Timolol 0.25% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Timolol maleate

Available from:

FDC International Ltd

ATC code:

S01ED01

INN (International Name):

Timolol maleate

Dosage:

2.5mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11060000; GTIN: 5050135001033

Patient Information 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, please 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.
-
Your medicine, Timolol Eye Drops will be referred to as Timolol in
this leaflet.
What is in this leaflet
1. What Timolol is and what it is used for
2. What you need to know before you use Timolol
3. How to use Timolol
4. Possible side effects
5. How to store Timolol
6. Contents of the pack and other information
1. What Timolol is and what it is used for
The active ingredient timolol belongs to a group of medicines called
beta-blockers. Timolol is used to treat raised
pressure of eye (intraocular pressure) which occurs in various
conditions including glaucoma and ocular
hypertension.
2. What you need to know before you use Timolol
Do not use Timolol if:
l
you are allergic (hypersensitive) to timolol ,beta-blockers or any
other ingredient of this medicine (see
section 6: Content of the pack and other information).
l
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 breathing and/or long-standing
cough).
l
you have a slow heart beat, heart problems, heart failure or disorders
of heart rhythm (irregular heart
beats).“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 are not sure whether you should use Timolol talk to your doctor
or pharmacist.
Warnings and precauti

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT Timolol Eye Drops 0.25% w/v
2 QUALITATIVE AND QUANTITTAIVE COMPOSITION
Active Ingredient
Timolol
2.5 mg/ml
(as Timolol maleate
3.4 mg/ml)
Excipient(s) with known effect:
Benzalkonium chloride 0.10 mg/ml
Disodium phosphate dodecahydate 16.72 mg/ml
Sodium dihydrogen phosphate dihydrate 3.12 mg/ml
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Clear, colourless to pale yellow, odourless solution, free of visible
particulate matter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Timolol is a beta-adrenoceptor blocking agent used topically in the
reduction of
elevated intra-ocular pressure in various conditions including
following:
-
Patients with ocular hypertension;
-
Patients with chronic open-angle glaucoma including aphakic patients
-
Some patient 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, 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 also section 4.4).
Intraocular pressure should be reassessed approximately four weeks
after
starting treatment because response to Timolol eye drops 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 Timolol eye drops
0.25%
the next day with one drop 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, if
the response is not adequate.
When transferring a patient from a single anti-glaucoma agent other