| Section 4.3
Change of wording from ‘famciclovir or the other constituents...’ to ‘famciclovir or any of the excipients ....’.
Section 4.4
First paragraph
Addition of words ‘(e.g. in the eyes, mouth, or nose or on the genitals)’ between ‘..mucous membranes’ and ‘Particular care....’.
Section 4.6
Paragraph beginning ‘Animal studies......in vivo to penciclovir)’ has been moved to section 5.3.
Section 4.8
First paragraph
Sentence beginning ‘In particular, application site.......clinical trials’ has been deleted.
New sentence inserted ‘The most common events are application site adverse events’.
Second and third paragraph deleted.
Additional information inserted :
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: 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); unknown (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
General disorders and administration site condition
Common: application site reactions (including skin burning sensation, pain of skin, hypoaesthesia)
Post-marketing surveillance has revealed the following adverse events (all reactions were either localised or generalised). Adverse events from post-marketing experience are difficult to calculate a frequency for and therefore the events are listed as unknown frequency.
Immune system disorders
hypersensitivity, urticaria
Skin and subcutaneous disorders
dermatitis allergic (including rash, pruritus, blisters and oedema).
Section 5.3
Addition of paragraph previously in section 4.6 beginning ‘Animal studies.....in vivo to penciclovir).’
Section 10
Change of date from 9 September 2008 to 7 April 2011.
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