Betoptic S

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Betaxolol hydrochloride 0.28%{relative} equivalent to to Betaxolol 2.5 mg/mL

Tilgængelig fra:

Novartis New Zealand Ltd

INN (International Name):

Betaxolol hydrochloride 0.28% w/v (Equiv. to Betaxolol 2.5 mg/mL)

Dosering:

0.25% w/v

Lægemiddelform:

Eye drops, suspension

Sammensætning:

Active: Betaxolol hydrochloride 0.28%{relative} equivalent to to Betaxolol 2.5 mg/mL Excipient: Amberlite Benzalkonium chloride as 50% soln + 5% overage. Equiv. to 0.1mg/mL Carbomer Disodium edetate dihydrate Hydrochloric acid Mannitol Purified water Sodium hydroxide

Enheder i pakken:

Bottle, dropper, 5mL, 5 mL

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Sanofi-Aventis Deutschland GmbH

Terapeutiske indikationer:

The treatment of ocular hypertension or chronic open angle glaucoma. May be used alone or in combination with other IOP-lowering medication.

Produkt oversigt:

Package - Contents - Shelf Life: Bottle, dropper, - 5 mL - 24 months from date of manufacture stored at or below 25°C. Store the bottle in the outer carton 4 weeks opened stored at or below 25°C. Store the bottle in the outer carton

Autorisation dato:

1991-04-11

Indlægsseddel

BETOPTIC
® EYE DROPS 0.5%
BETOPTIC
® S EYE DROPS 0.25%
Betaxolol hydrochloride
CONSUMER MEDICINE INFORMATION
_ _
WHAT IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY
BEFORE YOU START TO USE
BETOPTIC AND BETOPTIC S
EYE DROPS.
This leaflet answers some
common questions about
Betoptic and Betoptic S Eye
Drops. It does not contain
all the available
information. It does not
take the place of talking to
your doctor or pharmacist.
The information in this
leaflet was last updated on
the date listed on the final
page. More recent
information on the medicine
may be available.
YOU SHOULD ENSURE THAT
YOU SPEAK TO YOUR
PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE
MEDICINE.
YOU CAN ALSO DOWNLOAD THE
MOST UP TO DATE LEAFLET
FROM
www.medsafe.govt.nz.
The updates may contain
important information about
the medicine and its use of
which you should be aware.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you
using Betoptic against the
expected benefits it will
have for you.
The information in this
leaflet applies to Betoptic
and Betoptic S Eye Drops
only. This information does
not apply to similar
products, even if they
contain the same
ingredients.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it
again.
WHAT BETOPTIC IS
USED FOR
Betoptic contains the active
ingredient
betaxolol
hydrochloride.
Betaxolol
hydrochloride belongs to a
class of medicines known as
“beta-adrenergic
blocking
agents”.
Your doctor has prescribed
Betoptic for you because the
pressure within your eye(s),
known
as
“intraocular
pressure”
is
higher
than
normal. This raised pressure
may damage your eyesight
and
lead
to
a
condition
known as glaucoma.
There
are
usually
no
symptoms of glaucoma. If
glaucoma is not treated it can
lead
to
serious
problems,
including
total
blindness.
Untreated glaucoma is one
of the most common causes
of blindness.
Betoptic is used, either alone
or in combination with other
medicines,

Produktets egenskaber

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
BETOPTIC
®
(betaxolol hydrochloride) Eye Drops 0.5%
BETOPTIC
®
S (betaxolol hydrochloride) Eye Drops 0.25%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betoptic Eye Drops contains betaxolol 5 mg in 1 mL.
Betoptic S Eye Drops contains betaxolol 2.5 mg in 1 mL.
Excipient with known effect
Benzalkonium chloride 0.1 mg in 1 mL (preservative).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Betoptic: eye drops, solution.
Betoptic S: eye drops, suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Betoptic Eye Drops 0.5% and Betoptic S Eye Drops 0.25% have been shown
to be effective
in lowering intraocular pressure and are indicated in the treatment of
ocular hypertension or
chronic open angle glaucoma.
Betoptic Eye Drops 0.5% or Betoptic S Eye Drops 0.25% may be used
alone or in
combination with other IOP-lowering medication.
4.2
DOSE AND METHOD OF ADMINISTRATION
NOTE: SHAKE BETOPTIC S EYE DROPS 0.25% WELL BEFORE USE.
The usual dose is one drop of Betoptic Eye Drops 0.5% or Betoptic S
Eye Drops 0.25% in the
affected eye(s) twice daily. In some patients, the intraocular
pressure lowering response to
Betoptic Eye Drops 0.5% or Betoptic S Eye Drops 0.25% may require a
few weeks to
stabilise. Clinical follow up should include a determination of the
intraocular pressure during
the first month of treatment with Betoptic Eye Drops 0.5% or Betoptic
S Eye Drops 0.25%.
Thereafter, intraocular pressure should be determined on an individual
basis at the judgement
of the physician.
Because of diurnal variations of intraocular pressure in individual
patients, satisfactory
response to twice-a-day therapy is best determined by measuring
intraocular pressure at
different times during the day. Intraocular pressure
≤
22 mmHg may not be optimal for
control of glaucoma in each patient; therefore, therapy should be
individualised.
If the intraocular pressure of the patient is not adequately
controlled on this regimen,
concomitant therapy with pilocarpine, other mi