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Artelac, SDU, Eye drops solution

  • Name:

    Artelac, SDU, Eye drops solution

  • Company:
    info
  • Active Ingredients:

    Hypromellose

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/05/20

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Summary of Product Characteristics last updated on medicines.ie: 4/5/2020

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Bausch Health Ireland Ltd.

Bausch & Lomb U

Company Products

Medicine NameActive Ingredients
Medicine Name Artelac, Eye drops solution Active Ingredients Hypromellose
Medicine Name Artelac, SDU, Eye drops solution Active Ingredients Hypromellose
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 Megace 160mg Tablets Active Ingredients megestrol acetate
Medicine Name Megace 40mg/ml oral suspension Active Ingredients megestrol acetate
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 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
Medicine Name Minims Tropicamide 0.5 %. Active Ingredients Tropicamide
Medicine Name Minims Tropicamide 1.0%. Active Ingredients Tropicamide
1 - 0 of 30 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 4 May 2020 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 4 May 2020 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 22 June 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to packaging
  • Change of manufacturer
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to how the medicine works
  • Change to further information section

Updated on 22 June 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 October 2015 SPC

Reasons for updating

  • 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 10 - Date of revision of the text
  • 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 4.4 - Special warnings and precautions for use

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The implementation of the recommended text by the CHMP regarding risk or corneal calcification (SmPC section 4.8 –very rare Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas and  in PIL section 4 In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.) for  phosphate containing eye drops. Additional QRD update done.

Updated on 15 October 2015 SPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Updated on 31 August 2012 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 30 July 2012 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided