OptaProst Ophthalmic Solution 0.005% wv

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LATANOPROST

Boleh didapati daripada:

Pharmaniaga Marketing Sdn Bhd

INN (Nama Antarabangsa):

LATANOPROST

Unit dalam pakej:

2.5 ml

Dikeluarkan oleh:

Nitto Medic Co., Ltd

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
OPTAPROST OPHTHALMIC SOLUTION 0.005%
W
/
V
Latanoprost (0.05 mg/ml)
1
WHAT IS IN THIS LEAFLET
1.
What OptaProst is used for
2.
How OptaProst works
3.
Before you use OptaProst
4.
How to use OptaProst
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of OptaProst
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT OPTAPROST IS USED FOR
OptaProst
is
used
to
treat
conditions
known as open angle glaucoma, chronic
angle
closure
glaucoma
and
ocular
hypertension.
All
of
these
conditions
linked with an increase in the pressure
within
your
eye,
eventually
affecting
your eye sight.
OptaProst is also used to treat increased
eye pressure and glaucoma in children.
HOW OPTAPROST WORKS
OptaProst contains Latanoprost which is
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
and reduce the pressure in the eye.
BEFORE YOU USE OPTAPROST_ _
-
_When you must not use it _
If
allergic
(hypersensitive)
to
the
Latanoprost
or
to
any
of
the
other
ingredients of OptaProst
_ _
If
_ _
you are not sure whether you should
start taking this medicine, talk to your
doctor or pharmacist.
_ _
-
_Before you start to use it _
Discuss with your doctor or pharmacist
if:
•
You are about to have any kind of eye
surgery (including cataract surgery) or
have had any kind of eye surgery in
the past;
•
You suffer from eye problems (such as
eye
pain,
eye
irritation
or
eye
inflammation or blurred vision);
•
You suffer from dry eyes;
•
You wear contact lenses. You should
remove the contact lenses before using
OptaProst
and
wait
for
15
minutes
before putting your contact lenses.
•
You use other eye drops. Wait at least
5
minutes
between
using
OptaProst
and taking other eye drops.
•
You suffered or are currently suffering
from a viral infection of the eye caused
by the herpes simplex virus (HSV)
_Pregnancy and lactation _
Do
not
take
Op

Ciri produk

OPTAPROST
Ophthalmic Solution 0.005% w/v
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT:
OptaProst Ophthalmic Solution 0.005% w/v
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
[ACTIVE INGREDIENT]
Each mL of eye drops, solution contains 50 micrograms of
latanoprost.
Each 2.5mL of eye drops, solution (content of 1 bottle) contains
125 micrograms of latanoprost.
[EXCIPIENTS]
This product contains preservative as Benzalkonium Chloride
0.01 % w/v.
Route of Administration: Ophthalmic.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM:
Eye drops, solution.
This product is a clear, colorless, sterile, aqueous ophthalmic
solution buffered to approximately pH 6.5 – 6.9.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS:
(1)
Reduction of elevated intraocular pressure (IOP) in patients
with open-angle glaucoma, chronic angle closure
glaucoma, and ocular hypertension.
(2)
Reduction of elevated intraocular pressure in paediatric
patients with elevated intraocular pressure and paediatric
glaucoma
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
_Use in adults (including the elderly): _
One 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.
Latanoprost may be used concomitantly with other classes of
topical ophthalmic drug products to lower IOP. If more than one
topical ophthalmic drug is being used, the drugs should be
administered at least five minutes apart.
Contact lenses should be removed before instillation of the
eye drops and may be reinserted after fifteen minutes.
_Pediatric 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