Timlatan 50 micrograms/ml + 5 mg/ml eye drops, solution

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

TIMOLOL MALEATE; Latanoprost

Disponible desde:

PharmaSwiss Ceska republika s.r.o.

Código ATC:

S01ED; S01ED51

Designación común internacional (DCI):

TIMOLOL MALEATE; Latanoprost

Dosis:

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

formulario farmacéutico:

Eye drops, solution

tipo de receta:

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

Área terapéutica:

Beta blocking agents1); timolol, combinations

Estado de Autorización:

Not marketed

Fecha de autorización:

2011-08-26

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TIMLATAN50 MICROGRAM/ML + 5 MG/ML EYE DROPS, SOLUTION
[To be completed nationally]
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 Timlatan is and what it is used for
2.
What you need to know before you use Timlatan
3.
How to use Timlatan
4.
Possible side effects
5.
How to store Timlatan
6.
Contents of the pack and other information
1.
WHAT TIMLATAN
IS AND WHAT IT IS USED FOR
Timlatan 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.
Timlatan 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 Timlatan when
other medicines have not worked adequately.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TIMLATAN
Timlatan 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 TIMLATAN:

if you are allergic (hypersensitive) to either of the medicines
(latanoprost or timolol), beta-
blockers, or any of the other ingredients of this medicine

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Timlatan 50 micrograms/ml + 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.
One drop contains approximately 1.5 micrograms latanoprost and 150
micrograms timolol.
Excipients with known effect: benzalkonium chloride 0.2 mg/ml
For the 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
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 (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.
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 bronchial asthma or a history of
bronchial asthma, severe chronic obstructive
pulmonary disease.
-
Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or
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