Sudafed 0.1% w/v Nasal Spray Solution
*Company:
KenvueStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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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
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
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
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
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
- Name changed to: Non-Drowsy Sudafed Decongestant 0.1% w/v Nasal Spray, Solution
- 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
- Changed to: Nasal spray solution (Nasal spray). A clear, colourless solution
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
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