Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Summary of the safety profile
In clinical trials with Maxitrol ophthalmic suspension and Maxitrol ophthalmic ointment, the most common adverse reactions were ocular discomfort, keratitis and eye irritation, occurring in 0.7% to 0.9% of patients.

Tabulated summary of adverse reactions
The following adverse reactions 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 <1/1000), very rare (<1/10,000) or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness. The adverse reactions were obtained from clinical trials and post-marketing experience for Maxitrol ophthalmic suspension and Maxitrol ophthalmic ointment.


MAX DRO API MAY21 V5                                                    UK SmPC (JAN 2021) System Organ                 MedDRA Preferred Term (v.18.0)
Classification
Immune system disorders      Not known: hypersensitivity (systemic or ocular) Endocrine disorders          Not known: Cushing's syndrome, adrenal suppression (see section 4.4) Nervous system disorders     Not known: headache
Eye disorders                Uncommon: keratitis, intraocular pressure increased, eye pruritus, ocular discomfort, eye irritation,
Not known: ulcerative keratitis, corneal thinning, vision blurred (see also section 4.4), photophobia, mydriasis, eyelid ptosis, eye pain, eye swelling, foreign body sensation in eyes, ocular hyperaemia, increased lacrimation Skin and subcutaneous       Not known: Stevens-Johnson syndrome tissue disorders


Description of selected adverse event
Due to the steroid component, in diseases causing thinning of the cornea or sclera there is a higher risk for perforation especially after long treatments (See Section Special warnings and precautions for use).
Topical ophthalmic steroid use may result in increased intraocular pressure with damage to the optic nerve, reduced visual acuity and visual field defects. Also it may lead to posterior subcapsular cataract formation (See Section Special warnings and precautions for use).
Sensitivity to topically administered aminoglycosides may occur in some patients (See Section Special warnings and precautions for use). Systemic side effects may occur with extensive use.

Corticosteroids may impair glucose tolerance, which can lead to new-onset or exacerbation of diabetes mellitus (see section 4.4).

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. 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/