BETOPTIC S-STERILE OPHTHALMIC SUSPENSION 5ML

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BETAXOLOL HYDROCHLORIDE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

BETAXOLOL HYDROCHLORIDE

Unit dalam pakej:

5ml mL

Dikeluarkan oleh:

S.A. ALCON-COUVREUR N.V.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
BETOPTIC S EYE SUSPENSION
_ _
Betaxolol Hydrochloride (2.5mg/ml)
____________________________________________________________________________________
____________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What BETOPTIC S is used
for
2.
How BETOPTIC S works
3.
Before
you
use
BETOPTIC S
4.
How to use BETOPTIC S
5.
While
you
are
using
BETOPTIC S
6.
Side effects of BETOPTIC
S
7.
Storage
and
Disposal
of
BETOPTIC S
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT BETOPTIC S IS USED FOR
BETOPTIC S is used in people with
increased
eye
pressure
such
as
chronic open-angle glaucoma and
ocular hypertension.
HOW BETOPTIC S WORKS
BETOPTIC S works by lowering
pressure in the eye.
BEFORE YOU USE
_- When you must not use it _
Do not use
BETOPTIC S
•
If you are allergic to betaxolol
or any of the other ingredients
of this medicine.
•
If you have a slow heart beat,
heart failure or irregular heart
beats.
_Pregnancy and lactation _
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.
Do not use BETOPTIC S if you are
pregnant
unless
your
doctor
considers it necessary. If you are
breastfeeding,
BETOPTIC
S
may
get into your milk.
_ _
_- Before you start to use it _
_ _
Talk to your doctor or pharmacist or
nurse before using BETOPTIC S:
•
Before you use this medicine,
tell your doctor if you have now
or have had in the past:
o
coronary
heart
disease
(symptoms
can
include
chest
pain
or
tightness,
breathlessness or choking),
low blood pressure
o
breathing
problems,
asthma
o
poor
blood
circulation
disease
o
diabetes as betaxolol may
mask signs and symptoms
of low blood sugar
o
overactivity of the thyroid
gland
as
betaxolol
may
mask signs and symptoms
o
muscle weakness
o
liver or kidney problems
•
Tell
your
doctor
before
you
have an operation that you are
us

Ciri produk

InDesign CS6
140 x 504 / 140 x 22 mm
AANTAL KLEUREN : 1
WS
20-04-2016
MAL
RECTO-verso
Betoptic S 0,25% 5 ml
GLOBAL
45477-3
BELGIUM
V5
PMS ZWART
À 100%
45477-3
BETOPTIC
*
0.25%
Eye Drops, Suspension
1.
NAME OF THE MEDICINAL PRODUCT
BETOPTIC* S 0.25%, Eye Drops, Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of BETOPTIC S Suspension contains 2.5 mg betaxolol base
(equivalent to 2.8 mg betaxolol
hydrochloride)
Preservative: 1 ml suspension contains 0.1 mg benzalkonium chloride
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
BETOPTIC S 0.25% Eye Drops, Suspension is formulated as a sterile,
multiple-dose suspension for
topical ophthalmic use. It is a white to off-white suspension.
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
BETOPTIC S Suspension has been shown to be effective in lowering
intraocular pressure and may be
used in patients with chronic open-angle glaucoma and ocular
hypertension. It may be used alone or in
combination with other intraocular pressure lowering medications.
4.2 Posology and method of administration
Posology
Use in adults (including elderly)
The recommended dose is one or two drops of BETOPTIC S Suspension in
the affected eye(s) twice
daily. In some patients, the intraocular pressure lowering responses
to BETOPTIC S Suspension may
require a few weeks to stabilize. As with any new medication, careful
monitoring of patients is advised.
If the intraocular pressure of the patient is not adequately
controlled on this regimen, concomitant
therapy with other anti-glaucoma agents can be instituted.
Use in hepatic and renal impairment
The safety and efficacy of BETOPTIC S Suspension in patients with
hepatic and renal impairment have
not been established.
Method of administration
For ocular use.
Shake well before use.
To prevent contamination of the dropper tip and suspension, care must
be taken not to touch the
eyelids, surrounding areas or other surfaces with the dropper tip.
Keep the bottle tightly closed when
not in use.
If more than one topical ophth