Dentinox Teething Gel

Dentinox Teething Gel

Lidocaine Hydrochloride BP 0.33 % w/w

Cetylpyridinium Chloride BP 0.10 % w/w

For full list of excipients, see section 6.1.

Dental gel

Greenish yellow brown gel.

For relief of pain and discomfort associated with teething in children from 5 months of age, where non-pharmacological treatments have failed to provide sufficient relief.

Apply a pea-sized amount (0.2 grams) of Dentinox Teething Gel with a clean finger to the affected area of gum.

The dose may be repeated if necessary after 3 hours, up to a maximum of 6 doses in 24 hours.

Treatment should be stopped once symptoms have resolved.

Not to be used for more than 7 days.

Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

In case of vomiting, spitting or accidental ingestion, the dose should not be repeated immediately. The dose may be repeated if necessary after 3 hours.

Hypersensitivity to the active substances or to any of the excipients.

Contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Keep all medicines out of sight and reach of children. Do not use if seal on nozzle is broken.

Do not use more than one product containing lidocaine at the same time.

None Known.

Not applicable.

Not applicable.

None Known.

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, website: www.mhra.gov.uk/yellowcard.

We are not aware of any problems caused by overdosage.

Pharmacotherapeutic group: Stomatological Preparation, ATC code: A01AD

Cetylpyridium Chloride is a cationic disinfectant which is used for minor wounds, treating superficial infections of the mouth and preserving the product.

Lidocaine Hydrochloride is a local anaesthetic. It works by blocking nerve conduction when applied topically to nerve tissue. It acts on any part of the nervous system and on every type of nerve fibre. For example, when it is applied to the motor cortex, impulse transmission from that area stops, and when it is injected into the skin it prevents the initiation and the transmission of the sensory impulses. A local anaesthetic in contact with a nerve trunk can cause both sensory and motor paralysis in the area innervated. Many kinds of compounds interfere with conduction, but they often permanently damage the nerve cells. The great practical advantage of the local anaesthetics is that their use is reversible, their use is followed by complete recovery in nerve function with no evidence of structural damage to nerve fibres or cells.

Lidocaine produces more prompt, more intense, longer-lasting and more intense anaesthesia than does an equal concentration of procaine. Unlike procaine it is an aminoethylamide. It is an agent of choice, therefore, in individuals sensitive to ester-type local anaesthetics. Lidocaine is relatively quickly absorbed. Lidocaine is metabolised in the liver by mixed-function oxidases by dealkylation to monoethyl glycine and xylidide. The latter compound retains significant local anaesthetic and toxic activity. In man about 75% of xylidide is excreted in the urine as the further metabolite 4-hydroxy-2,6-dimethylaniline. The typical dose of Dentinox gel is about 150mg containing about 0.5mg of lidocaine hydrochloride (which approximates to about 0.1 mg/kg of bodyweight). Martindale recommends that the total dose of lidocaine hydrochloride should not exceed 200mg (3mg per kg of bodyweight). Thus, the dosage of Dentinox Gel is well within this level.

Not applicable.

None Known.

3 years

Do not store above 25°C

Internally lacquered aluminium tube, the nozzle of which contains a membrane.

Pack size 10g (tube), 1 g sachet

Not all pack sizes may be marketed.

No special requirements.

DDD Limited,

94, Rickmansworth Road,

Watford,

Hertfordshire,

United Kingdom,

WD18 7JJ.

PL 00133/5010R

19/01/2007

31/08/2018