EYFLOX

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 < 1 year have not yet been established.

No data are available. Method of administration Ocular use. Before instillation of the eye drops - Users should be instructed to wash their hands before opening the bottle. - Users should also be instructed to not use this medicine if they notice that the tamper-proof seal on the bottle neck is broken before they first use it.

- When used for the first time, before delivering a drop to the eye, the patient should practise using the dropper bottle by squeezing it slowly to deliver one drop away from the eye. - When the patient is confident they can deliver one drop at a time, the patient should adopt a position that is the most comfortable for the instillation of the drops (the patient can sit down, lie on their back, or stand in front of a mirror).

Instillation 1. The bottle should be held directly below the cap and the cap should be turned to open the bottle. To avoid contamination of the solution, the tip of the bottle must not touch anything. 2. The patient should tilt their head backwards and hold the bottle above their eye.

3. The patient should pull the lower eyelid down and look up. The bottle should be squeezed gently in the middle and a drop should be allowed to fall into the patient’s eye. Please note that there might be a few seconds delay between squeezing and the drop coming out.

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. Tabulated list of adverse reactions 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.

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 the available data). System organ Class Frequency Adverse reaction 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, not known (cannot be estimated from the available data) Laryngeal oedema 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).

Eyflox 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. Systemic fluoroquinolones have been associated with hypersensitivity reactions, even following a single dose.

If an allergic reaction to levofloxacin occurs, discontinue the medication. 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.

Patients with a history of contact hypersensitivity to silver should not use this product as dispensed drops may contain traces of silver. 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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