Arrow - Timolol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Timolol maleate 6.8 mg/mL equivalent to timolol 5 mg/mL

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Timolol maleate 6.8 mg/mL (equivalent to timolol 5 mg/mL)

Dosage:

0.5% w/v

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Timolol maleate 6.8 mg/mL equivalent to timolol 5 mg/mL Excipient: Benzalkonium chloride Dibasic sodium phosphate dodecahydrate Disodium edetate dihydrate Monobasic sodium phosphate dihydrate Sodium chloride Sodium hydroxide Water for injection

Units in package:

Vial, LDPE droper vial with polystyrene cap, 5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

FDC Limited

Product summary:

Package - Contents - Shelf Life: Vial, LDPE droper vial with polystyrene cap - 5 mL - 24 months unopened stored at or below 25°C 28 days opened stored at or below 25°C

Authorization date:

2004-07-27

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
ARROW – TIMOLOL
TIMOLOL MALEATE EYE DROPS BP 0.25% & 0.5% W/V
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ARROW - TIMOLOL.
It does not contain all of the available information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have benefits and risks. Your doctor or pharmacist has
weighed the risks of
you using ARROW - TIMOLOL against the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again.
WHAT ARROW - TIMOLOL IS USED FOR
ARROW - TIMOLOL 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 ARROW
- TIMOLOL
helps control your glaucoma it does not cure it.
ARROW - TIMOLOL is used, either alone or in combin

Summary of Product characteristics

Version 1.0
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NEW ZEALAND DATA SHEET
1 NAME OF THE MEDICINE
Arrow – Timolol,
0.25% w/v, Eye drops, solution
Arrow – Timolol, 0.5% w/v, Eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 2.5 mg of timolol (3.4 mg of timolol maleate) or 5 mg
of timolol (6.8 mg of timolol
maleate).
Excipient with known effect:
benzalkonium chloride 0.01% w/v as a preservative
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Eye drop solution.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Timolol 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
•
chronic open-angle glaucoma
•
Aphakic glaucoma
•
some forms of secondary glaucoma
•
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
Special warnings and precautions for use)
Timolol is also indicated as concomitant therapy in patients with
paediatric glaucoma, who are
inadequately controlled, with other antiglaucoma therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULT
The usual starting dose is one drop of 0.25% Arrow-Timolol in the
affected eye(s) twice a day. If the
clinical response is not adequate, the dosage may be changed to one
drop of 0.5% solution in the
affected eye(s) twice a day.
If needed, concomitant therapy with other agent(s) for lowering
intraocular pressure may be given
with Arrow-Timolol. 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 Arrow-Timolol
may require a few weeks to
stabilise, evaluation should include a determination of intraocular
pressure after approximately four
weeks of treatment with Arrow-Timolol.
If the intraocular pressure is maintai