Timoptol-XE

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Timolol maleate 6.84 mg/mL equivalent to 5 mg/mL timolol

Available from:

Mundipharma New Zealand Ltd

INN (International Name):

Timolol maleate 6.84 mg/mL (=5 mg/mL timolol)

Dosage:

0.5 %

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Timolol maleate 6.84 mg/mL equivalent to 5 mg/mL timolol Excipient: Benzododecinium bromide Gelrite Mannitol Trometamol Water for injection

Units in package:

Bottle, plastic, 2.5mL sample pack, 2.5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Fareva La Vallee

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, sample pack - 2.5 mL - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, Occumeter Plus-HDPE (Lupolen) - 2.5 mL - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1993-07-07

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
1
TIMOPTOL-XE
®
_timolol maleate_
2.5 mL ophthalmic solution
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 New Zealand,
Department of
Ophthalmology

Summary of Product characteristics

NEW ZEALAND DATA SHEET
TIMOPTOL-XE® TIM-XE002
18 Mar 2020
Page 1 of 14
TIMOPTOL-XE® OPHTHALMIC GEL FORMING SOLUTION
Timolol maleate
1 PRODUCT NAME
TIMOPTOL-XE® 0.25% Ophthalmic Gel Forming Solution
TIMOPTOL-XE® 0.5% Ophthalmic Gel Forming Solution
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).
Excipient(s) with known effect:
Benzododecinium bromide 0.012% is added as preservative.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye drops solution.
A colourless to nearly colourless, slightly opalescent, slightly
viscous, aqueous ophthalmic solution.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TIMOPTOL-XE is indicated for the reduction of elevated intraocular
pressure in patients with:

ocular hypertension

chronic open-angle glaucoma

aphakic glaucoma

secondary glaucoma (some cases)

narrow angles and a history of spontaneous or iatrogenically induced
narrow-angle closure in the
opposite eye in whom reduction of intraocular pressure is necessary
(see section 4.4)
4.2
DOSE 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 before each use. It is not
necessary to shake the container more than once.
If needed, concomitant therapy with other agent(s) for lowering
intraocular pressure may be given
with TIMOPTOL-XE. The use of two topical beta-adrenergic blocking
agents is not recommended (see
section 4.4). Other topically applied medications should be
administered no less than 10 minutes
before TIMOPTOL-XE.
NEW ZEALAND DATA SHEET
TIMOPTOL-XE® TIM-XE002
18 Mar 2020
Page 2 of 14
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