Latanoprost / Timolol 50 microgram/5.0 mg per ml Eye Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Latanoprost; Timolol

Available from:

Actavis Group PTC ehf

ATC code:

S01ED; S01ED51

INN (International Name):

Latanoprost; Timolol

Dosage:

50 mcg/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:

2011-08-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LATANOPROST/TIMOLOL 50 MICROGRAM/5.0 MG PER 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 LATANOPROST/TIMOLOL IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST/TIMOLOL
3.
HOW TO USE LATANOPROST/TIMOLOL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LATANOPROST/TIMOLOL
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT LATANOPROST/TIMOLOL IS AND WHAT IT IS USED FOR
Latanoprost/Timolol 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.
Latanoprost/Timolol 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
Latanoprost/Timolol when other medicines have not worked adequately.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST/TIMOLOL
Latanoprost/Timolol 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 LATANOPROST/TIMOLOL:

if you are allergic to latanoprost, timolol, beta-blockers or any

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Latanoprost / Timolol 50 microgram/5.0 mg per ml Eye Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 50 microgram latanoprost and 6.8 mg timolol
maleate equivalent to 5 mg timolol.
Excipient with known effect:
Benzalkonium chloride 0.2 mg/ml (see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
The solution is a clear, colourless liquid.
Osmolality: 280~320 mOsmol/kg
pH: 5.0 – 7.0
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
Posology
_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.
_Paediatric population:_
Safety and effectiveness 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.
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.
If more than one topical ophthalmic drug is being used, the drugs
should be administered at least five minutes apart.
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