Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Ofloxacin is not intended for injection.
Safety and effectiveness in infants below the age of one year have not been established.

Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching.

If an allergic reaction to ofloxacin occurs, discontinue the drug. Use Floxal® with caution in patients who have exhibited sensitivities to other quinolone antibacterial agents.

When using ophthalmologicals containing ofloxacin, the risk of rhinopharyngeal passage which can contribute to the occurrence and the diffusion of bacterial resistance should be considered.
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms.

If worsening infection occurs, or if clinical improvement is not noted within a reasonable period, discontinue use and institute alternative therapy.

Data are very limited to establish efficacy and safety of 0.3% ofloxacin ophthalmologicals in the treatment of conjunctivitis in neonates.

The use of ofloxacin ophthalmologicals in neonates with ophthalmia neonatorum caused by Neisseria gonorrhoeae or Chlamydia trachomatis is not recommended, as it has not been evaluated in such patients.

Clinical and non-clinical publications have reported the occurrence of corneal perforation in patients with pre-existing corneal epithelial defect or corneal ulcer, when treated with topical fluoroquinolone antibiotics. However, significant confounding factors were involved in many of these reports, including advanced age, presence of large ulcers, concomitant ocular conditions (e.g. severe dry eye), systemic inflammatory diseases (e.g. rheumatoid arthritis), and concomitant use of ocular steroids or non-steroidal anti-inflammatory drugs.
Nevertheless, it is necessary to advise caution regarding the risk of corneal perforation when using this medicinal product to treat patients with corneal epithelial defects or corneal ulcers.

Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including ofloxacin, particularly in older patients and those treated concurrently with corticosteroids.

Therefore, caution should be exercised and treatment with Floxal® should be discontinued at the first sign of tendon inflammation (see section 4.8).

Corneal precipitates have been reported during treatment with topical ophthalmic ofloxacin.
However, a causal relationship has not been established.

Excessive sun or UV-exposition (e. g. sunlamp, solarium etc.) should be avoided during use of ofloxacin (potential for photosensitivity).

Use of contact lenses is not recommended in patients receiving treatment for an eye infection.

Wool fat (lanolin) is known to cause localised skin reactions (e.g. contact dermatitis).

Effects on Driving

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.
Transient blurring of vision for only a few minutes may occur through formation of streaks at insertion of eye ointment in the conjunctival sac. Do not drive, operate machinery or work without a secure hold unless vision is clear.