PATADAY OPHTHALMIC SOLUTION 0.2%w/v

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

OLOPATADINE HYDROCHLORIDE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

OLOPATADINE HYDROCHLORIDE

Unit dalam pakej:

2.5ml mL

Dikeluarkan oleh:

ALCON LABS INC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
PATADAY EYE DROPS
_ _
Olopatadine hydrochloride (2mg/ml)
1
WHAT IS IN THIS LEAFLET
1.
What PATADAY is used for
2.
How PATADAY works
3.
Before you use PATADAY
4.
How to use PATADAY
5.
While you are using PATADAY
6.
Side effects of PATADAY
7.
Storage
and
Disposal
of
PATADAY
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT PATADAY IS USED FOR
Pataday
is
used
for
the
temporary
prevention of itching of the eye due to
allergic
conjunctivitis
(allergic
reactions resulting in itching, redness
as well as swelling of the surface of
your eye).
HOW PATADAY WORKS
Pataday
belongs
to
a
group
of
medicines
called
antihistamines.
It
relieves eye itchiness associated with
allergic condition of the eye.
BEFORE YOU USE PATADAY
-
_When you must not use it _
Do not use Pataday if you are allergic
to
olopatadine
or
any
of
the
other
ingredients of this medicine.
_Pregnancy, _
_breast-feeding _
_and _
_fertility _
If you are pregnant or breast-feeding,
you think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice before
using this medicine.
Antihistamines may affect the milk
production
of
a
nursing
mother.
Olopatadine can be used by women of
childbearing potential.
Safety and effectiveness in children
below the age of 3 years have not been
established.
_ _
-
_Before you start to use it _
Talk
to
your
doctor
or
pharmacist
before using Pataday.
_ _
A
preservative
in
Pataday
(benzalkonium
chloride)
may
cause
eye irritation and is also known to
discolour soft contact lenses. If you
wear
contact
lenses
you
should
remove them before using Pataday and
wait at least 15 minutes before putting
your lenses back in.
_ _
-
_Taking other medicines _
Tell your doctor or pharmacist if you
are using, have recently used or might
use any other medicines.
HOW TO USE PATADAY
-
_How much to use _
The recommended dose is one drop in
each affected eye once a day.
_ _
-
_When to use it _
Use once a day or as directed by yo

Ciri produk

1 NAME OF THE MEDICINAL PRODUCT
PAT AD AY * Ophthalmic Solution
2 Q UALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients: 2.22 mg of olopatadine hydrochloride in one mL solution (0.2%)
Preservative: benzalkonium chloride
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye Drops, solution
Colorless to light yellow solution
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
PATADAY* is indicated for the temporary prevention of itching of the eye due to allergic conjunctivitis.
4.2 Posology and Method of Administration
Adults
The recommended dose is one drop in each affected eye once a day.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Geriatric Use
No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Method of administration
• For topical ocular use only. Not for injection or oral use.
• To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip
of the bottle.
• Keep the bottle tightly closed when not in use.
• In case of concomitant therapy with other topical ocular medi cines, an interval of 5 minutes should be allowed between successive applications. Eye ointments
should be administered last.
• Patients should be advised not to wear a contact lens if their eye is red.
• PATADAY* should not be used to treat contact lens related irritation.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
4.4 Special Warnings and Precautions f or Use
PATADAY* contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses.
Patients must be instructed to remove contact lenses prior to application of PATADAY* and w ait at least 15 minutes before reinsertion.
4.5 Interaction with other Medicinal Products and Other Forms of Interaction
No clinically