XALATAN 0.005% EYE DROPS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LATANOPROST

Boleh didapati daripada:

UPJOHN (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

LATANOPROST

Unit dalam pakej:

2.5 ml mL

Dikeluarkan oleh:

PFIZER MANUFACTURING BELGIUM NV,

Risalah maklumat

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
XALATAN

EYE DROPS
Latanoprost (50 mcg/ml)
1
WHAT IS IN THIS LEAFLET
1.
What XALATAN is used for
2.
How XALATAN works
3.
Before you use XALATAN
4.
How to use XALATAN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of XALATAN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT XALATAN IS USED FOR
XALATAN is used to treat eye
conditions that are linked to an increase
in the pressure within the eye (glaucoma,
ocular hypertension), that can eventually
affect your eyesight.
XALATAN is also used in all ages of
children and babies. Data in the age
group <1 year is limited.
HOW XALATAN WORKS
XALATAN works by increasing the
natural outflow of fluid from inside the
eye into the bloodstream and thus
reducing the eye pressure.
BEFORE YOU USE XALATAN

_When you must not use it_
Do not start using XALATAN if you
or your child is allergic
(hypersensitive) to latanoprost or any
of the other ingredients of XALATAN
eye drops (see Section on ‘Product
Description’).
_Pregnancy and lactation_
Tell your doctor immediately if you are
pregnant, think you are pregnant, or are
planning to become pregnant. Your
doctor will discuss the possible risks and
benefits of using XALATAN during
pregnancy.
XALATAN should be used with caution
if you are breastfeeding. Ask your doctor
or pharmacist for advice before using
XALATAN if you are breastfeeding.

_Before you start to use it_
Check with your doctor or pharmacist
before using XALATAN if you think
any of the following applies to you.
The same applies if your child has
been prescribed XALATAN.

If you or your child suffer from eye
problem (such as absence of the lens
in the eye, or presence of artificial
lens)

If you or your child have severe
asthma or if the asthma is not well
controlled

If you or your child wear contact
lenses. You can still use XALATAN,
but follow the instruction for contact
lens wearers in Section ‘Th

Ciri produk

PFIZER CONFIDENTIAL
1
1.
NAME OF THE MEDICINAL PRODUCT
XALATAN
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 50 mcg of latanoprost and benzalkonium chloride 0.2
mg/mL.
One drop contains approximately 1.5 mcg of latanoprost. Each bottle
contains 2.5 mL
eye drops corresponding to approximately 80 drops of solution.
3.
PHARMACEUTICAL FORM
Ophthalmic solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure (IOP) in patients with
open-angle
glaucoma, chronic angle closure 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
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 IOP 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 (see section 4.4).
PFIZER CONFIDENTIAL
2
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 year (4 patients) are
limited (see
section 5.1).
4.3
CONTRAINDICATIONS
Known hypersensitivity to latanoprost or any other component of the
product.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
_Iris pigmentation changes _
_ _
Latanoprost may gradually increase the brown pigment of the iris. The
eye
color change is du