Summary of Product Characteristics (SmPC) - Crescent Pharma Antiseptic Gargle 0.71% w/v mouthwash
1 NAME OF THE MEDICINAL PRODUCT
Crescent Pharma Antiseptic Gargle 0.71% w/v Mouthwash
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenol BP 0.71% w/v
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Mouthwash
Clear, bright red liquid with odour of peppermint and phenol.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For relief of sore throats symptoms, including those associated with cold and flu, bad breath, mouth ulcers, painful gums.
4.2 Posology and method of administration
Posology
Adults, children and the elderly.
For relief of sore throats symptoms and bad breath:
Dilute one part of the solution with three parts of warm water.
Thoroughly rinse the mouth or gargle with the diluted product for up to 20 seconds morning and evening.
For mouth ulcers:
Dab undiluted on the affected area three times daily. If symptoms persist for more than 14 days consult your dentist.
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
If symptoms persist for more than 14 days a doctor should be consulted.
DO NOT SWALLOW THIS SOLUTION
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
There is no experience of the use of the product in pregnancy and lactation, however the product has been widely used for many years with no adverse effects.
4.7 Effects on ability to drive and use machines
Not known.
4.8 Undesirable effects
There are no adverse events reported.
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Serious adverse events are unlikely to result from overdosage of this product. Accidental ingestion: If a quantity (over 30ml) of neat Antiseptic Gargle and Mouthwash is swallowed accidentally, drink 0.5 to 1 litre of water immediately. If discomfort persists, seek medical advice.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Throat preparations. Antiseptics, ATC code: R02AA19
Phenol act on all pathogenic micro-organisms similarly and to approximately the same degree - i.e. they are non-specific, their activity is not appreciably reduced by the presence of relatively large amounts of non-living organic matter, their relatively simple chemical constitution means that their use is not liable to encourage the emergence of strains of micro-organisms adapted to resist their action.
5.2 Pharmacokinetic properties
This medicinal product is for oromucosal use only. Significant absorption from this topical dosage form is considered unlikely.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerine BP
Peppermint Oil BP
Amaranth Solution BP
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 Years
6.4 Special precautions for storage
Keep the container in the outer carton in order to protect from light.
6.5 Nature and contents of container
White flint glass bottles of 200ml, with a plastic cap.
Plastic container of 2000ml with a plastic cap.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
GlobeGen Laboratories Ltd,
1406 Coventry Road,
South Yardley,
Birmingham,
B25 8AE
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 41318/0034
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14/01/2009
10 DATE OF REVISION OF THE TEXT
02/08/2021