Novartis Consumer Health

Section 4.1

“ For the treatment of nasal congestion ...” amended to “ For the relief of nasal congestion associated with the common cold ...”

Section 4.4

“Patients are advised not to take decongestants for more than five consecutive days without the advice of a doctor” amended to “Patients are advised not to take decongestants for more than five consecutive days.”

Addition of “ For reasons of hygiene do not use this bottle for more than 28 days after first opening it.”

Other side effects are very rare amended to “ Other side effects such as palpitations, nausea and headache are very rare.”

Hallucinations removed from the list of potential side effects that small children may show.

Deletion of “ Use with caution in occlusive vascular disease” and “Keep away from eyes”

Minor re-words to other bullet points in this section.

Section 4.5

Interactions section has been amended from very specific mentions of interactions to a more general statement. Wording has changed to:

“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 wording:

“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 wording:

“In isolated cases, systemic allergic reactions and transient visual disturbances.”

Section 4.9

Deletion of statement “ No cases of overdosage in adults have yet been reported.”

Deletion of drowsiness, respiratory depression or irregularity as signs of accidental poisoning – replaced with “ and sometimes consciousness clouding.”

Section 6.1

Addition of  text “70% (non-crystallising)” to Sorbitol

Section 10

Date change from 22 December 2009 to 05 April 2012

Section 5.1

Addition of :

In a double-blind, saline solution (Otrisal) controlled study in patients with common cold, the decongestant effect of Otrivine was significantly superior (p<0.0001) to Otrisal saline solution based on rhinomanometry measurement at 1 hour after administration of the study drugs.

Section 10

Date change from 21 May 2009 to 22 December 2009

Section 4.2

Addition of ‘Otrivine Child Nasal Drops are contra-indicated in children under 6 years of age’.

Addition of ‘Not to be used for more than 5 days without the advice of a doctor.  Parents or carers should seek medical attention if the child’s condition deteriorates during treatment.’

Deletion of ‘Consult your pharmacist or healthcare professional before use in children under 6 years.’

Deletion of ‘Not to be used in children less than 2 years of age.’

Addition of ‘Do not exceed the stated dose.’

Addition of ‘Keep out of the reach and sight of children.’

Section 4.3

Addition of words ‘or any of the excipients’ following ‘Known hypersensitivity to Otrivine’.

Addition of:

‘Cardiovascular disease including hypertension

Diabetes mellitus

Phaeochromocytoma

Hyperthyroidism

Closed angle glaucoma

Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5)

Beta-blockers – (see section 4.5)

Inflammation of the skin and/or mucosa of the nasal vestibule

Trans-sphenoidal hypophysectomy or nasal surgery exposing the dura mater

Not to be used in children under the age of 6 years’

Deletion of ‘Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.’

Section 4.4

Addition of words ‘without the advice of a doctor’ following ‘Patients are advised not to take decongestants……..

Addition of words ‘or experience hallucinations’ added to section beginning ‘Occasionally small children may show…..’

Addition of ‘Use with caution in occlusive vascular disease’.

Addition of ‘Keep away from the eyes.’

Section 4.5

Deletion of ‘None’.

Addition of :

‘MAOIs and /or RIMAs: should not be given to patients treated with MAOIs or

within 14 days of stopping treatment: increased risk of hypertensive crisis

• Moclobemide: risk of hypertensive crisis

• Antihypertensives (including adrenergic neurone blockers & beta-blockers):

Otrivine Child Nasal Drops may block the hypotensive effects

• Cardiac glycosides: increased risk of dysrhythmias

• Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism

• Appetite suppressants and amphetamine-like psychostimulants: risk of

hypertension

·         Oxytocin – risk of hypertension’

Section 4.8

Addition of:

‘Oral agents

Cardiovascular effects

• Tachycardia/palpitations

• Other cardiac dysrhythmias and hypertension

· CNS effects

• Irritability

• Anxiety

• Restlessness

• Excitability

• Insomnia

• Hallucinations and paranoid delusions

Skin reactions including rash’

Hypersensitivity reactions – including that cross-sensitivity may occur with other

sympathomimetics

Other reactions

• Nausea and/or vomiting

• Headache

• Urinary retention

Topical agents

• Local effects – irritation and dryness

• Nausea

• Headache

• Rebound congestion (rhinitis medicamentosa) – especially with prolonged

and/or heavy use

• Tolerance with diminished effect – especially with prolonged and/or heavy

use

• Cardiovascular effects (as with oral agents) particularly with prolonged and/or

excessive use

• CNS effects (as with oral agents) particularly with prolonged and/or

excessive use

Section 10

Addition of ’21 May 2009’.