MYLAN-LATANOPROST

1 Dosing Considerations Contact lenses should be removed prior to the administration of MYLAN-LATANOPROST, and may be reinserted 15 minutes after administration (see PATIENT MEDICATION INFORMATION). MYLAN-LATANOPROST may be used concomitantly with other topical ophthalmic products to further lower intraocular pressure.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart. 2 Recommended Dose and Dosage Adjustment The recommended dose for adults, including the elderly (over 60 years of age), is one drop in the affected eye(s) once daily.

The dose of MYLAN-LATANOPROST should not exceed once daily as it has been shown that more frequent administration decreases the IOP lowering effect. Reduction of IOP in humans starts about 3 to 4 hours after treatment and maximum effect is reached after 8 to 12 hours.

Pressure reduction is maintained for at least 24 hours. 3 Pediatrics). 4 Administration Optimal effect is obtained if MYLAN-LATANOPROST (latanoprost) is administered in the evening. 5 Missed Dose If one dose is missed, treatment should continue with the next dose the following day.

). Skin Eyelid skin darkening, which may be reversible, has been reported in association with the use of MYLAN-LATANOPROST (see 7 WARNINGS AND PRECAUTIONS). MYLAN-LATANOPROST may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes.

Eyelash changes are usually reversible upon discontinuation of treatment. 1 Pregnant Women Reproduction studies have been performed in rats and rabbits. In rabbits an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the MYLAN-LATANOPROST (latanoprost) Page 8 of 28 Protected B / Protégé B maximum human dose (see 16 NON-CLINICAL TOXICOLOGY).

MYLAN-LATANOPROST should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 2 Breast-feeding The active substance in MYLAN-LATANOPROST and its metabolites may pass into breast milk and MYLAN-LATANOPROST should therefore be used with caution in nursing women (see 16 NON-CLINICAL TOXICOLOGY).

3 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of the use of MYLAN-LATANOPROST in children has not been established; therefore, Health Canada has not authorized an indication for pediatric use. 2 Clinical Trial Adverse Reactions).

2 Clinical Trial Adverse Reactions). 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. The ocular adverse events and ocular signs and symptoms reported in 5 to 15% of the patients on latanoprost in the three 6 month, multi-centre, double-masked, active-controlled trials were blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased iris pigmentation and punctate epithelial keratopathy.

General MYLAN-LATANOPROST (latanoprost) has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes, and growth of eyelashes.

Pigmentation is expected to increase as long as MYLAN-LATANOPROST is administered. After discontinuation of MYLAN- LATANOPROST, pigmentation of the iris is likely to be permanent while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients.

Patients who receive treatment should be informed of the possibility of increased pigmentation. The effects of increased pigmentation beyond 5 years are not known. Patients who are expected to receive treatment in only one eye should be informed about the potential for increased pigmentation in the treatment eye and thus, heterochromia between the eyes.

MYLAN-LATANOPROST may gradually increase the pigmentation of the iris. , blue-brown, grey-brown, green-brown or yellow-brown. The eye colour change is due to increased melanin content in the stromal melanocytes rather than to an increase in the number of melanocytes.

This change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish.

Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with MYLAN-LATANOPROST can be continued in patients who develop noticeably increased pigmentation, these patients should be examined regularly.

During clinical trials, the increase in brown iris pigment has not been shown to progress further upon discontinuation of treatment, but the resultant colour change may be permanent. Hepatic/Biliary/Pancreatic MYLAN-LATANOPROST has not been studied in patients with hepatic impairment and should, therefore, be used with caution in such patients.

Latanoprost is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.