Travoprost Polpharma 40 microgram/ml, oogdruppels, oplossing

Maa: Alankomaat

Kieli: hollanti

Lähde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiivinen ainesosa:

TRAVOPROST

Saatavilla:

Zaklady Farmaceutyczne POLPHARMA Joint-Stock Company Pelplinska 19 83 200 STAROGRAD GDANSKI (POLEN)

ATC-koodi:

S01EE04

INN (Kansainvälinen yleisnimi):

TRAVOPROST

Lääkemuoto:

Oogdruppels, oplossing

Koostumus:

BENZALKONIUMCHLORIDE ; BOORZUUR (E 284) ; CASTOROLIE, GEHYDREERD ; DINATRIUMEDETAAT 2-WATER ; MANNITOL (D-) (E 421) ; NATRIUMHYDROXIDE (E 524) ; TROMETAMOL ; WATER, GEZUIVERD ; ZOUTZUUR (E 507),

Antoreitti:

Oculair gebruik

Terapeuttinen alue:

Travoprost

Tuoteyhteenveto:

Hulpstoffen: BENZALKONIUMCHLORIDE; BOORZUUR (E 284); CASTOROLIE, GEHYDREERD; DINATRIUMEDETAAT 2-WATER; MANNITOL (D-) (E 421); NATRIUMHYDROXIDE (E 524); TROMETAMOL; WATER, GEZUIVERD; ZOUTZUUR (E 507);

Valtuutus päivämäärä:

2013-11-14

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRAVOPROST POLPHARMA 40 MICROGRAM/ML, OOGDRUPPELS, OPLOSSING
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 XXX is and what it is used for
2.
What you need to know before you use Travoprost XXX
3.
How to use Travoprost XXX
4.
Possible side effects
5.
How to store Travoprost XXX
6.
Contents of the pack and other information
1.
WHAT TRAVOPROST XXX IS AND WHAT IT IS USED FOR
Travoprost XXX 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 XXX 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 XXX
DO NOT USE TRAVOPROST XXX:
-
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 XXX
-
Travoprost XXX 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 XXX may change the colour of your iris (the coloured part
of your eye). This
change may be permanent. A change in the col

Valmisteyhteenveto

1
SUMMARY OF PRODUCT CHARACTERSITICS
1.
NAME OF THE MEDICINAL PRODUCT
Travoprost Polpharma 40 microgram/ml, oogdruppels, oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 40 micrograms of travoprost.
One drop of solution contains 1.2 micrograms of travoprost.
Excipients with known effect:
each ml of solution contains 5 mg polyoxyethylene hydrogenated castor
oil 40
each ml of solution contains 0.15 mg of benzalkonium chloride
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Eye drops, solution
Clear, colourless solution, isotonic and with a neutral pH
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 Travoprost XXX 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 XXX, the
other medicinal product should be discontinued and Travoprost XXX
should be started the following
day.
2
_Hepatic and renal impairment _
Travoprost XXX has been studied in patients with mild