Latanoprost+Timolol 50 micrograms/ml + 5 mg/ml Eye Drops, Solution

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: myHealthbox

Aktiivinen ainesosa:

Latanoprost, Timolol

Saatavilla:

Tubilux Pharma

ATC-koodi:

S01ED51

INN (Kansainvälinen yleisnimi):

Latanoprost, Timolol

Annos:

50 micrograms/ml + 5 mg/ml

Lääkemuoto:

Eye drops

Antoreitti:

Eye solution use

Kpl paketissa:

1 × 2.5 ml, 3 × 2.5 ml, 6 × 2.5 ml bottle

Prescription tyyppi:

POM - Prescription Only Medicine

Valmistaja:

Tubilux Pharma

Terapeuttinen ryhmä:

Ophthalmological-betablocking agents - timolol, combinations

Käyttöaiheet:

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.

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-01-13

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Latanoprost+Timolol 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 0.20 mg/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 older people): 
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. 
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. 
_ _
_Paediatric population: _
Safety and effectiveness in children and adolescents has
not been established. No data 
are available. 

4.3 CONTRAINDICATIONS 
Latanoprost+Timolol is contraindicated in patients with: 
•

Hypersensitivity to the active substances or to any of the
excipients listed in 
section 6.1. 
•

Reactive airway disease including