Strepsils Extra Blackcurrant 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 16 September 2024
File name
Strepsils Extra Blackcurrant SmPC Aug21.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
- Change to section 6.1 - List of excipients
Legal category:Supply through general sale
Updated on 14 December 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 14 December 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 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.2:
Additional details:
One lozenge every 3 hours or as required. Do not take more than 12 lozenges in 24 hours. Duration of therapy should be limited to a maximum of 3 days.
Paediatric population - children of 6 years and over, same as for adults.
Elderly population - no dosage adjustment required
Method of administration: For oral administration. Allow the lozenge to dissolve slowly in the mouth.
Section 4.3:
Text amended to read: Hypersensitivity to hexylresorcinol or to any of the excipients listed in section 6.
Section 4.4:
Addition of "If symptoms do not improve or worsen within 3 days, consult a healthcare professional"
Section 4.6:
Addition of:
Pregnancy - The product should be used with caution during pregnancy. There are no or limited amount of data from the use of hexylresorcinol in pregnant women. No effects during pregnancy are anticipated.
Breast-feeding - The product should be used with caution during breast-feeding. It is unknown whether hexylresorcinol metabolites are excreted in human milk. No effects on the breastfed newborn/infant are anticipated.
Fertility - There are no data available regarding the use of hexylresorcinol on male or female fertility. No effects on fertility are anticipated.
Section 4.7:
Text amended to read "The product has no or negligible influence on the ability to drive and use machines"
Section 4.8:
Addition of the Reporting of Suspected Adverse Reactions paragraph
Section 5.2:
Addition of "Pharmacotherapeutic group: Throat preparations, antiseptics. ATC Code: R02AA12"
Addition of "Hexylresorcinol is a phenol derivative"
Addition of "The local anaesthetic-like properties of hexylresorcinol are due, at least in part, to sodium channel-blocking effects"
Additional details:
One lozenge every 3 hours or as required. Do not take more than 12 lozenges in 24 hours. Duration of therapy should be limited to a maximum of 3 days.
Paediatric population - children of 6 years and over, same as for adults.
Elderly population - no dosage adjustment required
Method of administration: For oral administration. Allow the lozenge to dissolve slowly in the mouth.
Section 4.3:
Text amended to read: Hypersensitivity to hexylresorcinol or to any of the excipients listed in section 6.
Section 4.4:
Addition of "If symptoms do not improve or worsen within 3 days, consult a healthcare professional"
Section 4.6:
Addition of:
Pregnancy - The product should be used with caution during pregnancy. There are no or limited amount of data from the use of hexylresorcinol in pregnant women. No effects during pregnancy are anticipated.
Breast-feeding - The product should be used with caution during breast-feeding. It is unknown whether hexylresorcinol metabolites are excreted in human milk. No effects on the breastfed newborn/infant are anticipated.
Fertility - There are no data available regarding the use of hexylresorcinol on male or female fertility. No effects on fertility are anticipated.
Section 4.7:
Text amended to read "The product has no or negligible influence on the ability to drive and use machines"
Section 4.8:
Addition of the Reporting of Suspected Adverse Reactions paragraph
Section 5.2:
Addition of "Pharmacotherapeutic group: Throat preparations, antiseptics. ATC Code: R02AA12"
Addition of "Hexylresorcinol is a phenol derivative"
Addition of "The local anaesthetic-like properties of hexylresorcinol are due, at least in part, to sodium channel-blocking effects"
Updated on 14 December 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 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
Section 4.2:
Additional details:
One lozenge every 3 hours or as required. Do not take more than 12 lozenges in 24 hours. Duration of therapy should be limited to a maximum of 3 days.
Paediatric population - children of 6 years and over, same as for adults.
Elderly population - no dosage adjustment required
Method of administration: For oral administration. Allow the lozenge to dissolve slowly in the mouth.
Section 4.3:
Text amended to read: Hypersensitivity to hexylresorcinol or to any of the excipients listed in section 6.
Section 4.4:
Addition of "If symptoms do not improve or worsen within 3 days, consult a healthcare professional"
Section 4.6:
Addition of:
Pregnancy - The product should be used with caution during pregnancy. There are no or limited amount of data from the use of hexylresorcinol in pregnant women. No effects during pregnancy are anticipated.
Breast-feeding - The product should be used with caution during breast-feeding. It is unknown whether hexylresorcinol metabolites are excreted in human milk. No effects on the breastfed newborn/infant are anticipated.
Fertility - There are no data available regarding the use of hexylresorcinol on male or female fertility. No effects on fertility are anticipated.
Section 4.7:
Text amended to read "The product has no or negligible influence on the ability to drive and use machines"
Section 4.8:
Addition of the Reporting of Suspected Adverse Reactions paragraph
Section 5.2:
Addition of "Pharmacotherapeutic group: Throat preparations, antiseptics. ATC Code: R02AA12"
Addition of "Hexylresorcinol is a phenol derivative"
Addition of "The local anaesthetic-like properties of hexylresorcinol are due, at least in part, to sodium channel-blocking effects"
Additional details:
One lozenge every 3 hours or as required. Do not take more than 12 lozenges in 24 hours. Duration of therapy should be limited to a maximum of 3 days.
Paediatric population - children of 6 years and over, same as for adults.
Elderly population - no dosage adjustment required
Method of administration: For oral administration. Allow the lozenge to dissolve slowly in the mouth.
Section 4.3:
Text amended to read: Hypersensitivity to hexylresorcinol or to any of the excipients listed in section 6.
Section 4.4:
Addition of "If symptoms do not improve or worsen within 3 days, consult a healthcare professional"
Section 4.6:
Addition of:
Pregnancy - The product should be used with caution during pregnancy. There are no or limited amount of data from the use of hexylresorcinol in pregnant women. No effects during pregnancy are anticipated.
Breast-feeding - The product should be used with caution during breast-feeding. It is unknown whether hexylresorcinol metabolites are excreted in human milk. No effects on the breastfed newborn/infant are anticipated.
Fertility - There are no data available regarding the use of hexylresorcinol on male or female fertility. No effects on fertility are anticipated.
Section 4.7:
Text amended to read "The product has no or negligible influence on the ability to drive and use machines"
Section 4.8:
Addition of the Reporting of Suspected Adverse Reactions paragraph
Section 5.2:
Addition of "Pharmacotherapeutic group: Throat preparations, antiseptics. ATC Code: R02AA12"
Addition of "Hexylresorcinol is a phenol derivative"
Addition of "The local anaesthetic-like properties of hexylresorcinol are due, at least in part, to sodium channel-blocking effects"
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 with relevant diabetic warnings
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 with relevant diabetic warnings
Updated on 24 April 2012
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 general sale
Free text change information supplied by the pharmaceutical company
" Excipients: Each lozenge contains 1.4g sucrose, 1.1g glucose and 0.13g Camoisine (E122). For a full list of excipeints, see section 6.1. added to Section 2.
"This product may cause allergic reactions" added to Section 4.4
"This product may cause allergic reactions" added to Section 4.4
Updated on 24 April 2012
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Free text change information supplied by the pharmaceutical company
" Excipients: Each lozenge contains 1.4g sucrose, 1.1g glucose and 0.13g Camoisine (E122). For a full list of excipeints, see section 6.1. added to Section 2.
"This product may cause allergic reactions" added to Section 4.4
"This product may cause allergic reactions" added to Section 4.4
Updated on 27 August 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
- Change to section 8 - MA number
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Transfer of MA holder to Reckitt Benckiser Ireland Ltd and change of PA number
Updated on 27 August 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
- Change to section 8 - MA number
Free text change information supplied by the pharmaceutical company
Transfer of MA holder to Reckitt Benckiser Ireland Ltd and change of PA number
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
Reckitt Benckiser Ireland Limited
Address:
7 Riverwalk, Citywest Business Campus, Dublin 24, IrelandTelephone:
+353 1 468 9200Fax:
+353 1 468 9299