For the temporary relief of toothache.

Dental use.

Adults, the elderly and children over 2 years old:

Apply a small amount on a cotton bud directly on the tooth cavity as required.

Hypersensitivity to clove oil, eugenol or Peru balsam.

Teething.

Use with caution in the mouth.

Avoid contact with the skin and gums.

Repeated use may cause gum damage.

Seek dental attention as soon as possible.

Not recommended for use in children under 2 years of age due to lack of adequate data.

May enhance inhibition of platelet activity in patients receiving anti-coagulant therapy e.g. warfarin.

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Studies on the effects on fertility have not been performed.

None known.

Contact with skin or soft tissue may cause transient irritation, contact dermatitis, inflammation of the lips, and inflammation or ulceration of the mouth. The eugenol present in clove oil may act as an irritant to skin and mucous membranes; it may also cause hypersensitivity and is reported to inhibit prostaglandin synthesis. Patients may become sensitive to clove oil.

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 the Yellow Card Scheme at: www.mgra.gov.uk/yellowcard.

No case of overdose from oromucosal or dental use has been reported.

After oral administration of 5-10 ml of clove oil in children below 2 years of age, life threatening conditions were observed. Adverse effects included coma, acidosis, a generalised seizure, disordered blood clotting, and acute liver damage.

Overdose 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.

Clove Oil has local anaesthetic, antiseptic and antihistaminic properties, and is used as an anodyne in toothache.

Clove Oil acts at the site of application.

No data exists on the human pharmacokinetics of Eugenol the principle ingredient of Clove Oil.

In the rat 20-30% of Eugenol is metabolised to homovanillic acid and 4-hydroxy-3-methoxymandelic acid.

None.

None.

None known.

10ml: 36 months unopened.

Store below 25° C.

Keep container tightly closed and protect from light.

10ml: amber glass bottle with white plastic child resistant cap with EPE/Saranex liner.

None.