| Section 4.4
Additional paragraph:
Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism, narrow angle glaucoma or diabetes mellitus.
Section 4.5
Deletion of word ‘None’.
Addition of: 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 prsecription whilst breastfeeding.
Section 4.8
Addition of paragraph:
In isolated cases, systemic allergic reactions and transient visual disturbances.
Section 4.9
Deletion of words : No cases of overdosage in adults have yet been reported.
Change of paragraph from :
In rare instances of accidental poisoning in children, the clinical picture has been marked chiefly by signs such as acceleration and irregularity of the pulse, elevated blood pressure, drowsiness, respiratory depression or irregularity. There is no specific treatment and appropriate supportive treatment should be initiated.
To:
In rare instances of accidental poisoning in children, the clinical picture has been marked chiefly by signs such as acceleration and irregularity of the pulse, elevated blood pressure and sometimes conscious clouding. There is no specific treatment. Appropriate supportive measures should be initiated.
Section 10
Date change from 31 August 2011 to 31 January 2012
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