Timoptol 0.25% and 0.5% w/v Eye Drops Solution

  • Name:

    Timoptol 0.25% and 0.5% w/v Eye Drops Solution

  • Company:
    info
  • Active Ingredients:

    Timolol Maleate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/10/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 21/3/2019

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Santen UK Limited

Santen UK Limited

Company Products

Medicine NameActive Ingredients
Medicine Name COSOPT 20 mg/ml + 5 mg/ml, eye drops, solution Active Ingredients Dorzolamide Hydrochloride, Timolol Maleate
Medicine Name COSOPT Preservative-Free 20 mg/ml + 5 mg/ml, eye drops, solution in single-dose container Active Ingredients Dorzolamide Hydrochloride, Timolol Maleate
Medicine Name IKERVIS 1 mg/mL eye drops, emulsion Active Ingredients Ciclosporin
Medicine Name Saflutan 15 micrograms/ml eye drops, solution Active Ingredients Tafluprost
Medicine Name SAFLUTAN 15 micrograms/ml eye drops, solution in single-dose container Active Ingredients Tafluprost
Medicine Name Taptiqom 15 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container Active Ingredients Tafluprost, Timolol Maleate
Medicine Name Timoptol 0.25% and 0.5% w/v Eye Drops Solution Active Ingredients Timolol Maleate
Medicine Name TRUSOPT 20 mg/ml eye drops, solution Active Ingredients Dorzolamide Hydrochloride
Medicine Name TRUSOPT Preservative-Free 20 mg/ml eye drops, solution Active Ingredients Dorzolamide Hydrochloride
1 - 0 of 9 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 24 October 2019 PIL

Reasons for updating

  • XPIL Updated

Updated on 24 October 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

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)

 

Updated on 2 April 2019

Updated on 27 March 2019

Updated on 21 March 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 21 March 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

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

Updated on 25 January 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 25 January 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 14 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 11 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 11 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 1 May 2018 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Shelf life chnaged from 2 years to 3 years

Updated on 4 January 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 January 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)