Lotemax 0.5% Eye Drops, Suspension

  • Name:

    Lotemax 0.5% Eye Drops, Suspension

  • Company:
    info
  • Active Ingredients:

    Loteprednol Etabonate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/03/20

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Summary of Product Characteristics last updated on medicines.ie: 9/10/2017
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Bausch Health Ireland Ltd.

Bausch & Lomb U

Company Products

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Medicine Name Artelac, Eye drops solution Active Ingredients Hypromellose
Medicine Name Artelac, SDU, Eye drops solution Active Ingredients Hypromellose
Medicine Name Emerade, 150 micrograms, solution for injection in pre-filled pen Active Ingredients Adrenaline tartrate
Medicine Name Emerade, 300 micrograms, solution for injection in pre-filled pen Active Ingredients Adrenaline tartrate
Medicine Name Emerade, 500 micrograms, solution for injection in pre-filled pen Active Ingredients Adrenaline tartrate
Medicine Name GelTears, Eye Gel Active Ingredients Carbomer
Medicine Name Liposic 2mg/g Eye Gel Active Ingredients Carbomer
Medicine Name Lotemax 0.5% Eye Drops, Suspension Active Ingredients Loteprednol Etabonate
Medicine Name Minims Artificial Tears, Eye drops solution Active Ingredients Hyetellose, Sodium Chloride
Medicine Name Minims Atropine Sulphate 1%w/v, Eye drops solution Active Ingredients Atropine sulfate
Medicine Name Minims Chloramphenicol 0.5% w/v, Eye drops solution Active Ingredients Chloramphenicol
Medicine Name Minims Cyclopentolate Hydrochloride 1.0% w/v, Eye drops solution Active Ingredients Cyclopentolate Hydrochloride
Medicine Name Minims Fluorescein Sodium 1%, Eye drops solution Active Ingredients Fluorescein Sodium
Medicine Name Minims Fluorescein Sodium 2%, Eye drops solution Active Ingredients Fluorescein Sodium
Medicine Name Minims Lidocaine & Fluorescein. Active Ingredients Fluorescein Sodium, Lidocaine Hydrochloride
Medicine Name Minims Oxybuprocaine Hydrochloride 0.4% w/v eye drop solution Active Ingredients Oxybuprocaine Hydrochloride
Medicine Name Minims Phenylephrine Hydrochloride 10%, Eye drops solution Active Ingredients Phenylephrine Hydrochloride
Medicine Name Minims Phenylephrine Hydrochloride 2.5%, Eye drops solution Active Ingredients Phenylephrine Hydrochloride
Medicine Name Minims Pilocarpine Nitrate 2% w/v, Eye drops solution Active Ingredients Pilocarpine nitrate
Medicine Name Minims Povidone Iodine 5% w/v eye drops, solution Active Ingredients Povidone Iodine
Medicine Name Minims Prednisolone Sodium Phosphate 0.5% Active Ingredients Prednisolone Sodium Phosphate
Medicine Name Minims Proxymetacaine 0.5% w/v, Eye Drops Solution Active Ingredients Proxymetacaine hydrochloride
Medicine Name Minims Saline Active Ingredients Sodium Chloride
Medicine Name Minims Tetracaine Hydrochloride 0.5% w/v, Eye drops solution Active Ingredients Tetracaine hydrochloride
Medicine Name Minims Tetracaine Hydrochloride 1.0% w/v, Eye drops solution Active Ingredients Tetracaine hydrochloride
1 - 0 of 31 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 20 March 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 9 October 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

IB/C.I.3 z) PSUSA outcome: Another variation for corticosteroids PSUSA/00000449/201604

Updated on 9 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 9 October 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 3 August 2017 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to section 6.3

Updated on 30 March 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

To update section 4.5 (interactions) of the SmPC in line with the PRAC recommendations on signals, adopted at the 24-27 October 2016 PRAC meeting (EMA/PRAC/700146/2016) concerning

interaction of cobicistat - containing products with corticosteroids leading to adrenal suppression for all corticosteroids other than beclomethasone (excluding cutaneous formulations). Consequently, the PIL is updated.

Updated on 15 March 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

QRD update

Updated on 11 April 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In Section 4.4 the following warning removed:

"The use of steroids after cataract surgery may delay healing and inc ease the incidence of bleb formation".

Updated on 31 August 2012 PIL

Reasons for updating

  • New PIL for medicines.ie
  • PIL - Product no longer marketed in Ireland

Updated on 31 July 2012 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided