Naseptin Nasal Cream
- Name:
Naseptin Nasal Cream
- Company:
Alliance Pharmaceuticals Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/03/19

XPIL
PATIENT INFORMATION LEAFLET
PATIENT INFORMATION LEAFLET
1. What Naseptin is and what it is used for
1. What Naseptin is and what it is used for
2. Check before you use Naseptin
2. Check before you use Naseptin
3. How to use Naseptin
3. How to use Naseptin
4. Possible side effects
4. Possible side effects
5. How to store Naseptin
5. How to store Naseptin
6. Further information
6. Further information
Click on this link to Download PDF directly
Alliance Pharmaceuticals Ireland

Company Products
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 March 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 22 March 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 22 March 2019 SPC
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 SPC
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 SPC
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 SPC
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
Addition of reporting of ADR statement
IMB name change
Updated on 28 October 2014 PIL
Reasons for updating
- New PIL for new product
Updated on 28 October 2014 PIL
Reasons for updating
- Addition of information on reporting a side effect.
- Correction of spelling/typing errors
Updated on 22 October 2014 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 23 January 2013 SPC
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
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
|
ï‚·
anaphylaxis, hypersensitivity
|
Nervous system disorders
|
Not known
|
ï‚·
temporary hyposmia
ï‚·
temporary ageusia
|
Ear and labyrinth disorders
|
Not known
|
ï‚·
ototoxicity1
|
Skin and subcutaneous tissue disorders
|
Not known
|
ï‚·
Irritative skin reactions
ï‚·
skin sensitisation
|
Renal and urinary disorders
|
Not known
|
ï‚·
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 PIL
Reasons for updating
- Change to side-effects
Updated on 15 August 2011 PIL
Reasons for updating
- Change to side-effects
- Change due to user-testing of patient information
Updated on 4 May 2011 SPC
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 8 March 2011 PIL
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 4 January 2010 SPC
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
Updated on 23 December 2009 PIL
Reasons for updating
- Change of trade or active ingredient name
Updated on 22 July 2008 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 17 June 2008 PIL
Reasons for updating
- Change of trade or active ingredient name
- Change to name of manufacturer
- Change to storage instructions
Updated on 16 June 2008 SPC
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
Chlorhexidine Hydrochloride 0.1 %w/w
Neomycin Sulphate 0.5 %w/w
Excipients: Contains 8% w/w (80mg/g) cetostearyl alcohol
Do not store above 30ºC. Keep the tube tightly closed. Keep the tube in the outer carton.
Updated on 22 December 2006 SPC
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
Updated on 22 December 2006 PIL
Reasons for updating
- Change of inactive ingredient
Updated on 27 November 2006 SPC
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
Updated on 16 May 2005 SPC
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 9 March 2005 SPC
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 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 23 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)