Strepsils +Plus anaesthetic Throat Spray *

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 30 September 2020

File name

Strepsils Plus Throat Spray PIL Sep20 - Medicines.ie_1601474770.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.

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)

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

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