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:
    info
  • Active Ingredients:

    Gentamicin sulfate, Hydrocortisone Acetate

  • Legal Category:

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

Summary of Product Characteristics last updated on medicines.ie: 1/11/2019

Click on this link to Download PDF directly

ADVANZ Pharma

advanz-full-rgb_1543842253

Company Products

Medicine NameActive Ingredients
Medicine Name Celevac 500 mg tablets Active Ingredients Methylcellulose
Medicine Name Chloromycetin 0.5% w/v Redidrops Eye Drops, Solution. Active Ingredients Chloramphenicol
Medicine Name Clarithromycin 500 mg, Powder for Concentrate for Solution for Infusion Active Ingredients Clarithromycin lactobionate
Medicine Name Codipar 15mg/500mg Capsules Active Ingredients Codeine Phosphate, Paracetamol
Medicine Name Codipar 15mg/500mg Capsules Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name Codipar 15mg/500mg Effervescent Tablets Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name Cyclimorph 10 Injection Active Ingredients Cyclizine tartrate, Morphine Tartrate
Medicine Name Cyclimorph 15 Solution for Injection Active Ingredients Cyclizine tartrate, Morphine Tartrate
Medicine Name Detrunorm XL 30 mg modified-release capsules Active Ingredients Propiverine hydrochloride
Medicine Name Eltroxin 100 microgram Tablets Active Ingredients Levothyroxine sodium
Medicine Name Eltroxin 50 microgram Tablets Active Ingredients Levothyroxine sodium
Medicine Name Erythrocin 250mg Tablets Active Ingredients Erythromycin Stearate
Medicine Name Erythrocin 500mg Tablets Active Ingredients Erythromycin Stearate
Medicine Name Erythrocin IV Lactobionate 1.0g Powder for Solution for Infusion Active Ingredients Erythromycin Lactobionate
Medicine Name Erythromycin Tablets BP 250mg. Active Ingredients Erythromycin
Medicine Name Erythroped Adult Tablets Active Ingredients Erythromycin Ethylsuccinate
Medicine Name Erythroped Forte SF 500mg/5ml granules for oral suspension Active Ingredients Erythromycin Ethylsuccinate
Medicine Name Erythroped PI SF 125mg/5ml granules for oral suspension Active Ingredients Erythromycin Ethylsuccinate
Medicine Name Erythroped SF 250mg/5ml granules for oral suspension Active Ingredients Erythromycin Ethylsuccinate
Medicine Name Fucithalmic 10 mg/g Viscous eye drops, suspension Active Ingredients Fusidic Acid Hemihydrate
Medicine Name Genticin 80 mg/2 ml Solution for Injection Active Ingredients Gentamicin sulfate
Medicine Name Genticin Eye/Ear Drops Solution Active Ingredients Gentamicin sulfate
Medicine Name Gentisone HC 0.3% w/v & 1.0% w/v Ear Drops, Suspension Active Ingredients Gentamicin sulfate, Hydrocortisone Acetate
Medicine Name HYTRIN Tablets 10mg Active Ingredients Terazosin monohydrochloride dihydrate
Medicine Name HYTRIN Tablets 2mg Active Ingredients Terazosin monohydrochloride dihydrate
1 - 0 of 44 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 1 November 2019 SmPC

Reasons for updating

  • Other

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

Updated on 18 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 18 July 2017 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - 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 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 4.3 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 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

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

Updated on 19 November 2014 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 4.8 - 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 4 December 2013 SmPC

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 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 4.8:- Undesirable effects Added Reporting of Suspected adverse reations
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 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

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