Dentogen Clove Oil Gel
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dentogen Clove Oil Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clove Oil 20.0% w/w.
For excipients list see Section 6.1
3 PHARMACEUTICAL FORM
Dental Gel.
A clear, pale yellow gel.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the temporary relief of toothache due to dental cavity.
4.2 Posology and method of administration
For dental use.
Adults, children over 2 years of age and the elderly: Apply a little gel accurately to the decayed part of the tooth using either a clean finger tip or a cotton bud. To be repeated after 20 minutes and then every 2 hours if required.
Infants: Not recommended.
4.3
Contraindications
Hypersensitivity to clove oil, eugenol, peru balsam or to any of the excipients.
Teething.
Not to be used if an abscess is suspected. Not recommended for use by infants.
4.4 Special warnings and precautions for use
Prolonged use of this product should be avoided, may cause gum damage. Dental attention should be sought as soon as possible.
This gel contains propylene glycol, which may cause gum or skin irritation. Care should be taken to ensure that the gel is applied directly onto the troublesome tooth and not to the gums or mouth.
Not recommended for use in children under 2 years of age due to lack of adequate data.
4.5 Interaction with other medicinal products and other forms of interaction
May enhance inhibition of platelet activity in patients receiving anti-coagulant therapy e.g. warfarin.
4.6 Fertility, pregnancy and lactation
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
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
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.mhra.gov.uk/yellowcard.
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. 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
A mild analgesic and surface anaesthetic.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
No additional data of relevance than that already provided in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Propylene Glycol
Peppermint Essence (containing peppermint oil and propylene glycol) Carbomers (Carbopol 980)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Three years from the date of manufacture.
6.4 Special precautions for storage Do not store above 25 °C.
6.5 Nature and contents of container
Aluminium collapsible tube, internally lacquered, 75 nozzle fitted with 75 white round milled plug seal and HDPE cap. Each tube contains 10g gel and is individually cartonned.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
CRESCENT PHARMA LIMITED
UNITS 3 AND 4, QUIDHAMPTON BUSINESS UNITS
POLHAMPTON LANE
OVERTON
HAMPSHIRE
RG25 3ED
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 20416/0205
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/09/2006
10
DATE OF REVISION OF THE TEXT
03/09/2015