LATANOPROST

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

LATANOPROST

Dostupné z:

Generics (UK) Limited

ATC kód:

S01EE01

INN (Medzinárodný Name):

LATANOPROST

Dávkovanie:

50 Microgram/ML

Forma lieku:

Eye Drops Solution

Typ predpisu:

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

Terapeutické oblasti:

latanoprost

Stav Autorizácia:

Not Marketed

Dátum Autorizácia:

2014-07-04

Príbalový leták

18
PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 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 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 contains the active ingredient latanoprost which 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. Both of these
conditions are linked with an increase in the pressure within your
eye, eventually affecting your eyesight.
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 to latanoprost or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your d

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Latanoprost 50 micrograms/ml Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 50 micrograms of latanoprost.
One drop of the solution contains approximately 1.5 micrograms of
latanoprost.
Excipients with known effect
Each ml of solution contains 0.2 mg benzalkonium chloride and 6.34 mg
phosphate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
A clear, colourless, aqueous solution, pH between 6.5 – 6.9 and
osmolality between 240 – 294 mOsmol/kg.
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 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 intraocular pressure lowering effect.
If one dose is missed, treatment should continue with the next dose as
normal.
_Paediatric population:_
Latanoprost 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 group < 1 year (4 patients) are very limited (see
section 5.1).
Method of administration
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