Section Number

Subject

Change

3

Pharmaceutical Form

AC clear, colourless solution with a pH of 6.0-7.5 and osmolality of 200-260 mOsm/kg.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipientsits ingredients

4.4

Special warnings and precautions for use

Section expanded – safety update.  All current text deleted and replaced as below.

The dropper tip should not be allowed to touch any surface.

If the patient experiences eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, use should be discontinued and the doctor should be consulted.

If irritation, pain, redness and changes in vision occur or worsen or persist for more than 72 hours, treatment should be discontinued and a new assessment considered.

To avoid contamination, the 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.

Liquifilm Tears contain benzalkonium chloride which is irritant to the eye and could cause discolouration of soft lenses.  Avoid contact with soft contact lenses.  Remove contact lenses before Liquifilm Tears is used and wait for at least 15 minutes before reinsertion.

Concomitant ocular medication should be administered 15 minutes prior to the instillation of Liquifilm Tears.

4.5

Interaction with other medicinal products and other forms of interaction

Text amended

No interat applicablection studies have been performed.

4.7

Effects on ability to drive and use machines

Section expanded

No studies on the effects on the ability to drive and use machines have been performed.

Based upon the information available, Liquifilm Tears has no or negligible influence on the ability to drive and use machines.  However, it Mmay cause transient blurring of vision.  Do not drive or use hazardous machinery unless vision is clear.

4.8

Undesirable effects

Text deleted and replaced with expanded section

May cause transient stinging or irritation on instillation.

The following undesirable effects have been reported since Liquifilm Tears was marketed.

Frequency:

Not known: the incidence cannot be determined from available information.

Eye disorders:

Not known: Eye irritation, eye pain, ocular hyperaemia, lacrimation increased, foreign body sensation, eye pruritus.

Immune system disorders:

Not known: hypersensitivity

4.9

Overdose

Text added

No case of overdose has been reported.

5.1

Pharmacodynamic properties

Text added (details of group)

Pharmacotherapeutic group: Artificial tears and other indifferent preparations, ATC code: S01AX20.

9

Date of first authorization/renewal of the authorization

Date of last renewal amended from 1^st November 2007 to 4^th July 2008.

10

Date of revision of text

Amended from 4^th July 2008 to 28^th January 2009.