LOMIDE Eye drops, solution Ref.[50540] Active ingredients: Lodoxamide

Lomide Eye Drops are not for injection.

Patients should be advised that effect of therapy with Lomide Eye Drops is dependent upon administration at regular intervals. The recommended frequency of administration should not be exceeded. Patients should also be advised that instillation of eye drops may cause discomfort or transient burning or stinging initially. Should these symptoms persist, the patient should be advised to contact the prescribing physician.

Lomide Eye Drops contain benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. If patients continue to wear soft (hydrophilic) contact lenses while under treatment with Lomide Eye Drops, they should remove their lens(es) prior to instilling Lomide Eye Drops in the affected eye(s) and should not insert their lens(es) until 15 minutes after instillation of the eye drops.

No specific drug interaction studies, either with ophthalmic or systemic medications, have been conducted. Limited concomitant medications, however, were permitted during the clinical studies and no interactions were observed. Concomitant medications included: corticosteroids (systemic and ophthalmic), naphazoline, antazoline, ketorolac, ciprofloxacin, gentamicin, sulfacetamide, tetracycline, tobramycin, timolol and dipivefrine.

Patients should be advised to wait 10 minutes after instilling LOMIDE Eye Drops before instilling any other eye drops.

Pregnancy

CATEGORY B1.

Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Lomide Eye Drops should only be used in pregnancy if clearly needed.

Breast-feeding

It is not known whether topically applied lodoxamide is excreted in human milk. There is insufficient information on the excretion of lodoxamide from Lomide Eye Drops in animal milk. A risk to the breastfed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Lomide Eye Drops therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Effects on fertility

There are no data available on the effect of lodoxamide on fertility in humans.

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.

During clinical studies of Lomide Eye Drops, the most frequently reported ocular adverse experiences were transient burning, stinging, or discomfort upon instillation, which occurred in 13% of patients. Other ocular events occurring in 1 to 3.5% of the patients included ocular pruritus (3.5%), blurred vision (1.8%), lid margin crusting (1.6%), dry eye (1.3%), tearing (1.2%) and hyperaemia (1.2%).

Events that occurred in less than 1% of the patients included foreign body sensation, ocular pain, discharge, ocular oedema, ocular fatigue, ocular warming sensation, lid oedema, chemosis, anterior chamber cells, epitheliopathy, keratopathy/keratitis, blepharitis, sticky sensation, corneal erosion, dim vision, corneal abrasion and allergy.

Non-ocular events are rare and reported at incidences less than 0.5%; these included a temporary warm sensation, headache, nausea, stomach discomfort, dizziness, somnolence, dry nose, sneezing and rash.

The following adverse reactions are classified according to the following convention: 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), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions have been observed during clinical trials and post-marketing experience for lodoxamide eye drops.

Additional adverse reactions identified from post-marketing surveillance include the following. Frequencies cannot be estimated from the available data. Within each system Organ Class adverse reactions are presented in order of decreasing seriousness.

System Organ Classification MedDRA Preferred Term Cardiac disorders Not known: palpitations

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting.

Unknown.