Strepsils Orange with Vitamin C 100mg Lozenges
*Company:
Reckitt Benckiser Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 July 2021
File name
Strepsils Orange & Vit C SmPC July21.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 16 December 2020
File name
Strepsils Orange + Vit C SmPC Dec20.pdf
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
Addition of 36 pack
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 11 August 2016
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Flavour Givaudan Blood Orange 78300 34 change to Blood Orange PHL 105288
Updated on 11 August 2016
Reasons for updating
- Change to section 6.1 - List of excipients
Free text change information supplied by the pharmaceutical company
Flavour Givaudan Blood Orange 78300 34 change to Blood Orange PHL 105288
Updated on 14 July 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
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Update to text and addition of the text: The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
Section 4.3:
Movement of the following text from Section 4.4 to Section 4.3: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Section 4.4:
Addition of the text: This product is not recommended for young children due to a risk of choking". "If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product". "Contains 0.968491g glucose and 0.14379g sucrose per dose. This should be taken into account in patients with diabetes mellitus".
Sect 4.6:
Addition of text in relation to breast-feeding: Ascorbic acid or metabolites are excreted in human milk but at therapeutic doses of the product no effects on breastfed newborns / infants are anticipated.
Movement of the following text from Pregnancy to Fertility: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Section 4.8:
Adverse effects, frequencies and MedDRA table added with the following information:
System organ class Frequency Adverse Reactions
Immune System disorders Not known Hypersensitivity
Gastrointestinal disorders Not known Abdominal pain, nausea, oral discomfort
Skin/Subcutaneous tissue Not known Rash
disorder
Local details regarding reporting of suspected adverse reactions also added.
Section 5.1:
Addition of the text: Pharmacotherapeutic group: Throat Preparations: Antiseptics.
ATC code: R02AA03 Dichlorobenzyl alcohol
Updated on 14 July 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
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
Update to text and addition of the text: The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
Section 4.3:
Movement of the following text from Section 4.4 to Section 4.3: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Section 4.4:
Addition of the text: This product is not recommended for young children due to a risk of choking". "If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product". "Contains 0.968491g glucose and 0.14379g sucrose per dose. This should be taken into account in patients with diabetes mellitus".
Sect 4.6:
Addition of text in relation to breast-feeding: Ascorbic acid or metabolites are excreted in human milk but at therapeutic doses of the product no effects on breastfed newborns / infants are anticipated.
Movement of the following text from Pregnancy to Fertility: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Section 4.8:
Adverse effects, frequencies and MedDRA table added with the following information:
System organ class Frequency Adverse Reactions
Immune System disorders Not known Hypersensitivity
Gastrointestinal disorders Not known Abdominal pain, nausea, oral discomfort
Skin/Subcutaneous tissue Not known Rash
disorder
Local details regarding reporting of suspected adverse reactions also added.
Section 5.1:
Addition of the text: Pharmacotherapeutic group: Throat Preparations: Antiseptics.
ATC code: R02AA03 Dichlorobenzyl alcohol
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
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
Updated on 11 October 2012
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
Updated on 11 October 2012
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Updated on 22 November 2011
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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
Section 4.4 updated to include Patients with rare hereditry problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficeincy should not take this medicine
The colours Sunset yellow FCF and Ponceau 4R may cause allergic reactions.
Updated on 22 November 2011
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.4 - Special warnings and precautions for use
Free text change information supplied by the pharmaceutical company
Section 4.4 updated to include Patients with rare hereditry problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficeincy should not take this medicine
The colours Sunset yellow FCF and Ponceau 4R may cause allergic reactions.
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 general sale
Free text change information supplied by the pharmaceutical company
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
Free text change information supplied by the pharmaceutical company
Updated on 24 May 2006
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 24 May 2006
Reasons for updating
- New SPC for new product