Izba

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

travoprost

Διαθέσιμο από:

Novartis Europharm Limited

Φαρμακολογική κατηγορία (ATC):

S01EE04

INN (Διεθνής Όνομα):

travoprost

Θεραπευτική ομάδα:

Ophthalmologicals, Antiglaucoma preparations and miotics

Θεραπευτική περιοχή:

Ocular Hypertension; Glaucoma, Open-Angle

Θεραπευτικές ενδείξεις:

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 paediatric patients aged 3 years to < 18 years with ocular hypertension or paediatric glaucoma.

Περίληψη προϊόντος:

Revision: 6

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-02-20

Φύλλο οδηγιών χρήσης

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET : INFORMATION FOR THE USER
IZBA 30 MICROGRAMS/ML EYE DROPS, SOLUTION
travoprost
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
INFORMATION IMPORTANT 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 IZBA is and what it is used for
2.
What you need to know before you use IZBA
3.
How to use IZBA
4.
Possible side effects
5.
How to store IZBA
6.
Contents of the pack and other information
1.
WHAT IZBA IS AND WHAT IT IS USED FOR
IZBA
CONTAINS TRAVOPROST,
one of a group of medicines called
PROSTAGLANDIN ANALOGUES
.
IZBA IS USED TO REDUCE HIGH PRESSURE IN THE EYE IN ADULTS, ADOLESCENTS AND
CHILDREN FROM 3 YEARS
OLD ONWARD.
This pressure can lead to an illness called
GLAUCOMA.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IZBA
DO NOT USE IZBA

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.
23
WARNINGS AND PRECAUTIONS

IZBA 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.

IZBA
may gradually
CHANGE THE COLOUR OF YOUR IRIS
(the coloured part of your eye). This
change may be permanent.

If you have had cataract surgery talk to your doctor before you use
IZBA. IZBA may increase
the risk of inflammation of the back of the eye.

If you have current or previous history of an eye inflammation (iritis
and uveitis) talk to your
doctor before you use IZBA. Eye inflammation is a possible side ef

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
IZBA 30 micrograms/mL eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of solution contains 30 micrograms of travoprost.
Excipients with known effect
One mL of solution contains 7.5 mg propylene glycol and 2 mg
polyoxyethylene hydrogenated castor
oil 40 (HCO-40) (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution (eye drops).
Clear, colourless solution.
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 paediatric patients aged
3 years to <18 years with ocular
hypertension or paediatric glaucoma (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Use in adults, including elderly patients _
The dose is one drop of travoprost 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.
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 IZBA, the other
medicinal product should be discontinued and IZBA should be started
the following day.
3
_Hepatic and renal impairment _
Travoprost 30 µg/mL has not been studied in patients with hepatic or
renal impairment. However,
travoprost 40 µg/mL has been studied in patients with mild to severe
hepatic impairment and in
p