LEVOFLOXACIN Eye drops, solution Ref.[7252] Active ingredients: Levofloxacin

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.

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. Levofloxacin 5 mg/ml eye drops contains benzalkonium chloride, which may be absorbed by soft contact lenses. Eye irritation and discolouration of the soft contact lenses may also occur because of the presence of benzalkonium chloride. Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.

Paediatric population

The special warnings and precautions for use are the same for adults and children aged ≥1 year.

Specific drug interaction studies have not been conducted with levofloxacin eye drops.

Since maximum plasma concentrations of levofloxacin after ocular administration are at least 1000 times lower than those reported after standard oral doses, interactions mentioned for systemic use are unlikely to be clinically relevant when using Levofloxacin 5 mg/ml eye drops.

Paediatric population

No interaction studies have been performed.

Pregnancy

There are no adequate data from the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Levofloxacin 5 mg/ml eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Breastfeeding

Levofloxacin is excreted in human milk. However, at therapeutic doses of Levofloxacin no effects on the suckling child are anticipated. Levofloxacin 5 mg/ml eye drops should be used during lactation only if the potential benefit justifies any potential risk to the nursing child.

Fertility

Levofloxacin caused no impairment of fertility in rats at exposures considerably in excess of the maximum human exposure after ocular administration (see section 5.3).

Levofloxacin has minor influence on the ability to drive and use machines.

If there are any transient effects on vision, the patient should be advised to wait until this clears before driving or operating machinery.

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 eye drops:

Immune system disorders

Rare (≥1/10,000 to <1/1,000): extra-ocular allergic reactions, including skin rash

Very rare (<1/10,000), not known (cannot be estimated from the available data): 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), Not known (cannot be estimated from the available data): Laryngeal oedema

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.