Travatan
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
07-06-2022
Charakterystyka produktu
(SPC)
07-06-2022
Sprawozdanie z oceny publicznego
(PAR)
02-03-2015
Składnik aktywny:
travoprost
Dostępny od:
Novartis Europharm Limited
Kod ATC:
S01EE04
INN (International Nazwa):
travoprost
Grupa terapeutyczna:
Ophthalmologicals
Dziedzina terapeutyczna:
Glaucoma, Open-Angle; Ocular Hypertension
Wskazania:
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 2 months to < 18 years with ocular hypertension or paediatric glaucoma (see section 5.1).
Podsumowanie produktu:
Revision: 30
Status autoryzacji:
Authorised
Data autoryzacji:
2001-11-27
Ulotka dla pacjenta
22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAVATAN 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 TRAVATAN is and what it is used for
2.
What you need to know before you use TRAVATAN
3.
How to use TRAVATAN
4.
Possible side effects
5.
How to store TRAVATAN
6.
Contents of the pack and other information
1.
WHAT TRAVATAN
IS AND WHAT IT IS USED FOR
TRAVATAN
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.
TRAVATAN
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 TRAVATAN
DO NOT USE TRAVATAN
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.
24
WARNING AND PRECAUTIONS
TRAVATAN
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.
TRAVATAN may
CHANGE THE COLOUR OF YOUR IRIS
(the coloured part of your eye). This change
may be permanent. A change in the colour of the skin around the eye
may also occur.
If you have had
CATARACT SURGERY
, talk to your doctor before yo
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
TRAVATAN 40 micrograms/mL eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 40 micrograms of travoprost.
Excipient(s) with known effect
Each mL of solution contains polyquaternium-1 (POLYQUAD) 10 microgram,
propylene glycol
7.5 mg, polyoxyethylene hydrogenated castor oil 40 (HCO-40) 2 mg (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
2 months 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 population _
The dose is one drop of TRAVATAN 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 TRAVATAN, the other
medicinal product should be discontinued and TRAVATAN should be
started the following day.
3
_Hepatic and renal impairment _
TRAVATAN has been studied in patients with mild to severe hepatic
impairment and in patients with
mild to severe renal
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