Strepsils Strawberry Sugar Free Lozenges

Summary of Product Characteristics last updated on medicines.ie: 22/5/2017
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Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

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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 22 May 2017 PIL

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 22 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 22 May 2017 SmPC

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 31 August 2016 PIL

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

Section 4.2
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 SmPC

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

Section 4.2
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 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

update with relevant warnings for diabetics 

Updated on 22 July 2015 SmPC

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

update with relevant warnings for diabetics 

Updated on 4 September 2014 PIL

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Free text change information supplied by the pharmaceutical company

Storage conditions amended to: Do not store above 25oC.

Updated on 4 September 2014 SmPC

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

Storage conditions amended to: Do not store above 25oC.

Updated on 29 November 2011 PIL

Reasons for updating

  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

February 2008  changed to April 2008

Updated on 29 November 2011 SmPC

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

February 2008  changed to April 2008

Updated on 6 May 2008 SmPC

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

Updates to all sections are as requested by the IMB during the license renewal

Updated on 6 May 2008 PIL

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

Updates to all sections are as requested by the IMB during the license renewal

Updated on 27 August 2007 PIL

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

Transfer of MA to Reckitt Benckiser Ireland Ltd. and change of PA number

Updated on 27 August 2007 SmPC

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

Transfer of MA to Reckitt Benckiser Ireland Ltd. and change of PA number

Updated on 24 May 2006 PIL

Reasons for updating

  • New SPC for new product

Updated on 24 May 2006 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through general sale