Timoptol 0.5% Eye Drops Bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

timolol maleate, Quantity: 6.83 mg/mL (Equivalent: timolol, Qty 5 mg/mL)

Tilgjengelig fra:

Mundipharma Pty Ltd

Legemiddelform:

Eye Drops, solution

Sammensetning:

Excipient Ingredients: monobasic sodium phosphate; dibasic sodium phosphate dodecahydrate; sodium hydroxide; benzalkonium chloride; water for injections

Administreringsrute:

Ophthalmic

Enheter i pakken:

5 mL

Klasse:

Medicine Registered

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

TIMOPTOL Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure. In clinical trials it has been shown to reduce intraocular pressure in: Patients with ocular hypertension - Patients with chronic open-angle glaucoma - Aphakic patients with glaucoma.

Produkt oppsummering:

Visual Identification: Clear colourless solution; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Restricted flow insert

Autorisasjon status:

Registered

Autorisasjon dato:

1991-10-30

Informasjon til brukeren

TIMOPTOL
®
EYE DROPS
1
TIMOPTOL
®
Timolol maleate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about TIMOPTOL. It does
not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using TIMOPTOL
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 the medicine.
You may need to read it again.
What TIMOPTOL is
used for
TIMOPTOL is used to lower raised
pressure in the eye and to treat
glaucoma. Glaucoma is a condition
in which the pressure of fluid in the
eye may be high. However, some
people with glaucoma may have
normal eye pressure. Also, some
people with raised eye pressure may
not have glaucoma.
Glaucoma is usually caused by a
build-up of the fluid which flows
through the eye. This build up occurs
because the fluid drains out of your
eye more slowly than it is being
pumped in. Since new fluid continues
to enter the eye, joining the fluid
already there, the pressure continues
to rise. This raised pressure may
damage the back of the eye resulting
in gradual loss of sight. Damage can
progress so slowly that the person is
not aware of this gradual loss of
sight. Sometimes even normal eye
pressure is associated with damage to
the back of the eye.
There are usually no symptoms of
glaucoma. The only way of knowing
that you have glaucoma is to have
your eye pressure, optic nerve and
visual field checked by an eye
specialist or optometrist. If glaucoma
is not treated it can lead to serious
problems. You may have no
symptoms but eventually glaucoma
can lead to total blindness. In fact,
untreated glaucoma is one of the
most common causes of blindness.
Although TIMOPTOL helps control
your glaucoma it does not cure it.
For more information about
glaucoma, contact Glaucoma
Australia Inc., PO Box 420, Crows
Nest 1585, telephone [phone]

Preparatomtale

TIMOPTOL® EYE DROPS
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION – TIMOPTOL
®
[TIMOLOL (AS
MALEATE)] EYE DROPS
1
NAME OF THE MEDICINE
Timolol maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of TIMOPTOL 0.25% contains 2.5 mg of timolol (3.4 mg of
timolol maleate). Each mL of
TIMOPTOL 0.5% contains 5.0 mg of timolol (6.8 mg of timolol maleate).
List of excipient(s) with known effect: benzalkonium chloride.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless sterile solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TIMOPTOL is indicated for the reduction of elevated intraocular
pressure.
In clinical trials it has been shown to reduce intraocular pressure
in:
Patients with ocular hypertension
Patients with chronic open-angle glaucoma
Aphakic patients with glaucoma
4.2
D
OSE AND METHOD OF ADMINISTRATION
Recommended therapy is one drop of 0.25% solution in the affected eye
twice a day.
If clinical response is not adequate, dosage may be changed to one
drop of 0.5% solution in each
affected eye twice a day. If needed, concomitant therapy with miotics,
adrenaline (epinephrine)
and systemically administered carbonic anhydrase inhibitors may be
instituted. The use of two
topical beta-adrenergic blocking agents is not recommended (see
Section 4.4 Special Warnings
and Precautions for Use).
Since in some patients the pressure-lowering response to TIMOPTOL may
require a few weeks
to stabilise, evaluation should include a determination of intraocular
pressure after
approximately 4 weeks of treatment with TIMOPTOL.
If the intraocular pressure is maintained at satisfactory levels, many
patients can be placed on
once-a-day therapy. Because of naturally occurring diurnal variations
in intraocular pressure,
TIMOPTOL® EYE DROPS
Page 2 of 12
satisfactory response is best determined by measuring the intraocular
pressure at different
times during the day.
Systemic absorption of drugs from ophthalmic solutions may be
minimised by pres