OPATANOL

Posology The dose is one drop of Opatanol in the conjunctival sac of the affected eye(s) twice daily (8 hourly). Treatment may be maintained for up to four months, if considered necessary. Use in elderly No dosage adjustment in elderly patients is necessary.

Paediatric patients Opatanol may be used in paediatric patients three years of age and older at the same dose as in adults. The safety and efficacy of Opatanol in children aged under 3 years has not been established. No data are available.

Use in hepatic and renal impairment Olopatadine in the form of eye drops (Opatanol) has not been studied in patients with renal or hepatic disease. 2). Method of administration For ocular use only. After the bottle cap is removed, if the tamper evident snap collar is loose, remove before using the product.

To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. In case of concomitant therapy with other topical ocular medicines, an interval of five minutes should be allowed between successive applications.

Eye ointments should be administered last.

Summary of safety profile In clinical studies involving 1680 patients, Opatanol was administered one to four times daily in both eyes for up to four months as monotherapy or adjunctive therapy to loratadine 10 mg. 6% of patients discontinued from the clinical studies due to these adverse reactions.

No serious ophthalmic or systemic adverse reactions related to Opatanol were reported in clinical studies. 7%. Tabulated list of adverse reactions The following adverse reactions have been reported during clinical studies and post- marketing data and 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 <1/1000)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. System Organ Classification Frequency Adverse Reactions Infections and infestations Uncommon rhinitis Immune system disorders Not known hypersensitivity, swelling face Nervous system disorders Common headache, dysgeusia Uncommon dizziness, hypoaesthesia Not known somnolence Eye disorders Common eye pain, eye irritation, dry eye, abnormal sensation in eyes Uncommon corneal erosion, corneal epithelium defect, corneal epithelium disorder, punctate keratitis, keratitis, corneal staining, eye discharge, photophobia, vision blurred, visual acuity reduced, blepharospasm, ocular discomfort, eye pruritus, conjunctival follicles, conjunctival disorder, foreign body sensation in eyes, lacrimation increased, erythema of eyelid, eyelid oedema, eyelid disorder, ocular hyperaemia Not known corneal oedema, eye oedema, eye swelling, conjunctivitis, mydriasis, visual disturbance, eyelid margin crusting Respiratory, thoracic, and mediastinal disorders Common nasal dryness Not known dyspnoea, sinusitis Gastrointestinal disorders Not known nausea, vomiting, Skin and subcutaneous tissue disorders Uncommon dermatitis contact, skin burning sensation, dry skin Not known dermatitis, erythema Common fatigueGeneral disorders and administration site conditions Not known asthenia, malaise Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Opatanol is an antiallergic/antihistaminic agent and, although administered topically, is absorbed systemically. If signs of serious reactions or hypersensitivity occur, discontinue the use of this treatment. Opatanol contains benzalkonium chloride which may cause eye irritation.

Benzalkonium chloride has also been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Close monitoring is required with frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised.

Contact lenses Benzalkonium is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients should be instructed to remove contact lenses prior to administration of the eye drop and wait at least15 minutes after instillation before re- inserting contact lenses.

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