Strepsils +Plus anaesthetic Lozenges

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/05/20

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Summary of Product Characteristics last updated on medicines.ie: 28/9/2016
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Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

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Medicine Name Gaviscon Advance Tablets Active Ingredients Potassium Bicarbonate, Sodium Alginate
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Medicine Name Gaviscon Extra Liquid Sachets Peppermint Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Extra Oral Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Infant Active Ingredients Magnesium Alginate, Sodium Alginate
Medicine Name Gaviscon Liquid - Peppermint Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Liquid Aniseed Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Peppermint Chewable Tablets Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Hydrogen Carbonate
Medicine Name Gaviscon Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Hc45 Hydrocortisone Acetate 1% w/w Cream Active Ingredients Hydrocortisone Acetate
Medicine Name Lemsip Chesty Cough 50 mg/5 ml Oral Solution Active Ingredients Guaifenesin
Medicine Name Lemsip Cold & Flu Headcold 500mg Powder for Oral Solution Active Ingredients Paracetamol
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1 - 0 of 64 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 26 May 2020 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 15 January 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 13 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 December 2016 PIL

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 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 4.5 - 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.
 
  

Updated on 28 September 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 9 April 2014 SmPC

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 8 April 2014 PIL

Reasons for updating

  • Change to date of revision
  • Changes to therapeutic indications

Updated on 24 October 2011 SmPC

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 4 October 2011 SmPC

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.

Updated on 3 October 2011 PIL

Reasons for updating

  • Change to appearance of the medicine

Updated on 15 September 2011 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 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".

Updated on 14 June 2011 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 August 2007 SmPC

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 9 June 2006 SmPC

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 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 23 July 2003 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category: Supply through pharmacy only