Laprol 0.05/5.0mg per ml Eye drops, solution

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

TIMOLOL, LATANOPROST

Dostopno od:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Koda artikla:

S01ED51

INN (mednarodno ime):

TIMOLOL 5 mg/ml LATANOPROST 50 µg/ml

Farmacevtska oblika:

EYE DROPS, SOLUTION

Sestava:

TIMOLOL 5 mg/ml LATANOPROST 50 µg/ml

Tip zastaranja:

POM

Terapevtsko območje:

OPHTHALMOLOGICALS

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2011-08-23

Navodilo za uporabo

 
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PACKAGE LEAFLET: INFORMATION FOR THE USER 

LAPROL 0.05/5.0 MG/ML EYE DROPS, SOLUTION 

Latanoprost /timolol 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATIONFOR 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. 

WHAT IS IN THIS LEAFLET 
1. 
What Laprol is and what it is used for 
2. 
What you need to know before you use Laprol 
3. 
How to use Laprol 
4. 
Possible side effects 
5. 
How to store Laprol 
6. 
Content of the pack and other information 

1. 
WHAT LAPROL IS AND WHAT IT IS USED FOR 

Laprol 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.  
Laprol 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 and increase in the pressure 
within your eye, eventually affecting your eyesight.
Your doctor will usually prescribe you Laprol 
when other medicines have not worked adequately.  

2. 
WHAT YOU NEED TO KNOW BEFORE YOU USE LAPROL 

Laprol can be used in adult men and women (including the elderly),
but is not recommended for use if 
you a

Lastnosti izdelka

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Laprol 0.05 /5.0 mg/ 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. 

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If more than one topical ophthalmic drug is being used, the drugs
should be administered at least five 
minutes apart. 

4.3.  CONTRAINDICATIONS 

Laprol eye drops, solution is contraindicate