ELUDRIL mouthwash

Each 1 ml contains chlorhexidine digluconate solution 0.005 ml (corresponding to 1 mg chlorhexidine digluconate).

The content of chlorhexidine digluconate per ml when diluted as recommended is 0.22 mg/ml – 0.33 mg/ml.

Each ml contains 5 mg of chlorobutanol.

The content of chlorobutanol per ml when diluted as recommended is 1.11 mg/ml – 1.66 mg/ml.

Excipients:Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216)

For a full list of excipients, see section 6.1.

Mouthwash.

Clear colourless Oromucosal solution.

Eludril mouthwash is an antibacterial solution which inhibits dental plaque formation. It is indicated as an aid in the treatment and prevention of gingivitis, and in maintaining oral hygiene, particularly in situations where toothbrushing is difficult to carry out (eg following oral surgery or in physically or mentally-handicapped patients). It is valuable in the management of aphtous ulceration and oral candidal infections (eg denture stomatitis and thrush) and can be used as an adjuvant treatment for minor infections of the throat.

As a disinfectant solution for the cleansing of removable dentures.

Eludril is contraindicated in infants and children under six years of age: see section 4.3.

1. As a mouthwash, dilute 10 to 15 ml in the measuring-cup provided for this purpose and fill with lukewarm water to the upper line and use as a mouthwash or a gargle two or three times a day.

2. As a disinfectant for removable dentures, prepare a 1 in 3 dilution of Eludril with water. The dentures previously cleansed should be soaked in the solution for one hour.

Route of administration

Oromucosal use. (This product is not intended to be swallowed)

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

- Use in infants and children less than 6 years of age.

- Use with anionic agents (see section 4.5).

Warnings

For oral use only

Do not swallow

Keep out of the eyes and ears. If the mouthwash 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 mouthwash or, in the case of dentures cleansing with a conventional cleanser: see sections 4.5, 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

This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E218) which may cause allergic reactions.

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 is no evidence of any adverse effects in infants arising from the use of Eludril mouthwash during pregnancy or lactation.

Therefore no special precautions are recommended.

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 solution as a mouthwash (normal dilution conditions for 10 ml is 7.4 %v/v and for 15 ml is 11.1 %v/v.). However, due to the undiluted product alcohol content (33.25 % 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.

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: Anti-infectives and antiseptics for local oral treatment.

ATC code: A01AB03.

CHLORHEXIDINE : broad-spectrum antibacterial (gram + and gram -) and anti-fungal product with extended bactericidal activity on buccal mucosa.

CHLOROBUTANOL: local anaesthetic providing a quick relief from pain, bacteriostatic reinforcing the activity of chlorhexidine.

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

CHLOROBUTANOL:

Systemic absorption after oral administration. Half-life of 9 to 10 days.

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

Poloxamer

Alcohol

Sorbitol solution 70 % (crystallising)

Menthol

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Peppermint spirit

Purified Water

See section 4.5

Unopened: 3 years

Store away from light,

Store at a temperature of 25°C maximum.

Clear glass bottle with aluminium cap and a measuring cup.

Pack sizes: 90ml, 250ml and 500ml.

Not all pack sizes may be marketed.

No special requirements

PIERRE FABRE LIMITED

Hyde Abbey House

23 Hyde Street

Winchester

Hampshire

SO23 7DR

UNITED KINGDOM

PL 00603/0012R

Date of first authorisation: 9^th August 1973

Date of last renewal: 16^th April 2007

27/01/2011