Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland
Hypersensitivity to the active substance levofloxacin, to other quinolones or to any of the excipients listed in section 6.1, e.g. benzalkonium chloride.
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.
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. Therefore, caution should be exercised and treatment with Oftaquix should be discontinued at the first sign of tendon inflammation (see section 4.8).
Oftaquix 5 mg/ml eye drops contain benzalkonium chloride as preservative. Contact lenses should be removed prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.
Patients with external bacterial ocular infections should not wear contact lenses.
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. Patients should be monitored in case of prolonged use.
The special warnings and precautions for use are the same in adults and children aged ≥1 year.
Specific drug interaction studies have not been conducted with Oftaquix 5 mg/ml 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 Oftaquix 5 mg/ml eye drops.
No interaction studies have been performed.
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. Oftaquix 5 mg/ml eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Levofloxacin is excreted in human milk. However, at therapeutic doses of Oftaquix no effects on the suckling child are anticipated. Oftaquix 5 mg/ml eye drops should be used during lactation only if the potential benefit justifies any potential risk to the nursing child.
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).
Oftaquix 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 containing eye drops (Oftaquix 5 mg/ml Eye Drops and Oftaquix 5 mg/ml eye drops in single-dose container):
Rare (≥1/10,000 to <1/1,000): Extra-ocular allergic reactions, including skin rash.
Very rare (<1/10,000): Anaphylaxis.
Uncommon (≥1/1,000 to <1/100): Headache.
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.
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. Studies and post marketing experience with systemic quinolones indicate that a risk of these ruptures may be increased in patients receiving corticosteroids, especially geriatric patients and in tendons under high stress, including Achilles tendon (see section 4.4).
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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