Activase Clove Oil
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Activase Clove Oil
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml consists of Clove oil 100% v/v (Syzygium aromaticum (L.) Merill et L. M. Perry).
There are no excipients.
3 PHARMACEUTICAL FORM
Dental solution.
Clear, yellow oil.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the temporary relief of toothache, based on traditional use only.
4.2 Posology and method of administration
For dental use only.
Adults and the elderly:
Soak a small piece of cotton wool and apply directly to the tooth. Repeat administration after 20 minutes, then every two hours if necessary.
Not recommended for use in children or adolescents under 18 years of age (See Section 4.4. special warnings and precautions for use)
Duration of use:
Not to be used for more than 7 days
If symptoms worsen or persist for more than one week, a doctor, dentist or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to clove oil or to Peru balsam
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen or persist for more than one week, a doctor, dentist or qualified healthcare practitioner should be consulted.
This product should only be applied directly to the affected tooth using a soaked cotton bud. Avoid contact with the gum.
Clove oil should not be swallowed. Accidental oral ingestion may lead to toxic effects (See section 4.9 Overdose).
The use in children and adolescents under 18 years of age has not been established due to lack of adequate data.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and lactation is not recommended.
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive or operate machines have been performed.
4.8 Undesirable effects
Mucosal irritations and allergic reactions have been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or qualified health care practitioner should be consulted.
4.9 Overdose
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.
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
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
Eugenol, the main component of clove oil, showed equivocal results in several test systems for genotoxicity and carcinogenicity.
Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity of the entire clove oil have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None
6.2 Incompatibilities
None stated
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original container.
6.5 Nature and contents of container
Glass bottle with plastic cap (10ml), (15ml).
Special precautions for disposal
6.6
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
Bell Sons and Company (Druggists) Limited
Gifford House
Slaidburn Crescent
Southport
PR9 9AL
8 MARKETING AUTHORISATION NUMBER(S)
THR 03105/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/01/2012
10 DATE OF REVISION OF THE TEXT
11/12/2013