Xalacom eye drops, solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TIMOLOL, LATANOPROST

Available from:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC code:

S01ED51

INN (International Name):

TIMOLOL 5 mg/ml LATANOPROST 50 µg/ml

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

TIMOLOL 5 mg/ml LATANOPROST 50 µg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Withdrawn

Authorization date:

2005-10-25

Patient Information leaflet

XM 13_0 UK 
  UK XM 067                                                                                                   2013 -0002875 
Page 1 of 10 

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, please tell your doctor
or pharmacist. 
WHAT IS IN THIS LEAFLET: 
What Xalacom is and what it is used for 
What you need to know before you use Xalacom 
How to use Xalacom 
Possible side effects 
How to store Xalacom 
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 Xal

Summary of Product characteristics

 
UK XM 067 
XM_18                                                                                                                                                   2013-0002875          

Page 1 of 13 
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: Benzalkonium chloride 200 microgram/ml. 
For a 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 
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 
_Recommended dosage for 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. 
_Administration:_ 
Contact lenses should be removed before instillation of
the eye drops and may be reinserted after 
15 minutes. 
If more than one topical ophthalmic drug is being used, the
drugs should be administered at least 
five minutes apart. 

UK XM 067 
XM_18                                                                                                                    �