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Minims Phenylephrine Hydrochloride 2.5%, Eye drops solution

  • Name:

    Minims Phenylephrine Hydrochloride 2.5%, Eye drops solution

  • Company:
    info
  • Active Ingredients:

    Phenylephrine Hydrochloride

  • Legal Category:

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

Summary of Product Characteristics last updated on medicines.ie: 20/6/2016
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Bausch Health Ireland Ltd.

Bausch & Lomb U

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Medicine Name Minims Cyclopentolate Hydrochloride 1.0% w/v, Eye drops solution Active Ingredients Cyclopentolate Hydrochloride
Medicine Name Minims Fluorescein sodium 1% & 2% w/v Active Ingredients Fluorescein Sodium
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% & 10% w/v, 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
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1 - 0 of 36 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 June 2016 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

$0Regulatory approval for amendments made to our product information (PSUSA/00002378/201501)$0

Updated on 20 June 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 20 June 2016 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

$0Regulatory approval for amendments made to our product information (PSUSA/00002378/201501)$0

Updated on 12 April 2016 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Regulatory Update Art 45 and QRD

Updated on 12 April 2016 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Regulatory Update Art 45 and QRD

Updated on 29 July 2015 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation

Free text change information supplied by the pharmaceutical company

change in marketing authorisation  holder and date of revision of text

Updated on 29 July 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

change in marketing authorisation  holder and date of revision of text

Updated on 25 July 2012 PIL

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

All SPCs on Medicines.ie have been updated for Bausch + Lomb following personnel changes to ensure accuracy of information.

Updated on 25 July 2012 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

All SPCs on Medicines.ie have been updated for Bausch + Lomb following personnel changes to ensure accuracy of information.

Updated on 24 July 2008 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

  Sections 1, 2, 3, 6.1 , 6.5 and 6.6: Change in the wording

Section 9 and 10 : update of renewal and revision dates

Updated on 24 July 2008 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • 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

  Sections 1, 2, 3, 6.1 , 6.5 and 6.6: Change in the wording

Section 9 and 10 : update of renewal and revision dates

Updated on 4 September 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
  • 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

 Section 1:     TRADE NAME OF THE MEDICINAL PRODUCT

Changed to  Minims Phenylephrine Hydrochloride 2.5% Eye Drops, Solution

Section 2.  QUALITATIVE AND QUANTITATIVE COMPOSITION

 Changed to Phenylephrine Hydrochloride 2.5% w/v. Each ml contains 25mg phenylephrine hydrochloride.

 For full list of excipients, see section 6.1

 Section 3.   PHARMACEUTICAL FORM

 Changed to Eye Drops, Solution. Clear, colourless, aqueous, sterile solution

Section 6.4.    Special Precautions for Storage
 
Do not store above 25°C.  Store in the original package.  Do not freeze.
 
Section 10  .        DATE OF (PARTIAL) REVISION OF THE TEXT

Changed to July 2006

 
 
 

Updated on 4 September 2006 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

 Section 1:     TRADE NAME OF THE MEDICINAL PRODUCT

Changed to  Minims Phenylephrine Hydrochloride 2.5% Eye Drops, Solution

Section 2.  QUALITATIVE AND QUANTITATIVE COMPOSITION

 Changed to Phenylephrine Hydrochloride 2.5% w/v. Each ml contains 25mg phenylephrine hydrochloride.

 For full list of excipients, see section 6.1

 Section 3.   PHARMACEUTICAL FORM

 Changed to Eye Drops, Solution. Clear, colourless, aqueous, sterile solution

Section 6.4.    Special Precautions for Storage
 
Do not store above 25°C.  Store in the original package.  Do not freeze.
 
Section 10  .        DATE OF (PARTIAL) REVISION OF THE TEXT

Changed to July 2006

 
 
 

Updated on 18 May 2005 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Updated on 18 May 2005 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

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

Updated on 16 July 2003 PIL

Reasons for updating

  • New SPC for medicines.ie

Updated on 16 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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