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- Strepsils Sore Throat and Blocked Nose
Strepsils
Summary of product characteristics
1. Name of the medicinal product
Strepsils Sore Throat and Blocked Nose Lozenges
Strepsils Sore Throat and Cough Lozenges
2. Qualitative and quantitative composition
| Amylmetacresol BP
| 0.6mg
|
| 2,4-Dichlorobenzyl alcohol HSE
| 1.2mg
|
| Levomenthol natural or synthetic EP
| 8.0mg
|
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
A blue circular lozenge with a characteristic taste.
4.1. Therapeutic indications
For the symptomatic relief of mouth and throat infections, dry, irritating cough associated with the common cold and nasal congestion.
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.
Patients with rare hereditary problems of fructose intolerance, glucose-glalctose malabsorption or sucrose-isomaltose insufficiency should not take this medicine.
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 levomenthol.
As with all medicines care should be taken when using this product in pregnancy and medical advice sought if necessary.
Breast-feeding
It is unknown whether 2,4-dichlorobenzyl alcohol, amylmetacresol, levomenthol 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.
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Throat Preparations; Antiseptics; ATC Code: R02AA03 Dichlorobenzyl alcohol
2,4-Dichlorobenzyl alcohol and amylmetacresol have antiseptic properties.
Menthol has a mild local anaesthetic action on the throat and also relieves the symptoms of cough and nasal congestion.
5.2. Pharmacokinetic properties
None available.
5.3. Preclinical safety data
None available.
6.1. List of excipients
Liquid sugar demineralised* or liquid sugar T & Y1001*, liquid glucose*, tartaric acid gran 572 GDE, eucalyptus oil, indigo carmine BP '73 (E132), water.
(*solids from sugar/glucose liquid syrup to give a 2.6g lozenge)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months for lozenges packed in blister strips within a carton.
18 months for blister pack attached to a stencilled card.
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.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorisation holder
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 3UH
8. Marketing authorisation number(s)
PL 00063/0398
9. Date of first authorisation/renewal of the authorisation
06/04/2010
10. Date of revision of the text
18/05/2020
4.1 Therapeutic indications
For the symptomatic relief of mouth and throat infections, dry, irritating cough associated with the common cold and nasal congestion.
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.
Patients with rare hereditary problems of fructose intolerance, glucose-glalctose malabsorption or sucrose-isomaltose insufficiency should not take this medicine.
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 levomenthol.
As with all medicines care should be taken when using this product in pregnancy and medical advice sought if necessary.
Breast-feeding
It is unknown whether 2,4-dichlorobenzyl alcohol, amylmetacresol, levomenthol 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.
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Disclaimer
The drug SPC information (indications, contra-indications, interactions, etc), has been developed in collaboration with eMC (www.medicines.org.uk/emc/). Medthority offers the whole library of SPC documents from eMC.
Medthority will not be held liable for explicit or implicit errors, or missing data.
Drug Licencing
Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).