Product Summary

1.    Trade Name of the Medicinal Product

Eludril Mouthwash

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Actives :	Quantity :	Unit :
Chlorhexidine digluconate	0.100	% W/V
Chlorobutanol	0.500	% W/V

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.

3 PHARMACEUTICAL FORM

Mouthwash.

Clear colourless Oromucosal solution.

4 CLINICAL PARTICULARS

Therapeutic indications

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.

4.2 Posology and method of administration

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)

4.3 Contraindications

-    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).

4.4 Special warnings and precautions for use

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.

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 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.

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

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.
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: In cases where oral desquamation occurs dilution of 10ml of the mouthwash with water to the upper line of the measuring cup will often allow continued use of the mouthwash: see section 4.4

4.9 Overdose

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.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Anti-infectives and antiseptics for local oral treatment,

ATC code: A01AB03.

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

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

5.2    Pharmacokinetic properties

CHLORHEXIDINE:

Oral

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

Distribution: Mainly in liver and kidney

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

Permucosal

When using local mouthwash, 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.

CHLOROBUTANOL

Oral

Absorption: When administered orally, chlorobutanol is rapidly absorbed. A 2-fold decrease is observed during the 24 hours after intake.

Excretion: The terminal half-life is approximately 10 days. Urinary excretion is low, about 10% of the ingested dose.

5.3    Preclinical safety data

Non-clinical data for chlorhexidine reveal no special hazard for humans based on studies of repeated dose toxicity and local tolerance, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.

Effects in oral non-clinical repeat-dose studies were observed only at dose levels considered sufficiently in excess of the maximum human dose level indicating little relevance to clinical use after topical application.

6    PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Poloxamer

Alcohol

Sorbitol solution 70 % (crystallising) Menthol

Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Peppermint spirit Purified water

Incompatibilities

See section 4.5.

6.3    Shelf life

Unopened: 3 years.

6.4    Special precautions for storage

Store away from light,

Store at a temperature of 25° C maximum.

6.5    Nature and contents of container

Clear glass bottle with aluminium cap and a measuring cup. Pack sizes: 90 ml, 250 ml and 500 ml.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

PIERRE FABRE LIMITED

Hyde Abbey House

23 Hyde Street

Winchester

Hampshire

SO23 7DR

Marketing Authorisation Number

PL 00603/0012R

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 9^th August 1973.

Date of last renewal: 16^th April 2007

DATE OF REVISION OF THE TEXT

23/01/2015