Summary of Product Characteristics
last updated on the eMC:
10/05/2012
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 10/05/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 02-May-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Please see below changes highlighted in Red:
4.4. Special Warnings and Precautions for Use
For nasal application only. Keep out of the eyes and ears.
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.
Irritative skin reactions can occasionally occur. Prolonged use of neomycin can lead to skin sensitisation, ototoxicity and nephrotoxicity. Use with caution in children, elderly patients and patients with impaired hearing (see Section 4.8 ‘Undesirable effects’).
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
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System Organ Class
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Frequency
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Undesirable Effect
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Immune system disorders
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Not known
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· anaphylaxis
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Nervous system disorders
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Not known
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· temporary hyposmia
· temporary ageusia
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Ear and labyrinth disorders
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Not known
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· ototoxicity1
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Skin and subcutaneous tissue disorders
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Not known
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· Irritative skin reactions
· skin sensitisation
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Renal and urinary disorders
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Not known
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· nephrotoxicity
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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.
1 Therefore, uUse with caution in children, elderly patients and patients Therefore, with impaired hearing (see Section 4.4 ‘Special warnings and precautions for use’).
Anaphylaxis to chlorhexidine has been reported rarely.
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Updated on 12/08/2010 and displayed until 10/05/2012
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.8 - Undesirable Effects
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| 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
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| 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.
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Updated on 16/03/2009 and displayed until 12/08/2010
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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| 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
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| Section 2 Now reads
Chlorhexidine dihydrochloride PhEur 0.1% w/w and neomycin sulphate PhEur 0.5% w/w.
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Updated on 24/09/2003 and displayed until 16/03/2009
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 16/07/2001 and displayed until 24/09/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 12/07/2001 and displayed until 16/07/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/03/2000 and displayed until 12/07/2001
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Reasons for adding or updating:
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