MINT-OLOPATADINE

2%. 2 Recommended Dose and Dosage Adjustment The recommended dose is one drop in each affected eye once a day. No dosage adjustment is required in hepatic or renal impairment. 5 Missed Dose If a dose is missed, a single drop should be taken as soon as possible before reverting to regular routine.

Do not use a double dose to make up for the one missed. 2% (Olopatadine Hydrochloride Ophthalmic Solution) Page 5 of 23

1 Adverse Reaction Overview In clinical trials involving 1137 patients dosed with long-term ophthalmic topical therapy, Olopatadine Hydrochloride Ophthalmic Solution was administered once-daily for 4 to 12 weeks. 4%). No serious adverse drug reactions related to Olopatadine Hydrochloride Ophthalmic Solution were reported in the clinical trials.

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. No treatment-related adverse drug reactions occurred at an incidence ≥ 1%. 1%) are presented below.

4 million units of Olopatadine Hydrochloride Ophthalmic Solution have been sold worldwide. 0007%. No post-market reports of serious adverse reactions have been received to date. The most frequent events reported being eye irritation, ocular hyperaemia, eye pain and vision blurred.

There were no new major findings bearing on the established overall safety profile of Olopatadine Hydrochloride Ophthalmic Solution Other events include dizziness, eye discharge, punctate keratitis, keratitis, erythema of eyelid, dermatitis contact, fatigue, hypersensitivity, ocular discomfort, lacrimation increased and nausea.

General For topical ocular use only. Not for injection or oral use. Contamination As with any eye drop, to prevent contamination of the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle.

Keep bottle tightly closed when not in use. Driving and Operating Machinery Olopatadine is a non-sedating anti-histamine. 2%, may affect the ability to drive or use machines. If blurred vision occurs after instillation, patients must wait until vision clears before driving or using machinery.

Ophthalmologic Patients should be advised not to wear contact lenses if their eye(s) are red. 2% should not be used to treat contact lens related irritation. 2%, benzalkonium chloride, may cause eye irritation and is known to discolour soft contact lenses.

Contact with soft contact lenses should be avoided. 2% and wait at least 15 minutes before they insert their contact lenses. 2% and the other drops. Eye ointments should be applied last.

Reproductive Health:

Female and Male Potential • Fertility Studies have not been performed to evaluate the effect of topical ocular administration of olopatadine on human fertility. 1 Pregnant Women There are no adequate and well controlled studies in pregnant women.

Studies in animals with olopatadine have shown reproductive toxicity following systemic administration considered sufficiently in excess of the maximum human exposure. Olopatadine was found not to be teratogenic in rats and rabbits at oral doses >90,000 and >60,000 times the maximum recommended ocular human use level, respectively (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).

2% should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. 2 Breast-feeding Olopatadine has been identified in the milk of nursing rats following oral administration.

Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph.