CILOXAN 3 mg/ml ear drops, solution *
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

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

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 27 October 2021

File name

Ciloxan 3mg_mL_REG PIL_PF 21-109_clean TBI 26 Apr 2022_1635320756.pdf

Reasons for updating

  • Change of manufacturer

Updated on 24 September 2020

File name

Ciloxan 3mgL REGPIL PF 20-0134 clean IPHA_1600952398.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Improved presentation of PIL

Updated on 24 September 2020

File name

Ciloxan Ear Drops Solution REG SPC PF20-0134 September 2020 Clean_1600952249.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Updated on 10 December 2019

File name

Ciloxan 3mgL REGPIL 670350 PF 19-0191 IPHA_1575982723.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 25 November 2019

File name

IPHACiloxan3mgml REGPIL 670350 PF 19-0191_1574676949.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 08 April 2019

File name

REG_SPC_Ciloxan Ear Drops Solution _PF18-0202_IPHA_1554727325.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 12 November 2018

File name

458428_IE_IPHA_1542037870.pdf

Reasons for updating

  • Change to marketing authorisation holder

Updated on 16 July 2018

File name

REG_SPC_Ciloxan Ear Drops Solution _PF18-0202clean.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

MAT Transfer

Updated on 30 May 2017

Reasons for updating

  • New SPC for new product

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

Updated on 30 May 2017

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

- Sections 7,8 and 10 updated following change of ownership from Alcon to Novartis.

Updated on 26 May 2017

File name

PIL_14755_595.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 May 2017

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 11 February 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

- Update of ADR reporting and IMB to HPRA name change

Updated on 09 February 2015

Reasons for updating

  • Change to side-effects

Updated on 25 September 2014

Reasons for updating

  • Improved electronic presentation

Updated on 25 March 2014

Reasons for updating

  • Improved electronic presentation

Updated on 18 February 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Spc updated to alingn with CCSI changes.

Updated on 12 February 2014

Reasons for updating

  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to side-effects

Updated on 10 September 2013

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.4
The storage conditions for Ciloxan 0.3% ear drops, solution cahnged from ‘no labelled storage conditions’ to ‘Do not refrigerate or freeze.

Updated on 05 September 2013

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 15 May 2013

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update of MAH address and Date of revision of text

Updated on 13 May 2013

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 07 December 2012

Reasons for updating

  • Change to section 4 - Clinical particulars
  • Change to section 5 - Pharmacological properties

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

Free text change information supplied by the pharmaceutical company

Changes affected Sec 4 and 5 of the SPC to be in line with the Company Core Safety Profile.

Updated on 05 December 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects

Updated on 07 December 2011

Reasons for updating

  • Change to improve clarity and readability

Updated on 24 February 2011

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

In Section 2, Qualitative and quantitative composition, the statements - ‘3.0 mg/ml ciprofloxacin equivalent to 3.5 mg/ml ciprofloxacin hydrochloride. For excipients, see 6.1.’ - are replaced with ‘Each ml contains 3mg ciprofloxacin as ciprofloxacin hydrochloride. Excipients: contains benzalkonium chloride 0.06mg/ml. For a full list of excipients, see section 6.1.’

 

In Section 4.3, Contraindications, ‘Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to quinolones.’ is replaced with ‘Hypersensitivity to ciprofloxacin, to other quinolones or any of the excipients.’

 

In section 4.4, Special warnings and precautions for use, the statement ‘Efficacy and safety in children less than one year old have not been assessed.’ is removed. A statement regarding ‘Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures-’ is added.

 

In Section 6.3, Shelf-life, ‘4 weeks after first opening.’ is replaced with ‘Discard 4 weeks after first opening.’

 

In Section 6.4, Special precautions for storage, ‘No special precautions for storage.’ is replaced with ‘This medicinal product does not require any special storage precautions.’

 

In Section 9, Date of first authorisation or renewal of the authorisation, ‘Date of last renewal: 03 February 2011’ is added.

 

In Section 10, Date of revision of the text, the date of revision is updated to February 2011.

Updated on 12 August 2010

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 May 2010

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.1 - 'Consideration should be given to official guidance on the appropriate use of antibacterial agents' added

Section 4.2 - Heading 'Adults and children 1 year and above' added

Section 4.3 - 'Hypersensitivty to the active substance or to any of the excipients' and 'Hypersensitivty to quinolones'.

Section 10 - Changed to 'February 2010'

Updated on 14 September 2009

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided