Minims Phenylephrine Hydrochloride 10%, Eye drops solution

  • Name:

    Minims Phenylephrine Hydrochloride 10%, 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 Phenylephrine Hydrochloride 10%, Eye drops solution Active Ingredients Phenylephrine Hydrochloride
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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

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

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

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

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 update

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 update

Updated on 29 July 2015 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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 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

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 13 August 2010 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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

1.         NAME OF THE MEDICINAL PRODUCT

 

            Minims Phenylephrine Hydrochloride 10% w/v Eye Drops, solution

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

            Phenylephrine Hydrochloride 10% w/v.

 

            For a full list of excipients, see 6.1

4.2       Posology and Method of Administration

 

                        Adults

 

                        Apply one drop to each eye.  If necessary, this dose may be repeated once only, at least one hour after the first drop.

 

                        N.B.  The use of a drop of topical anaesthetic a few minutes before instillation of phenylephrine is recommended to prevent stinging.

 

                        Children and the Elderly

 

                        The use of phenylephrine 10% solution is contraindicated in these groups because of the increased risks of systemic toxicity (see section 4.3)


9.         DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

 

Date of first authorisation: 1st April 1979

 

Date of last renewal: 1st April 2009

 

10.       DATE OF (PARTIAL) REVISION OF THE TEXT

           

January 2010

Updated on 13 August 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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

1.         NAME OF THE MEDICINAL PRODUCT

 

            Minims Phenylephrine Hydrochloride 10% w/v Eye Drops, solution

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

            Phenylephrine Hydrochloride 10% w/v.

 

            For a full list of excipients, see 6.1

4.2       Posology and Method of Administration

 

                        Adults

 

                        Apply one drop to each eye.  If necessary, this dose may be repeated once only, at least one hour after the first drop.

 

                        N.B.  The use of a drop of topical anaesthetic a few minutes before instillation of phenylephrine is recommended to prevent stinging.

 

                        Children and the Elderly

 

                        The use of phenylephrine 10% solution is contraindicated in these groups because of the increased risks of systemic toxicity (see section 4.3)


9.         DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

 

Date of first authorisation: 1st April 1979

 

Date of last renewal: 1st April 2009

 

10.       DATE OF (PARTIAL) REVISION OF THE TEXT

           

January 2010

Updated on 24 July 2008 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.3, 6.5 and 9 : change in the wording

Section 10 : update of revision date

Updated on 24 July 2008 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.3, 6.5 and 9 : change in the wording

Section 10 : update of revision date

Updated on 16 May 2005 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Updated on 16 May 2005 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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)