  28^th March 2008.

Section Number

Subject

Change

2

Qualitative and quantitative composition

Word Inserted:

For a full list of excipients, see section 6.1.

4.2

Posology and method of administration

New Text:

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.

Replaces:

Do not contaminate the open-end of the ampoule when in use. Twist-off tab and apply drops topically as follows:

Instil one to two drops as required or directed into conjunctival sac.

4.3

Contraindications

Words Inserted:

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

4.4

Special warnings and precautions for use

New text:

Discard open single dose container after use.

Replaces:

Discard open ampoule after use.

4.5

Interaction with other medicinal products and other forms of interaction

Text added:

No interaction studies have been performed

4.7

Effects on ability to drive and use machines

New text:

Celluvisc has minor or moderate influence on the ability to drive and use machines as it may cause transient blurring of vision. 

Replaces:

May cause transient blurring of vision. 

4.8

Undesirable effects

New text:

The frequency of undesirable effects is defined as follows:

• Very Common (³ 1/10)
• Common (³1/100, <1/10)
• Uncommon (³1/1,000, <1/100)
• Rare (³1/10,000, <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.

Replaces:

Ocular events (transient – typically lasting 1 to 15 minutes):

Ocular irritation, burning or stinging sensation

Blurring of vision

Tearing.

4.9

Overdose

Word change:

Accidental overdose will present no hazard.

Replaces:

Accidental overdosage will present no hazard.

5.1

Pharmacodynamic properties

New text:

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.

Replaces:

Celluvisc exerts a physical, not a pharmacological action. Carmellose sodium is a viscosity enhancer which increases the retention time of the product.

5.2

Pharmacokinetic properties

New text:

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

Replaces:

Carmellose sodium has a large molecular weight and is unlikely to penetrate the cornea.  The period of retention on the cornea is approximately 22 minutes in healthy eyes.

    6.5

Nature and contents of container

Words deleted:

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

6.6

Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Heading change:

Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Replaces:

Instructions for use and handling

Word change:

Ensure that the single dose container is intact before use.

Replaces:

Ensure that ampoule is intact before use

9

Date of first authorization /renewal of authorization

New text:

Date of first authorisation: 23^rd April 1997

Date of last renewal: 29^th September 2003

Replaces:

23rd April 1997 / 29th September 2003

10

Date of revision of text

New Text:

28^th March

Replaces:

31^st January 2007