Latanoprost 50 micrograms/ml Eye drops solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
26-04-2024
Summary of Product characteristics
(SPC)
26-04-2024
Active ingredient:
Latanoprost
Available from:
Cipla (EU) Limited
ATC code:
S01EE01
INN (International Name):
Latanoprost
Dosage:
50 micrograms/ml
Pharmaceutical form:
Eye drops, solution
Administration route:
Eye instillation
Units in package:
Pack sizes: 1 x 2.5 ml, 3 x 2.5 ml, 6 x 2.5 ml
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
S&D Pharma CZ
Therapeutic group:
Antiglaucoma preparations and miotics, prostaglandin analogues
Therapeutic indications:
It 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
Authorization status:
Authorised
Authorization date:
2015-07-24
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 ALLER
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Summary of Product characteristics
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):_
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 27/07/2015_
_CRN 214154
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