Sudafed 0.1% w/v Nasal Spray Solution
- Name:
Sudafed 0.1% w/v Nasal Spray Solution
- Company:
Johnson & Johnson (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/10/20

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Johnson & Johnson (Ireland) Ltd
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Company Products
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 23 October 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 2 May 2019 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 1 March 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 1 March 2019 SPC
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 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 15 October 2018 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 27 August 2013 SPC
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 27 August 2013 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 21 August 2013 PIL
Reasons for updating
- New PIL for new product
Updated on 21 August 2013 PIL
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to date of revision
Updated on 22 November 2012 SPC
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 SPC
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 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 22 December 2009 SPC
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 PIL
Reasons for updating
- Change of trade or active ingredient name
Updated on 11 September 2009 SPC
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 8 September 2009 PIL
Reasons for updating
- Change to dosage and administration
Updated on 30 October 2008 SPC
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 SPC
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 PIL
Reasons for updating
- Change of trade or active ingredient name
- Change to date of revision
Updated on 19 May 2008 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 11 March 2008 SPC
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 PIL
Reasons for updating
- Change of manufacturer
Updated on 30 March 2006 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Supply through pharmacy only
Updated on 28 February 2006 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 30 December 2003 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only