Summary of Product Characteristics
last updated on the eMC:
05/08/2008
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 05/08/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Jun-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section Number
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Subject
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Change
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4.2
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Posology and method of administration
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Added
Ensure container is intact. Twist off tab and apply eyedrops.
Installation changed to instillation
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4.3
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Contraindications
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Changed to
Hypersensitivity to the active substance polyvinyl alcohol or any of the other excipients.
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4.4
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Special warnings and precautions for use
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Changed from
If symptoms worsen or persist or other adverse effects occur, discontinue use and consult a doctor.
In order to avoid contamination, dropper should not be allowed to touch the eye or any other surface.
Use immediately after opening.
Do not store opened container.
to
If irritation, pain, redness and changes in vision occur or worsen, 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.
Concomitant ocular medication should be administered 15 minutes prior to the instillation of Liquifilm Tears Preservative Free or Refresh Ophthalmic.
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4.5
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Interactions with other medicinal products and other forms of interaction
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Changed from
None known
To
No interaction studies have been performed
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4.6
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Pregnancy and lactation
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Minor format changes
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4.7
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Effects on ability to drive and use machines
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Changed from
May cause transient blurring. Do not drive or use hazardous machinery unless vision is clear.
To
Liquifilm Tears Preservative Free or 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.
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4.8
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Undesirable effects
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Changed from
May cause transient stinging or irritation on instillation.
To
Liquifilm Tears Preservative Free or Refresh Ophthalmic may cause transient stinging or irritation on instillation.
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
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4.9
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Overdose
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Added
No case of overdose has been reported.
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10
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Date of revision of the text
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Changed to
June 2008
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Updated on 26/09/2003 and displayed until 05/08/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 26/09/2003 and displayed until 26/09/2003
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 01/08/2001 and displayed until 26/09/2003
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Updated on 06/09/1999 and displayed until 01/08/2001
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Reasons for adding or updating:
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