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Gentisone HC 0.3% w/v & 1.0% w/v Ear Drops, Suspension

*
Pharmacy Only: Prescription

  • Company:

    ADVANZ Pharma

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Gentamicin SulfateHydrocortisone Acetate

    *Additional information is available within the SPC or upon request to the company

Updated on 21 June 2021

File name

GENTIS~2.pdf

Reasons for updating

  • Updated inline with QRD template and/or excipient guideline

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

Updated on 21 June 2021

File name

GENTIS~1.pdf

Reasons for updating

  • New PIL for new product

Updated on 01 November 2019

File name

1.3.1 SmPC - Clean.pdf

Reasons for updating

  • Other

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

Updated on 18 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 18 July 2017

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

In section 4.3 changed the active substances
In section 4.4 special warning and precautions deleted paragraph - Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids  
In section 4.7 added Not applicable instead of not relevant

Updated on 18 July 2017

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

In section 4.3 changed the active substances
In section 4.4 special warning and precautions deleted paragraph - Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids  
In section 4.7 added Not applicable instead of not relevant

Updated on 19 November 2014

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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

The Sections 4.3-4.5, 4.8, 4.9, 5.1 & 5.2 of the SmPC were updated

Updated on 19 November 2014

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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

The Sections 4.3-4.5, 4.8, 4.9, 5.1 & 5.2 of the SmPC were updated

Updated on 04 December 2013

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8:- Undesirable effects Added Reporting of Suspected adverse reations
Section 10:- DATE OF (PARTIAL) REVISION OF THE TEXT

Updated on 04 December 2013

Reasons for updating

  • 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

Section 4.8:- Undesirable effects Added Reporting of Suspected adverse reations
Section 10:- DATE OF (PARTIAL) REVISION OF THE TEXT

Updated on 15 May 2013

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 1: NAME OF MEDICINAL PRODUCT

 

Removed the word ‘Trade’ from the title of section 1 to read: NAME OF MEDICINAL PRODUCT

Updated name of product to read: Gentisone HC 0.3% w/v & 1.0% w/v Ear Drops, Suspension

 

 

Section 2: QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Inserted a statement regarding the presence of benzalkonium chloride in product.

 

 

Section 4.4 Special warnings and special precautions for use

 

Inserted text regarding the risk of irritation due to the presence of benzalkonium chloride.

 

 

Section 4.6.      Fertility, pregnancy and lactation

 

Added word ‘fertility’ to title of this section (previously used to read ‘Pregnancy & lactation).

 

Section 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

Title of section amended to text above.


Section 9.        DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Amended to read:

Date of first authorisation: 18 May 1995

Date of last renewal: 18 May 2010

 

 

10.        DATE OF REVISION OF THE TEXT

 

Updated to read:

May 2012

Updated on 15 May 2013

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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

Free text change information supplied by the pharmaceutical company

Section 1: NAME OF MEDICINAL PRODUCT

 

Removed the word ‘Trade’ from the title of section 1 to read: NAME OF MEDICINAL PRODUCT

Updated name of product to read: Gentisone HC 0.3% w/v & 1.0% w/v Ear Drops, Suspension

 

 

Section 2: QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Inserted a statement regarding the presence of benzalkonium chloride in product.

 

 

Section 4.4 Special warnings and special precautions for use

 

Inserted text regarding the risk of irritation due to the presence of benzalkonium chloride.

 

 

Section 4.6.      Fertility, pregnancy and lactation

 

Added word ‘fertility’ to title of this section (previously used to read ‘Pregnancy & lactation).

 

Section 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

Title of section amended to text above.


Section 9.        DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Amended to read:

Date of first authorisation: 18 May 1995

Date of last renewal: 18 May 2010

 

 

10.        DATE OF REVISION OF THE TEXT

 

Updated to read:

May 2012

Updated on 14 August 2008

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 14 August 2008

Reasons for updating

  • New SPC for medicines.ie