Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Santen Oy, Niittyhaankatu 20, 33720, Tampere, Finland
Timoptol 0.25% w/v eye drops, solution.
Timoptol 0.5% w/v eye drops, solution.
| Pharmaceutical Form |
|---|
|
Eye drops, solution. Clear, colourless to light yellow, sterile eye drops, solution. |
Each millilitre of 0.25% w/v solution contains an amount of timolol maleate equivalent to 2.5 mg timolol.
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 29.21 mg/ml (Timoptol 0.25%) or 30.42 mg/ml (Timoptol 0.5%).
Sodium dihydrogen phosphate dihydrate 8.15 mg/ml (Timoptol 0.25%) or 6.10 mg/ml (Timoptol 0.5%).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Timolol |
Timolol is a non-selective beta-adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic activity. Timolol reduces intra-ocular pressure, whether or not this is associated with glaucoma. |
| List of Excipients |
|---|
|
Disodium phosphate dodecahydrate |
‘Timoptol’ Eye Drops Solution bottle contains 5 ml of solution. Two alternative bottles may be marketed.
White translucent low-density polyethylene (LDPE) bottle with a transparent linear LDPE dropper tip and a white polypropylene (PP) cap
or
OCUMETER Plus ophthalmic dispenser consists of a translucent high-density polyethylene bottle with a sealed dropper tip, a flexible fluted side area, which is depressed to dispense the drops, and a two-piece cap assembly. The two-piece cap mechanism punctures the sealed dropper tip upon initial use, then locks together to provide a single cap during the usage period.
Tamper evidence is provided by a safety strip on the bottle label.
Santen Oy, Niittyhaankatu 20, 33720, Tampere, Finland
0.25% w/v eye drops, solution: PL 16058/0020
0.5% w/v eye drops, solution: PL 16058/0019
Date of first authorisation: 5 January 1979
Date of the latest renewal: 5 March 2010
| Drug | Countries | |
|---|---|---|
| TIMOPTOL | Australia, Brazil, Ecuador, France, Hong Kong, Ireland, Italy, Japan, Mexico, New Zealand, Singapore, United Kingdom |
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