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Naseptin Nasal Cream

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Pharmacy Only: Prescription

Updated on 20 January 2023

File name

Naseptin SPC ROI 012.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

file upload

Updated on 20 January 2023

File name

Naseptin PIL ROI 013.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to improve clarity and readability

Free text change information supplied by the pharmaceutical company

change to improve clarity and readability to sections 2, 3 4, 5 and 6

section 4 possible side effects- change to include side effect of change of skin colour at application site

section 4 how to report side effects- change to HPRA reporting details

Updated on 20 January 2023

File name

Naseptin SPC ROI 012.pdf

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 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

*updating pdf file version

Section 2. Qualitative and Quantitative composition - addition of text "excipient with known effects"

section 4.3 Contraindications - addition of text to refer to excipients list in section 6.1

section 4.4 Special warnings and precautions for use- addition of text to highlight medicines contains cetostearyl alcohol

section 4.8 Undesirable effects- addition of undesirable effects to include general disorders and administration site conditions

section 4.8 reporting adverse events- update to HPRA details

section 10 date of revision


Updated on 20 January 2023

File name

Naseptin SPC ROI 011.pdf

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 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

section 2. Qualitative and Quantitative composition - Addition of text "excipient with known effect"

section 4.3 Contra-indications - addition of text to refer to excipient list in section 6.1

section 4.4 Special warning and precaution for use- addition of text to highlight medicine contains cetostearyl alcohol

section 4.8 Undesirable effects - Addition of undesirable effects to include general disorders and administration site conditions

section 4.8 Reporting adverse events - update to HPRA reporting details

section 10 date of revision

Updated on 27 March 2019

File name

Naseptin PIL ROI 012.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 22 March 2019

File name

Naseptin PIL ROI 012.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 22 March 2019

File name

Naseptin SPC ROI 011.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 July 2018

File name

Naseptin SPC ROI 010.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

File format update to PDF

Updated on 29 October 2014

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 29 October 2014

Reasons for updating

  • Correction of spelling/typing errors
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change spelling of Sulphate to Sulfate
Addition of reporting of  ADR statement
IMB name change

Updated on 28 October 2014

File name

PIL_7806_857.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 October 2014

Reasons for updating

  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 22 October 2014

Reasons for updating

  • Correction of spelling/typing errors

Updated on 23 January 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes highlighted in red below:

 

4.8 Undesirable effects

Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:
Very common: ≥1/10
Common: ≥1/100 to <1/10
Uncommon: ≥1/1,000 to <1/100
Rare: ≥1/10,000 to <1/1,000
Very rare: <1/10,000

Not known: cannot be estimated from the available data

 

 

System Organ Class

Frequency

 

 

Undesirable Effect

 

 

Immune system disorders

 

 

 

Not known

 

 

 

 

anaphylaxis, hypersensitivity

 

Nervous system disorders

 

 

 

Not known

 

 

 

 

temporary hyposmia

 

 

temporary ageusia

 

Ear and labyrinth disorders

 

 

 

Not known

 

 

 

 

ototoxicity1

 

Skin and subcutaneous tissue disorders

 

 

 

Not known

 

 

 

 

Irritative skin reactions

 

 

skin sensitisation

 

Renal and urinary disorders

 

 

 

Not known

 

 

 

 

nephrotoxicity

 

1

 

Use with caution in children, elderly patients and patients with impaired hearing (see Section 4.4 ‘Special warnings and precautions for use’).

 

Local irritation and hypersensitivity can occasionally occur.

Prolonged use may lead to skin sensitisation to neomycin.

Anaphylaxis to chlorhexidine has been reported rarely.

Updated on 21 January 2013

Reasons for updating

  • Change to side-effects

Updated on 15 August 2011

Reasons for updating

  • Change to side-effects
  • Change due to user-testing of patient information

Updated on 04 May 2011

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Additions/Changes higlighted in red text:

2.                  QUALITATIVE AND QUANTITATIVE COMPOSITION

 

            Chlorhexidine dihydrochloride         0.1       %w/w

            Neomycin Sulphate                       0.5       %w/w (3250 IU/g)

 

            Excipients: Contains 8% w/w (80mg/g) cetostearyl alcohol

 

            For a full list of excipients, see section 6.1.

 

4.3             Contraindications

 

Hypersensitivity to chlorhexidine and neomycin or to any of the excipients.

            Some patients have shown a hypersensitivity reaction to neomycin or chlorhexidine, although such reactions are extremely rare. 

4.8             Undesirable effects

 

            Local irritation and hypersensitivity can occasionally occur.

 

            Prolonged use may lead to skin sensitisation to neomycin.

 

            Anaphylaxis to chlorhexidine has been reported rarely.


 

5.1             Pharmacodynamic properties

 

            Pharmacotherapeutic group: Other antibiotics for topical use

 

            ATC code: D06AX

 

         

Updated on 08 March 2011

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 04 January 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2: The active ingredient has changed from chlorhexidine hydrochloride to chlorhexidine dihydrochloride

Updated on 23 December 2009

Reasons for updating

  • Change of trade or active ingredient name

Updated on 22 July 2008

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 17 June 2008

Reasons for updating

  • Change of trade or active ingredient name
  • Change to name of manufacturer
  • Change to storage instructions

Updated on 16 June 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.4 - Special precautions for storage
  • Change to improve clarity and readability

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1. Now reads
Naseptin 0.1% & 0.5% w/w Nasal Cream
 
Section 2. Now reads

Chlorhexidine Hydrochloride           0.1       %w/w

Neomycin Sulphate                           0.5       %w/w

 

Excipients: Contains 8% w/w (80mg/g) cetostearyl alcohol

 

For a full list of excipients, see section 6.1.
 
Section 6.4. Now reads

Do not store above 30ºC.  Keep the tube tightly closed. Keep the tube in the outer carton.

Updated on 22 December 2006

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4  
Naseptin contains Arachis oil (peanut oil) and should not be taken/applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Naseptin, has been removed.

 

Section 6.1
Excipients changed to medium-chain triglycerides instead of arachis oil.

Updated on 22 December 2006

Reasons for updating

  • Change of inactive ingredient

Updated on 27 November 2006

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The arachis oil excipient has been removed and replaced with medium chain triglycerides

Updated on 16 May 2005

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 March 2005

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 30 July 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)