- Approval Id
- a862167a0d6e1dee
- Drug Approval Emc Name
- Strepsils Extra Triple Action Blackcurrant Lozenges
- Drug Name
- Strepsils Extra Triple Action Blackcurrant Lozenges
- Company Address
- RB Consumer Relations, PO Box 4644, SLOUGH, SL1 0NS, UK
- Company Website
- http://www.reckittbenckiser.com
- Company Telephone
- 0333 2005 345
- Company Medical Info Direct Line
- 0333 2005 345
- Company Customer Care Direct Line
- 0333 2005 345
- Legal Category
- General Sales List
- Authorisation Holder
- Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 3UH
- Authorisation Number
- PL 00063/0392
- Authorisation Date
- 19/03/2010
- Instruction Authorisation Holder
- Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 3UH
- Instruction Authorisation Number
- PL 00063/0392
- Instruction Authorisation Date
- 19/03/2010
- Instruction Composition
- Each lozenge contains Hexylresorcinol 2.4mg
Excipient(s) with known effect:
Glucose
Fragrance containing allergens - d-Limonene and Linalool\\*\\*
Carmoisine (E122)
Sucrose
Sulphites – Sulphur Dioxide (E220)\\*
Wheat starch (containing Gluten)\\*
Propylene glycol \\*\\*
\\* present in liquid glucose
\\*\\* present in blackcurrant flavour
For excipients see Section 6.1
- Instruction Dosage Form
- Lozenge
A round purple lozenge
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
As an antiseptic and local anaesthetic for the relief of sore throat and its associated pain.4.2 Posology and method of administration
For oral administration.
Adults, the elderly and children 6 years and over: One lozenge dissolved slowly in the mouth every three hours or as required.
Do not take more than 12 lozenges in 24 hours.
Not to be given to children under 6 years.4.3 Contraindications
Hypersensitivity to any of the ingredients.4.4 Special warnings and precautions for use
The label will convey:
Keep out of the reach and sight of children.
If symptoms persist consult your doctor.
Not to be given to children under 6 years.
\*\*Important information about some of the ingredients of this medicine\*\*
• This medicine contains only very low levels of gluten (from wheat starch). It is regarded as 'gluten-free' and is very unlikely to cause problems if you have coeliac disease.
One lozenge contains no more than 22.42 micrograms of gluten.
If you have wheat allergy (different from coeliac disease) you should not take this medicine.
• This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
• This medicine contains fragrance with d-Limonene and Linalool.
d-Limonene and Linalool may cause allergic reactions.
• This medicine contains carmoisine (E122) which may cause allergic reactions
• This medicine contains Sulphites – Sulphur Dioxide (E220) – present in liquid glucose which may rarely cause severe hypersensitivity reactions and bronchospasm.
• Patients with rare glucose-galactose malabsorption should not take this medicine
• Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6 Pregnancy and lactation
There is lack of evidence of safety of the product in human pregnancy and in animals, but hexylresorcinol has been used widely in lozenges for many years without apparent ill consequence. However, as with all medicines, caution should be exercised during pregnancy and lactation.4.7 Effects on ability to drive and use machines
None known.4.8 Undesirable effects
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse Events\*\* |
| Immune System Disorders | Not known | Hypersensitivity1 |
1 Hypersensitivity reactions may include rash, urticaria and angioedema, which may include swelling of the face, neck, throat or tongue that could affect breathing.
\*\*Reporting of Suspected Adverse Reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Hexylresorcinol overdosage may cause minor gastrointestinal irritation. Treatment would be withdrawal of the product and symptomatic measures as appropriate.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Hexylresorcinol is a local anaesthetic for topical use on the mucous membranes of the mouth and throat. Mild antiseptic activity has also been demonstrated.
The product base has a demulcent action.5.2 Pharmacokinetic properties
Pharmacokinetic considerations do not arise since the pharmacological action is local to the oro-pharyngeal cavity.5.3 Preclinical safety data
There are no preclinical data of relevance additional to those already included in other sections of the SPC.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Liquid sucrose
Liquid glucose (prepared from wheat starch (containing gluten) and Sulphites – Sulphur Dioxide)
Blackcurrant flavour (containing Propylene glycol, d-Limonene and Linalool)
Levomenthol
Carmoisine (E122)
Patent blue V (E131)6.2 Incompatibilities
Not applicable6.3 Shelf life
36 months for the unopened blister pack6.4 Special precautions for storage
Do not store above 25°C. Store in the original packaging. Keep in the outer carton.6.5 Nature and contents of container
Blister packs of 250 micron PVC/coated 40gsm PVDC with 20 micron hard temper aluminium foil heat-sealed to the PVC/PVDC blister. The tray contains an appropriate number of lozenges to give a pack sizes of 2, 4, 6, 12, 16, 24, 32, 36 and 48.
8 lozenges in a blister in a carton or a flow wrap outer composed of PET/aluminium foil/polyethylene.6.6 Special precautions for disposal and other handling
None specific to the product/pack.
- Instruction Content
- ## Composition
Each lozenge contains Hexylresorcinol 2.4mg
Excipient(s) with known effect:
Glucose
Fragrance containing allergens - d-Limonene and Linalool\\*\\*
Carmoisine (E122)
Sucrose
Sulphites – Sulphur Dioxide (E220)\\*
Wheat starch (containing Gluten)\\*
Propylene glycol \\*\\*
\\* present in liquid glucose
\\*\\* present in blackcurrant flavour
For excipients see Section 6.1
## Pharmaceutical Form
Lozenge
A round purple lozenge
## Clinical Particulars
4.1 Therapeutic indications
As an antiseptic and local anaesthetic for the relief of sore throat and its associated pain.4.2 Posology and method of administration
For oral administration.
Adults, the elderly and children 6 years and over: One lozenge dissolved slowly in the mouth every three hours or as required.
Do not take more than 12 lozenges in 24 hours.
Not to be given to children under 6 years.4.3 Contraindications
Hypersensitivity to any of the ingredients.4.4 Special warnings and precautions for use
The label will convey:
Keep out of the reach and sight of children.
If symptoms persist consult your doctor.
Not to be given to children under 6 years.
\*\*Important information about some of the ingredients of this medicine\*\*
• This medicine contains only very low levels of gluten (from wheat starch). It is regarded as 'gluten-free' and is very unlikely to cause problems if you have coeliac disease.
One lozenge contains no more than 22.42 micrograms of gluten.
If you have wheat allergy (different from coeliac disease) you should not take this medicine.
• This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
• This medicine contains fragrance with d-Limonene and Linalool.
d-Limonene and Linalool may cause allergic reactions.
• This medicine contains carmoisine (E122) which may cause allergic reactions
• This medicine contains Sulphites – Sulphur Dioxide (E220) – present in liquid glucose which may rarely cause severe hypersensitivity reactions and bronchospasm.
• Patients with rare glucose-galactose malabsorption should not take this medicine
• Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6 Pregnancy and lactation
There is lack of evidence of safety of the product in human pregnancy and in animals, but hexylresorcinol has been used widely in lozenges for many years without apparent ill consequence. However, as with all medicines, caution should be exercised during pregnancy and lactation.4.7 Effects on ability to drive and use machines
None known.4.8 Undesirable effects
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse Events\*\* |
| Immune System Disorders | Not known | Hypersensitivity1 |
1 Hypersensitivity reactions may include rash, urticaria and angioedema, which may include swelling of the face, neck, throat or tongue that could affect breathing.
\*\*Reporting of Suspected Adverse Reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Hexylresorcinol overdosage may cause minor gastrointestinal irritation. Treatment would be withdrawal of the product and symptomatic measures as appropriate.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Hexylresorcinol is a local anaesthetic for topical use on the mucous membranes of the mouth and throat. Mild antiseptic activity has also been demonstrated.
The product base has a demulcent action.5.2 Pharmacokinetic properties
Pharmacokinetic considerations do not arise since the pharmacological action is local to the oro-pharyngeal cavity.5.3 Preclinical safety data
There are no preclinical data of relevance additional to those already included in other sections of the SPC.
## Pharmaceutical Particulars
6.1 List of excipients
Liquid sucrose
Liquid glucose (prepared from wheat starch (containing gluten) and Sulphites – Sulphur Dioxide)
Blackcurrant flavour (containing Propylene glycol, d-Limonene and Linalool)
Levomenthol
Carmoisine (E122)
Patent blue V (E131)6.2 Incompatibilities
Not applicable6.3 Shelf life
36 months for the unopened blister pack6.4 Special precautions for storage
Do not store above 25°C. Store in the original packaging. Keep in the outer carton.6.5 Nature and contents of container
Blister packs of 250 micron PVC/coated 40gsm PVDC with 20 micron hard temper aluminium foil heat-sealed to the PVC/PVDC blister. The tray contains an appropriate number of lozenges to give a pack sizes of 2, 4, 6, 12, 16, 24, 32, 36 and 48.
8 lozenges in a blister in a carton or a flow wrap outer composed of PET/aluminium foil/polyethylene.6.6 Special precautions for disposal and other handling
None specific to the product/pack.
- Company Detail Path
- /organization/reckitt-benckiser-healthcare-uk-ltd
