Latanoprost Teva

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Latanoprost

Tilgjengelig fra:

Teva Pharma B.V.

ATC-kode:

S01EE; S01EE01

INN (International Name):

Latanoprost

Dosering :

50 microgram(s)/millilitre

Legemiddelform:

Eye drops, solution

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Prostaglandin analogues1); latanoprost

Autorisasjon status:

Not marketed

Autorisasjon dato:

2012-10-19

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Latanoprost Teva 50 micrograms/ml eye drop solution
Latanoprost
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 Latanoprost Teva 50 micrograms/ml eye drop solution is and what
it is used for
2.
What you need to know before you use Latanoprost Teva 50 micrograms/ml
eye drop solution
3.
How to use Latanoprost Teva 50 micrograms/ml eye drop solution
4.
Possible side effects
5.
How to store Latanoprost Teva 50 micrograms/ml eye drop solution
6.
Contents of the pack and other information
1.
WHAT LATANOPROST TEVA 50 MICROGRAMS/ML EYE DROP SOLUTION IS AND WHAT
IT IS USED FOR
Latanoprost Teva 50 micrograms/ml eye drop solution belongs to a group
of medicines known as prostaglandin
analogues. It works by increasing the natural outflow of fluid from
inside the eye into the bloodstream.
Latanoprost Teva 50 micrograms/ml eye drop solution is used to treat
conditions known as open angle
glaucoma and ocular hypertension in adults. Both of these conditions
are linked with an increase in the pressure
within your eye, eventually affecting your eye sight.
Latanoprost Teva 50 micrograms/ml eye drop solution is also used to
treat increased eye pressure and
glaucoma in all ages of children and babies.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST TEVA 50 MICROGRAMS/ML
EYE DROP SOLUTION
Latanoprost Teva 50 micrograms/ml eye drop solution can be used in
adult men and women (including the
elderly) and in children from birth to 18 years of age. Latanoprost
Teva 50 microgr

Preparatomtale

Health Products Regulatory Authority
20 August 2019
CRN008JQ9
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Latanoprost Teva
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml eye drops solution contains 50 micrograms of latanoprost.
2.5 ml eye drops solution contains 125 micrograms of latanoprost
corresponding to approximately 80 drops of solution.
One drop contains approximately 1.56 micrograms of latanoprost.
Excipients with known effect:
Benzalkonium chloride 0.2 mg/ml.
-Phosphates 17.2 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
A clear colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in patients with open angle
glaucoma and ocular hypertension.
Reduction of elevated intraocular pressure in paediatric patients with
elevated intraocular pressure and paediatric glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults (including the elderly):_
Recommended therapy is one eye drop in the affected eye(s) once daily.
Optimal effect is obtained if Latanoprost Teva 50
micrograms/ml eye drop solution is administered in the evening.
The dosage of Latanoprost Teva 50 micrograms/ml eye drop solution
should not exceed once daily since it has been shown
that more frequent administration decreases the intraocular pressure
lowering effect.
If one dose is missed, treatment should continue with the next dose as
normal.
METHOD OF ADMINISTRATION:
Ocular use
As with any eye drops, to reduce possible systemic absorption, it is
recommended that the lachrymal sac be compressed at the
medial canthus (punctal occlusion) for one minute. This should be
performed immediately following the instillation of each
drop.
Contact lenses should be removed before instillation of the eye drops
and may be reinserted after 15 minutes.
If more than one topical ophthalmic medicinal product is being used,
the medicinal products should be administered at least
five minutes apart.
_ _
_Paediatr