Strepsils Honey and Lemon *
General Sale: Non-prescription

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 19 July 2021

File name

Strepsils Honey & Lemon SmPC July21_1626707925.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 in line with CCDS

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 in line with CCDS

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

update to SmPC with relevant diabetic warnings 

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

update to SmPC with relevant diabetic warnings 

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 6.3 - added 3 years for 36 lozenge pack.

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

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

In section 6.3 - added 3 years for 36 lozenge pack.

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

In section 6.5, An injection moulded white pigmented polypropylene tube fitted with a plastic spring with an injection moulded white polyethylene cap (containing white silica gel that is sealed with a white cardboard disc).

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

In section 6.5, An injection moulded white pigmented polypropylene tube fitted with a plastic spring with an injection moulded white polyethylene cap (containing white silica gel that is sealed with a white cardboard disc).

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

Section 1 changed from Strepsils Honey & Lemon to Strepsils Honey & Lemon Lozenges amylmetacresol 0.6mg, 2,4 - dichlorobenzyl alcohol 1.2mg

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

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 1 changed from Strepsils Honey & Lemon to Strepsils Honey & Lemon Lozenges amylmetacresol 0.6mg, 2,4 - dichlorobenzyl alcohol 1.2mg

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

Section 6.5 - addition of new pack type

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

Section 6.5 - addition of new pack type

Updated on 27 August 2007

Reasons for updating

  • New SPC for medicines.ie

Updated on 27 August 2007

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale