Summary of Product Characteristics (SmPC) - Strepsils Herbal Chesty Cough syrup
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Herbal Chesty Cough Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 6 ml of the syrup contains 49.5 mg of extract (as dry extract) of Ivy leaf (Hedera helix L.,) (DER 4-8:1). Extraction solvent: ethanol 30% (m/m).
Excipient with known effect:
Each 6 ml dose of syrup contains up to 2814 mg of sorbitol.
Each 6ml dose of syrup contains 0.0114 mg of benzyl alcohol.
Each 6 ml dose of syrup contains 50.4 mg propylene glycol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
Brown, opalescent liquid with a sweet taste and possible slight sediment.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used to relieve chesty coughs associated with the common cold, based on traditional use only.
4.2 Posology and method of administration
Posology
Adults, the elderly and children aged 12 years and over:
The recommended dose is 6 ml of syrup twice daily using the graduated measuring spoon provided
Children under 12 years of age:
The use in children under 12 years of age is not recommended (see section 4.4 Special warnings and precautions for use).
Patients with renal and/or hepatic impairment
Due to the lack of pharmacokinetic data in these patient groups, a dose recommendation is not possible. Patients are advised to consult their doctor or qualified healthcare practitioner before taking Strepsils Herbal Chesty Cough Syrup.
Method of administration
Oral use.
It is recommended that the dose of 6 ml is administered with a full measuring spoon (4 ml) plus half a measuring spoon (2 ml).
The bottle must be shaken well before each use. A sediment may occur during storage. This does not affect the quality of the product.
Duration of use
If the symptoms worsen, or persist longer than one week during the use of the medicinal product, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active substance, to other plants of the Araliaceae (ivy) family or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use of this product in children under 12 years of age is not recommended because data are not sufficient and medical advice should be sought.
If dyspnoea, fever or purulent sputum occurs, a doctor should be consulted.
Caution is recommended in patients with gastritis or gastric ulcer.
If the symptoms worsen, or persist longer than one week, a doctor or qualified healthcare practitioner should be consulted.
Concomitant use with antitussives such as codeine or dextromethorphan is not recommended without medical advice.
Strepsils Herbal Chesty Cough Syrup contains sorbitol (E420).
This medicine contains 2814 mg of sorbitol (E 420) in each 6ml dose.
Sorbitol is a source of fructose. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
Strepsils Herbal Chesty Cough Syrup syrup contains propylene glycol
This medicine contains 50.4 mg propylene glycol in each 6 ml dose which is equivalent to 8.4 mg/ml.
Strepsils Herbal Chesty Cough Syrup syrup contains benzyl alcohol
This medicine contains 0.0114 mg benzyl alcohol in each 6 ml dose which is equivalent to 0.0019 mg/ml.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.
High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis). Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
4.5 Interaction with other medicinal products and other forms of interaction
No interactions studies have been performed.
4.6 Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
Fertility
No studies on the effect on fertility have been performed.
4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Gastrointestinal reactions (nausea, vomiting, diarrhoea) have been reported. The frequency is not known.
Allergic reactions (urticaria, skin rash, dyspnoea, anaphylactic reaction) have been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a pharmacist should be consulted.
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
Intake of doses larger than those recommended can provoke nausea, vomiting, diarrhoea and agitation. Treatment is symptomatic.
A case of an overdose has been reported in a 4 year old child. Following an accidental ingestion of a large amount of ivy extract (corresponding to 1.8 g of ivy leaf, which approximately amounts to 36 ml of Strepsils Herbal Chesty Cough syrup, aggressiveness and diarrhoea occurred.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
The non-clinical data on Ivy leaf dry extract are incomplete. In a bacterial reverse mutation test (AMES test), no mutagenic effects of the Ivy leaf dry extract contained in Strepsils Herbal Chesty Cough Syrup were detected.
Reverse mutation assays (Ames test) on bacteria indicated that the herbal preparation was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 1535 and TA 1537) mutation assays with or without metabolic activation.
Adequate tests on carcinogenicity and reproductive toxicity of Ivy leaf dry extract have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sorbitol liquid (non-crystallising) (E420)
Potassium sorbate (E202)
Xanthan gum (E415)
Citric acid (E330)
Natural honey thyme flavour (benzyl alcohol, propylene glycol, flavouring preparations, natural flavouring substances)
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Originally sealed package: 3 years
After first opening: 3 months
6.4 Special precautions for storage
This medicinal product does not require any special temperature storage conditions before opening.
Do not store above 25°C after first opening.
Store in the original container.
6.5 Nature and contents of container
Brown glass bottle with white screw cap (PE). The bottle is packed into a carton together with a measuring spoon (PP) with graduations of 2 ml and 4 ml.
Pack size: 100 ml, 200 ml
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
103 – 105 Bath Road
Slough
SL1 3UH
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
THR 00063/0557