Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The most frequent adverse reactions to Tobrex Eye Ointment are localised ocular toxicity and hypersensitivity, including punctate keratitis, eye and lid itching, lid swelling, ocular hyperaemia, conjunctival erythema and lacrimation. These reactions occur in approximately 3% of patients treated with Tobrex.
Other adverse reactions associated with ophthalmic tobramycin are burning and stinging of the eyes. For ophthalmic ointment dosage form: blurred vision.
A summary of treatment emergent adverse events based on literature and postmarketing experience and their estimate of frequencies (very common, common, uncommon, rare, very rare, and not known) in accordance with preferred term and system organ classes (SOC) of any severity are listed below.
Within each frequency-grouping, undesirable effects are presented in decreasing order of seriousness. These adverse reactions were observed following ophthalmic use of Tobramycin:
Immune system disorders
Uncommon (> 0.1% to ≤ 1%): hypersensitivity.
Not known: anaphylactic reaction.
Nervous system disorders
Uncommon (> 0.1% to ≤ 1%): headache.
Eye disorders
Common (> 1% to < 10%): ocular discomfort, ocular hyperaemia.
Uncommon (> 0.1% to ≤ 1%): keratitis, corneal abrasion, conjunctival disorder, visual impairment, vision blurred, erythema of eyelid, conjunctival oedema, eyelid oedema, eyelid disorder, eye pain, dry eye, eye discharge, eye pruritus, foreign body sensation in eyes, lacrimation increased.
Not known: eye allergy, eye irritation, eyelids pruritus.
Skin and subcutaneous tissue disorders
Uncommon (> 0.1% to ≤ 1%): urticaria, dermatitis, madarosis, leukoderma, pruritus, dry skin.
Not known: Stevens-Johnson syndrome, erythema multiforme, rash.
If topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, the possibility of increased systemic toxicity cannot be excluded and care should be taken to monitor the total serum concentration.
Prolonged levels above 12 micrograms/mL should be avoided.


Reporting of suspected adverse reactions
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is 
TOB OIN API APR20 V1                                         NEW ZEALAND SPC MAY 2019 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