Latanoprost Eye Drops Solution 50mcg/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LATANOPROST

Available from:

Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom

ATC code:

S01EE01

INN (International Name):

LATANOPROST 50 µg/ml

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

LATANOPROST 50 µg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Withdrawn

Authorization date:

2016-02-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LATANOPROST 50 MICROGRAMS/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 or your child’s doctor
or 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 or your child’s doctoror
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What latanoprost eye drops are and what it is used for
2.
What you need to know before you use latanoprost eye drops
3.
How to use latanoprost eye drops
4.
Possible side effects
5.
How to store latanoprost eye drops
6.
Contents of the pack and other information
1.
WHAT LATANOPROST EYE DROPS ARE 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 contains the active substance Latanoprost 0.005% w/v (50
micrograms per ml) eye
drops solution.
Latanoprost is used to treat conditions known as open angle glaucoma
and ocular hypertension.
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 EYE DROPS
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 EYE DROPS
-
if you are
ALLERGIC
(hypersensitive) to the active substance latanoprost or any of the
oth

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Latanoprost 50 micrograms/ml eye drops solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml eye drops solution contains 50 micrograms latanoprost.
One drop contains approximately 1.5 micrograms latanoprost.
Excipient with known effects:
Benzalkonium chloride 0.02% w/v (0.21mg/ml) is included as a
preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution practically free from particles filled in 5
ml FFS vial.
pH: 6.40-7.00
Osmolality: 240-300 mOsmols / kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Latanoprost in indicated for reduction of elevated intraocular
pressure
•
in patients with open angle glaucoma and ocular hypertension.
•
in paediatric patients with elevated intraocular pressure and
paediatric glaucoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Recommended dosage for adults (including the elderly): _
Page 2 of 12
Recommended therapy is one eye drop in the affected eye(s) once daily.
Optimal effect is
obtained if Latanoprost eye drops is administered in the evening.
The dosage of Latanoprost eye drops 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 is 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 drug is being used, the drugs
should be administered at
least five minutes apart.
_Paediatric population _
Latanoprost eye drops may be used in paediatric patients at the same
posology as in adults.
No data are availa