Latacris 50 microgram/ml eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Latanoprost

Available from:

NTC Srl

ATC code:

S01EE; S01EE01

INN (International Name):

Latanoprost

Dosage:

50 microgram(s)/millilitre

Pharmaceutical form:

Eye drops, solution

Prescription type:

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

Therapeutic area:

Prostaglandin analogues1); latanoprost

Authorization status:

Marketed

Authorization date:

2011-08-26

Patient Information leaflet

LATANOPROST 0.005% EYE DROPS, SOLUTION
1.3.1 COMMON
PACKAGE LEAFLET: INFORMATION FOR THE USER
LATACRIS 50 MICROGRAM/ML EYE DROPS, 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 the doctor
treating your child or your
pharmacist.
-
This medicine has been prescribed for you or for your child. 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 the doctor
treating your child or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Latacris Eye Drops is and what it is used for
2.
What you need to know before you use Latacris Eye Drops
3.
How to use Latacris Eye Drops
4.
Possible side effects
5.
How to store Latacris Eye Drops
6.
Content of the pack and other information
1.
WHAT LATACRIS EYE DROPS IS AND WHAT IT IS USED FOR
Latacris Eye Drops belongs to a group of medicines known as
prostaglandins-analogues. It works by
increasing the natural outflow of fluid from inside the eye into the
bloodstream.
Latacris Eye Drops is used to treat conditions known as open angle
glaucome and ocular hypertension.
Both of these conditions are linked with an increase in the pressure
within your eye, eventually
affecting your eye sight.
Latacris
is also used to treat increased eye pressure and glaucoma in all ages
of children and
babies.
2.
WHAT DO YOU NEED TO KNOW BEFORE YOU USE LATACRIS EYE DROPS
Latacris Eye Drops can be used in adult men and women (including the
elderly) and in children from
birth to 18 years of age. Latacris has not been investigated in
prematurely born infants (less than 36
weeks gestation).
DO NOT USE LATACRIS EYE DROPS:
-
if you are allergic (hypersensitive) to latanoprost or to any of the
other ingredients of this
medicine ( liste

Summary of Product characteristics

Health Products Regulatory Authority
12 January 2021
CRN00C3RV
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Latacris 50 microgram/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml eye drops solution contains 5 mg latanoprost.
One drop contains approximately 1.5 micrograms latanoprost.
Excipients with known effect:
Benzalkonium chloride 0.02% w/v is included as a preservative and
phosphates
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
The solution is a clear colourless liquid.
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 1 eye drop in the affected eye(s) once daily.
Optimal effect is obtained if Latacris is administered in
the evening.
The dosage of Latacris 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.
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.
Method of administration
Contact lenses should be removed before instillation of the eye drops
and may be reinserted after 15 minutes.
If more than one topical ophthalmic drug is being used, the drugs
should be administered at least 5 minutes apart.
_Paediatric population:_
Latacris eye drops may be used in paediatric patients at the same
posology as in adults. No data are available for preterm
infants (less than 36 weeks gestational age). Data in the age g