Pataday® Sterile Ophthalmic Solution 0.2%

4.1 Therapeutic indications

Treatment of ocular itching associated with allergic conjunctivitis.

Results from clinical studies up to 12 weeks duration demonstrate that PATADAY solution when dosed once a day is effective in the treatment of the ocular signs and symptoms of allergic conjunctivitis and rhinoconjunctivitis, and the nasal symptoms of allergic rhinoconjunctivitis. Conjunctival allergen challenge studies demonstrated that PATADAY solution is significantly more effective than its vehicle within 3 minutes after antigen challenge and up to 24 hours after dosing.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

4.2 Posology and Method of Administration

Posology

Adults

One drop in each affected eye once daily.

Elderly

No dosage adjustment in elderly patients is necessary in patients of 65 years of age or above.

Pediatric population (below 18 years)

Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

Special populations

Renal Impairment

No studies have been performed in patients with renal impairment. No dosage regimen adjustment is required for patients with renal impairment.

Hepatic Impairment

No studies have been performed in patients with hepatic impairment. No dosage regimen adjustment is required for patients with hepatic impairment.

Method of administration

• For topical ocular use only. Not for injection or oral use.
• After the bottle cap is removed, if the tamper evident snap collar is loose, snap collar should be removed before using the product.
• To avoid contamination, the dropper tip should not touch any surface. The dropper tip should also not come into contact with the eye as this may cause injury to the eye. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity.
• The bottle should be kept tightly closed when not in use.
• If more than one topical ophthalmic medicinal product is being used, the medicinal productsmust be administered at least 5 minutes apart. Eye ointments should be administered last.
• Patients should be advised not to wear a contact lens if their eye is red.
• PATADAY Eye Drops, Solution 0.2% should not be used to treat contact lens related irritation.