Strepsils Strawberry Sugar Free Lozenges
*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 Strawberry Sugar Free 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 - how to report a side effect
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 31 August 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 4.8 - Undesirable effects
- 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
Breakdown of posology into adults, paediatric and elderly populations.
Addition of Posology - the lowest effective dose should be used for the shortest duration necessary to relieve symptoms. It is recommended that the product should be used for a maximum of 3 days.
Addition of Method of Administration - for oromucosal administration. To be dissolved slowly in the mouth.
Section 4.3:
Addition of: hypersensitivity "to the active substances or to any of the excipients listed in Section 6.1"
Section 4.4:
Addition of: "This product is not recommended for young children due to a risk of choking". Contains maltitol syrup (E956). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Section 4.6:
Addition of paragraph headers Pregnancy, Breastfeeding, Fertility
Movement of: "Animal studies to not indicate direct or indirect harmful effects with respect to reproductive toxicity" from pregnancy to fertility paragraphs.
Addition of: "A risk to the newborn/infant cannot be excluded" to breast-feeding paragraph
Section 4.8:
Addition of MEDdra table detailing disorders by system organ class, frequency and adverse events.
Addition of Reporting of Adverse Events information
Section 5.1:
Addition of "Pharmacotherapeutic group: Throat Preparations; Antiseptics: ATC Code RO2AA03 Dichlorobenzyl alcohol"
Updated on 31 August 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 4.8 - Undesirable effects
- 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
Breakdown of posology into adults, paediatric and elderly populations.
Addition of Posology - the lowest effective dose should be used for the shortest duration necessary to relieve symptoms. It is recommended that the product should be used for a maximum of 3 days.
Addition of Method of Administration - for oromucosal administration. To be dissolved slowly in the mouth.
Section 4.3:
Addition of: hypersensitivity "to the active substances or to any of the excipients listed in Section 6.1"
Section 4.4:
Addition of: "This product is not recommended for young children due to a risk of choking". Contains maltitol syrup (E956). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Section 4.6:
Addition of paragraph headers Pregnancy, Breastfeeding, Fertility
Movement of: "Animal studies to not indicate direct or indirect harmful effects with respect to reproductive toxicity" from pregnancy to fertility paragraphs.
Addition of: "A risk to the newborn/infant cannot be excluded" to breast-feeding paragraph
Section 4.8:
Addition of MEDdra table detailing disorders by system organ class, frequency and adverse events.
Addition of Reporting of Adverse Events information
Section 5.1:
Addition of "Pharmacotherapeutic group: Throat Preparations; Antiseptics: ATC Code RO2AA03 Dichlorobenzyl alcohol"
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 04 September 2014
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 04 September 2014
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Free text change information supplied by the pharmaceutical company
Updated on 29 November 2011
Reasons for updating
- 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
Updated on 29 November 2011
Reasons for updating
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 06 May 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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 general sale
Free text change information supplied by the pharmaceutical company
Updated on 06 May 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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
Free text change information supplied by the pharmaceutical company
Updated on 27 August 2007
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 general sale
Free text change information supplied by the pharmaceutical company
Updated on 27 August 2007
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
Free text change information supplied by the pharmaceutical company
Updated on 24 May 2006
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 24 May 2006
Reasons for updating
- New SPC for new product