When a pharmaceutical company changes an SPC or PIL, 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.
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
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
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.
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
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
5.1 Pharmacodynamic properties Pharmacotherapeutic group: Other antibiotics for topical use ATC code: D06AX
Pharmacotherapeutic group: Other antibiotics for topical use
ATC code: D06AX
Chlorhexidine Hydrochloride 0.1 %w/w
Neomycin Sulphate 0.5 %w/w
Do not store above 30ºC. Keep the tube tightly closed. Keep the tube in the outer carton.