LEVOFLOXACIN

Posology All patients should 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 the third to the fifth day. If different topical ophthalmic medicinal products are used at the same time, an interval of at least 15 minutes should be observed between the individual applications.

The duration of treatment depends on the severity of the eye disease, as well as on the clinical and bacteriological course of infection. The usual treatment duration is 5 days. Safety and efficacy in the treatment of corneal ulcers and ophthalmia neonatorum have not been established.

Levofloxacin 5 mg/ml eye drops is not recommended for use in children below age 1 year due to a lack of data on safety and efficacy. Elderly No dose adjustment is necessary in elderly patients. Paediatric population The posology is the same in adults and children ≥1 year of age.

The safety and efficacy of Levofloxacin eye drops in children aged ≥1 year have been established. The safety and efficacy of Levofloxacin eye drops in children aged < 1 year have not been established. There are no studies available. Method of administration Levofloxacin eye drops is for ocular use only.

For single use only. A single-dose container contains enough solution to treat both eyes. The eye drops, solution should be used immediately after first opening the single dose container. The used single dose container should be discarded.

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. 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.

Adverse reactions are listed below, sorted by MedDRA system organ class and frequency.

Frequencies are defined as follows:

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). System organ class Common Uncommon Rare Very rare Immune system disorders Extra-ocular allergic reactions including skin rash Anaphylaxis Nervous system disorders Headache Eye disorders Ocular burning, decreased vision and mucous strand 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 Rhinitis Laryngeal oedema Additional adverse reactions observed with the systemic use of the active substance (levofloxacin) and which may potentially occur also with Levofloxacin eye drops: Rupture of tendons in 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.

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.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Levofloxacin eye drops should 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 clinical improvement is not noted within a reasonable period, the medicinal product should be discontinued and alternative therapy instituted. Whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.

Patients with bacterial infections in the anterior segment of the eye should not wear contact lenses. Systemic fluoroquinolones have been associated with hypersensitivity reactions, even following a single dose. If an allergic reaction occurs after administration of levofloxacin, treatment should be discontinued.

Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy, including levofloxacin, particularly in elderly patients and those treated concurrently with corticosteroids. 8). Paediatric population The special warnings and precautions for use are the same in adults and children aged ≥1 year.

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