Summary of Product Characteristics (SmPC) - Sandersons Throat Specific Mixture
1 NAME OF THE MEDICINAL PRODUCT
Sanderson’s Throat Specific Mixture
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains:
0.025 ml of Capsicum Tincture (Capsicum annuum L. var. minimum (Miller) Heiser), corresponding to 7.5 to 12.5 micrograms capsaicinoids calculated as capsaicin. Extraction solvent: ethanol 90% v/v.
0.025 ml of extract (as liquid extract) from Squill bulb (Drimia maritima (L.) Stearn) (1:1). Extraction solvent: ethanol 65% v/v.
37.5 mg of Acetic acid
Each 5 ml contains 62.66 mg of ethanol (see section 4.4 'Special warnings and precautions for use').
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Mixture
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For symptomatic relief of sore throat, hoarseness, loss of voice and catarrh, and as a preventative gargle when these symptoms begin to appear or are expected to appear.
Sanderson's Throat Specific Mixture is indicated in adults and children aged 8 years and over.
4.2 Posology and method of administration
Posology
Adults, the elderly and children over 8 years
Gargle with 10 ml (two 5 ml spoonfuls) in an equal amount of water hourly. Also swallow slowly one 5 ml spoonful undiluted, three times daily. If symptoms of sore throat, hoarseness, loss of voice or catarrh are expected to appear, gargle well with 10 ml (two 5 ml spoonfuls) in twice the amount of water in the morning before breakfast and last thing at night. Do not use for more than 7 consecutive days (see section 4.4) Paediatric population
Not recommended for children under 8 years of age.
Method of administration
For oral and oromucosal use.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Cardio-pulmonary disorders or breathing difficulties.
History of alcohol abuse, liver disease or renal impairment. Raised intracranial pressure.
4.4 Special warnings and precautions for use
This product contains small amounts of alcohol (less than 100 mg per 5 ml dose).
This product has a sharp biting taste.
If symptoms worsen or persist after 7 days, a doctor should be consulted.
Patients should be advised not to exceed the stated dose.
If dyspnoea, fever or purulent sputum occurs, a doctor should be consulted.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
In view of the potential for squill to interact with other medicines administered concurrently, the product should not be taken with digoxin or any medicine for a heart condition.
Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole).
4.6 Fertility, pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established, therefore use during pregnancy and lactation is not recommended. No studies on the effects 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 or use machines have been performed.
This product contains alcohol (see section 4.4).
4.8 Undesirable effects
Hypersensitivity.
Squill is reported to cause gastric irritation. The frequency is not known.
Reporting of 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.
4.9 Overdose
No specific problem anticipated
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
None applicable.
5.2 Pharmacokinetic properties
None applicable.
5.3 Preclinical safety data
None applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Quassia liquid extract Benzoic acid
Caramel
Ethanol 96%
Saccharin sodium Purified water
6.2 Incompatibilities
None known.
6.3 Shelf life
5 years.
6.4 Special precautions for storage
Store in a cool place.
6.5 Nature and contents of container
Clear, round, Type III glass bottles, each containing 200 ml.
White HDPE/PP tamper-evident, child-resistant caps with EPE liners.
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
Infohealth Limited
28 Chipstead Valley Road
Coulsdon
Surrey
CR5 2RA
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 19664/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07 May 1992 / 24 June 1997
10 DATE OF REVISION OF THE TEXT
27/06/2023