Xalacom 50 micrograms/mL + 5 mg/mL, eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Latanoprost; Timolol

Available from:

Pfizer Healthcare Ireland

ATC code:

S01ED; S01ED51

INN (International Name):

Latanoprost; Timolol

Dosage:

50mcg/ml + 5 milligram(s)/millilitre

Pharmaceutical form:

Eye drops, solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Beta blocking agents1); timolol, combinations

Authorization status:

Marketed

Authorization date:

2001-09-07

Patient Information leaflet

Page 1 of 9
2019-0056117
PACKAGE LEAFLET: INFORMATION FOR THE USER
XALACOM
® 50 MICROGRAMS/ML AND 5 MG/ML EYE DROPS, SOLUTION
LATANOPROST + TIMOLOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. (See section 4).
WHAT IS IN THIS LEAFLET:
1.
What Xalacom is and what it is used for
2.
What you need to know before you use Xalacom
3.
How to use Xalacom
4.
Possible side effects
5.
How to store Xalacom
6.
Contents of the pack and other information
1.
WHAT XALACOM IS AND WHAT IT IS USED FOR
Xalacom contains two medicines: latanoprost and timolol. Latanoprost
belongs to a group of
medicines known as prostaglandin analogues. Timolol belongs to a group
of medicines
known as beta-blockers. Latanoprost works by increasing the natural
outflow of fluid from
the eye into the bloodstream. Timolol works by slowing the formation
of fluid in the eye.
Xalacom is used to reduce the pressure in your eye if you have
conditions known as open
angle glaucoma or ocular hypertension. Both these conditions are
linked to an increase in the
pressure within your eye, eventually affecting your eyesight. Your
doctor will usually
prescribe you Xalacom when other medicines have not worked adequately.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE XALACOM
Xalacom can be used in adult men and women (including the elderly),
but is not
recommended for use if you are less than 18 years of age.
DO NOT USE XALACOM:

if you are allergic (hypersensitive) to either of the medicines in
Xalacom (latanoprost or
timolol), beta-blockers, or any of the other ingredients of Xalacom
(listed

Summary of Product characteristics

Health Products Regulatory Authority
30 September 2020
CRN009L06
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xalacom 50 micrograms/mL + 5 mg/mL, eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL solution contains latanoprost 50 micrograms and timolol maleate
6.8 mg equivalent to 5 mg timolol.
Excipients with known effect:
Benzalkonium chloride 0.2 mg/mL
Disodium phosphate (E339ii), sodium dihydrogen phosphate monohydrate
(E339i) (containing total phosphate 6.3 mg/mL)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
The solution is a clear, colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Xalacom is indicated in adults (including the elderly) for the
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly)_
Recommended therapy is one eye drop in the affected eye(s) once daily.
If one dose is missed, treatment should continue with the next dose as
planned. The dose should not exceed one drop in the
affected eye(s) daily.
_Paediatric population_
The safety and efficacy of Xalacom in children and adolescents has not
been established.
Method of administration
Contact lenses should be removed before instillation of the eye drops
and may be reinserted after 15 minutes (see section 4.4).
If more than one topical ophthalmic drug is being used, the drugs
should be administered at least five minutes apart. 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.
4.3 CONTRAINDICATIONS
Xalacom is contraindicated in patients with:

Reactive airway disease including bronchial asthma or a history of
bronchial asthma, severe chronic obstructive
pulmonary disease.