SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Dentinox Teething Gel

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Lidocaine Hydrochloride BP 0.33 % w/w Cetylpyridinium Chloride BP 0.10 % w/w

For a full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Dental gel

Greenish yellow brown gel.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Dentinox Gel relieves the pain of baby's teething and soothes the gums.

4.2.    Posology and Method of Administration

Place a small quantity of Dentinox Teething Gel on a pad of cotton wool or a clean finger and rub gently on baby's gum. Repeat after 20 minutes if necessary. Use when necessary during the teething period.

Contraindications

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.

4.4    Special warnings and precautions for use

Keep all medicines out of sight and reach of children.

Do not use if seal on nozzle is broken.

4.5    Interaction with other medicinal products and other forms of interaction

None known.

4.6.    Pregnancy and Lactation

Not applicable.

4.7.    Effects on Ability to Drive and Use Machines

Not applicable.

4.8    Undesirable effects

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.

4.9    Overdose

We are not aware of any problems caused by overdosage.

5.1 Pharmacodynamic properties

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.

5.2. Pharmacokinetic Properties

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.

5.3 Preclinical safety data

Not applicable.

6.1 List of excipients

Purified Water BP	43	31	%	w/w
Sorbitol Solution 70 % (Non-Crystallising) BP	21	00	%	w/w
Xylitol HSE	14	00	%	w/w
Ethanol 96% BP	9.	36	%	w/w
Glycerol BP	7.	00	%	w/w
Hydroxethylcellulose BP	2.	50	%	w/w
Polyoxyl 40 hydrogenated castor oils HSE	1.	00	%	w/w
Pharmaceutical Liquid Flavour HSE	0.	48	%	w/w
Hydroxypolyethoxy Dodecane HSE	0.	33	%	w/w
Macrogol 300 BP	0.	33	%	w/w
Sodium Saccharin BP	0.	10	%	w/w
Caramel E150 HSE	0.	10	%	w/w
Levomenthol BP	0.	06	%	w/w

6.2. Incompatibilities

None known.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25 °C.

6.5 Nature and contents of container

Internally lacquered aluminium tube, the nozzle of which contains a membrane. Sachet-40gsm craft paper, 10 gsm polyethylene, 8 gsm aluminium foil and 30 gsm surlyn.

Pack sizes: 15 g and 10 g tube, 1 g sachet.

Not all pack sizes may be marketed.

Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

DDD Limited,

94, Rickmansworth Road,

Watford,

Hertfordshire,

WD18 7JJ.

United Kingdom,

8    MARKETING AUTHORISATION NUMBER(S)

PL 00133/5010R

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/01/2007

10 DATE OF REVISION OF THE TEXT

05/01/2016