Otrivine Adult 0.1% w/v Nasal Drops, Solution

Addition of detailed warnings about the interactions of tri- and tetra-cyclic antidepressants, monoamine oxidase inhibitors, anti-hypertensives and Xylometazoline

Addition of detailed warnings about the interactions of tri- and tetra-cyclic antidepressants, monoamine oxidase inhibitors, anti-hypertensives and Xylometazoline

Section 4.2

Added

It is recommended to make the last application shortly before retiring to bed.

Section 4.3

Added:

Rhinitis sicca and Atrophic rhinitis.

Section 4.5

Added:

Monoamine oxidase inhibitors (MAO inhibitors): xylometazoline may potentiate the action of monoamine oxidase inhibitors and may induce hypertensive crisis. Xylometazoline is not recommended in patients who are taking or have taken MAOIs within the past two weeks (see section 4.3).

Tri- and tetra-cyclic antidepressants: concomitant use of tri- or tetra cyclic antidepressants and sympathomimetic preparations may result in an increased sympathomimetic effect of xylometazoline and is therefore not recommended.

Section  4.8.

Sentence changed from:
Common: Nasal dryness or discomfort, burning sensation to
Common: Nasal dryness or nasal discomfort, burning sensation

Added:
Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

Deleted:

Freepost section.

10.          Date of (Partial) Revision of the Text

Date changed from: 20th June 2014 to April 2015

SPC Changes – Otrivine Adult 0.1% w/v Nasal Drops, Solution – 20 June 2014

Section 7

Address changed to Camberley.

Section 10

Change of date from 14 February 2014 to 20 June 2014.

SPC Changes – Otrivine Adult 0.1% w/v Nasal Drops, Solution – 14 February 2014

Section 2

Added: “Excipients: Benzalkonium chloride 0.01 w/v”

Section 3

Added “nasal spray” in brackets.

Section 4.1

After “influenza” added “Relief of sinusitis.”

Section 4.2

Posology and Method of Administration section reworded.

Added: “Do not exceed 3 applications daily into each nostril.”

Paediatric population section added & several points added with information on Application.

Added: “Otrivine Adult Nasal Drops should not be used in children aged less than 12 years.”

Section 4.3

Contraindications section reworded.

Section 4.4

Added: “Use with caution in patients showing a strong reaction to adrenergic substances, as manifested by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.” and section reworded;

Added: “Otrivine contains benzalkonium chloride, which can cause nasal irritation and bronchospasm.”

Section 4.5

Added information to heading “Interactions with other Medicaments and other forms of Interaction”

Section 4.6

Information added under subheading “Pregnancy”

Added subheadings with information on: “Fertility” & “Breastfeeding”

Section 4.7

“None” replaced with: “Otrivine has no or negligible influence on the ability to drive and use machines.”

Section 4.8

Reworded “Undesirable Effects” section.

Adverse frequency descriptions added. Adverse events reactions listed and information on reporting suspected adverse reactions added.

Section 4.9

Removed: “No cases of overdosage in adults have yet been reported.” 

Overdose section reworded.

Section 5.1

Added Pharmacotherapeutic group and ATC code;

Added subheading with information on: “Mechanism of action and pharmacodynamic effects”

Section 5.2

Added: “Plasma concentrations of xylometazoline in man after local nasal application of the product are very low and close to the limit of detection.”

Section 5.3

“Not applicable” replaced with: “Xylometazoline has no mutagenic effect. No teratogenic effects were shown in a study where xylometazoline was given subcutaneously in mice and rats.”

Section 6.6

The Heading changed from: “Instructions for Use/Handling” to “Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product.”

Listed Instructions have been deleted and “No special requirements” added.

Section 10

Change of date from 20 April 2011 to 14 February 2014.

Section 1

Change of product name from Otrivine Adult Nasal Drops to Otrivine Adult 0.1% w/v Nasal Drops, Solution.

Section 10

Change of date from June 2010 to 20 April 2011

Section 3

The words ‘The drops are’ have  been deleted.

Section 6.1

Addition of words ‘(Non-crystallising), E420’ follow Sorbitol liquid.

Section 6.6

Addition of following :

1.     Clear the nose

2.     Tilt the head back as far as comfortable or, if lying on a bed, hang the head over the side

3.     Apply the drops into each nostril and keep the head tilted back for a short time to allow the drops to spread throughout the nose

4.     Replace cap right after use

Section 9

Date changed from 24^th May 1994/24^th May 2004 to 24^th May 1984/24 May 2009

Section 10

Date changed from 28^th May 2004 to June 2010

Section 3: Addition of “the drops are a clear, colourless solution”

Section 6.4: Addition of: “Do not store above 25°C. Keep the bottle in the outer container.”

Section 6.6: Text revised from “medicines should be kept out of the reach of children” to “no special requirements”

Section 9: Updated renewal of authorisation

Section 10: Revision date changed