Timolol 0.5% w/v eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TIMOLOL MALEATE

Available from:

Wockhardt UK Limited

ATC code:

S01ED; S01ED01

INN (International Name):

TIMOLOL MALEATE

Dosage:

0.5 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents1); timolol

Authorization status:

Not marketed

Authorization date:

2010-12-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TIMOLOL 0.25% W/V EYE DROPS, SOLUTION
TIMOLOL 0.5% W/V EYE DROPS, SOLUTION
(TIMOLOL MALEATE)
(referred to as Timolol Eye Drops in the rest of this leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Timolol Eye Drops are and what they are used for
2.
What you need to know before you use Timolol Eye Drops
3.
How to use Timolol Eye Drops
4.
Possible side effects
5.
How to store Timolol Eye Drops
6.
Contents of the pack and other information
1.
WHAT TIMOLOL EYE DROPS ARE AND WHAT THEY ARE USED FOR
Timolol Eye Drops are available in two strengths: Timolol 0.25% w/v
Eye Drops, Solution
and Timolol 0.5% w/v Eye Drops, Solution.
Timolol Eye Drops is a member of a group of medicines known as
beta-blockers and it is
used to reduce the pressure inside your eyeball(s) if you have a
condition such as high blood
pressure that is affecting your eyes, or glaucoma (high pressure in
your eyeball), including
glaucoma that developed after you had surgery to remove a cataract
from your eye(s).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TIMOLOL EYE DROPS
DO NOT USE TIMOLOL EYE DROPS

if you are allergic to timolol, beta-blockers such as propranolol
(used mainly for high
blood pressure) or betaxolol (also used for glaucoma) or any of the
other ingredients of
this medicine (listed in section 6)

if you have now or have had in past respiratory problems such as
asthma, severe chronic
obstructive bronchitis, (severe lung disease which may cause
wheeziness, difficulty in
breathin

Summary of Product characteristics

Health Products Regulatory Authority
01 May 2020
CRN009NNK
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Timolol 0.5% w/v eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of eye drops contains 5 mg of timolol (as 6.8 mg of timolol
maleate).
Excipient(s) with known effect:
Benzalkonium chloride 0.1mg/ml eye drops, solution.
1ml of eye drops contains 16.72 mg of disodium hydrogen phosphate
dodecahydrate, equivalent to 4.43 mg of phosphates.
1ml of eye drops contains 3.12 mg of sodium dihydrogen phosphate
dehydrate, equivalent to 1.9 mg of phosphates.
The total content of phosphates in each 1ml of eye drops is 6.33 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to light yellow, eye drops solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Timolol is a beta-adrenoreceptor blocking agent used topically in the
reduction of elevated intra-ocular pressure in various
conditions including the following: patients with ocular hypertension;
patients with chronic open-angle glaucoma including
aphakic patients; some patients with secondary glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended therapy is one drop of timolol 0.25% w/v eye drops,
solution in the affected eye(s) twice a day.
Another strength (timolol 0.25% w/v eye drops, solution) is available.
If clinical response is not adequate, dosage may be
changed to one drop of timolol 0.5% w/v eye drops, solution in each
affected eye twice a day. If needed, timolol may be used
with other agent(s) for lowering intra-ocular pressure. The use of two
topical beta-adrenergic blocking agents is not
recommended (see 4.4 'Special warnings and precautions for use').
Intra-ocular pressure should be reassessed approximately four weeks
after starting treatment because response to timolol may
take a few weeks to stabilise.
Provided that the intra-ocular pressure is maintained at satisfactory
levels, many patients can then be placed on once-a