Timolol 0.25% eye drops

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Timolol maleate

Dostupné z:

Kent Pharma (UK) Ltd

ATC kód:

S01ED01

INN (Medzinárodný Name):

Timolol maleate

Dávkovanie:

2.5mg/1ml

Forma lieku:

Eye drops

Spôsob podávania:

Ocular

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 11060000

Príbalový leták

READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION
FOR YOU.
-
Keep this leaflet. You may need
to read it again.
-
I f y o u h a v e a n y f u r t h e r
questions, ask your doctor or
pharmacist or nurse.
-
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, pharmacist or
nurse. This includes any
possible side effects not listed in
this leaflet. See section 4.
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
Timolol Eye Drops contain 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 TIMOLOL
DO NOT USE TIMOLOL EYE DROPS IF:
•
you are allergic (hypersensitive)
to timolol, beta-blockers or any
of the other ingredients of
timolol (see section 6 Contents
o f t h e p a c k a n d o t h e r
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
p r e s s u r e , w h i c h m a y
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 Eye Drops talk
to your doctor or pharmacist.
WARNINGS AND PRECAUTI

Súhrn charakteristických

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