Draft - confidential

Xalatan® 0.005% w/v eye drops solution

Prescribing Information
Please refer to the SmPC before prescribing Xalatan® 0.005% w/v eye drops solution (latanoprost)
Presentation Plastic bottle containing 2.5ml eye drops. Each 1ml contains latanoprost 50 micrograms
(0.005%) and benzalkonium chloride. Indication Reduction of elevated intraocular pressure in
patients with OAG and ocular hypertension. Reduction of elevated intraocular pressure in paediatric
patients with elevated intraocular pressure and paediatric glaucoma. Dosage and Administration
Adults including the Elderly: One eye drop into the affected eye(s) once daily in the evening. Contact
lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes
(see Precautions). Paediatric population: Xalatan eye drops may be used in paediatric patients at the
same posology as in adults. No efficacy and safety data are available for preterm infants (less than 36
weeks gestational age) and data in the age group <1 year is very limited. Contra-indications Known
hypersensitivity to any component. Precautions Xalatan may increase brown pigment within the iris
leading to a gradual change in eye colour usually within the first 8 months of treatment, rarely during
the second or third year, and has not been seen after the fourth year of treatment. The rate of progression
of iris pigmentation decreases with time and is stable for five years. The effect of increased
pigmentation beyond five years has not been evaluated.In an open 5-year latanoprost safety study, 33%
of patients developed iris pigmentation. This has predominantly been seen in patients with mixed
coloured irides and may be permanent. Patients should be examined regularly and treatment
discontinued if appropriate. Unilateral treatment can result in permanent heterochromia. Exercise
caution in patients with asthma, inflammatory ocular conditions and other types of glaucoma,
including chronic angle closure, OAG of pseudophakic patients and in pigmentary glaucoma.
Xalatan should be used with caution in patients with a history of herpetic keratitis, and should
be avoided in cases of active herpes simplex keratitis and in patients with a history of
recurrent herpetic keratitis specifically associated with prostaglandin analogues. Also caution
is recommended in aphakic patients, pseudophakic patients with torn posterior lens capsule or
anterior chamber lenses or patients with known risk factors for cystoid macular oedema. Latanoprost
may gradually change eyelashes and vellus hair in the treated eye and surrounding areas; these
changes include increased length, thickness, pigmentation, number of lashes or hairs and misdirected
growth of eyelashes. Eyelash changes are reversible upon discontinuation of treatment. Xalatan
contains the preservative benzalkonium chloride which has been reported to cause punctate
keratopathy and/or toxic ulcerative keratopathy, may cause eye irritation and is known to discolour
soft contact lenses. Close monitoring required with frequent or prolonged use of Xalatan in dry eye
patients/ conditions where the cornea is compromised. Contact lenses may absorb benzalkonium
chloride. These should be removed before applying Xalatan but may be reinserted after 15 minutes
(see Dosage and Administration). Paediatric population: In children from 0 to < 3 years old that
mainly suffers from PCG (Primary Congenital Glaucoma), surgery (e.g. trabeculotomy/goniotomy)
remains the first line treatment. Pregnancy Do not use. Lactation Do not use or stop breast feeding.
Driving: In common with other eye preparations, instillation of eye drops may cause transient
blurring of vision. Until this has resolved, patients should not drive or use machines. Interactions
Definitive data are not available. There have been reports of paradoxical elevations in intraocular
pressure following the concomitant ophthalmic administration of two prostaglandin analogues.
Therefore, the use of two or more prostaglandins, prostaglandin analogues or prostaglandin
derivatives is not recommended. Any other eye drops should be administered five minutes apart.
Paediatric population: Interaction studies have only been performed in adults. Side Effects Ocular
side effects - Very common (≥1/10): Increased iris pigmentation, mild to moderate conjunctival
hyperaemia, eye irritation (burning, grittiness, itching, stinging and foreign body sensation), eyelash
and vellus hair changes (increased length, thickness, pigmentation and number); Common (≥1/100
and <1/10): transient punctate epithelial erosions (mostly without symptoms), blepharitis, eye pain.
Please refer to SmPC for other ocular side-effects. Non-ocular side-effects – Uncommon (≥1/1000
and <1/100): Skin rash; Rare (≥1/10,000 and <1/1000): Asthma, asthma exacerbation, dyspnoea,
localised skin reaction on the eyelids, darkening of the palpebral skin of the eyelids; Very rare
(<1/10,000): Aggravation of angina in patients with pre-existing disease, chest pain. There have been
additional post-marketing spontanoueous reports with unknown frequency (cannot be estimated from
the available data) of: herpetic keratitis, iris cyst, headache, dizziness, palpitations, myalgia and
arthralgia. Paediatric Population: In two short term clinical trials ( 12 weeks), involving 93
paediatric patients the safety profile was similar to that in adults and no new adverse events were
identified. The short term safety profiles in the different paediatric subsets were also similar. Adverse
events seen more frequently in the paediatric population as compared to adults are: nasopharyngitis
and pyrexia. Long term side effects in children (ie iris pigmentation) have not been established.
Driving Instillation of eye drops may cause transient blurring of vision. Overdosage Symptomatic
treatment. Pharmaceutical Precautions Store at 2°C - 8°C. Protect from light. Once opened, store at
room temperature (≤25°C) and discard after 1 month. Legal category POM. Packaging Quantities
and Basic NHS price 2.5 ml £12.48. PL number PL 00057/1057. PL Holder Pfizer Limited,
Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK.
Date of preparation of PI: October 2012. Further information is available on request from:
Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK.
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Pfizer
Medical Information on 01304 616161

Source: http://www.medisis.com/client_docs/PI_XN.pdf