OFTAQUIX

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.

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.

Oftaquix Unit Dose 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 Oftaquix in children aged ≥1 year have been established. The safety and efficacy of Oftaquix in children < 1 year have not yet been established. No data are available. Method of administration Ocular use. For single use only.

The contents of one single-dose container are sufficient for 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 (Oftaquix 5 mg/ml eye drops and Oftaquix Unit Dose 5 mg/ml eye drops in single-dose container): Immune system disorders Rare (≥1/10,000 to <1/1,000): Extra-ocular allergic reactions, including skin rash.

Very rare (<1/10,000):

Anaphylaxis.

Nervous system disorders Uncommon (≥1/1,000 to <1/100):

Headache.

Eye disorders Common (≥1/100 to <1/10):

Ocular burning, decreased vision and mucous strand.

Uncommon (≥1/1,000 to <1/100):

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 (≥1/1,000 to <1/100):

Rhinitis.

Very rare (<1/10,000):

Laryngeal oedema. Additional adverse reactions that have been seen with the systemic use of the active substance (levofloxacin), and may potentially occur also with Oftaquix: 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.

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.

Oftaquix 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.

Patients with external bacterial ocular infections should not wear contact lenses. Oftaquix 5 mg/ml eye drops contain benzalkonium chloride, which may cause eye irritation. 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). Paediatric population The special warnings and precautions for use are the same in adults and children aged ≥1 year.

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