CELLUVISC Eye drops, solution Ref.[6361] Active ingredients: Carmellose

If irritation, pain, redness or changes in vision occur or if the patient’s condition is worsened treatment discontinuation should be considered and a new assessment made.

None known.

For the use of concomitant ocular products, see section 4.2.

Pregnancy and Breast-feeding

Due to the negligible systemic exposure and the lack of pharmacological activity Celluvisc can be used during pregnancy and breast-feeding.

Celluvisc may cause transient blurring of vision which may impair the ability to drive or operate machines. The patient should wait until their vision has cleared before driving or using machinery.

The frequency of adverse reactions documented during clinical trials is given. The frequency is defined as follows: Very Common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Very Rare (<1/10,000), not known (cannot be estimated from the available data).

Eye disorders

Common: Eye irritation (including burning and discomfort), eye pain, eye pruritus, visual disturbance.

Postmarketing Experience

The following additional adverse reactions have been identified during postmarketing use of Celluvisc in clinical practice. Because postmarketing reporting of these reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions.

Immune System Disorders: Hypersensitivity including eye allergy.

Eye Disorders: Blurred vision, eye discharge, lacrimation increased, ocular hyperemia.

Injury, Poisons and Procedural Complications: Superficial injury of eye (from the vial tip touching the eye during administration) and/or corneal abrasion.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.

Not applicable.