| Section 4.4
Addition of paragraph:
Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism, narrow angle glaucoma or diabetes mellitus.
Addition of description of the label warnings.
New points added :
For reasons of hygiene do not use this bottle for more than 28 days after first opening it.
Do not use if you are sensitive to any of the ingredients of Otrivine
Do not use if you have had recent neurosurgery
Consult your doctor before using Otrivine if you have heart or circulatory disease
Other side effects such as palpitations, nausea and headache are very rare
Section 4.5
The words ‘none’ have been deleted.
Addition of new paragraph
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 new 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
Addition of new 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
Change of date from 22 December 2009 to 31 January 2012
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