Prescribing information

Xalacom® eye drops solution


Prescribing Information
Please refer to the SmPC before prescribing Xalacom® eye drops solution (latanoprost and
timolol maleate)
Presentation plastic bottle containing 2.5ml eye drops. Each 1 ml contains latanoprost 50
micrograms (0.005%), timolol maleate 6.8 mg equivalent to timolol 5 mg (0.5%) and
benzalkonium chloride. Indication Reduction of intraocular pressure (IOP) in patients with open
angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-
blockers or prostaglandin analogues. Dosage and Administration Adults including the Elderly:
One eye drop into the affected eye(s) once daily. Contact lenses should be removed before
instillation of the eye drops and may be reinserted after 15 minutes (see Warnings and
Precautions). Children and Adolescents: Not recommended. Contra-indications
Hypersensitivity to any component of this product. Reactive airway disease including bronchial
asthma, severe chronic obstructive pulmonary disease. Sinus bradycardia, sick sinus syndrome,
sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker,
overt cardiac failure, cardiogenic shock. Warnings and Precautions Systemic effects: Due to
the beta-adrenergic component timolol, the same types of cardiovascular, pulmonary and other
adverse reactions as seen with systemic beta-adrenergic blocking agents may occur. Cardiac
disorders: In patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal’s
Angina and cardiac failure) and hypotension, the therapy with beta-blockers should be critically
assessed and the therapy with other active substances should be considered. Patients with
cardiovascular diseases should be watched for signs of deterioration of these diseases and of
adverse reactions. Due to its negative effect on conduction time, beta-blockers should only be
given with caution to patients with first degree heart block. Cardiac reactions, and rarely, death
in association with cardiac failures have been reported following administration of timolol.
Vascular disorders: Patients with severe peripheral circulatory disturbance/disorders (i.e. severe
forms of Raynaud’s disease or Raynaud’s syndrome) should be treated with caution. Respiratory
disorders: Respiratory reactions, including death due to bronchospasm in patients with asthma
have been reported following administration of some ophthalmic beta-blockers. Xalacom should
be used with caution, in patients with mild/moderate chronic obstructive pulmonary disease
(COPD) and only if the potential benefit outweighs the potential risk. Hypoglycaemia/diabetes:
Beta-blockers should be administered with caution in patients subject to spontaneous
hypoglycaemia or to patients with labile diabetes, as beta-blockers may mask the signs and
symptoms of acute hypoglycaemia. Beta-blockers may also mask the signs of hyperthyroidism.
Corneal diseases: Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal
diseases should be treated with caution. Other beta-blocking agents: The effect on intra-ocular
pressure or the known effects of systemic beta-blockade may be potentiated when timolol is given
to the patients already receiving a systemic beta-blocking agent. The response of these patients
should be closely observed. The use of two topical beta-adrenergic blocking agents is not
recommended. Anaphylactic reactions: While taking beta-blockers, patients with a history of
atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive
to repeated challenge with such allergens and unresponsive to the usual doses of adrenaline used
to treat anaphylactic reactions. Choroidal detachment: Choroidal detachment has been reported
with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration
procedures. Surgical anaesthesia: Beta-blocking ophthalmological preparations may block
systemic beta-agonist effects e.g. of adrenaline. The anaesthetist should be informed when the
patient is receiving timolol. Concomitant therapy: The use of two local beta-blockers or two
local prostaglandins is not recommended. Ocular effects: Latanoprost may increase brown
pigment within the iris leading to a gradual change in eye colour. 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 other types of glaucoma, including
inflammatory, neovascular, chronic angle closure or congenital glaucoma, OAG of pseudophakic
patients and pigmentary glaucoma. Xalacom should be used with caution in acute attacks of
closed angle glaucoma until more experience is obtained. Latanoprost 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. Caution in aphakic patients, pseudophakic patients with
torn posterior lens capsule and other patients with known risk factors for macular oedema. Use of
contact lenses: Xalacom 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 Xalacom in dry eye patients/ conditions where the cornea is compromised.
Soft contact lenses may absorb and be discoloured by benzalkonium chloride. All contact lens
should be removed before applying Xalacom but may be reinserted after 15 minutes (see
Warnings and Precautions). Pregnancy Do not use. Lactation Stop breast feeding or do not
use. Interactions No specific drug interaction studies have been performed with Xalacom. 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. The
effect on intraocular pressure or the known effects of systemic beta-blockade may be potentiated
when Xalacom is given to patients already receiving an oral beta-adrenergic blocking agent, and
the use of two or more topical beta-adrenergic blocking agents is not recommended. Mydriasis
resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has
been reported occasionally. There is a potential for additive effects resulting in hypotension
and/or marked bradycardia when opthalmic beta-blockers solution is administered concomitantly
with oral calcium channel blockers, beta-adrenergic blocking agents, antiarrhythmics (including
amiodarone), digitalis glycosides, parasympathomimetics, guanethidine. Potentiated systemic
beta blockade (e.g., decreased heart rate, depression) has been reported during combined
treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol. Adverse
Effects Treatment related ocular adverse events seen in clinical trials with Xalacom: Very
common (≥1/10): Increased iris pigmentation. Common (≥1/100 and <1/10): Eye irritation
(including stinging, burning and itching), Eye pain. Please refer to SmPC for other ocular side-
effects. Ocular adverse effects that have been seen with one of the components may potentially
occur also with Xalacom: Latanoprost: eyelash and vellus hair changes (increased length,
thickness, pigmentation and number), punctate epithelial erosions, periorbital oedema,
iritis/uveitis, macular oedema, dry eye, keratitis, corneal oedema and erosions, misdirected
eyelashes sometimes resulting in eye irritation and iris cyst, light sensitivity (photophobia),
sunken eye appearance (deepening of the eyelid sulcus). Timolol: Signs and symptoms of ocular
irritation including keratitis, decreased corneal sensitivity, and dry eyes, visual disturbances
including refractive changes, diplopia, ptosis, choroidal detachment (following filtration surgery).
Treatment related non-ocular adverse events seen in clinical trials with Xalacom – Uncommon
(≥1/1000 and <1/100): Headache, skin rash, pruritus. Non-Ocular adverse effects that have been
seen with one of the components may potentially occur also with Xalacom: Latanoprost:
Herpetic keratitis and dizziness. Aggravation of angina in patients with pre-existing disease,
palpitations. Asthma, asthma aggravation and dyspnoea. Darkening of palpebral skin. Joint pain,
muscle pain, chest pain. Timolol: Signs and symptoms of systemic allergic reactions.
Hypoglycaemia. Depression, memory loss, insomnia, nightmares. Dizziness, paraesthesia,
cerebral ischaemia, cerebrovascular accident, increase in signs and symptoms of myasthenia
gravis, syncope. Tinnitus. Palpitation, oedema, arrhythmia, bradycardia, chest pain, cardiac arrest,
cardiac failure, atrioventricular block, congestive heart failure. Hypotension, Raynaud’s
phenomenon, cold hands and feet. Bronchospasm, dyspnoea, cough. Dysgeusia, nausea,
diarrhoea, dyspepsia, dry mouth, abdominal pain, vomiting. Alopecia, psoriasiform rash or
exacerbation of psoriasis, skin rash. Myalgia. Decreased libido. Asthenia, fatigue. Driving
Instillation of eye drops may cause transient blurring of vision. Until this is resolved, patients
should not drive or use machines. Pharmaceutical Precautions Store at 2 ºC - 8 ºC. Once
opened, do not store above 25 ºC and discard after 4 weeks. Keep bottle in the outer carton in
order to protect from light. Legal category POM. Packaging Quantities and Basic NHS price
1 x 2.5ml £14.32. PL Number PL 00057/1056. PL Holder Pfizer Limited, Ramsgate Road,
Sandwich, Kent, CT13 9NJ, UK.
Date of Preparation of PI July 2012
Further information is available on request from: Medical Information, Pfizer Limited, Walton
Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK. Tel: +44 (0) 1304 616161
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://medisis.info/client_docs/PI_XM.pdf