- Approval Id
- 5396402a0cdb3e15
- Drug Approval Emc Name
- Strepsils Orange with Vitamin C 100mg
- Drug Name
- Strepsils Orange with Vitamin C 100mg
- 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
- Atc Code
- R02AA03
- Legal Category
- General Sales List
- Authorisation Holder
- Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 3UH
- Authorisation Number
- PL 00063/0391
- Authorisation Date
- 19/03/2010
- Instruction Authorisation Holder
- Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 3UH
- Instruction Authorisation Number
- PL 00063/0391
- Instruction Authorisation Date
- 19/03/2010
- Instruction Composition
- Amylmetacresol BP 0.6mg
2,4-Dichlorobenzyl Alcohol HSE 1.2mg
Vitamin C, (Ascorbic Acid, Sodium Ascorbate Equivalent to EP) 100.0mg
Excipient(s) with known effect:
Propylene Glycol
Fragrance containing allergens (Blood Orange Flavour – containing Citral, Citronellol, d-Limonene, Geraniol and Linalool)
Glucose (containing wheat starch (containing gluten), Sulphites- Sulphur Dioxide (E220))
Sucrose
Azo colouring agents – Ponceau 4R (E124) and Sunset Yellow (E110)
For a full list of excipients, see section 6.1.
- Instruction Dosage Form
- Orange flavoured and coloured circular lozenge.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the symptomatic relief of mouth and throat infections.4.2 Posology and method of administration
\*\*Posology\*\*
Use the lowest dose for the shortest duration necessary to relieve symptoms.
\*\*Adults:\*\*
One lozenge every 2-3 hours up to a maximum of 12 lozenges in 24 hours.
\*\*Children over 6 years old:\*\*
As above for adults.
\*\*Elderly:\*\*
There is no need for dosage reduction in the elderly.
\*\*Children under 6 years old:\*\*
Not suitable for children under 6 years (see section 4.4).
\*\*Method of administration\*\*
For oral administration. To be dissolved slowly in the mouth.4.3 Contraindications
Hypersensitivity to any of the ingredients.4.4 Special warnings and precautions for use
Not to be given to children under 6 years
If symptoms persist, have not improved, or have worsened after 3 days, consult a doctor or health care professional.
\*\*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 19.36 micrograms of gluten.
If you have wheat allergy (different from coeliac disease) you should not take this medicine.
This medicine contains 3 mg propylene glycol in each Lozenge.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
This medicine contains fragrance with Citral, Citronellol, d-Limonene, Geraniol and Linalool. Citral, Citronellol, d-Limonene, Geraniol and Linalool may cause allergic reactions.
This medicine contains glucose (0.97g per lozenge) and sucrose (1.44g per lozenge). This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltose insufficiency should not take this medicine.
This medicine contains sulphites – Sulphur dioxide (E220) which may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains colouring agents (Ponceau 4R (E124) and Sunset Yellow (E110)), which may cause allergic reactions.4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions are known.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
There are no or limited amount of data from the use of amylmetacresol, 2,4-dichlorbenzyl alcohol and ascorbic acid.
As with all medicines care should be taken when using this product in pregnancy and medical advice sought if necessary.
\*\*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. It is unknown whether 2,4-dichlorobenzyl alcohol, amylmetacresol or metabolites are excreted in human milk. A risk to the newborns / infants cannot be excluded.
\*\*Fertility\*\*
No data are available regarding the effects on fertility.4.7 Effects on ability to drive and use machines
No or negligible influence on the ability to drive and use machines.4.8 Undesirable effects
The list of the following adverse effects relates to those experienced with 2,4-dichlorobenzyl alcohol and amylmetacresol at OTC doses, in short term use..
Adverse events which have been associated with 2,4-dichlorobenzyl alcohol and amylmetacresol are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse Events\*\* |
| Immune System Disorders | Not known | Hypersensitivityab1 |
| Gastrointestinal Disorders | Not known | Glossodyniaab, oral discomfortab |
a2,4-dichlorobenzyl alcohol bamylmetacresol
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
Overdosage should not present a problem other than gastrointestinal discomfort.
Treatment should be symptomatic.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic group:\*\* Throat Preparations; Antiseptics\*\*; ATC Code:\*\* R02AA03 Dichlorobenzyl alcohol.
2,4-Dichlorobenzyl alcohol and amylmetacresol have antiseptic properties.
Ascorbic acid provides a source of vitamin C, which may be beneficial during infection when vitamin C levels are believed to fall.5.2 Pharmacokinetic properties
None stated.5.3 Preclinical safety data
None available.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Menthol natural or menthol synthetic
Tartaric acid
Blood Orange PHL 105288 (containing Citral, Citronellol, d-Limonene, Geraniol and Linalool)
Propylene glycol
Sunset yellow FCF (E110)
Ponceau 4R (E124) (containing Sodium)
Liquid Sucrose Liquid glucose BPC 1963 (containing wheat starch (containing gluten), Sulphites- Sulphur Dioxide (E220))6.2 Incompatibilities
Not applicable.6.3 Shelf life
36 months for lozenges packed in blister strips within a carton.
18 months for blister packs attached to a stencilled card.
24 months for lozenges packed in polypropylene tube, with an in-use shelf life of 'use within 3 months of opening'.6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a PVC/PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 6, 8, 10, 12, 16, 20, 24, 32 and 36 lozenges in a cardboard carton.
A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a PVC/PVDC blister. Two, four or six blisters are attached to a stencilled card.
A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a PVC/PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 8 lozenges in a wrap-round cardboard carton with tamper-evident seal.
An injection moulded white pigmented polypropylene tube with an injection moulded white polyethylene cap (containing white silica gel that is sealed with a white cardboard disc).
The tube contains 10 lozenges.6.6 Special precautions for disposal and other handling
Not applicable.
- Instruction Content
- ## Composition
Amylmetacresol BP 0.6mg
2,4-Dichlorobenzyl Alcohol HSE 1.2mg
Vitamin C, (Ascorbic Acid, Sodium Ascorbate Equivalent to EP) 100.0mg
Excipient(s) with known effect:
Propylene Glycol
Fragrance containing allergens (Blood Orange Flavour – containing Citral, Citronellol, d-Limonene, Geraniol and Linalool)
Glucose (containing wheat starch (containing gluten), Sulphites- Sulphur Dioxide (E220))
Sucrose
Azo colouring agents – Ponceau 4R (E124) and Sunset Yellow (E110)
For a full list of excipients, see section 6.1.
## Pharmaceutical Form
Orange flavoured and coloured circular lozenge.
## Clinical Particulars
4.1 Therapeutic indications
For the symptomatic relief of mouth and throat infections.4.2 Posology and method of administration
\*\*Posology\*\*
Use the lowest dose for the shortest duration necessary to relieve symptoms.
\*\*Adults:\*\*
One lozenge every 2-3 hours up to a maximum of 12 lozenges in 24 hours.
\*\*Children over 6 years old:\*\*
As above for adults.
\*\*Elderly:\*\*
There is no need for dosage reduction in the elderly.
\*\*Children under 6 years old:\*\*
Not suitable for children under 6 years (see section 4.4).
\*\*Method of administration\*\*
For oral administration. To be dissolved slowly in the mouth.4.3 Contraindications
Hypersensitivity to any of the ingredients.4.4 Special warnings and precautions for use
Not to be given to children under 6 years
If symptoms persist, have not improved, or have worsened after 3 days, consult a doctor or health care professional.
\*\*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 19.36 micrograms of gluten.
If you have wheat allergy (different from coeliac disease) you should not take this medicine.
This medicine contains 3 mg propylene glycol in each Lozenge.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
This medicine contains fragrance with Citral, Citronellol, d-Limonene, Geraniol and Linalool. Citral, Citronellol, d-Limonene, Geraniol and Linalool may cause allergic reactions.
This medicine contains glucose (0.97g per lozenge) and sucrose (1.44g per lozenge). This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltose insufficiency should not take this medicine.
This medicine contains sulphites – Sulphur dioxide (E220) which may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains colouring agents (Ponceau 4R (E124) and Sunset Yellow (E110)), which may cause allergic reactions.4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions are known.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
There are no or limited amount of data from the use of amylmetacresol, 2,4-dichlorbenzyl alcohol and ascorbic acid.
As with all medicines care should be taken when using this product in pregnancy and medical advice sought if necessary.
\*\*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. It is unknown whether 2,4-dichlorobenzyl alcohol, amylmetacresol or metabolites are excreted in human milk. A risk to the newborns / infants cannot be excluded.
\*\*Fertility\*\*
No data are available regarding the effects on fertility.4.7 Effects on ability to drive and use machines
No or negligible influence on the ability to drive and use machines.4.8 Undesirable effects
The list of the following adverse effects relates to those experienced with 2,4-dichlorobenzyl alcohol and amylmetacresol at OTC doses, in short term use..
Adverse events which have been associated with 2,4-dichlorobenzyl alcohol and amylmetacresol are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse Events\*\* |
| Immune System Disorders | Not known | Hypersensitivityab1 |
| Gastrointestinal Disorders | Not known | Glossodyniaab, oral discomfortab |
a2,4-dichlorobenzyl alcohol bamylmetacresol
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
Overdosage should not present a problem other than gastrointestinal discomfort.
Treatment should be symptomatic.
## Pharmacological Properties
5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic group:\*\* Throat Preparations; Antiseptics\*\*; ATC Code:\*\* R02AA03 Dichlorobenzyl alcohol.
2,4-Dichlorobenzyl alcohol and amylmetacresol have antiseptic properties.
Ascorbic acid provides a source of vitamin C, which may be beneficial during infection when vitamin C levels are believed to fall.5.2 Pharmacokinetic properties
None stated.5.3 Preclinical safety data
None available.
## Pharmaceutical Particulars
6.1 List of excipients
Menthol natural or menthol synthetic
Tartaric acid
Blood Orange PHL 105288 (containing Citral, Citronellol, d-Limonene, Geraniol and Linalool)
Propylene glycol
Sunset yellow FCF (E110)
Ponceau 4R (E124) (containing Sodium)
Liquid Sucrose Liquid glucose BPC 1963 (containing wheat starch (containing gluten), Sulphites- Sulphur Dioxide (E220))6.2 Incompatibilities
Not applicable.6.3 Shelf life
36 months for lozenges packed in blister strips within a carton.
18 months for blister packs attached to a stencilled card.
24 months for lozenges packed in polypropylene tube, with an in-use shelf life of 'use within 3 months of opening'.6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a PVC/PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 6, 8, 10, 12, 16, 20, 24, 32 and 36 lozenges in a cardboard carton.
A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a PVC/PVDC blister. Two, four or six blisters are attached to a stencilled card.
A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a PVC/PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 8 lozenges in a wrap-round cardboard carton with tamper-evident seal.
An injection moulded white pigmented polypropylene tube with an injection moulded white polyethylene cap (containing white silica gel that is sealed with a white cardboard disc).
The tube contains 10 lozenges.6.6 Special precautions for disposal and other handling
Not applicable.
- Company Detail Path
- /organization/reckitt-benckiser-healthcare-uk-ltd
