TCP LIQUID ANTISEPTIC - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

2.   QUALITATIVE AND QUANTITATIVE COMPOSITION

3. PHARMACEUTICAL FORM

Aqueous liquid antiseptic.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Symptomatic relief of sore throats including those associated with colds and influenza. Common mouth ulcers, cuts, grazes, bites, stings, boils, spots and pimples.

4.2 Posology and method of administration

Adults, children and the elderly.

Symptomatic relief of sore throats including those associated with colds and flu.

Gargle twice a day with TCP diluted with 5 parts water. Do not swallow.

Common mouth ulcers.

Dab undiluted onto affected areas three times a day. If symptoms persist for more than 14 days, consult your doctor or dentist.

Cuts, grazes, bites and stings.

Dilute with an equal quantity of water and apply freely. In emergencies may be used undiluted.

Boils, spots and pimples.

Dab undiluted every 4 hours. Do not cover.

4.3 Contra-indications

Hypersensitivity to any of the active ingredients

4.4 Special warnings and precautions for use

Seek medical advice if symptoms persist for more than a few days.

Keep out of the reach and sight of children.

4.5 Interactions with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

There is no experience of the use of the product in pregnancy and lactation, but the product has been widely used for many years with no adverse effects.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Use in allergic skin conditions should be avoided.

4.9 Overdose

Serious adverse events are unlikely to result from overdosage of this product.

Accidental ingestion: If a quantity (over 30ml) of neat TCP is swallowed accidentally, drink 0.5 to 1 litre of water immediately. If discomfort persists, seek medical advice.

5.1 Pharmacodynamic properties

Halogenated phenols 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

TCP Liquid Antiseptic is for topical use only. Significant absorption from this topical dosage form is considered unlikely.

5.3 Preclinical safety data

None stated.

6.1 List of excipients

Other ingredients: glycerol, concentrated phosphoric acid, quinoline yellow (E104) and purified water.

6.2 Incompatibilities

None known.

6.3

Shelf life

36 months.

6.4 Special precautions for storage

None.

6.5 Nature and Contents of Container

TCP Liquid Antiseptic is stored in amber flint glass bottles of 50ml, 100ml and 200ml capacity, with white wadless polypropylene tamper-evident caps, or 500ml amber flint glass bottles with white wadless polypropylene caps.

6.6 Instruction for use and handling

None stated.

7. MARKETING AUTHORISATION HOLDER

Omega Pharma Ltd.

1st Floor

32 Vauxhall Bridge Road

LONDON, SW1V 2SA

United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 02855/0021