Antiseptic Gargle And Mouthwash
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Antiseptic Gargle and Mouthwash
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenol BP 0.7 1% w/v
3 PHARMACEUTICAL FORM
Mouthwash
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Used to freshen breath and soothing sore throats. Use as a mouthwash
4.2 Posology and method of administration
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 or more frequently if required.
4.3 Contraindications
Hypersensitivity to the active or any of the excipients (6.1).
4.4 Special warnings and precautions for use
The label states:
-Do not swallow
-Any unused diluted products should be discarded
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Acceptable for use during pregnancy and lactation.
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
None stated.
4.9 Overdose
When taken by mouth in large doses, Phenol causes extensive local corrosion with pain, nausea, vomiting, sweating and diarrhoea. Treatment is by emptying the stomach by aspiration and lavage, taking care to avoid perforation. Keep the patient warm and treat pulmonary oedema, systemic acidosis, respiratory failure, and circulatory failure symptomatically. Respiration may have to be assisted.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Phenol in the solution acts as a bacteriostatic thus removing infection.
5.2 Pharmacokinetic properties
Phenol is absorbed by the mucous membranes and is metabolised to phenyl glucuronide and phenyl sulphate, and small amounts are oxidised to catechol and quinol which are mainly conjugated. The metabolites are excreted in the urine; on oxidation to quinones. They may tint the urine green.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
BP 12.5% v/v
BP 0.08% v/v
BP 1.4% v/v
to 100% v/v
Glycerine Peppermint Oil Amaranth Solution Water
6.2 Incompatibilities
None known.
6.3 Shelf life
3 Years
6.4 Special precautions for storage
None stated.
6.5
White flint glass Winchester with a plastic cap 200ml Plastic container with plastic cap 2000ml
White flint glass Winchester with a plastic cap 200ml (available in a cardboard carton which also contains a measuring cup),
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MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas,
PC. 1060 Nicosia.
Cyprus
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09/10/2013