Summary of medicine characteristics - STREPSILS DRY THROAT LOZENGES, STREPSILS CITRUS FLAVOUR LOZENGES
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Citrus Flavour Lozenges
Strepsils Dry Throat Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amylmetacresol 0.6mg/lozenge
2,4-Dichlorobenzyl alcohol 1.2mg/lozenge
Excipient(s) with known effect:
Isomalt
Maltitol liquid
Fragrance containing allergens – benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool (in the Lemon flavour)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
A white to pale yellow, circular lozenge with a characteristic lemon taste and the Strepsils brand icon intagliated on both sides.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
As an antiseptic for the relief of sore throat and its associated pain.
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
Strepsils Citrus Flavour Lozenges are contraindicated in persons who have previously shown 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, or if symptoms are accompanied by a high fever or headache consult a doctor or health care professional.
Important information about some of the ingredients of this medicine:
Contains isomalt and maltitol syrup, which may have a mild laxative effect if several are taken a day. Patients with rare hereditary problems of fructose intolerance 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 Benzyl Alcohol, Citral, Citronellol, d-Limonene, Geraniol and Linalool. Benzyl Alcohol, Citral, Citronellol, d-Limonene, Geraniol and Linalool may cause allergic reactions.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of amylmetacresol and 2,4-dichlorbenzyl alcohol.
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 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
4.9 OverdoseIn view of the nature and presentation of Strepsils Citrus Flavour Lozenges, accidental or deliberate overdosage is highly unlikely.
Overdosage should not present a problem other than gastrointestinal discomfort.
Treatment should be symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5 PHARMACOLOGICAL PROPERTIES5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Throat Preparations; Antiseptics; ATC Code:
R02AA03 Dichlorobenzyl alcohol.
2,4– Dichlorobenzyl alcohol and amylmetacresol have antiseptic properties.
5.2 Pharmacokinetic properties
An oral bioavailability study conducted on Strepsils lozenges demonstrated a rapid release of 2,4-dichlorobenzyl alcohol and amylmetacresol into saliva with peak levels achieved within 3–4 minutes of sucking the lozenge. A doubling of saliva volume was observed within a minute* and levels above baseline were maintained whilst the lozenge dissolved over approximately 6 minutes. Quantifiable amounts of actives were expectorated up to 20–30 minutes post dose; net recovery of actives was suggestive of a prolonged residency in mouth and throat mucosa.
5.3
There are no preclinical data available specific to the product.
6.1 List of excipients
Lemon flavour (fragrance containing allergens – benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool)
Saccharin sodium Ph Eur (E954)
Tartaric acid
Isomalt (Isomaltitol E 953)
Maltitol syrup (E965)
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
6.5 Nature and contents of containerThe lozenges are contained in a strip pack containing either 6, 8, 12, 16, 18, 20, 22, 24, 32 or 36 lozenges packed into a cardboard carton. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00063/0462
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/09/2004 / 02/07/2009