Travoprost Pharmathen 40 microgram/ml, oogdruppels, oplossing

Country: Netherlands

Language: Dutch

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

Active ingredient:

TRAVOPROST 40 µg/ml

Available from:

Pharmathen S.A. 6, Dervanakion St. 153 51 PALLINI ATTICA (GRIEKENLAND)

ATC code:

S01EE04

INN (International Name):

TRAVOPROST 40 µg/ml

Pharmaceutical form:

Oogdruppels, oplossing

Composition:

BENZALKONIUMCHLORIDE ; BOORZUUR (E 284) ; DINATRIUMEDETAAT 2-WATER ; MACROGOLGLYCEROLHYDROXYSTEARAAT ; MANNITOL (D-) (E 421) ; NATRIUMHYDROXIDE (E 524) ; TROMETAMOL ; WATER VOOR INJECTIE,

Administration route:

Oculair gebruik

Therapeutic area:

Travoprost

Product summary:

Hulpstoffen: BENZALKONIUMCHLORIDE; BOORZUUR (E 284); DINATRIUMEDETAAT 2-WATER; MACROGOLGLYCEROLHYDROXYSTEARAAT; MANNITOL (D-) (E 421); NATRIUMHYDROXIDE (E 524); TROMETAMOL; WATER VOOR INJECTIE;

Authorization date:

2014-04-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAVOPROST PHARMATHEN 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 your 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] is and what it is used for
2.
What you need to know before you use [Travoprost]
3.
How to use [Travoprost]
4.
Possible side effects
5.
How to store [Travoprost]
6.
Contents of the pack and other information
1. WHAT [TRAVOPROST] IS AND WHAT IT IS USED FOR
[Travoprost] eye drops are used to treat high pressure in the eye.
This pressure can lead to
an illness called GLAUCOMA.
HIGH PRESSURE IN THE EYE. Your eyeballs contain a clear, watery liquid
which feeds the
inside of the eye. Liquid is always emptying out of the eye, and more
liquid is always
being produced. If the eye fills up faster than it empties, the
pressure inside the eye builds
up. If it gets too high, it can damage your sight.
[Travoprost] is one of a group of medicines for glaucoma called
prostaglandin analogues.
It works by increasing the outflow of liquid, which lowers the
pressure in the eye. It may
be used on its own or with other drops e.g. beta-blockers, which also
reduce pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE [TRAVOPROST]
DO NOT USE [TRAVOPROST]

if you are allergic to travoprost or any of the other ingredients of
this medicine (listed
in section 6)
WARNINGS AND PRECAUTIONS

IF YOU ARE UNDER 18. [Travoprost] is not to be used by people under 18
years of age.
[Travoprost] may:

increase the length, thickness, colour and/or n

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
Travoprost Pharmathen40 micrograms/mL eye drops, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of solution contains 40 micrograms of travoprost.
Average active substance/drop: 0.97 - 1.4 μg
Excipients with known effect
benzalkonium chloride 150 micrograms/mL, macrogolglycerol
hydroxystearate 40 5 mg/mL
(see section 4.4).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution.
pH: 5.5-7.0
Osmolality: 266-294 mOsm/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 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 the elderly population _
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 (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 should be discontinued and [Travoprost] should
be started the
following day.
_Hepatic and renal impairment _
Travoprost has been studied in patients with mild to severe hepatic
impairment and in patients
with mild to severe renal impairment (creat