BETOPTIC betaxolol 5mg/mL (as hydrochloride) eye drops bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

betaxolol hydrochloride, Quantity: 5.6 mg/mL

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: benzalkonium chloride; sodium hydroxide; sodium chloride; hydrochloric acid; disodium edetate; purified water

Administration route:

Ophthalmic

Units in package:

5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 23 March 1999: BETOPTIC 0.5% have been shown to be effective in lowering intraocular pressure and are indicated in the treatment of ocular hypertension or chronic open angular glaucoma. BETOPTIC Eye Drops 0.5% may be used alone or in combination with other IOP-lowering medication.

Product summary:

Visual Identification: Colourless solution.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-15

Patient Information leaflet

BETOPTIC
® EYE DROPS
0.5%
_Betaxolol hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IN THIS LEAFLET
Read this leaflet carefully before you
start to use Betoptic.
This leaflet answers some common
questions about Betoptic. 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.novartis.com.au
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 benefits they expect it
will have for you.
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, to
lower the raised pressure within your
eye(s). Betoptic does this by reducing
the amount of fluid produced within
your eye(s).
ALTHOUGH BETOPTIC HELPS CONTROL
YOUR GLAUCOMA IT DOES NOT CURE IT.
SO YOU MUST KEEP USING IT UNTIL
YOUR DOCTOR TELLS YOU TO STOP.
For mor

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – BETOPTIC (BETAXOLOL
HYDROCHLORIDE) EYE DROPS, SOLUTION
1
NAME OF THE MEDICINE
betaxolol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BETOPTIC Eye Drops 0.5% contain 5 mg/mL of betaxolol as betaxolol
hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, solution.
BETOPTIC is a sterile isotonic colourless solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
BETOPTIC Eye Drops 0.5% 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% may be used alone or in combination with other IOP-lowering
medication.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The usual dose is one drop of BETOPTIC Eye Drops 0.5% in the affected
eye(s) twice daily. In some
patients, the intraocular pressure lowering response to BETOPTIC Eye
Drops 0.5% 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%. 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 miotics, adrenaline or systemically
administered carbonic anhydrase
inhibitors can be instituted.
When a patient is transferred from several concomitantly administered
anti-glaucoma agents,
individual adjustment is required. Adjustment should involve one agent
at a time made at intervals
of not less