Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The side effects are listed in the following frequencies: 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 current available data).
In very rare cases, uncontrolled use, i.e. long-term and/or too frequent use, may result in keratopathy, hypopyon, or central corneal erosion including central scarring.
Corneal perforation may also be possible.
Transient irritation, stinging and blurring of vision may occur on instillation.
In rare cases, local anaesthetic preparations have been associated with allergic reactions (in the most severe instances, anaphylactic shock).
Table 1.

Eye disorders
Not known:         Eye pain, eye irritation, blurred vision, keratopathy, hypopyon, corneal erosion, corneal perforation, eye allergy, allergic blepharitis.
Immune system disorders:
Not known:                 Hypersensitivity, anaphylactic reaction/shock.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il/