ZANOPRO PLUS 0.05/5 Mg/Ml Eye Drops Solution

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

LATANOPROST TIMOLOL MALEATE

Предлага се от:

Clonmel Healthcare Ltd

INN (Международно Name):

LATANOPROST TIMOLOL MALEATE

дозиране:

0.05/5 Mg/Ml

Лекарствена форма:

Eye Drops Solution

Вид предписание :

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

Статус Оторизация:

Authorised

Дата Оторизация:

0000-00-00

Листовка

Page 1 of 8 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

ZANOPRO PLUS 50MICROGRAMS/ML AND 5MG/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 Zanopro Plus is and what it is used for 
2.  What you need to know before you use Zanopro Plus 
3.  How to use Zanopro Plus 
4.  Possible side effects 
5.  How to store Zanopro Plus 
6.  Contents of the pack and other information 

1. 
WHAT ZANOPRO PLUS IS AND WHAT IT IS USED FOR 
Zanopro Plus is a medicine for the treatment of INCREASED
INTRAOCULAR PRESSURE (pressure inside the 
eye). 

Zanopro Plus is a drug combination containing two active substances:
latanoprost (a prostaglandin 
derivative) and timolol maleate (a beta-blocker). 

Fluid known as aqueous humour is produced inside the eye. This fluid
is then drained back into the 
bloodstream, thereby maintaining the required pressure within the
eye. If this outflow is obstructed, 
pressure within the eye increases. 

Among other things, beta-blockers reduce pressure inside the
eye, by reducing the production of 
aqueous humour. Prostaglandins promote the outflow of aqueous
humour. 

ZANOPRO PLUS IS USED: 
 
to reduce inner eye pressure in patients with open-angle
glaucoma (damage to the optic nerve, 
caused by excessive pressure within the eye). 
 
to reduce inner eye pressure in patients for whom the effect o

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zanopro Plus 50 micrograms/ml and 5 mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 50 micrograms latanoprost and 6.8 mg timolol maleate equivalent to 5 mg timolol.
Excipient: Benzalkonium chloride 0.2 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
The solution is a clear colourless liquid.
pH 5.5 - 6.5; osmolality 270 - 330 mOsmol/kg
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 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.
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.
Paediatric population:
Safety and effectiveness in children and adolescents has not been established.
4.3 CONTRAINDICATIONS
Latanoprost/timolol is contraindicated in patients with:
-
Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive
pulmona