Summary of medicine characteristics - BOOTS SORE THROAT RELIEF HONEY & LEMON FLAVOUR 0.6 MG LOZENGES
1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCTBoots Sore Throat Relief Honey & Lemon Flavour 0.6 mg Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amylmetacresol BP 0.6 mg per Lozenge
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Lozenge
Clear, yellow lozenge.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of sore throat and coughs
4.2 Posology and method of administration
Posology
Adults, the Elderly, and Children aged 3 years and over :-
Suck one lozenge slowly as required.
Do not take more than 12 lozenges in 24 hours.
Not to be given to children under 3 years.
Method of administration Oral
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Not to be given to children under 3 years.
Contains a total of 2.4g of sucrose and glucose per lozenge. 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 Fertility, pregnancy and lactation
Pregnancy
There is no or inadequate evidence of the safety of the active ingredients in this medicine in human pregnancy. The potential risk for humans is unknown.
In the absence of sufficient data, the use during pregnancy is not recommended.
Breast-feeding
It is not known whether the active ingredients of this product are excreted in human breast milk.
In the absence of sufficient data, the use during lactation is not recommended.
Fertility
Studies of the effects on fertility have not been investigated.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
The following adverse events have been reported during post-marketing experience with amylmetacresol-containing products:
Immune system disorders
Frequency unknown – Hypersensitivity
Gastrointestinal disorders
Frequency unknown – Glossodynia
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 OverdoseTheoretically symptoms are possible in children if at least 50 lozenges (more than 4 packs) are consumed in a short space of time. In such extreme overdosage, related to menthol ingestion, symptoms may include nausea and vomiting, diarrhoea, profuse sweating and intense thirst.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: R02 AA20
Amylmetacresol is an antiseptic.
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-pharangeal cavity and the constituents are systemically innocuous in the concentrations used.
5.3 Preclinical safety data
5.3 Preclinical safety dataNone available specific to the product.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Liquid Glucose
Tartaric Acid
Menthol, Laevo
Lemon Flavour
Honey Flavour 510167E
Beta-carotene E160a
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
24 months for the unopened pack
6.4 Special precautions for storage
Do not store above 25°C.
Store in the original package.
6.5 Nature and contents of container
Blister sizes: 8 and 12 lozenges.
Individual blisters of 250micron PVC coated 60gsm PVDC, lidded with HT aluminium foil of 20 micron. Packs sizes: 12 (1×12), 16 (2× 8), 24 (2×12), 36 (3×12) lozenges.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.