Gentisone HC 0.3% w/v & 1.0% w/v Ear Drops, Suspension
- Name:
Gentisone HC 0.3% w/v & 1.0% w/v Ear Drops, Suspension
- Company:
ADVANZ Pharma
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
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ADVANZ Pharma
Company Products
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 1 November 2019 SPC
Reasons for updating
- Other
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 18 July 2017 SPC
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 SPC
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 4.4 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 PIL
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - 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 4.4 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 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 4.8 - 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
Updated on 19 November 2014 SPC
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
Updated on 4 December 2013 SPC
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 10:- DATE OF (PARTIAL) REVISION OF THE TEXT
Updated on 4 December 2013 PIL
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 10:- DATE OF (PARTIAL) REVISION OF THE TEXT
Updated on 15 May 2013 PIL
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 15 May 2013 SPC
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 14 August 2008 PIL
Reasons for updating
- New SPC for medicines.ie
Updated on 14 August 2008 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)