Otrivine Congestion Relief 0.1% w/v Nasal Spray, Solution

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

Addition of "Other Medicines and Otrivine" detailing warnings about the interactions of tri- and tetra-cyclic antidepressants, monoamine oxidase inhibitors, high blood pressure medications and Xylometazoline

Addition of "Other Medicines and Otrivine" detailing warnings about the interactions of tri- and tetra-cyclic antidepressants, monoamine oxidase inhibitors, high blood pressure medications and Xylometazoline

Shelf life reduced from 36 months to 24 months.

Section 4.2

Section amended to:

1 to 2 sprays into each nostril, up to 3 times daily as needed. Do not exceed 3 applications daily into each nostril.

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 and discomfort,

to:

Common: Nasal dryness and nasal discomfort,

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.

Section 4.9:

Changed 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 and some clouding of consciousness. 

There is no specific treatment.  Appropriate supportive measures should be initiated and symptomatic treatment under medical supervision is indicated.

To:

Overdose of oral or excessive administration of topical xylometazoline hydrochloride may cause severe dizziness, perspiration, severely lowered body temperature, headache, bradycardia, hypertension, respiratory depression, coma and convulsions. Hypertension may be followed by hypotension. Small children are more sensitive to toxicity than adults.

Appropriate supportive measures should be initiated in all individuals suspected of an overdose, and urgent symptomatic treatment under medical supervision is indicated when warranted. This may include observation of the individual for at least several hours.

Section 5.1

Mechanism of action and pharmacodynamic effects:

Added:

It also reduces associated symptoms of mucus hypersecretion and facilitates drainage of blocked secretions.

Deleted:

In a double-blind, saline solution controlled study in 61 patients with common cold, the decongestant effect of Otrivine 0.1% solution was significantly superior (p<0.0001) to saline solution based on rhinomanometry measurement.

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 Spray, 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 Spray, Solution – 14 February 2014

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 has been added & points have been added with information on application.

Section 4.3

Contraindications section reworded.

Section 4.4

Added: “Use with great caution in patients showing a strong reaction to adrenergic agents as manifested by signs of insomnia, dizziness, tremor, cardiac arrhythmia or elevated blood pressure.”

Removed:

“If you are pregnant or taking other medicines, or are under a doctor’s care consult him before using Otrivine.”

“Other side effects are very rare.”

“Keep all medicines out of reach of children.”

Added: “Otrivine Adult Nasal Spray contains benzalkonium chloride which can cause nasal irritation or bronchospasm.”

Section 4.5

Added further information in the Interactions section.

Section 4.6

Reworded “Pregnancy” section.  

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

Section 4.7

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

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

Overdose section reworded.

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

Replaced “There is no specific treatment and appropriate supportive treatment should be initiated” with: “There is no specific treatment. Appropriate supportive measures should be initiated and symptomatic treatment under medical supervision is indicated.”

After “irregularity” added: “and some clouding of consciousness.”

Section 5.1

Removed: “A sympathomimetic agent with marked alpha-adrenergic activity. It is a vasoconstrictor with a rapid and prolonged action used for the relief of nasal congestion.

Added Pharmacotherapeutic group and ATC code; section slightly reworded.”

Added subheadings 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 6.3

Removed: “For reasons of hygiene, it is recommended that the bottle is not used for more than 28 days after first opening.”

Section 6.6

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

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

Section 9

Year ”1994” replaced with “1984” and “2004” replaced with “2009”

Section 10

Change of date from April 2011 to 14 February 2014.

Section 1

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

Section 10

Change of date from June 2010 to April 2011

Section 2

Addition of line :

Excipients: Benzalkonium chloride 0.01%w/v.

Section 4.4

Change of word from ‘drops’ to ‘spray’.

Section 6.4

Addition of words:  Keep the bottle in the outer carton.

Section 6.5

Deletion of :

Bottle: High density polyethylene/polypropylene copolymer

And addition of:

Bottle:  Low density polyethylene

Section 6.6

Deletion of: No special requirements

Addition of:

To produce a fine spray, the nebuliser should be held upright with the nozzle pointing upwards.

1.   Clear the nose.

2.   Lean forward slightly and insert the nozzle into a nostril.

3.   Squeeze the bottle once and sniff at the same time.

4.   Remove the nozzle before releasing the pressure on the bottle.

5.   Repeat for the other nostril.

6.   Replace cap right after use.

Section 10

Change of date from 28^th May 2004 to June 2010.

Section 2: Addition of “for excipients see 6.1”

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

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