Timolol 0.5% w/v Eye Drops, Solution

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

TIMOLOL MALEATE

थमां उपलब्ध:

Brown & Burk UK LTD

ए.टी.सी कोड:

C07AA; C07AA06

INN (इंटरनेशनल नाम):

TIMOLOL MALEATE

डोज़:

0.5 percent weight/volume

फार्मास्यूटिकल फॉर्म:

Eye drops, solution

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

Beta blocking agents, non-selective; timolol

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2013-02-15

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
TIMOLOL 0.25% W/V EYE DROPS SOLUTION
TIMOLOL 0.5% W/V EYE DROPS SOLUTION
Timolol
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.
-
If you have any further 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 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 sh

उत्पाद विशेषताएं

Health Products Regulatory Authority
17 April 2020
CRN008L95
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Timolol 0.5% w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Timolol 0.5% w/v Eye Drops Solution contains timolol maleate
equivalent to 0.5% w/v solution of timolol with preservative.
Also contains Benzalkonium chloride.
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
Timolol Eye Drops Solution 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
PosologyRecommended 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 section 4.4 'Special warnings
and precautions for use').
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 agents: _
When another topical beta-blocking agent is being used, discontinue
its use after a full day of therapy and start treatment with
Timolol the next day with one drop of 0.25% Timolol 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 adequat