Latanoprost 50 microgram/ml eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Latanoprost

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

S01EE; S01EE01

INN (International Name):

Latanoprost

Dosage:

50 microgram(s)/millilitre

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

Prostaglandin analogues1); latanoprost

Authorization status:

Marketed

Authorization date:

2011-01-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LATANOPROST 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 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 or your child get any side effects, talk to your doctor or the
doctor treating your
child or your pharmacist. This includes any possible side effects not
listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Latanoprost is and what it is used for
2.
What you need to know before you use Latanoprost
3.
How to use Latanoprost
4.
Possible side effects
5.
How to store Latanoprost
6.
Contents of the pack and other information
1.
WHAT LATANOPROST IS AND WHAT IT IS USED FOR
Latanoprost 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 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 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
Latanoprost can be used in adult men and women (including the elderly)
and in children from
birth to 18 years of age. Latanoprost has not been investigated in
prematurely born infants
(less than 36 weeks gestation).
DO NOT USE LATANOPROST IF YOU ARE

Allergic (hypersensitive) to latanoprost or any of the other
ingredients of this
medicine (listed in section 6)

Pregnant or trying to become pregnant

Breast feeding
WARNINGS AND P

Summary of Product characteristics

Health Products Regulatory Authority
06 May 2022
CRN00CVC7
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Latanoprost 50 microgram/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml eye drops, solution, contains 50 microgram latanoprost.
One drop contains approximately 1.5 microgram latanoprost.
Excipient with known effect:
Benzalkonium chloride 0.2 mg/ml.
Sodium dihydrogen phosphate monohydrate 4.60 mg.ml
Disodium phosphate 4.74 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
The solution is a clear colourless liquid. pH 6.4-7.0.
Osmolality 240-290 mOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure (IOP) in patients with open
angle glaucoma and ocular hypertension in adults
(including the elderly).
Reduction of elevated IOP in paediatric patients with elevated IOP 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 is
administered in the evening.
The dosage of Latanoprost should not exceed once daily since it has
been shown that more frequent administration decreases
the IOP lowering effect.
If one dose is missed, treatment should continue with the next dose as
normal.
Method of administration
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.
_Paediatric population_
Health Products Regulatory Authority
06 May 2022
CRN00CVC7
Page 2 of 9
Latanop