Carmellose Other names: Carboxymethyl cellulose Cellulose gum

Due to the negligible systemic exposure and the lack of pharmacological activity carmellose sodium can be used during pregnancy.

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

Carmellose sodium 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 carmellose 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.