CILOXAN 3 mg/ml ear drops, solution
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal 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
Updated on 13 July 2022
File name
Ciloxan_REG PIL_PF22-0056_13.07.2022_clean_IPHA.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
Updated on 13 July 2022
File name
Ciloxan_REG SPC_PF22-0056_07.07.2022_clean_IPHA.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- 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)
Updated on 08 February 2022
File name
Ciloxan_3mg_ml_REG PIL_PF21-0255_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
Updated on 27 October 2021
File name
Ciloxan 3mg_mL_REG PIL_PF 21-109_clean TBI 26 Apr 2022.pdf
Reasons for updating
- Change of manufacturer
Updated on 24 September 2020
File name
Ciloxan 3mgL REGPIL PF 20-0134 clean IPHA.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.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.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 25 November 2019
File name
IPHACiloxan3mgml REGPIL 670350 PF 19-0191.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.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.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
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
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
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
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
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 4.2 - 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)