| Section 4.4
Deletion of word ‘Precautions’.
Addition of paragraph:
Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism, narrow angle glaucoma or diabetes mellitus
Bullet point under label warnings and precautions
‘Not suitable for children under 12 years’ has changed to ‘Not to be used for infants or children under 12 years.’
Section 4.5
Deletion of word ‘None’.
New paragraph added:
As for all sympathomimetics, a reinforcement of the systemic effects of xylometazoline by concomitant use of monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants, cannot be excluded, especially in case of overdose.
Section 4.6
Addition of paragraph:
No evidence of any adverse effect on the breast-fed infant. However, it is not known if xylometazoline is excreted in breast milk, therefore caution should be exercised and Otrivine should be used only on the advice of a doctor whilst breastfeeding.
Section 4.8
Second paragraph. Change of word from ‘patients’ to ‘people’.
Addition of paragraph: In isolated cases, systemic allergic reactions and transient visual disturbances.
Section 4.9
Wording ‘No cases of overdosage in adults have yet been reported’ have been deleted. Words ‘drowsiness, respiratory depression or irregularity’ have been deleted and replaced by ‘and sometimes conscious clouding’.
Second paragraph
Word changed from ‘treatment’ to ‘measures’.
Section 10
Date changed from 12 February 2003 to 31 January 2012
|
