Travoprost Sandoz 40 micrograms/ml Eye drops, solution

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Travopost

Διαθέσιμο από:

Rowex Ltd

Φαρμακολογική κατηγορία (ATC):

S01EE; S01EE04

INN (Διεθνής Όνομα):

Travopost

Δοσολογία:

40 microgram(s)/millilitre

Φαρμακοτεχνική μορφή:

Eye drops, solution

Τρόπος διάθεσης:

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

Θεραπευτική περιοχή:

Prostaglandin analogues1); travoprost

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2014-07-18

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAVOPROST SANDOZ 40 MICROGRAMS/ML EYE DROPS, SOLUTION
travoprost
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 Travoprost Sandoz is and what it is used for
2.
What you need to know before you use Travoprost Sandoz
3.
How to use Travoprost Sandoz
4.
Possible side effects
5.
How to store Travoprost Sandoz
6.
Contents of the pack and other information
1.
WHAT TRAVOPROST SANDOZ IS AND WHAT IT IS USED FOR
Travoprost Sandoz contains travoprost, one of a group of medicines
called prostaglandin
analogues. It works by reducing the pressure in the eye. It may be
used on its own or with
other drops e.g. beta-blockers, which also reduce pressure.
Travoprost Sandoz is used to reduce high pressure in the eye in
adults, adolescents and
children from 2 months old onward. This pressure can lead to an
illness called glaucoma.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TRAVOPROST SANDOZ
DO NOT USE TRAVOPROST SANDOZ

if you are allergic to travoprost or any of the other ingredients of
this medicine (listed in
section 6).
Ask your doctor for advice if this applies to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Travoprost Sandoz.
-
Travoprost Sandoz may increase the length, thickness, colour and/or
number of your
eyelashes. Changes in the eyelids including unusual hair growth or in
the tissues around
the eye have also been observed.
-
Travoprost Sandoz may change the colour of your iris (the coloured
part of your eye).
This change may be per

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Travoprost Sandoz 40 micrograms/ml Eye drops, solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 40 micrograms of travoprost.
Excipients with known effect: 1 ml of solution contains benzalkonium
chloride solution (equivalent to 0.15 mg
benzalkonium chloride), 5 mg macrogolglycerol hydroxystearate 40 (see
section 4.4.).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution.
pH: 5.5 – 6.5.
Osmolality: 265-320 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Decrease of elevated intraocular pressure in adult patients with
ocular hypertension or open
-
angle glaucoma (see
section 5.1).
Decrease of elevated intraocular pressure in pediatric patients aged 2
months to <18 years with ocular hypertension or
pediatric glaucoma (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For ocular use.
Posology
_Use in adults, including elderly population_
The dose is one drop of Travoprost Sandoz 40micrograms/ml Eye drops,
solution in the conjunctival sac of the affected
eye(s) once daily. Optimal effect is obtained if the dose is
administered in the evening.
Nasolacrimal occlusion or gently closing the eyelid after
administration is recommended. This may reduce the systemic
absorption of medicinal products administered via the ocular route and
result in a decrease in systemic adverse
reactions.
If more than one topical ophthalmic medicinal product is being used,
the medicinal products must be administered at
least 5 minutes apart (see section 4.5).
If a dose is missed, treatment should be continued with the next dose
as planned. The dose should not exceed one drop
in the affected eye(s) daily.
When substituting another ophthalmic antiglaucoma medicinal product
with travoprost, the other medicinal product
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