Otrivine Adult 0.1% w/v Nasal Drops, Solution

  • Name:

    Otrivine Adult 0.1% w/v Nasal Drops, Solution

  • Company:
    info
  • Active Ingredients:

    Xylometazoline Hydrochloride

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/06/19

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Summary of Product Characteristics last updated on medicines.ie: 3/10/2016
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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

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1 - 0 of 52 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 18 June 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 2 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 November 2016 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 3 October 2016 SmPC

Reasons for updating

  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Sections 7, 8 & 10 updated following Change of Ownership approval

Updated on 3 October 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 3 May 2016 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 5 April 2016 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 5.1 (pharmacodynamics properties) is updated to align with the current HPRA-approved version.

Updated on 20 May 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

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

Updated on 3 July 2014 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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.

 

 

Updated on 19 March 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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.

 

 

 

 

 

 

 

 

 

Updated on 28 July 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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

Updated on 22 October 2010 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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 24th May 1994/24th May 2004 to 24th May 1984/24 May 2009

 

 

Section 10

Date changed from 28th May 2004 to June 2010

Updated on 11 July 2008 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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

Updated on 10 August 2004 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category: Supply through pharmacy only

Updated on 7 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only