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Sudafed 0.1% w/v Nasal Spray Solution

*
Pharmacy Only: Non-prescription

  • Company:

    Kenvue

  • Status:

    No Recent Update

  • Legal Category:

    Supply through pharmacy only

  • Active Ingredient(s):

    Xylometazoline Hydrochloride

    *Additional information is available within the SPC or upon request to the company

  • 62636 SUDAFED® Nasal Spray Solution(15ml).jpeg
  • SUDAFED® Nasal Spray Solution with bottle(15ml).png

Updated on 09 June 2024

File name

ie-pl-sudafed-nasal-spray-2414.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 09 June 2024

File name

ie-spc-v12-sudafed-nasal-spray-2414.pdf

Reasons for updating

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

Legal category:Supply through pharmacy only

Updated on 20 July 2021

File name

ie-leaflet-proposed-sudafed-nasl-spray-2144.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 20 July 2021

File name

ie-spc-v11-sudafed-nasal-spray-2144.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Updated on 23 October 2020

File name

ie-pl-proposed-sudafed-nasal-spray-2058.pdf

Reasons for updating

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

Updated on 02 May 2019

File name

ie-mockup-pl-clean-1886.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 01 March 2019

File name

ie-pil-mockup-clean-1886.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 01 March 2019

File name

ie-spc V10 SFO021886.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 15 October 2018

File name

LN516601_PIL SUDAFED NS 15 ml IEV10.2_v1_FVID483287.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 15 October 2018

File name

ie-spc V9 proposed tracked SFO02 1788.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category:Supply through pharmacy only

Updated on 28 May 2018

File name

1663_spc.docx

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Supply through pharmacy only

Updated on 18 May 2018

File name

ie-pil proposed clean-1663.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 27 August 2013

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 27 August 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 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:

Changed from:

Adults and children 12 years and over:

Nasal. One spray to expressed into each nostril 2-3 times daily, as necessary.

Maximum daily dose: 3 Sprays

Use for more than seven consecutive days is not recommended. [See Undesirable Effects]

 

Children aged 6 to 12 years: Use only when simple measures have failed to bring adequate relief. Use for more than five consecutive days is not recommended. [See Undesirable Effects]


To:

Adults and children 12 years and over:

Nasal. One spray to be expressed into each nostril 2-3 times daily, as necessary.

Maximum daily dose: 3 Sprays per nostril

 

Use for more than seven consecutive days is not recommended. [See Undesirable Effects]

 

Children aged 6 to 12 years:

Nasal. One spray to be expressed into each nostril 2-3 times daily, as necessary.

Maximum daily dose: 3 Sprays per nostril

 


Section 4.4:

Added:

Prolonged treatment may lead to hyperaemia of the nasal mucosa.

 

This rebound effect may lead to nasal congestion or nasal obstruction during continued use or after discontinuation, resulting in repeated or even continuous use of the medicine by the patient (see section 4.8).


Section 4.5

Added:

No interaction studies have been performed.



Section 4.6:

'Fertility' added to title.

Plus the follwijng text deleted:


At the recommended dosages, topical sympathomimetic agents such as xylometazoline have minimal systemic absorption. Any small amount excreted in breast milk is not expected to reach clinically significant levels absorbed by the suckling infant.


And repleaced with:

It is not known whether xylometazoline or its metabolites 

are excreted in the human milk.


Section 4.7

No special comment – unlikely to produce an effect


replaced with:

It is not known if xylometazoline has an effect on the ability to drive and use machines.



Updated on 21 August 2013

File name

PIL_10745_927.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 August 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration

Updated on 20 December 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to date of revision

Updated on 22 November 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Reinstaing SPC with amends to section 4.2 (Clarity re. dosage - aligned to PIL), 4.4 (Addition of excipient warnings), 4.6 (Update pregnancy warning)

Updated on 18 July 2011

Reasons for updating

  • Correction of spelling/typing errors
  • SPC retired pending re-submission

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.2  Posology and Method of Administration

 

Adults and children 6 years and over:

Nasal. One spray to expressed into each nostril 2-3 times daily, as necessary.

Maximum daily dose: 3 Sprays



            Corrected to read:-


4.2  Posology and Method of Administration

 

Adults and children 6 years and over:

Nasal. One spray to be expressed into each nostril 2-3 times daily, as necessary.

Maximum daily dose: 3 Sprays

Updated on 29 June 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 22 December 2009

Reasons for updating

  • Change to product name

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The name of the product has changed from Non Drowsy Sudafed Decongestant 0.1% w/v Nasal Spray Solution to Sudafed 0.1% w/v Nasal Spray Solution.

Updated on 25 November 2009

Reasons for updating

  • Change of trade or active ingredient name

Updated on 11 September 2009

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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

 

Statement added –

 

Children aged 6 to 12 years: Use only when simple measures have failed to bring adequate relief. Use for more than five consecutive days is not recommended. [See Undesirable Effects]

 

Section 4.3

 

Statement added –

 

Non-Drowsy Sudafed Decongestant Nasal Spray is contraindicated for use in children under the age of 6 years.

 

 

Section 10

 

 

Changed to June 2009

Updated on 08 September 2009

Reasons for updating

  • Change to dosage and administration

Updated on 30 October 2008

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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 6.5
Seal changed to "polethylene/butadiene seal"
 
Section 10
Changed to October 2008

Updated on 26 September 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 6.5 - Nature and contents of container

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

  1. Name changed to: Non-Drowsy Sudafed Decongestant 0.1% w/v Nasal Spray, Solution

 

 

  1. Inclusion if metered spray and excipients: The Solution contains 0.1% w/v Xylometazoline Hydrochloride. Each metered spray (0.14 ml) delivers 140 micrograms of xylometazoline hydrocholoride.Excipients: The solution contains 0.040% w/v benzalkonium chloride solution. For a full list of excipients, see section 6.1

 

  1. Changed to: Nasal spray solution (Nasal spray). A clear, colourless solution
    6.1 Inclusion of:             Sorbitol, Liquid (Non-crystallising)
 
    6.5. Inclusion of:   Type III amber glass bottle of either 10 ml or 15ml minimal fill volume.
 

Updated on 26 September 2008

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 19 May 2008

Reasons for updating

  • Change to marketing authorisation holder

Updated on 11 March 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change to the name of the MAH from Pfizer Consumer Healthcare, Pottery Road Dun Laoghaire, Co. Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24

Updated on 13 October 2006

Reasons for updating

  • Change of manufacturer

Updated on 30 March 2006

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Updated on 28 February 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 30 December 2003

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only