Timoptol 0.25% w/v Eye Drops Solution

Removal of information relating to Timoptol 0.5% (sections 1, 2, 8) as separate SPC created.

Marketing Authorisation Holder and Manufacturer

Santen Oy
Niittyhaankatu 20
33720 Tampere

Finland

Marketing Authorisation Holder

This leaflet was last revised in November 2019March 2020.

Section 4:

Under heading Nervous system: ADD hallucination

Under heading Reporting side effects: DELETE HPRA address and email address

Section 6

Date of revision chnaged from January 2019 to November 2019

Section 4.8

under heading Psychiatric disorders:ADD Hallucination

under heading how to report suspected adverse reactions: DELETE HPRA postal address & email address.

3. How to use Timoptol

Instructions for use updated for new bottle.

6. Contents of the pack and other information

Marketing Authorisation Holder and Manufacturer is now Santen Oy (Manufacturer - Laboratories MSD (Mirabel) deleted)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Timoptol 0.25% w/v eye drops, solution.

Each millilitre of 0.25% w/v solution contains an amount of timolol maleate equivalent to 2.5 mg/ml timolol

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.

Excipients with known effect:

0.10 mg/ml benzalkonium chloride

29.21 mg/ml disodium phosphate dodecahydrate
8.15 mg/ml sodium dihydrogen phosphate dihydrate.

 For athe full list of excipients, see section 6.1.

Timoptol 0.25% w/v eye drops, solution.

Each millilitre of 0.5% w/v solution contains an amount of timolol maleate equivalent to 5 mg/ml timolol.

Timolol Maleate equivalent to 0.5% w/v solution of timolol (5 mg/ml).

 Also includes 0.22mg/ml benzalkonium chloride 50% solution, equivalent to 0.11mg/ml.

Excipients with known effect:

0.10 mg/ml benzalkonium chloride

30.42 mg/ml disodium phosphate dodecahydrate
6.10 mg/ml sodium dihydrogen phosphate dihydrate.

For athe full list of excipients, see section 6.1.

4.2       Posology and method of administration

Information regarding dosing elderly relocated within section.

4.3       Contraindications

 Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1 or other beta-blocking agents.

4.4       Special warnings and precautions for use

....

Surgical anaesthesia

Betaβ-blocking ophthalmological preparations may block systemic betaβ-agonist effects e.g. of adrenaline. The anaesthesiologist should be informed when the patient is receiving timolol.

Timoptol has been generally well tolerated in glaucoma patients wearing conventional hard contact lenses. Timoptol has not been studied in patients wearing lenses made with material other than polymethylmethacrylate (PMMA), which is used to make hard contact lenses.

‘Timoptol’ Timoptol contains benzalkonium chloride as a preservative which may be deposited on soft contact lenses; therefore, ‘Timoptol’ Timoptol should not be used while wearing these lenses.   The lenses should be removed before application of the drops and not reinserted earlier than 15 minutes after use.

‘Timoptol’ has been generally well tolerated in glaucoma patients wearing conventional hard contact lenses.  ‘Timoptol’ has not been studied in patients wearing lenses made with material other than polymethylmethacrylate (PMMA), which is used to make hard contact lenses.

Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.

In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle.   This requires constricting the pupil with a miotic.   ‘Timoptol’ Timoptol has little or no effect on the pupil.   When ‘Timoptol’ Timoptol is used to reduce elevated intra-ocular pressure in angle-closure glaucoma it should be used with a miotic and not alone.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.

Patients should also be instructed that ocular solutions, if handled, improperly, can become contaminated by common bacteria known to cause ocular infections.  Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Patients should be advised that if they develop an intercurrent ocular condition (e.g. trauma, ocular surgery or infection), they should immediately seek their physician’s advice concerning the continued use of the present multidose container.

.................

5.1       Pharmacodynamic properties

 Pharmacotherapeutic group: Ophthalmologicals, antiglaucoma preparations and miotics, betablocking agents, ATC code: S01ED01.

Mechanism of action

Timolol maleate is a non -selective beta‑adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic activity. Timolol maleate combines reversibly with the beta‑adrenergic receptor, and this inhibits the usual biologic response that would occur with stimulation of that receptor.   This specific competitive antagonism blocks stimulation of the beta‑adrenergic stimulating (agonist) activity, whether these originate from an endogenous or exogenous source.   Reversal of this blockade can be accomplished by increasing the concentration of the agonist which will restore the usual biological response.

 Clinical efficacy and safety

Unlike miotics, ‘Timoptol’ Timoptol  reduces IOP with little or no effect on accommodation or pupil size.   In patients with cataracts, the inability to see around lenticular opacities when the pupil is constricted is avoided.   When changing patients from miotics to ‘Timoptol’ Timoptol a refraction might be necessary when the effects of the miotic have passed.

6.1       List of excipients

 Benzalkonium chloride

Disodium phosphate dodecahydrate

(may be replaced by equivalent amounts of the dihydrate or anhydrous)

Sodium dihydrogen phosphate dihydrate

(may be replaced by equivalent amounts of monohydrate)

Sodium hydroxide (for pH adjustment only)

Water for injection

6.6       Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

10.       DATE OF REVISION OF THE TEXT

18 January 2019 14 March 2019

Shelf life chnaged from 2 years to 3 years