Xalacom 50 micrograms/ml + 5 mg/ml, eye drops, solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
26-02-2024
Summary of Product characteristics
(SPC)
26-02-2024
Active ingredient:
Latanoprost; Timolol
Available from:
PCO Manufacturing Ltd.
ATC code:
S01ED; S01ED51
INN (International Name):
Latanoprost; Timolol
Dosage:
50mcg/ml + 5 milligram(s)/millilitre
Pharmaceutical form:
Eye drops, solution
Administration route:
Eye solution use
Units in package:
Pack sizes: 1 × 2.5 ml
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
Pfizer Manufacturing Belgium
Therapeutic group:
Ophthalmological-betablocking agents - timolol, combinations
Therapeutic area:
Beta blocking agents1); timolol, combinations
Therapeutic indications:
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
Authorization status:
Authorised
Authorization date:
2015-04-17
Patient Information leaflet
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
XALACOM
® 50 MICROGRAMS/ML + 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 in section 6)
•
if yo
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
26 February 2024
CRN00F3FQ
Page 1 of 2
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.
Excipient(s) with known effect:
Benzalkonium chloride,
Disodium phosphate anhydrous (E339ii),
Sodium dihydrogen phosphate monohydrate (E339i).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
_Product imported from Greece, Lithuania and Belgium_
The solution is a clear, colourless liquid.
4 CLINICAL PARTICULARS
As per PA23055/008/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23055/008/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium chloride
Benzalkonium chloride
Sodium dihydrogen phosphate monohydrate (E339i)
Disodium phosphate anhydrous (E339ii)
Hydrochloric acid solution (for adjustment to pH 6.0)
Sodium hydroxide solution (for adjustment to pH 6.0)
Water for injections
6.2 INCOMPATIBILITIES
In vitro studies have shown that precipitation occurs when eye drops
containing thiomersal are mixed with Xalatan. If such
drugs are used concomitantly with Xalacom, the eye drops should be
administered with an interval of at least five minutes.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer carton of the product as marketed in the
country of origin.
After opening of container: 4 weeks
Health Products Regulatory Authority
26 February 2024
CRN00F3FQ
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Before first opening: Store in a refrigerator (2°C - 8°C)
After first opening: Do not store above 25°C.
Use within 4 weeks (see section 6.3).
Keep the bottle in the outer carton in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Dropper container (5ml) with a screw cap and tamper evident overcap.
Each bottle contains 2.5 ml eye drop solution.
Pack sizes: 1 × 2.5
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