Timoptol Unit Dose 0.25% ophthalmic solution 0.2ml unit dose

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Timolol maleate

Commercializzato da:

Santen UK Ltd

Codice ATC:

S01ED01

INN (Nome Internazionale):

Timolol maleate

Dosaggio:

2.5mg/1ml

Forma farmaceutica:

Eye drops

Via di somministrazione:

Ocular

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 11060000; GTIN: 5013945164008

Foglio illustrativo

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Technical Info
Item No.:
Revision Date & No.:
Pharma Code:
MBS Job No.:
517224Z
310315-1
491
362968
ITEM# and REVISION#
in OCRB font
Horizontal Scale 71%
Size 5 points
PACKAGE LEAFLET: INFORMATION FOR THE USER
TIMOPTOL® UNIT DOSE 0.25% W/V
EYE DROPS SOLUTION
TIMOPTOL® UNIT DOSE 0.5% W/V
EYE DROPS SOLUTION
TIMOLOL (AS MALEATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE.
-
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. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
What Timoptol Unit Dose is and what it is used for
2.
Before you use Timoptol Unit Dose
3.
How to use Timoptol Unit Dose
4.
Possible side effects
5.
How to store Timoptol Unit Dose
6.
Further information
1.
WHAT TIMOPTOL UNIT DOSE IS AND WHAT IT IS USED
FOR
Timoptol Unit Dose 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.
BEFORE YOU USE TIMOPTOL UNIT DOSE
DO NOT USE TIMOPTOL UNIT DOSE IF:
•
you are allergic (hypersensitive) to timolol, beta-blockers
or any of the other ingredients of Timoptol Unit Dose
(see section 6 for Further 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 followin

Scheda tecnica

OBJECT 1
TIMOPTOL UNIT DOSE 0.25% AND 0.5% W/V EYE
DROPS SOLUTION
Summary of Product Characteristics Updated 21-Dec-2015 | Santen UK
Limited
1. Name of the medicinal product
Timoptol® Unit Dose 0.25% w/v Eye Drops Solution
Timoptol® Unit Dose 0.5% w/v Eye Drops Solution
2. Qualitative and quantitative composition
'Timoptol' Unit Dose 0.25% contains timolol maleate Ph Eur equivalent
to 0.25% w/v solution of timolol
without preservative.
'Timoptol' Unit Dose 0.5% contains timolol maleate Ph Eur equivalent
to 0.5% w/v solution of timolol
without preservative.
3. Pharmaceutical form
Eye drops solution.
Clear, colourless to light yellow, sterile eye drops.
4. Clinical particulars
4.1 Therapeutic indications
'Timoptol' 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
Recommended therapy is one drop 0.25% solution in the affected eye
twice a day.
When using nasolacrimal occlusion or closing the eyelids for 2
minutes, the systemic absorption is
reduced. This may result in a decrease in systemic side effects and an
increase in local activity.
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 4.4 'Special warnings
and precautions for use').
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-b