Timolol 0.25% w/v Eye Drops, Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TIMOLOL

Available from:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC code:

S01ED01

INN (International Name):

TIMOLOL 2.5 mg/ml

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

TIMOLOL 2.5 mg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Withdrawn

Authorization date:

2010-09-28

Patient Information leaflet

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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, difficult

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Timolol 0.25 % w/v Eye Drops, Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSTION
One ml of eye drops contains 2.5 mg of timolol (as 3.4 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 6.33mg.
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 0.5% w/v eye drops, solution) is available.
If clinical response is
not adequate, dosage may be changed to one drop 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').
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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-day therapy.
_Transfer from other topical