Strepsils +Plus anaesthetic Throat Spray
*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 Spray 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 30 September 2020
File name
Strepsils Plus Throat Spray PIL Sep20 - Medicines.ie.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 22 December 2016
File name
PIL_15030_692.pdf
Reasons for updating
- New PIL for new product
Updated on 22 December 2016
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to section 3 - how to take/use
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 - 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. The nozzle should be aimed at the back of the throat and the product sprayed on to the affected area.
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
Patients should not inhale whilst using the spray
Excessive dosage, short intervals between doses or exposure onto traumatised mucosa may result in unnecessary systemic exposure. Care should be exercised.
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, to include hypersensitivity, nausea, oral discomfort and rash
Section 4.9:
Addition of headers Symptoms and Management
Section 5.1:
Additional pharmacodynamics information for lidocaine
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. The nozzle should be aimed at the back of the throat and the product sprayed on to the affected area.
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
Patients should not inhale whilst using the spray
Excessive dosage, short intervals between doses or exposure onto traumatised mucosa may result in unnecessary systemic exposure. Care should be exercised.
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, to include hypersensitivity, nausea, oral discomfort and rash
Section 4.9:
Addition of headers Symptoms and Management
Section 5.1:
Additional pharmacodynamics information for lidocaine
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 13 August 2015
Reasons for updating
- 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
updated with relevant warnings for diabetics
Updated on 16 October 2012
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
name changed from
Strepsils +Plus Anaesthetic Throat Spray, Amylmetacresol 0.58mg/dose, 2,4-Dichlorobenzyl Alcohol 1.16mg/dose, Lidocaine 1.56mg/dose to
Strepsils +Plus Anaesthetic Throat Spray, Amylmetacresol 0.29mg/spray, 2,4-Dichlorobenzyl Alcohol 0.58mg/spray, Lidocaine 0.78mg/spray
Section 2
Amylemtacresol 0.223% w/v (0.580mg/dose)
2,4- Dichlorobenzyl alcohol 0.446% w/v (1.160mg/dose)
Lidocaine 0.6% w/v (1.560mg/dose)
changed to
Amylemtacresol 0.223% w/v (0.290mg/spray)
2,4- Dichlorobenzyl alcohol 0.446% w/v (0.580mg/spray)
Lidocaine 0.6% w/v (0.780mg/spray)
Strepsils +Plus Anaesthetic Throat Spray, Amylmetacresol 0.58mg/dose, 2,4-Dichlorobenzyl Alcohol 1.16mg/dose, Lidocaine 1.56mg/dose to
Strepsils +Plus Anaesthetic Throat Spray, Amylmetacresol 0.29mg/spray, 2,4-Dichlorobenzyl Alcohol 0.58mg/spray, Lidocaine 0.78mg/spray
Section 2
Amylemtacresol 0.223% w/v (0.580mg/dose)
2,4- Dichlorobenzyl alcohol 0.446% w/v (1.160mg/dose)
Lidocaine 0.6% w/v (1.560mg/dose)
changed to
Amylemtacresol 0.223% w/v (0.290mg/spray)
2,4- Dichlorobenzyl alcohol 0.446% w/v (0.580mg/spray)
Lidocaine 0.6% w/v (0.780mg/spray)
Updated on 30 June 2011
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 1 name changed from Strepsils +Plus anaesthetic Throat Spray to
Strepsils +Plus anaesthetic Throat Spray, amylmetacresol 0.58mg, 2,4- Dichlorobenzyl alcohol1.16mg , Lidocaine 1.56mg
Strepsils +Plus anaesthetic Throat Spray, amylmetacresol 0.58mg, 2,4- Dichlorobenzyl alcohol1.16mg , Lidocaine 1.56mg
Updated on 29 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 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