NAME OF THE MEDICINAL PRODUCT

ELUDRIL SPRAY

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Actives :	Quantity :	Unit :
Chlorhexidine digluconate	0.05	% W/V
Tetracaine hydrochloride	0.015	% W/V

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Oromucosal spray

4    CLINICAL PARTICULARS

4.1 Therapeutic indications

Eludril is an antibacterial and anaesthetic 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 is indicated in adults and children over 12 years old.

Additional therapy is required in the event of bacterial infection accompanied by fever.

4.2 Posology and method of administration

Posology

Adults and children over 12 years:

For routine use spray the mouth and throat three or four times a day. Allow at least 4 hours between each dose.

The duration of treatment should not exceed 5 days.

Method of Administration:

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.

4.3    Contraindications

-    Hypersensivity to the active substances or to any of the excipients listed in section 6.1.

-    Children under 12 years.

4.4    Special warnings and precautions for use

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.

4.5    Interaction with other medicinal products and other forms of interaction

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.

4.6    Pregnancy and lactation

There are no adequate data from the use of chlorhexidine digluconate in pregnant or lactating women. Therefore, use during pregnancy and lactation should be avoided unless under the guidance of a medical practitioner.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

Body System	Adverse Reactions (frequency not known)
Immune system disorders	Anaphylactic shock, anaphylactic reaction, hypersensitivity
Nervous system disorders	-Dysgeusia: transient disturbance of taste sensation -Mucosal burning sensation: burning sensation of the tongue. These effects may occur on initial use of the product and usually diminish with continued use. -    Oral hypoaesthesia (transient): numbness of tongue: see section 4.4. -    Choking: see section 4.4.
Gastrointestinal disorders	-Tongue discoloration: Superficial discoloration of the dorsum of the tongue, reversible after discontinuing treatment: see section 4.4. -Teeth discoloration: Discoloration of the teeth and silicate or composite restorations: see section 4.4. -Parotid gland enlargement: swelling of the parotid glands reversible after discontinuing treatment. - Oral desquamation: see section 4.4

4.9 Overdose

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.

5 PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

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%).

5.2    Pharmacokinetic properties

CHLORHEXIDINE

Oral

Absorption: Chlorhexidine is poorly absorbed and very low circulating levels are found in blood

Metabolism and excretion: Chlorhexidine undergoes a limited biotransformation and is excreted mainly unchanged faeces (99.5% of the ingested dose).

Permucosal: When used locally, chlorhexidine is adsorbed onto the tooth enamel, dentine, cementum, mucosa and dentures with a slow desorption. Chlorhexidine remains detectable in saliva for 8 to 12 hours.

Due to its cationic nature, chlorhexidine digluconate binds strongly to skin, mucosa and other tissues, and is thus very poorly absorbed.

After contact with the mucous membrane, chlorhexidine is absorbed onto organic structures, which gives rise to a long local residual effect and again limits passage into the systemic circulation.

TETRACAINE

Tetracine is rapidly absorbed orally and through the mouth mucosa. Tetracaine is moderately bound to plasma proteins (76%) and metabolised in liver to para-aminobenzoic acid.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity and local tolerance (ocular and primary cutaneous irritation studies), genotoxicity, and toxicity to reproduction and development.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Ethyl alcohol 95 %

Polyethylene glycol Saccharin sodium Aromatic compound Phosphoric acid Purified water Nitrogen (propellant gas)

6.2    Incompatibilities

See section 4.5

6.3    Shelf life

Unopened: 2 years.

6.4    Special precautions for storage

Store away from light.

Store at room temperature.

6.5    Nature and contents of container

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

6.6    Special precautions for disposal

No special requirements.