• Change to section 1 - what the product is
• Change to section 1 - what the product is used for
• Change to section 2 - what you need to know - warnings and precautions
• Change to section 2 - use in children/adolescents
• Change to section 2 - interactions with other medicines, food or drink
• Change to section 3 - how to take/use
• Change to section 4 - possible side effects
• Change to section 5 - how to store or dispose
• Change to section 6 - what the product contains
• Change to section 6 - what the product looks like and pack contents
• Change to section 6 - date of revision
• Change to information for healthcare professionals

·         In section 2

o   The title ‘XEOMIN 50 units powder for solution for injection’ has been added above the 50 units sentence. Titles have also been added for the other strengths as well with corresponding units listed in the title

·         In section 4.1

o   The indication has been updated to include ‘and chronic sialorrhea due to neurological disorders’, and a minor update on grammar

·          In section 4.2

a)      Subsection  ‘general’ removed

b)      Text ‘in the treated muscle’ removed in the first paragraph of the sentence starting with ‘the optimum dose, frequency’

c)       New title added below 4^th paragraph, ‘the recommended single doses of Xeomin should not be exceeded.’

d)      New section titled ‘chronic sialorrhea’ with new content below title

e)      In first sentence under paragraph ‘all indications’, remove ‘and for instructions on disposal of the vials’ wording. In second sentence, remove ‘reconstituted’ before Xeomin and replace ‘injection’ with ‘and intraglandular (intra-salivary gland) use.’

f)       New section called ‘chronic sialorrhea’ added after last paragraph of this section. Content added under this title

·         In section 4.4

a)      Remove title ‘general’

b)      Second paragraph, only keep first sentence. Remove the rest.

c)       Remove,

’ The recommended single doses of XEOMIN should not be exceeded.

Previously akinetic or sedentary patients should be reminded to gradually resume activities following the injection of XEOMIN.’

d)      In the next paragraph, replace ‘the injected muscle’ with ‘injection sites’

e)      In the Subsection, ‘local and distant spread of toxin’, after the second paragraph, new paragraph added starting ‘patients treated with therapeutic’

f)       Under the title, ‘Pre-existing neuromuscular disorders’,

§  Remove first sentence and last sentence

§  ‘particular when treated intramuscularly’ added to end of second sentence

§  Second paragraph replaced with new title beginning with ‘generally,’

g)      ‘Indications’ Subsection replaced with ‘indication-specific warnings

h)      Under Subsection, ‘Spasmodic torticollis, two new paragraphs added at the beginning

i)        New Subsection, ‘Chronic sialorrhea’ added with content

·         In section 4.5

a)      First sentence – remove ‘drug’

b)      Paragraph added above last paragraph

·         In section 4.8

a)      Remove Subsection ‘Undesirable effects dependent from indication’ and ‘Spasmodic torticollis’ subsection

b)      Under Subsection, ‘Undesirable effects from clinical experience’

§  Under title Blepharospasm

·         Added ‘Spasmodic torticollis’  and content below title

§  Removed title ‘Spasmodic torticollis’

§  Infection and infestations title moved up

§  Sentence ‘Some of these undesirable effects may be disease related.’ Removed

§  New title ‘Chronic sialorrhea’ added with new content

·         In section 4.9

a)      New paragraph added at the start of the section

·         In section 5.1

a)      Under Blepharospasm, ‘Botox’ replaced with ‘comparator product’

b)      New section, ‘Chronic sialorrhea’ added

c)       Under Subsection ‘paediatric population’

§  Reference to section 4.2 removed in first section

§  Second bullet point added

·         In section 5.3

a)      Second paragraph, ‘after intramuscular injection’ added next to XEOMIN

b)      New paragraph added below second paragraph

·         In section 6.5

a)      ‘each containing 50 units’ added next to 50 units, and to the other preparation with respective units

·         In section 6.6

a)      Rewording across the section. Meaning remains the same.

·         In section 10

a)      Date updated

  In section 2

o   The title ‘XEOMIN 50 units powder for solution for injection’ has been added above the 50 units sentence. Titles have also been added for the other strengths as well with corresponding units listed in the title

·         In section 4.1

o   The indication has been updated to include ‘and chronic sialorrhea due to neurological disorders’, and a minor update on grammar

·          In section 4.2

a)      Subsection  ‘general’ removed

b)      Text ‘in the treated muscle’ removed in the first paragraph of the sentence starting with ‘the optimum dose, frequency’

c)       New title added below 4^th paragraph, ‘the recommended single doses of Xeomin should not be exceeded.’

d)      New section titled ‘chronic sialorrhea’ with new content below title

e)      In first sentence under paragraph ‘all indications’, remove ‘and for instructions on disposal of the vials’ wording. In second sentence, remove ‘reconstituted’ before Xeomin and replace ‘injection’ with ‘and intraglandular (intra-salivary gland) use.’

f)       New section called ‘chronic sialorrhea’ added after last paragraph of this section. Content added under this title

·         In section 4.4

a)      Remove title ‘general’

b)      Second paragraph, only keep first sentence. Remove the rest.

c)       Remove,

’ The recommended single doses of XEOMIN should not be exceeded.

Previously akinetic or sedentary patients should be reminded to gradually resume activities following the injection of XEOMIN.’

d)      In the next paragraph, replace ‘the injected muscle’ with ‘injection sites’

e)      In the Subsection, ‘local and distant spread of toxin’, after the second paragraph, new paragraph added starting ‘patients treated with therapeutic’

f)       Under the title, ‘Pre-existing neuromuscular disorders’,

§  Remove first sentence and last sentence

§  ‘particular when treated intramuscularly’ added to end of second sentence

§  Second paragraph replaced with new title beginning with ‘generally,’

g)      ‘Indications’ Subsection replaced with ‘indication-specific warnings

h)      Under Subsection, ‘Spasmodic torticollis, two new paragraphs added at the beginning

i)        New Subsection, ‘Chronic sialorrhea’ added with content

·         In section 4.5

a)      First sentence – remove ‘drug’

b)      Paragraph added above last paragraph

·         In section 4.8

a)      Remove Subsection ‘Undesirable effects dependent from indication’ and ‘Spasmodic torticollis’ subsection

b)      Under Subsection, ‘Undesirable effects from clinical experience’

§  Under title Blepharospasm

·         Added ‘Spasmodic torticollis’  and content below title

§  Removed title ‘Spasmodic torticollis’

§  Infection and infestations title moved up

§  Sentence ‘Some of these undesirable effects may be disease related.’ Removed

§  New title ‘Chronic sialorrhea’ added with new content

·         In section 4.9

a)      New paragraph added at the start of the section

·         In section 5.1

a)      Under Blepharospasm, ‘Botox’ replaced with ‘comparator product’

b)      New section, ‘Chronic sialorrhea’ added

c)       Under Subsection ‘paediatric population’

§  Reference to section 4.2 removed in first section

§  Second bullet point added

·         In section 5.3

a)      Second paragraph, ‘after intramuscular injection’ added next to XEOMIN

b)      New paragraph added below second paragraph

·         In section 6.5

a)      ‘each containing 50 units’ added next to 50 units, and to the other preparation with respective units

·         In section 6.6

a)      Rewording across the section. Meaning remains the same.

·         In section 10

a)      Date updated