Strepsils Orange with Vitamin C 100mg 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 11 August 2016 PIL

Reasons for updating

  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

Section 6.1
Flavour Givaudan Blood Orange 78300 34 change to Blood Orange PHL 105288

Updated on 11 August 2016 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 6.1
Flavour Givaudan Blood Orange 78300 34 change to Blood Orange PHL 105288

Updated on 14 July 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

Section 4.2:
Update to text and addition of the text: The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.

Section 4.3:
Movement of the following text from Section 4.4 to Section 4.3: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

Section 4.4:
Addition of the text: This product is not recommended for young children due to a risk of choking". "If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product".  "Contains 0.968491g glucose and 0.14379g sucrose per dose.  This should be taken into account in patients with diabetes mellitus".

Sect 4.6:
Addition of text in relation to breast-feeding: Ascorbic acid or metabolites are excreted in human milk but at therapeutic doses of the product no effects on breastfed newborns / infants are anticipated. 
Movement of the following text from Pregnancy to Fertility: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Section 4.8:
Adverse effects, frequencies and MedDRA table added with the following information:
System organ class               Frequency       Adverse Reactions
Immune System disorders    Not known       Hypersensitivity
Gastrointestinal disorders      Not known      Abdominal pain, nausea, oral discomfort
Skin/Subcutaneous tissue     Not known       Rash
      disorder

Local details regarding reporting of suspected adverse reactions also added.

Section 5.1:
Addition of the text: Pharmacotherapeutic group: Throat Preparations: Antiseptics.
ATC code: R02AA03 Dichlorobenzyl alcohol
  

Updated on 14 July 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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:
Update to text and addition of the text: The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.

Section 4.3:
Movement of the following text from Section 4.4 to Section 4.3: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

Section 4.4:
Addition of the text: This product is not recommended for young children due to a risk of choking". "If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product".  "Contains 0.968491g glucose and 0.14379g sucrose per dose.  This should be taken into account in patients with diabetes mellitus".

Sect 4.6:
Addition of text in relation to breast-feeding: Ascorbic acid or metabolites are excreted in human milk but at therapeutic doses of the product no effects on breastfed newborns / infants are anticipated. 
Movement of the following text from Pregnancy to Fertility: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Section 4.8:
Adverse effects, frequencies and MedDRA table added with the following information:
System organ class               Frequency       Adverse Reactions
Immune System disorders    Not known       Hypersensitivity
Gastrointestinal disorders      Not known      Abdominal pain, nausea, oral discomfort
Skin/Subcutaneous tissue     Not known       Rash
      disorder

Local details regarding reporting of suspected adverse reactions also added.

Section 5.1:
Addition of the text: Pharmacotherapeutic group: Throat Preparations: Antiseptics.
ATC code: R02AA03 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 to SmPC with relevant diabetic warnings 

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 to SmPC with relevant diabetic warnings 

Updated on 11 October 2012 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

In section 6.5, the 40gsm blister has been removed and is replaced with the 90gsm blister.

Updated on 11 October 2012 SmPC

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

In section 6.5, the 40gsm blister has been removed and is replaced with the 90gsm blister.

Updated on 22 November 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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

Section 1 updated tp Strepsils orange with Vitamin C Lozenges Amylmetacresol 0.6mg, 2,4-Dichlorobenzyl alcohol 1.2mg, Vitamin C 100mg
Section 4.4 updated to include Patients with rare hereditry problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficeincy should not take this medicine
The colours Sunset yellow FCF and Ponceau 4R may cause allergic reactions.

Updated on 22 November 2011 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

Section 1 updated tp Strepsils orange with Vitamin C Lozenges Amylmetacresol 0.6mg, 2,4-Dichlorobenzyl alcohol 1.2mg, Vitamin C 100mg
Section 4.4 updated to include Patients with rare hereditry problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficeincy should not take this medicine
The colours Sunset yellow FCF and Ponceau 4R may cause allergic reactions.

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