ISOPTO CARPINE 2% OPHTHALMIC SOLUTION

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PILOCARPINE HYDROCHLORIDE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

PILOCARPINE HYDROCHLORIDE

Unit dalam pakej:

15ml mL

Dikeluarkan oleh:

S.A. ALCON-COUVREUR N.V.

Risalah maklumat

ISOPTO CARPINE EYE DROP
Pilocarpine Hydrochloride (2%w/v)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Isopto Carpine
_ _
is used for
2.
How Isopto Carpine
_ _
works
3.
Before you use Isopto Carpine
4.
How to use Isopto Carpine
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Isopto
Carpine
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ISOPTO CARPINE_ _IS USED FOR
Isopto
Carpine
ophthalmic
solution
is
used to control pressure in the eyes in
glaucoma.
HOW ISOPTO CARPINE_ _WORKS
Isopto Carpine ophthalmic solution works
by causing the pupil of the eye to shrink
and decreasing the amount of fluid within
the eye.
BEFORE YOU USE ISOPTO CARPINE
-
_When you must not use it _
Do not use Isopto Carpine
•
If you are allergic to pilocarpine or
any of the other ingredients of Isopto
Carpine.
•
If you have inflammation of the eye.
_ _
_Pregnancy and breast-feeding _
If you are pregnant or breast-feeding, you
think you may be pregnant or are planning
to have a baby or breast-feed, ask your
doctor or pharmacist for advice before
using Isopto Carpine.
_Older people (65 years of age or above) _
You can use Isopto Carpine if you are
aged 65 years or over at the same dose as
younger adults.
_ _
_ _
-
_Before you start to use it _
WARNINGS AND PRECAUTIONS
If any of these applies to you, tell your
doctor or pharmacist before taking Isopto
Carpine:
•
If you have had a detached retina.
•
If you are young and near-sighted
(myopic).
•
If
you
have
any
damage
to
your
cornea or other parts of your eye
•
If
you
have
problems
with
the
outflow of aqueous humour (liquid
inside the eye)
•
If you have heart problems or recent
heart attack
•
If you have blood pressure disorder
•
If you have asthma
•
If
you
have
inability or
difficulty
urinating
•
If
you
have
stomach
ulcers,
or
gastrointestinal spasm
•
If you have overactive thyroid
•
If you have Parkinson’s disease
IF YOU WEAR CONTACT LENSES
You should remove con

Ciri produk

Novartis
Page 2
Malaysia Package Leaflet
25-Oct-2021
Isopto Carpine
ISOPTO
® CARPINE
Cholinergic agonist (miotic)
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Eye drops, solution
Slightly viscous, practically clear and practically colorless to pale
yellow solution
Certain dosage strengths may not be available in all countries.
ACTIVE SUBSTANCE
Pilocarpine hydrochloride 2%
20 mg of pilocarpine hydrochloride in 1 mL solution (2%)
EXCIPIENTS
Excipients with known effect: 1 mL of the eye drop solution contains
0.01% of benzalkonium
chloride.
Other excipients: boric acid; hydroxypropyl methylcellulose; sodium
citrate; sodium hydroxide
and/or concentrated hydrochloric acid (for pH adjustment) and purified
water.
INDICATIONS
Isopto Carpine contains pilocarpine hydrochloride, a miotic
(parasympathomimetic).
Isopto Carpine ophthalmic solution is used to control intraocular
pressure in chronic simple
glaucoma. In acute glaucoma it may be used alone prior to emergency
surgery, or in combination
with other miotics or carbonic anhydrase inhibitors. Patients can be
maintained on Isopto Carpine
ophthalmic solution as long as intraocular tension is controlled and
there is no visual deterioration
as indicated by changes in the visual field.
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
2 drops topically in the eye(s) 3 times daily or as directed by a
physician.
SPECIAL POPULATIONS
RENAL AND HEPATIC IMPAIRMENT
Novartis
Page 3
Malaysia Package Leaflet
25-Oct-2021
Isopto Carpine

Safety and efficacy of Isopto Carpine in patients with hepatic or
renal impairment have not
been established.
PEDIATRIC PATIENTS (BELOW 18 YEARS)

Safety and efficacy of Isopto Carpine in pediatric patients have not
been established. Due to a
lack of pharmacokinetic data for the pediatric population, it is not
possible to make particular
evidence-based dose recommendations for children.
GERIATRIC PATIENTS (65 YEARS OF AGE OR ABOVE)

No overall differences in safety and efficacy have been observed
between elderly and younger
patients.
METH