Strepsils +Plus anaesthetic Lozenges
*Company:
Reckitt Benckiser Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 02 March 2022
File name
Strepsils Plus Lozenge SmPC (clean) Mar22.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 6.1 - List of excipients
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Information added regarding excipient warnings.
Updated on 26 May 2020
File name
Strepsils +Plus anaesthetic Lozenges (3).pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 15 January 2020
File name
Strepsils +Plus anaesthetic Lozenges.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 13 December 2016
File name
PIL_15017_255.pdf
Reasons for updating
- New PIL for new product
Updated on 13 December 2016
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 28 September 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 28 September 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.2:
Addition of: The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
More distinct posology breakdown
Addition of: Method of Administration - For oromucosal administration. To be dissolved slowly in the mouth.
Section 4.3:
Addition of:
[hypersensitivity] to any of the active ingredients or to any of the excipients listed in section 6.1.
A history of allergy to local anaesthetics of the amide type
In patients who have a history of or are suspected to have methaemoglobinaemia.
Deletion of: Patients suffering from asthma or bronchospasm
Section 4.4
Addition of:
Consult your doctor if you suffer from asthma or bronchospasm
Section 4.5
Deletion of:
No clinically significant interactions are known
Addition of: details relating to toxicity of oral lidocaine when taken in combination with the following drugs; CYP34A, CYP1A2, Beta blockers and other anti-arythmic drugs
Section 4.6
Addition of headers Pregnancy, Breast-feeding & Fertility.
In pregnancy paragraph - additional information regarding API's
In breast-feeding paragraph - additional information regarding lidocaine metabolites
Addition of Fertility paragraph.
Section 4.8:
Removal of "occasional hypersensitivity reactions"
Addition of MEDdra table of adverse events, including hypersensitivity, nausea, oral discomfort and rash
Section 4.9:
Addition of headers Symptoms and Management
Section 5.1:
Additional pharmacodynamics information for each API
Section 5.2:
Addition of information regarding metabolism of 2,4-dichlorobenzyl alcohol
Section 5.3:
Removal of "not applicable"
Addition of safety data for 2,4-dichlorobenzyl alcohol.
Addition of: The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
More distinct posology breakdown
Addition of: Method of Administration - For oromucosal administration. To be dissolved slowly in the mouth.
Section 4.3:
Addition of:
[hypersensitivity] to any of the active ingredients or to any of the excipients listed in section 6.1.
A history of allergy to local anaesthetics of the amide type
In patients who have a history of or are suspected to have methaemoglobinaemia.
Deletion of: Patients suffering from asthma or bronchospasm
Section 4.4
Addition of:
Consult your doctor if you suffer from asthma or bronchospasm
Section 4.5
Deletion of:
No clinically significant interactions are known
Addition of: details relating to toxicity of oral lidocaine when taken in combination with the following drugs; CYP34A, CYP1A2, Beta blockers and other anti-arythmic drugs
Section 4.6
Addition of headers Pregnancy, Breast-feeding & Fertility.
In pregnancy paragraph - additional information regarding API's
In breast-feeding paragraph - additional information regarding lidocaine metabolites
Addition of Fertility paragraph.
Section 4.8:
Removal of "occasional hypersensitivity reactions"
Addition of MEDdra table of adverse events, including hypersensitivity, nausea, oral discomfort and rash
Section 4.9:
Addition of headers Symptoms and Management
Section 5.1:
Additional pharmacodynamics information for each API
Section 5.2:
Addition of information regarding metabolism of 2,4-dichlorobenzyl alcohol
Section 5.3:
Removal of "not applicable"
Addition of safety data for 2,4-dichlorobenzyl alcohol.
Updated on 09 April 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
4.1 Therapeutic Indications
Strepsils +Plus anaesthetic Lozenges are indicated for the symptomatic relief of mouth and throat infections including severe sore throat.
Strepsils +Plus Anaesthetic Lozenges are indicated in adults and children over 12 years of age. and adolescents aged 12 to 18 years.
Updated on 08 April 2014
Reasons for updating
- Change to date of revision
- Changes to therapeutic indications
Updated on 24 October 2011
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Text amended in section 3 from 2with the Strepsils brand icon pressed on both sides" to "embossed on both sides with Strepsils brand icon"
Updated on 04 October 2011
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 3.0 Pharmaceutical form updated to;
Lozenge, pale blue/green circular lozenge with the Strepsils brand icon pressed on both sides.
Lozenge, pale blue/green circular lozenge with the Strepsils brand icon pressed on both sides.
Updated on 03 October 2011
Reasons for updating
- Change to appearance of the medicine
Updated on 15 September 2011
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 pharmacy only
Free text change information supplied by the pharmaceutical company
In Section 2 the following has been added "Excipients: also contains glucose 0.98g and sucrose 1.52g per lozenge"
In Section 4.4 the following has been added "Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine".
In Section 4.4 the following has been added "Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine".
Updated on 14 June 2011
Reasons for updating
- New PIL for medicines.ie
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 pharmacy only
Free text change information supplied by the pharmaceutical company
Transfer of MA to Reckitt Benchiser Ireland Ltd and change of PA number
Updated on 09 June 2006
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Supply through pharmacy only
Updated on 21 August 2003
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 23 July 2003
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category:Supply through pharmacy only