LATANOPROST/TIMOLOL 50mcg/ml + 5 Mg/Ml Eye Drops Solution

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

LATANOPROST, TIMOLOL

Доступно од:

Generics (UK) Limited

АТЦ код:

S01ED51

INN (Међународно име):

LATANOPROST, TIMOLOL

Дозирање:

50mcg/ml + 5 Mg/Ml

Фармацеутски облик:

Eye Drops Solution

Тип рецептора:

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

Терапеутска област:

Beta blocking agents

Статус ауторизације:

Authorised

Датум одобрења:

2014-09-26

Информативни летак

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24 SEP 2014
1/2
08:45
LATANOPROST/TIMOLOL MALEATE 0.05MG/ML + 5MG/ML 1X2.5ML
LEAFLET
428184
NA
428184
405/70/1
WINTAC
TBC
1
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TIMES
9PT
127 X 500 MM
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231209
4
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1. WHAT LATANOPROST / TIMOLOL IS AND WHAT 
IT IS USED FOR
Latanoprost / Timolol contains two active 
substances: 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 of these conditions are 
linked to an increase in the pressure within 
your eye, which may eventually affect 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).
Children and adolescents
Latanoprost/Timolol is not recommended for 
children or adolescents less than 18 years of age.
DO NOT USE LATANOPROST / TIMOLOL:
-   if you are allergic to latanoprost or 
timolol, beta-blockers, or any of the other 
ingredients of this medicine (listed in 
section 6).
-   if you have now or have had in the past 
respiratory problems such as asthma or 
severe chronic obstructive bronchitis (severe 
lung disease which may cause wheeziness, 
difficulty in breathing

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Latanoprost/Timolol 50 micrograms/ml + 5mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 50 micrograms of latanoprost and 6.83 mg of timolol maleate (equivalent to 5 mg of
timolol).
One drop of the solution contains approximately 1.5 micrograms latanoprost and 150 micrograms timolol.
Excipient with known effect:
Each ml eye drops solution contains 0.2 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
A clear, colourless, aqueous solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Latanoprost/Timolol is indicated for the reduction of intraocular pressure (IOP) in adults 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_
The safety and efficacy of Latanoprost / Timolol in children and adolescents has not yet been established.
Method of 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.
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 activi