LATANDROPS 0.005%WV EYE DROPS

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

LATANOPROST

Boleh didapati daripada:

MMS PHARMA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

LATANOPROST

Unit dalam pakej:

2.5ml mL

Dikeluarkan oleh:

VIANEX S.A. - Plant A

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
LATANDROPS 0.005% W/V EYE DROPS
_®_
Latanoprost 0.005% w/v
- 1 -
WHAT IS IN THIS LEAFLET
1.
What LATANDROPS is used fo
r
2.
How LATANDROPS works
3.
Before you use LATANDROPS
4.
How to use LATANDROPS
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
LATANDROPS
8.
Product Description
9.
Manufacturer and Produc
t
Regi
stration Holder
10.
Date of revi
sion
W
HAT LATANDROPS IS USED FOR
LATANDROPS Eye Drops is used to
reduce the pressure in your eye, if
you have conditions known as open
angle glaucoma, chronic angle
closure glaucoma (CACG) or ocular
hypertension. These conditions are
linked to an increase in the pressure
within your eye, eventually affecting
your eyesight
HOW LATANDROPS WORKS
LATANDROPS
contains active
ingredient: latanoprost.
Latanoprost belongs to a group of
medicines known as prostaglangin
analogues. Latanoprost works by
increasing the natural outflow of fluid
from the eye into the bloodstream.
BEFORE YOU USE LATANDROPS
_- When you must not use it_
_ _

if
you are allergic (hypersensitive)
to the active ingredient of
LATANDROPS
(latanoprost) or to
any of the other ingredients of
LATANDROPS;

if
you are pregnant or trying to
become pregnant;

if you are breast-feeding.
_- Before you start to use it_
_ _
Talk to your doctor or pharmacist
before using LATANDROPS,
if you
think that any of the following apply
to you:

i
f you are about to have any kind of
eye surgery (including cataract
surgery) or have had any kind of eye
surgery in the past;

if you suffer from eye problems
(such as eye pain, eye irritation or eye
inflammation or blurred vision);

i
f you know that you suffer from
dry eyes;

If
you wear contact lenses, y
ou
sho
uld remove them before using
LATANDROPS. After using
LATANDROPS
you should wait 15
minutes before putting your contact
lenses back in;

i
f you have difficulty breathing
because of lung disease or problems
with your lungs.
_- Taking other medicines_
_ _
LATANDROPS
may interact with

Ciri produk

LATANDROPS 0.005% W/V EYE DROPS
LATANOPROST 0.005% W/V
PRESENTATION:
LATANDROPS 0.005% W/V EYE DROPS is a sterile, clear, colourless,
odourless, free from visible particles ophthalmic solution. It is
formulated as isotonic, preserved ophthalmic solution supplied in a
multidose dropper container equipped with a dropper applicator
and tamper evident screw cap. Each dropper container contains 2.5mL
eye drops solution corresponding to approximately 80 drops
of solution.
COMPOSITION:
Each mL of eye drops solution contains of active ingredient,
latanoprost 50 µg (0.005% w/v). One drop contains approximately
latanoprost 1.5 µg. Other excipients include benzalkonium chloride
0.02% w/v as preservative, sodium chloride, sodium dihydrogen
phosphate monohydrate, disodium phosphate anhydrous and Water for
Injections.
PHARMACODYNAMIC:
The active substance latanoprost, a prostaglandin F
2α
analogue, is a selective prostanoid FP receptor agonist which reduces
the
intraocular pressure by increasing the outflow of aqueous humour.
Reduction of the intraocular pressure in man starts about three
to four hours after administration and maximum effect is reached after
eight to twelve hours. Pressure reduction is maintained for
at least 24 hours.
Studies in animals and man indicate that the main mechanism of action
is increased uveoscleral outflow, although some increase in
outflow facility (decrease in outflow resistance) has been reported in
man.
Pivotal studies have demonstrated that latanoprost is effective as
monotherapy. In addition, clinical trials investigating combination
use have been performed. These include studies that show that
latanoprost is effective in combination with beta-adrenergic
antagonist (timolol). Short term (1 or 2 weeks) studies suggest that
the effect of latanoprost is additive in combination with adrenergic
agonists (dipivalyl epinephrine), carbonic anhydrase inhibitors
(acetazolamide) and at least partly additive with cholinergic agonists
(pilocarpine).
Clinical trials have shown that latanoprost has no