Timoptol 0.5% w/v eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Timolol base

Available from:

Santen OY

ATC code:

S01ED; S01ED01

INN (International Name):

Timolol base

Dosage:

0.5 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Administration route:

via the ocular route

Units in package:

single bottles containing 5 ml of solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents1); timolol

Therapeutic indications:

It 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.

Authorization status:

Marketed

Authorization date:

1978-08-24

Patient Information leaflet

Page 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TIMOPTOL 0.25% W/V EYE DROPS, SOLUTION
TIMOPTOL
0.5% W/V EYE DROPS, SOLUTION
TIMOLOL (AS MALEATE)
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. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Timoptol is and what it is used for
2.
What you need to know before you use Timoptol
3.
How to use Timoptol
4.
Possible side effects
5.
How to store Timoptol
6.
Contents of the pack and other information
1.
WHAT TIMOPTOL IS AND WHAT IT IS USED FOR
Timoptol contains a substance called timolol which belongs to a group
of medicines called
beta-blockers. Timolol lowers the pressure in your eye(s). It is used
to treat glaucoma, when the
pressure in the eye is raised.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TIMOPTOL
DO NOT USE
TIMOPTOL IF:

you are allergic (hypersensitive) to timolol maleate, beta-blockers or
any of the other ingredients
of Timoptol (see section 6: Contents of the pack and other
information)

you have now or have had in the past respiratory problems, such as
asthma, severe chronic
obstructive bronchitis (severe lung condition which may cause
wheeziness, difficulty in breathing
and/or long-standing cough)

you have heart problems

slow heart beat, heart failure or disorders of heart rhythm (irregular
heart beats)

heart failure
-
“cardiogenic shock” – a serious heart condition caused by very
low blood pressure, which
may result in the following symptoms: dizziness and lightheadedness,
fast pulse rate,
white skin, sweating, restlessness, loss of consciousness.
If you ar

Summary of Product characteristics

Health Products Regulatory Authority
18 December 2019
CRN009GZT
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Timoptol 0.5% w/v eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of 0.5% w/v solution contains an amount of timolol
maleate equivalent to 5 mg/ml timolol.
Excipients with known effect:
0.10 mg/ml benzalkonium chloride
30.42 mg/ml disodium phosphate dodecahydrate
6.10 mg/ml sodium dihydrogen phosphate dihydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to light yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Timoptol 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 0.25% solution in the affected eye
twice a day.
If clinical response is not adequate, dosage may be changed to one
drop 0.5% solution in each affected eye twice a day. If
needed, Timoptol 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 also section 4.4).
Intra-ocular pressure should be reassessed approximately four weeks
after starting treatment because response to Timoptol
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-day
therapy.
Transfer from other agents
When another topical beta-blocking agent is being used, discontinue
its use after a full day of therapy and start treatment with
Timoptol the next day with one drop of 0.25% Timoptol in each affected
eye twice a day. The dosage may be increased to one
drop of 0.5% solution in each affected eye twice a day i