Strepsils Extra Blackcurrant Lozenges

  • Name:

    Strepsils Extra Blackcurrant Lozenges

  • Company:
    info
  • Active Ingredients:

    Hexylresorcinol

  • Legal Category:

    Supply through general sale

Summary of Product Characteristics last updated on medicines.ie: 14/12/2016
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Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

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1 - 0 of 66 items.Total: Infinity pages

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 14 December 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 4.7 - Effects on ability to drive and use machines
  • 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:
Additional details:
One lozenge every 3 hours or as required.  Do not take more than 12 lozenges in 24 hours.  Duration of therapy should be limited to a maximum of 3 days.
Paediatric population - children of 6 years and over, same as for adults.
Elderly population - no dosage adjustment required
Method of administration: For oral administration.  Allow the lozenge to dissolve slowly in the mouth.

Section 4.3:
Text amended to read: Hypersensitivity to hexylresorcinol or to any of the excipients listed in section 6.

Section 4.4:
Addition of "If symptoms do not improve or worsen within 3 days, consult a healthcare professional"

Section 4.6:
Addition of:
Pregnancy - The product should be used with caution during pregnancy.  There are no or limited amount of data from the use of hexylresorcinol in pregnant women.  No effects during pregnancy are anticipated.
Breast-feeding - The product should be used with caution during breast-feeding.  It is unknown whether hexylresorcinol metabolites are excreted in human milk.  No effects on the breastfed newborn/infant are anticipated.
Fertility - There are no data available regarding the use of hexylresorcinol on male or female fertility.  No effects on fertility are anticipated.

Section 4.7:
Text amended to read "The product has no or negligible influence on the ability to drive and use machines"

Section 4.8:
Addition of the Reporting of Suspected Adverse Reactions paragraph

Section 5.2:
Addition of "Pharmacotherapeutic group: Throat preparations, antiseptics.  ATC Code: R02AA12"
Addition of "Hexylresorcinol is a phenol derivative"
Addition of "The local anaesthetic-like properties of hexylresorcinol are due, at least in part, to sodium channel-blocking effects"

 

Updated on 14 December 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 14 December 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 4.7 - Effects on ability to drive and use machines
  • 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:
Additional details:
One lozenge every 3 hours or as required.  Do not take more than 12 lozenges in 24 hours.  Duration of therapy should be limited to a maximum of 3 days.
Paediatric population - children of 6 years and over, same as for adults.
Elderly population - no dosage adjustment required
Method of administration: For oral administration.  Allow the lozenge to dissolve slowly in the mouth.

Section 4.3:
Text amended to read: Hypersensitivity to hexylresorcinol or to any of the excipients listed in section 6.

Section 4.4:
Addition of "If symptoms do not improve or worsen within 3 days, consult a healthcare professional"

Section 4.6:
Addition of:
Pregnancy - The product should be used with caution during pregnancy.  There are no or limited amount of data from the use of hexylresorcinol in pregnant women.  No effects during pregnancy are anticipated.
Breast-feeding - The product should be used with caution during breast-feeding.  It is unknown whether hexylresorcinol metabolites are excreted in human milk.  No effects on the breastfed newborn/infant are anticipated.
Fertility - There are no data available regarding the use of hexylresorcinol on male or female fertility.  No effects on fertility are anticipated.

Section 4.7:
Text amended to read "The product has no or negligible influence on the ability to drive and use machines"

Section 4.8:
Addition of the Reporting of Suspected Adverse Reactions paragraph

Section 5.2:
Addition of "Pharmacotherapeutic group: Throat preparations, antiseptics.  ATC Code: R02AA12"
Addition of "Hexylresorcinol is a phenol derivative"
Addition of "The local anaesthetic-like properties of hexylresorcinol are due, at least in part, to sodium channel-blocking effects"

 

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

updated 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

updated with relevant diabetic warnings 

Updated on 24 April 2012 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

" Excipients: Each lozenge contains 1.4g sucrose, 1.1g glucose and 0.13g Camoisine (E122). For a full list of excipeints, see section 6.1. added to Section 2.

"This product may cause allergic reactions" added to Section 4.4

Updated on 24 April 2012 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

" Excipients: Each lozenge contains 1.4g sucrose, 1.1g glucose and 0.13g Camoisine (E122). For a full list of excipeints, see section 6.1. added to Section 2.

"This product may cause allergic reactions" added to Section 4.4

Updated on 27 August 2007 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to section 8 - MA number

Free text change information supplied by the pharmaceutical company

Transfer of MA holder 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 10 - Date of revision of the text
  • Change to section 8 - MA number

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Transfer of MA holder 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