ELUDRIL SPRAY

For a full list of excipients, see section 6.1.

Oromucosal spray

Eludril is an antibacterial and anaesthesic spray.

It is used as adjuvant treatment in conditions such as gingivitis, recurrent minor aphtous ulceration and minor infections of the mouth and throat.

Likewise as adjuvant treatment in tonsillitis, pharyngitis, vincent's angina and oral thrush.

Also after operative or dental procedures in the mouth or throat and for general oral hygiene.

Eludril spray is contra-indicated in infants and children under 12 years of age: see section 4.3.

For routine use spray the mouth and throat three or four times a day.

ELUDRIL SPRAY should not be used immediately before eating.

The usual duration of treatment should not exceed 5 days.

The spray bottle should be shaken before use, and the end of the nozzle positioned just inside the mouth. Direct the spray towards the affected area of the mouth or throat and activate the spray for two or three seconds.

- Hypersensivity to the active substances or to any of the excipients.

- Use in infants and children less than 12 years of age.

- Use with anionic agents: see section 4.5.

Warnings

For oral use only

Do not swallow

Keep out of the eyes, ears and nose. If the spray comes into contact with the eyes or ears, wash out promptly and thoroughly with water

Discoloration of the tongue, teeth and silicate or composite restorations may occur. This stain is not permanent and can largely be prevented by brushing with a conventional toothpaste daily before using the spray or, in the case of dentures cleansing with a conventional cleanser: see sections 4.5, 4.8.

Tetracaine has the potential to cause choking due to anaesthesia of the oropharyngeal junction: see section 4.8.

In case of soreness, swelling or irritation of the mouth, stop using the product and consult a healthcare professional: see section 4.8

Precautions for use

Chlorhexidine is an irritant and should be used with caution. If there is evidence of irritation or aggravation of the condition, a doctor or dentist should be consulted.

Chlorhexidine is incompatible with anionic agents which are usually present in conventional toothpastes. Therefore, thorough rinsing of the mouth with water, after toothbrushing with toothpaste, should be done before using this medicine: see section 4.3. A short time should elapse between using the two products.

There are no adequate data from the use of Eludril spray in pregnant or lactating women. No teratogenesis preclinical studies have been performed. Therefore, because of the risk of resorption of tetracaine, use during pregnancy or lactation should be avoided unless under the guidance of a medical practitioner.

No studies on the effects on the ability to drive and use machines have been performed.

Overdose is not expected under normal conditions of use of this spray. However, due to the product alcohol content (6.65 % v/v) accidental ingestion of large amounts by children requires prompt medical attention for appropriate action.

Symptoms

Chlorhexidine when taken orally is poorly absorbed. Most patients will develop very few symptoms. Local effects like burning sensation in the mouth and throat may occur. Systemic effects are unlikely if large volumes are ingested. However, large amounts may cause digestive disorders (epigastric pain, diarrhoea) and if chlorhexidine passes into the general system, signs of neurological toxicity may develop.

Tetracaine ingested in large amounts will induce temporary tongue numbness and choking due to anaesthesia of the oropharyngeal junction.

Emergency procedures

- Do not attempt to empty the stomach

- Administration of milk, water to drink, raw egg, gelatin or mild soap may be advisable provided the airway can be protected.

- General supportive measures should be instituted as deemed necessary by the physician.

Pharmacotherapeutic group: Various substances: ATC code: A01AB11

CHLORHEXIDINE: Broad spectrum anti-bacterial (gram + and gram-) and antifungal. Extended bactericidal activity on buccal mucosa.

TETRACAINE: Local anaesthetic blocking nerve terminals in the skin and mucosa. (ophtalmological use in solution of 0.25 - 1%).

CHLORHEXIDINE:

Oral: very weak systemic absorption, distribution mainly via liver and kidneys: little metabolism (no degradation of the molecule): elimination mainly in faeces (99.5% of the ingested dose).

Permucosal Absorption: - negligible. Distribution, metabolism and elimination same as oral route.

TETRACAINE: Rapid mucosal absorption. Heavily protein-bound in blood.

Metabolised in liver (and sometimes in kidney) to para-aminobenzoic acid

No information further to that contained in other sections of the is included.

Ethyl alcohol 95 %

Polyethylene glycol

Saccharin sodium

Aromatic compound

Phosphoric acid

Purified water

Nitrogen (propellant gas)

See section 4.5

Unopened: 2 years

Store away from light.

Store at room temperature.

75 ml white plastic coated glass bottle containing 55 ml of solution and standard valve 20 mm in diameter.

No special requirements.

PIERRE FABRE LIMITED

Hyde Abbey House

23 Hyde Street

Winchester

Hants

SO23 7DR

UNITED KINGDOM

PL 00603/0013R

Date of first authorisation: 7^th August 1973

Date of last renewal: 4^th September 2001

13/01/2011