TIMOPTOL-XE timolol 5mg/mL (as maleate) eye drops

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

timolol maleate, Quantity: 6.84 mg/mL (Equivalent: timolol, Qty 5 mg)

Tilgjengelig fra:

Mundipharma Pty Ltd

Legemiddelform:

Eye Drops, solution

Sammensetning:

Excipient Ingredients: mannitol; gellan gum; benzododecinium bromide; water for injections; trometamol

Administreringsrute:

Ophthalmic

Enheter i pakken:

2.5mL

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

OTHER STORAGE CONDITIONS: Do not freeze. INDICATIONS: For the reduction of elevated intraocular pressure in patients with: ocular hypertension; chronic open-angle glaucoma; aphakia and glaucoma.

Produkt oppsummering:

Visual Identification: A bottle with a white cap, containing slightly opalescent,nearly colourless,slightly viscous sol.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Restricted flow insert

Autorisasjon status:

Licence status A

Autorisasjon dato:

1995-01-17

Informasjon til brukeren

TIMOPTOL-XE
®
EYE DROPS
1
TIMOPTOL-XE
®
Timolol maleate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about TIMOPTOL-XE. 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-
XE 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-XE is
used for
TIMOPTOL-XE 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-XE helps
control your glaucoma it does not
cure it.
For more information about
glaucoma, contact Glaucoma
Australia Inc., PO Box 420, Crows
Nest 1585,

Preparatomtale

TIMOPTOL-XE® EYE DROPS
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION – TIMOPTOL
-
XE
®
[TIMOLOL
(AS MALEATE)] EYE DROPS
1
NAME OF THE MEDICINE
Timolol maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of TIMOPTOL-XE 0.25% contains 2.5 mg of timolol (3.4 mg of
timolol maleate). Each
mL of TIMOPTOL-XE 0.5% contains 5.0 mg of timolol (6.8 mg of timolol
maleate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
TIMOPTOL-XE is a sterile, colourless to nearly colourless, slightly
opalescent, slightly viscous,
aqueous ophthalmic (eye drop) solution containing gellan gum.
Gellan gum is a highly purified anionic heteropolysaccharide. Aqueous
solutions of gellan gum
form a clear transparent gel at low polymer concentrations in the
presence of cations. When
TIMOPTOL-XE contacts the precorneal tear film, it becomes a gel. The
concentration of sodium
cation in tears is ideally suited to cause gelation of the material
when topically instilled in the
conjunctival sac.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TIMOPTOL-XE is indicated for the reduction of elevated intraocular
pressure in patients with:

ocular hypertension

chronic open-angle glaucoma

aphakia and glaucoma
4.2
D
OSE AND METHOD OF ADMINISTRATION
The usual starting dose is one drop of 0.25% TIMOPTOL-XE in the
affected eye(s) once a day. If
the clinical response is not adequate, the dosage may be changed to
one drop of 0.5%
TIMOPTOL-XE in the affected eye(s) once a day. Invert the closed
container and shake once
energetically before instillation. Depress the finger-press area on
the side of the bottle to
dispense one drop.
Dosages higher than one drop of 0.5% TIMOPTOL-XE once a day have not
been studied.
If needed, concomitant therapy with other agent(s) for lowering
intraocular pressure may be
given with TIMOPTOL-XE. Other topically applied medications should be
administered no less
TIMOPTOL-XE® EYE DROPS
Page 2 of 13
than 10 minutes before TIMOPTOL-XE. The use of two topical
beta-adrenergic