Adverse reactions : תופעות לוואי

     4.8 Undesirable effects
General
Serious reactions after use of systemic ofloxacin are rare and most symptoms are reversible.
Since a small amount of ofloxacin is systemically absorbed after topical administration, side effects reported with systemic use could possibly occur.

Adverse reactions have been ranked under headings of frequency using 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 <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from available data).


Frequency        Common            Rare            Very rare              Not known System organ class
Immune system                                               Hypersensitivity disorders                                                   (including angioedema,
dyspnoea,
anaphylactic reaction/ anaphylactic shock,
oropharyngeal swelling and swollen tongue).
Nervous system                                                                     Dizziness disorders
Eye disorders             Eye irritation;   Corneal                                Keratitis; conjunctivitis; mild eye pain     precipitates,                          blurred vision; especially in                          photophobia; eye oedema;
pre-existing                           foreign body sensation in corneal                                the eyes; increased disorders                              lacrimation; dry eye; eye pain, ocular hyperaemia,
hypersensitivity
(including eye pruritus and eyelid pruritus),
periorbital oedema

(including eyelid oedema).
Hypersensitivity reactions in the form of conjunctival redness and/or mild burning in the treated eye are possible.
However, these symptoms are usually short term.
Gastrointestinal tract                                                                Nausea disorders

Skin and subcutaneous                                                                 Periorbital oedema, facial tissue disorders                                                                      oedema, Stevens-Johnson syndrome, toxic epidermal necrolysis


Tendon ruptures of the shoulder, hand, Achilles’ heel, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving systemic fluoroquinolones. Studies and post marketing experience with systemic quinolones indicate that a risk of these ruptures may be increased in patients receiving corticosteroids, especially geriatric patients and in tendons under high stress, including Achilles tendon (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