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Section Number
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Subject
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Change
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1
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NAME OF THE MEDICINAL PRODUCT
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Text added 1.4% w/v eye drops, solution
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2
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QUALITATIVE AND QUANTITATIVE COMPOSITION
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Text added
Excipient: Benzalkonium chloride 0.005% w/v
For a full list of excipients, see section 6.1.
USP text deleted after polyvinyl alcohol
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3
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Pharmaceutical Form
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Text added: Eye drops, solution. A clear, colourless solution.
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4.2
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Posology and Method of Administration
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Text re-ordered and route of administration added.
Now reads:
Dosage schedule: One to two drops as required or directed for all ages.
Route of administration: Topical instillation into conjunctival sac.
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4.3
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Contraindications
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Text Sensitivity to any of the ingredients amended to read:
Hypersensitivity to the active substance or to any of the excipients.
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4.4
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Special Warnings and
Precautions for Use
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Section completely reworded and expanded. Extra administration and contact lens information added as follows:
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.
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4.5
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Interaction with other
Medicaments and other
forms of Interaction.
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Text amended from None known to read:
No interaction studies have been performed.
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4.7
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Effects on Ability to Drive
and Use Machines
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Text expanded / amended to read:
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 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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Existing text deleted May cause transient ocular stinging, irritation or burning sensation on
instillation.
Section amended to reflect post-marketing data.
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
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4.9
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Overdose
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Text amended from “none” to read:
No case of overdose has been reported.
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5.1
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Pharmacodynamic
Properties
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Pharmacotherapeutic group information added
Pharmacotherapeutic group: Artificial tears and other indifferent preparations, ATC code:
S01AX20.
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6.1
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List of Excipients
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All references to USP or EP deleted.
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6.6
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Special precautions for
disposal and other handling
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Section heading amended to opposite from “Instructions for Use/Handling”
Text amended from “not applicable” to “No special requirements”.
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9
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DATE OF FIRST
AUTHORISATION/RENEWAL
OF THE AUTHORISATION
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Date of first authorization added. Now reads:
Date of first authorisation: 19th September 1974
Date of latest renewal: 10th October 2005
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10
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DATE OF REVISION OF THE TEXT
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Amended from 20th December 2007 to read 15th July 2009.
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