Timoptol Unit Dose 0.25%w/v Eye Drops Solution

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Timolol Maleate

Fáanlegur frá:

Santen OY

ATC númer:

S01ED51

INN (Alþjóðlegt nafn):

Timolol Maleate

Skammtar:

0.25%w/v

Lyfjaform:

Eye drops, solution

Stjórnsýsluleið:

via the ocular route

Einingar í pakka:

0.20 ml Unit Dose in packs of 30

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Ábendingar:

It is a beta-adrenoreceptor blocking agent used topically in the reduction of elevated intraocular 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.

Leyfisstaða:

Authorised

Leyfisdagur:

2015-07-31

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Timoptol 0.25% w/v Eye Drops Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Timolol Maleate equivalent to 0.25 % w/v solution of timolol (2.5 mg/ml).
Also includes 0.22mg/ml benzalkonium chloride 50% solution, equivalent to 0.11mg/ml.
For a full list excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to light yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Timoptol 0.25% w/v 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.
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-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% ‘Timopto