Timoptol 0.25% eye drops

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Timolol maleate

Disponible depuis:

Sigma Pharmaceuticals Plc

Code ATC:

S01ED01

DCI (Dénomination commune internationale):

Timolol maleate

Dosage:

2.5mg/1ml

forme pharmaceutique:

Eye drops

Mode d'administration:

Ocular

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 11060000

Notice patient

1
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, 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 disease which may cause
wheeziness, difficulty in
breathing and/or long-standing cough)

you have heart problems

slow heart beat

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 are not sure whether you should

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Timoptol 0.25% 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 timolol.
Excipients with known effect:
Benzalkonium chloride 0.10 mg/ml
Disodium phosphate dodecahydrate 30.42 mg/ml
Sodium dihydrogen phosphate dihydrate 6.10 mg/ml.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to light yellow, sterile eye drops, 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
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, if the response is
not adequate.
When transferring a patient from