Travoprost 40mcg/ml eye drops solution

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

TRAVOPROST

Disponible depuis:

1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany

Code ATC:

S01EE04

DCI (Dénomination commune internationale):

TRAVOPROST 40 µg

forme pharmaceutique:

EYE DROPS, SOLUTION

Composition:

TRAVOPROST 40 µg

Type d'ordonnance:

POM

Domaine thérapeutique:

OPHTHALMOLOGICALS

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2017-08-22

Notice patient

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Travoprost 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 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 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 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
DO NOT USE TRAVOPROST

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
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-
Travoprost
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
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
oc

Résumé des caractéristiques du produit

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_ _
Travoprost 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 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.
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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 t