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Alliance Pharmaceuticals
Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB
Telephone: +44 (0)1249 466 966
Fax: +44 (0)1249 466 977
WWW: http://www.alliancepharma.co.uk
Medical Information e-mail: medinfo@alliancepharma.co.uk

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 12/08/2010
SPC Naseptin Nasal Cream

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 12/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   30-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Changes highlighted in red:

2. Qualitative and Quantitative Composition

Chlorhexidine dihydrochloride         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

 

4.8.      Undesirable Effects

Irritative skin reactions can occasionally occur.

 

Topical application of neomycin preparations can lead to skin sensitisation in a small number of patients.  Prolonged use of neomycin can lead to ototoxicity and nephrotoxicity.  Therefore, use with caution in children, elderly patients and patients with impaired hearing.

 

Anaphylaxis to chlorhexidine has been reported rarely.
Updated on 16/03/2009 and displayed until 12/08/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   13-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 Now reads

Chlorhexidine dihydrochloride PhEur 0.1% w/w and neomycin sulphate PhEur 0.5% w/w.

 
Updated on 24/09/2003 and displayed until 16/03/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 16/07/2001 and displayed until 24/09/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 12/07/2001 and displayed until 16/07/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/03/2000 and displayed until 12/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  neomycin sulphate
  chlorhexidine dihydrochloride