LEVOFLOXACIN

Posology For all patients instil one to two drops in the affected eye(s) every two hours up to 8 times per day while awake for the first two days and then four times daily on days 3 through 5. If different topical ocular medications are used concomitantly, at least a 15-minute interval is required between instillations.

To prevent contaminating the dropper tip and solution, the dropper tip should not come into contact with the eyelids or surrounding areas. The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection.

The usual treatment duration is 5 days. Safety and efficacy in the treatment of corneal ulcer and ophthalmia neonatorum has not been established. Levofloxacin is not recommended for use in children below age 1 year due to a lack of data on safety and efficacy.

Use in the elderly No adjustment of dosage is required. Paediatric population The posology is the same in adults and children aged ≥1 year. The safety and efficacy of Levofloxacin in children aged ≥1 year have been established. The safety and efficacy of Levofloxacin in children aged < 1 year have not yet been established.

No data are available. Method of administration Ocular use.

Approximately 10 % of patients can be expected to experience adverse reactions. The reactions are usually graded as mild or moderate, are transient, and are generally restricted to the eye. As the product contains benzalkonium chloride, contact eczema and/or irritation may be due to the active component or to this preservative.

The following undesirable effects assessed as definitely, probably or possibly related to treatment were reported during clinical trials and post-marketing experience with levofloxacin containing eye drops: Frequency categories are expressed as: 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): Immune system disorders Rare: Extra-ocular allergic reactions, including skin rash Very rare: Anaphylaxis Nervous system disorders Uncommon: Headache Eye disorders Common: Ocular burning, decreased vision and mucous strand.

Uncommon:

Lid matting, chemosis, conjunctival papillary reaction, lid oedema, ocular discomfort, ocular itching, ocular pain, conjunctival injection, conjunctival follicles, ocular dryness, lid erythema, and photophobia. No corneal precipitates were observed in clinical studies.

Respiratory, thoracic and mediastinal disorders Uncommon:

Rhinitis Very rare: Laryngeal oedema Additional adverse reactions that have been seen with the systemic use of the active substance (levofloxacin), and may potentially occur also with Levofloxacin 5mg/ml eye drops Musculoskeletal and connective tissue disorders Rare: Ruptures of the shoulder, hand, Achilles, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving systemic fluoroquinolones.

4). Paediatric population Frequency, type and severity of adverse reactions in children are expected to be the same as in adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Levofloxacin 5 mg/ml eye drops must not be injected sub-conjunctivally. The solution should not be introduced directly into the anterior chamber of the eye. As with other anti-infectives, prolonged use may result in overgrowth of non- susceptible organisms, including fungi.

If worsening of infection occurs, or if a clinical improvement is not noted within a reasonable period, discontinue use and institute alternative therapy. Whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.

Systemic fluoroquinolones have been associated with hypersensitivity reactions, even following a single dose. If an allergic reaction to levofloxacin occurs, discontinue the medication. Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including levofloxacin, particularly in older patients and those treated concurrently with corticosteroids.

8). Patients with external bacterial ocular infections should not wear contact lenses. Paediatric population The special warnings and precautions for use are the same for adults and children aged ≥1 year. Excipients Levofloxacin 5 mg/ml eye drops contain benzalkonium chloride, which may be absorbed by soft contact lenses and may change the colour of the contact lenses.

Contact lenses should be removed before using this medicine and may be put back in 15 minutes afterwards. From the limited data available, there is no difference in the adverse event profile in children compared to adults. Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye.

Irritation may have an effect on treatment adherence in children. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised.

g. benzalkonium chloride.