Latop-Comp 50 micrograms/ml + 5 mg/ml eye drops, solution

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Latanoprost; TIMOLOL MALEATE

Tilgængelig fra:

Rowex Ltd

ATC-kode:

S01ED; S01ED51

INN (International Name):

Latanoprost; TIMOLOL MALEATE

Dosering:

50mcg/ml + 5 milligram(s)/millilitre

Lægemiddelform:

Eye drops, solution

Recept type:

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

Terapeutisk område:

Beta blocking agents1); timolol, combinations

Autorisation status:

Not marketed

Autorisation dato:

2011-05-20

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
LATOP-COMP 50 MICROGRAMS/ML + 5 MG/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 effect, 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 Latop-Comp is and what it is used for
2.
What you need to know before you use Latop-Comp
3.
How to use Latop-Comp
4.
Possible side effects
5.
How to store Latop-Comp
6.
Contents of the pack and other information
1.
WHAT LATOP-COMP IS AND WHAT IT IS USED FOR
Latop-Comp 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.
Latop-Comp 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 Latop-Comp when other
medicines have not worked adequately.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LATOP-COMP
Latop-Comp 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 LATOP-COMP IF YOU _

are allergic to latanoprost or timolol, to beta-blockers or any of the
other ingredients of this medicine
(listed in section 6)

have now or have had in the past

Produktets egenskaber

Health Products Regulatory Authority
10 May 2019
CRN008JGS
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Latop-Comp 50 micrograms/ml + 5 mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 50 micrograms latanoprost and 6.8 mg timolol maleate
equivalent to 5 mg timolol.
Excipient with known effect benzalkonium chloride 0.20 mg/ml is
included as a preservative.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Latop-Comp is indicated in adults for the 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
_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.
If more than one topical ophthalmic medicinal product is being used,
the medicinal products should be administered at least 5
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.
4.3 CONTRAINDICATIONS
Latop-Comp 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 bronchial asthma or a history of
bronchial asthma, severe chronic obstructive pulmonary
disease
● sinus bradycardia, sick sinus syndrome,