VISCOTEARS LIQUID

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 and adolescents aged to 18 years: The safety and efficacy of Viscotears Liquid Gel in children and adolescents at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available.

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.

79% of patients. The following adverse reactions have been reported during clinical trials with Carbomer 2mg/g, 3mg/g and are classified according to the following convention: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. System Organ Classification Adverse reactions Eye disorders Very common: vision blurred Common: ocular discomfort, eyelid margin crusting, eye irritation Uncommon: periorbital oedema, conjunctival oedema, eye pain, eye pruritus, ocular hyperaemia, lacrimation increased Skin and subcutaneous tissue disorders Uncommon: dermatitis contact Additional adverse reactions identified from post-marketing surveillance include the following.

Frequencies cannot be estimated from the available data.

System Organ Classification Adverse reactions Immune system disorders Not known:

Hypersensitivity Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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• For ocular use only • If patients experience eye pain, vision changes, irritation of the eyes, persistent redness or if the condition worsens or persists, they are to discontinue use and consult their doctor. • Viscotears Liquid Gel contains cetrimide which may cause eye irritation and is known to discolour soft contact lenses.

Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of Viscotears. After instillation there should be an interval of at least 15 minutes before reinsertion.

Patients with known hypersensitivity to carbomer (polyacrylic acid) or to any of the excipients.