4.3

Contraindications

Hypersensitivity to the active substances or any of the other excipients replaces Hypersensitivity to any component of the formulation.

4.4

Special warnings and precautions for use

Text edited as follows:

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

To avoid contamination Tthe dropper tip should not be allowed to touch the eye or any other surface.

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

4.7

Effects on ability to drive and use machines

Text edited as follows:

Refresh Ophthalmic 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 hazardous machinery unless vision is clear.

4.8

Undesirable effects

The following text was added:

The frequency of the following undesirable effects is not known (cannot be estimated from the available data).

Eye disorders

• Eye irritation
• Eye pain
• Ocular hyperaemia
• Vision blurred
• Eye pruritus
• Foreign body sensation
• Eye discharge
• Hypersensitivity

4.9

Overdosage

The following text was added:

No case of overdose has been reported

5.1

Pharmacodynamic properties

The following text was added:

Pharmacotherapeutic group: Artificial tears and other indifferent preparations – S01XA20

6.3

Shelf life

Text edited as follows:

After first opening the container: Use immediately after opening. Discard any unused contents solution.

10

DATE OF REVISION OF THE TEXT

July 2009 replaces June 2009

4.3

Contraindications

Hypersensitivity to the active substances or any of the other excipients replaces Hypersensitivity to any component of the formulation.

4.4

Special warnings and precautions for use

Text edited as follows:

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

To avoid contamination Tthe dropper tip should not be allowed to touch the eye or any other surface.

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

4.7

Effects on ability to drive and use machines

Text edited as follows:

Refresh Ophthalmic 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 hazardous machinery unless vision is clear.

4.8

Undesirable effects

The following text was added:

The frequency of the following undesirable effects is not known (cannot be estimated from the available data).

Eye disorders

• Eye irritation
• Eye pain
• Ocular hyperaemia
• Vision blurred
• Eye pruritus
• Foreign body sensation
• Eye discharge
• Hypersensitivity

4.9

Overdosage

The following text was added:

No case of overdose has been reported

5.1

Pharmacodynamic properties

The following text was added:

Pharmacotherapeutic group: Artificial tears and other indifferent preparations – S01XA20

6.3

Shelf life

Text edited as follows:

After first opening the container: Use immediately after opening. Discard any unused contents solution.

10

DATE OF REVISION OF THE TEXT

July 2009 replaces June 2009

Section Number

Subject

Change

1

Name of the Medicinal Product

Name amended from REFRESH OPHTHALMIC to read Refresh Ophthalmic 1.4% w/v + 0.6% w/v

2

Qualitative and quantitative composition

Text expanded to read “For a full list of excipients, see section 6.1.

6.1

List of excipients

Phrase “(for pH adjustment)” added to 2 of the excipients.

6.2

Incompatibilities

Text deleted “None known” and replaced with “In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products”

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

Section subject heading amended from “Instructions for use and handling”

9

Date of first authorization / renewal of the authorization

Amended from7^th March 1989 / 7^th March 2004 to read 7th March 1989 / 7th March 2009.

10

Date of revision of the text

Amended from 20^th June 2007 to read 25^th June 2009.

Section Number

Subject

Change

1

Name of the Medicinal Product

Name amended from REFRESH OPHTHALMIC to read Refresh Ophthalmic 1.4% w/v + 0.6% w/v

2

Qualitative and quantitative composition

Text expanded to read “For a full list of excipients, see section 6.1.

6.1

List of excipients

Phrase “(for pH adjustment)” added to 2 of the excipients.

6.2

Incompatibilities

Text deleted “None known” and replaced with “In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products”

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

Section subject heading amended from “Instructions for use and handling”

9

Date of first authorization / renewal of the authorization

Amended from7^th March 1989 / 7^th March 2004 to read 7th March 1989 / 7th March 2009.

10

Date of revision of the text

Amended from 20^th June 2007 to read 25^th June 2009.