Otrivine Adult Measured Dose Sinusitus 0.1% w/v Nasal Spray, Solution

  • Name:

    Otrivine Adult Measured Dose Sinusitus 0.1% w/v Nasal Spray, 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 3 October 2016 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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

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 4 June 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 2

Added: For full list of excipients, see section 6.1

Section 4.2:

Added:
"Otrivine should not be used for more than seven consecutive days. (see section 4.4). The recommended dose should not be exceeded, especially in children and older people."

"up to" added before "3 times daily"

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

Deleted:
"The meter-dose spray permits accuracy of dosage and ensures that the solution is well distributed over the surface of the nasal mucosa. It precludes the possibility of unintentional overdose."

Amended:
Priming instructions

Section 4.3
Added:
Rhinitis sicca and atrophic rhinitis

Section 4.4
Amended:
Cautions for use with concomitant conditions e.g. diabetes, restructured.

Deleted:
"especially in children and the elderly"

Section 4.5:
Added:
More information about interactions with MAO inhibitors and tri- and tetra-cyclic antidepressants.

Section 4.8
Added:
"nasal" in front of ""discomfort"

Reporting of suspected adverse reactions section added

Section 4.9

Deleted:
information about accidental poisoning of children.

Added:
overdose symptoms information and supportive measures

Section 5.1:

Added:
"Mechanism of action and pharmacodynamic effects" heading

"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."

Section 10:
Date changed from 20th June 2014 to 24 April 2015

Updated on 8 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 Measured Dose Sinusitis 0.1% w/v Nasal Spray, Solution – 20 June 2014

 

 

Section 7

 

Address changed to Camberley.

 

Section 10

 

Change of date from 24 March 2014 to 20 June 2014.

 

 

 

 

 

 

 

 

 

Updated on 2 April 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.1 - List of excipients
  • 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 Measured Dose Sinusitis 0.1% w/v Nasal Spray, Solution 24 March 2014

 

Section 2

Qualitative and Quantitative Composition slightly reworded.

 

Removed: “For full list of excipients, see section 6.1”.

 

Section 3

Added “nasal spray” in brackets.

 

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.

 

Section 4.3

Contraindications section reworded.

 

Inserted: “Use in patients who are receiving monoamine oxidase inhibitors, or within 14 days of stopping such treatments.”

“Use in acute coronary disease, hyperthyroidism or narrow angle glaucoma.”

 

Section 4.4

After “consecutive days” added: “Prolonged or excessive use may cause rebound congestion.”

 

Special Warnings and Precautions for Use section reworded;

After “insomnia, dizziness” added: “tremor, cardiac arrhythmias or elevated blood pressure.”

 

Added further warnings for patients with hypertension, cardiovascular disease, diabetic and prostatic enlargement.

 

Addition of paragraph:

“Otrivine Adult Measured Dose Sinusitis Nasal Spray contains benzalkonium chloride which may cause nasal irritation and bronchospasm.

Do not exceed the recommended dose, especially in children and in the elderly.

For prevention of cross infection, it is recommended that each product package is used by one person only.”

 

Section 4.5

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

 

Section 4.6

Under subheading “Pregnancy:” removed: “Label warning: If you are pregnant or taking any other medicines, or are under a doctor’s care, consult him before using Otrivine.”

 

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

 

Section 4.7

“None” replaced with: “Otrivine Adult Measured Dose Sinusitis Nasal Spray has no or negligible influence on the ability to drive or use machines.”

 

Section 4.8

Removed: “The following side effects have occasionally been encountered: A burning sensation in the nose and throat, local irritation, nausea, headache, and dryness of the nasal mucosa.”

 

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.” 

 

Section 5.1

Added Pharmacotherapeutic group and ATC code; section slightly reworded.

 

Added: “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.”

 

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 6.1

“Liquid” added before “Sorbitol” and “(non-crystallising)” added after

 

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”

 

Section 10

Change of date from 20 April 2011 to 24 March 2014.

 

 

 

 

 

 

 

 

 

 

Updated on 28 July 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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

Section 1

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

 

Section 7

Addition of new heading ‘Administrative Data’ just above this section.

 

Section 10

Change of date from 25 August 2006 to April 2011

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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • 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 2: Addition of: “Excipients: Benzalkonium chloride”

Section 3: Text revised to: “a clear, colourless, virtually odourless solution”

Section 6.1: E number added

Section 6.2: Text revised from “None” to “Not applicable”

Section 6.4: text revised from “no special precautions” to “this medicinal product does not require any special storage conditions”

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 7 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only