Strepsils Honey and Lemon
*Company:
Reckitt Benckiser Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 July 2021
File name
Strepsils Honey & Lemon SmPC July21.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Supply through general sale
Updated on 22 May 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 22 May 2017
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Addition of the following text:
Pharmacotherapeutic group: throat Preparations; Antiseptics;
ATC Code: R02AA03 Dichlorobenzyl alcohol
Mechanism of action
2, 4-Dichlorobenzyl alcohol and amylmetacresol are antiseptics and possess antibacterial, antifungal and antiviral properties. Both AMC and DCBA also reversibly block depolarisation-induced ion channels in a similar way to local anaesthetics. When the two active agents are combined, a synergistic antibacterial action is observed leading to the reduced combined dose used in Strepsils lozenges.
Clinical efficacy and safety
Evidence of an analgesic effect for Strepsils in reducing throat soreness, providing pain relief and relief from difficulty in swallowing has been demonstrated to clinical studies with an onset in 5 minutes which lasts for up to 2 hours. Significantly more relief than nonmedical lozenge was also demonstrated for up to 3 days treatment.
Strepsils lozenge have also been shown to significantly decrease postoperative throat soreness and hoarseness 20 minutes and 24 hours after intubation.
A study in children (6-16 years) with acute and recurring chronic sore throat demonstrates a reduction in subjective and objective signs of sore throat over 3 days.
Updated on 22 May 2017
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
Addition of the following text:
Pharmacotherapeutic group: throat Preparations; Antiseptics;
ATC Code: R02AA03 Dichlorobenzyl alcohol
Mechanism of action
2, 4-Dichlorobenzyl alcohol and amylmetacresol are antiseptics and possess antibacterial, antifungal and antiviral properties. Both AMC and DCBA also reversibly block depolarisation-induced ion channels in a similar way to local anaesthetics. When the two active agents are combined, a synergistic antibacterial action is observed leading to the reduced combined dose used in Strepsils lozenges.
Clinical efficacy and safety
Evidence of an analgesic effect for Strepsils in reducing throat soreness, providing pain relief and relief from difficulty in swallowing has been demonstrated to clinical studies with an onset in 5 minutes which lasts for up to 2 hours. Significantly more relief than nonmedical lozenge was also demonstrated for up to 3 days treatment.
Strepsils lozenge have also been shown to significantly decrease postoperative throat soreness and hoarseness 20 minutes and 24 hours after intubation.
A study in children (6-16 years) with acute and recurring chronic sore throat demonstrates a reduction in subjective and objective signs of sore throat over 3 days.
Updated on 25 April 2016
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 25 April 2016
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
Updated on 22 July 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 22 July 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Free text change information supplied by the pharmaceutical company
Updated on 13 September 2013
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
In Section 6.5 - added "Each blister contains 12 lozenges. Three trays are packed in a carton."
In section 10 - changed date of revision of the text to January 2013.
Updated on 13 September 2013
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In Section 6.5 - added "Each blister contains 12 lozenges. Three trays are packed in a carton."
In section 10 - changed date of revision of the text to January 2013.
Updated on 23 June 2011
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 23 June 2011
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Updated on 15 June 2011
Reasons for updating
- Change to product name
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Revision of text changed from May 2009 to June 2011
Updated on 15 June 2011
Reasons for updating
- Change to product name
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Revision of text changed from May 2009 to June 2011
Updated on 19 October 2009
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 19 October 2009
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Updated on 27 August 2007
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale
Updated on 27 August 2007
Reasons for updating
- New SPC for medicines.ie