Summary of Product Characteristics
last updated on the eMC:
20/12/2011
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 20/12/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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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: 07-Dec-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update to Section 4.8 as shown below:
4.8 Undesirable effects
The following adverse events have been occasionally reported:
Common
· mild, transient eye irritation
· sticky eyelids
· blurred vision after instillation of the gel
Ocular hyperaemia, eye swelling, eyelid oedema, eye pruritis and eye pain have been reported during post-marketing experience.
Unknown
- Hypersensitivity
- Ocular hyperaemia
- Eye swelling
- Eyelid oedema
- Eye pruritis
- Eye pain
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Updated on 10/01/2011 and displayed until 20/12/2011
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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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| Date of revision of text on the SPC: 25-Nov-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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A paragraph has been added to Section 4.2 as shown below in bold:
4.2 Posology and method of administration
For ocular use.
Adults:
1 drop 3 - 4 times daily or as required, depending upon the severity of the disease
Elderly:
No dosage amendment is necessary in the elderly
Children:
No specific studies with Viscotears have been performed in children. Use in these patients, is therefore, at the responsibility of the physician.
Viscotears Liquid Gel contains a sterile gel until the original closure is broken. The tip of the container should not come into contact with any surface including the eye, as this may cause injury to the eye and contaminate the gel. Discard four weeks after first opening.
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Updated on 30/12/2008 and displayed until 10/01/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.3 - Contraindications
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 4 - Special Precautions for Storage
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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: 05-Dec-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SECTION 2
The following has been added:
“(polyacrylic acid)”
“For a full list of excipients, see section 6.1 List of excipients”
SECTION 4.3
Text changed from:
“Patients with known hypersensitivity to any of the ingredients”.
To
“Patients with known hypersensitivity to carbomer (polyacrylic acid) or to any of the excipients”.
SECTION 4.8
“burning sensation”
changed to
“eye irritation”
The following has also been added:
“Ocular hyperaemia, eye swelling, eyelid oedema, eye pruritus and eye pain have been reported during post-marketing experience.”
SECTION 6.4
The following has been added:
“Viscotears Liquid Gel must be kept out of the reach and sight of children.”
SECTION 10
Date of revision of text changed from:
“01July2002”
to
“05Dec2008”
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Updated on 07/01/2005 and displayed until 30/12/2008
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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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Updated on 23/12/2004 and displayed until 07/01/2005
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 01/10/2004 and displayed until 23/12/2004
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 30/09/2003 and displayed until 01/10/2004
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Updated on 21/08/2001 and displayed until 30/09/2003
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Reasons for adding or updating:
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Transferred from eMC version 1
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