SOOTHAKE TOOTHACHE TINCTURE - summary of medicine characteristics

Soothake Toothache Tincture

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Lidocaine Hydrochloride BP 0.70 % w/w

Clove Oil BP l0.00%w/w

3 PHARMACEUTICAL FORM

Topical local anaesthetic liquid

4.1 Therapeutic indications

A first aid treatment for the temporary relief of toothache caused by dental cavity.

4.2 Posology and method of administration

Dip a clean cotton bud into the product and apply to the dental cavity in the aching tooth.

4.3 Contraindications

Contraindicated in patients hypersensitive to any of the ingredients or for dental pain other than that caused by cavities e.g. gum infections.

4.4 Special warnings and precautions for use

Keep out of reach of children.

Toothache Tincture is only intended as a First Aid measure avoid prolonged use.

Consult a doctor as soon as possible.

4.5 Interaction with other medicinal products and other forms of interaction None known

4.6 Fertility, Pregnancy and lactation

Not applicable

4.7 Effects on ability to drive and use machines

Not applicable

4.8 Undesirable effects

Hypersensitivity reactions to any of the ingredients have been reported rarely.

Excessive contact with the gums or lips may cause ulceration.

4.9 Overdose

Accidental oral ingestion of clove oil may lead to CNS depression, urinary abnormalities, anion gap acidosis, deterioration of liver function, coma, seizure and low blood glucose levels. Treatment should be supportive and symptomatic; there have been reports in the literature that N-acetylcysteine has been successfully used as an antidote.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Lidocaine Hydrochloride is a local anaesthetic. It is widely used as a local anaesthetic in dentistry. Clove Oil has along history of use as a domestic remedy for toothache.

5.2 Pharmacokinetic properties Not applicable.

5.3 Preclinical safety data Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol 96% (Alcohol)

6.2 Incompatibilities

None Known

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C. Do not freeze.

6.5 Nature and contents of container

Brown glass vial with screw top containing 10ml

6.6 Special precautions for disposal

Keep out of reach of children.

Dip a clean cotton bud into the product and apply to the dental cavity in the aching tooth

7 MARKETING AUTHORISATION HOLDER

Optima Consumer Health Ltd

Concept house,

Brackenbeck Road,

Bradford,

BD7 2LW, UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 40575/0008

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

28/04/2005