CHLORHEXIDINE GLUCONATE ANTISEPTIC MOUTHWASH ORIGINAL FLAVOUR

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CHLORHEXIDINE GLUCONATE
Available from:
Ecolab Limited
ATC code:
A01AB03
INN (International Name):
CHLORHEXIDINE GLUCONATE
Dosage:
0.2 %w/v
Pharmaceutical form:
Oromucosal Solution
Prescription type:
Product not subject to medical prescription
Therapeutic area:
chlorhexidine
Authorization status:
Marketed
Authorization number:
PA1110/011/001
Authorization date:
2000-02-18

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Chlorhexidine Gluconate Antiseptic Mouthwash Original Flavour 0.2% w/v Oromucosal Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Chlorhexidine Gluconate 0.2% w/v.

Excipients:

Ponceau 4R 0.001%w/w

Macrogol glycerol hydroxystearate 0.7% w/w

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oromucosal Solution.

A clear pink solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Chlorhexidine Gluconate Antiseptic Mouthwash is an antimicrobial solution which inhibits the formation of dental

plaque. It is indicated as an aid to the treatment and prevention of gingivitis and in the maintenance of oral hygiene,

particularly in situations where toothbrushing cannot be adequately employed (eg following oral surgery or in

physically handicapped patients).

It is used to promote gingival healing following periodontal surgery, to manage

recurrent oral ulceration.

Additionally it is useful in the treatment of denture stomatitis and thrush.

4.2 Posology and method of administration

Children, adults and the elderly.

Chlorhexidine Gluconate Antiseptic Mouthwash should be used as required up to twice daily.

Rinse the mouth thoroughly for about 1 minute with 10 ml.

Prior to dental surgery, the patient should be instructed to

rinse the mouth with 10 ml for 1 minute.

In the treatment of gingivitis a course of about one month is recommended (ie

two bottles).

For denture stomatitis cleanse and soak the denture in solution for 15 minutes twice daily.

In the case of

aphthous ulceration and oral candidal infections, treatment should be continued for 48 hours after clinical resolution.

4.3 Contraindications

Known hypersensitivity to the product or any of its components, especially in those with a history of possible

chlorhexidine-related allergic reactions (see sections 4.4 and 4.8).

4.4 Special warnings and precautions for use

Chlorhexidine Gluconate Antiseptic Mouthwash contains chlorhexidine. Chlorhexidine is known to induce

hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine

hypersensitivity is not known, but available literature suggests this is likely to be very rare. Chlorhexidine Gluconate

Antiseptic Mouthwash should not be administered to anyone with a potential history of an allergic reaction to a

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chlorhexidine-containing compound (see sections 4.3 and 4.8).

For oral use only.

Keep away from the eyes and ears.

If solution comes into contact with the eyes, wash out well with

water.

Keep out of the reach and sight of children.

Ponceau 4R may cause allergic reactions.

Macrogol glycerol hydroxystearate may cause skin reactions.

4.5 Interaction with other medicinal products and other forms of interaction

Chlorhexidine Gluconate 0.2% is incompatible with anionic agents which are usually present in conventional

dentifrices.

These should therefore be used before Chlorhexidine Gluconate Antiseptic Mouthwash (rinsing the mouth

between applications) or at a different time of the day.

4.6 Fertility, pregnancy and lactation

Chlorhexidine has been in widespread use for many years and no harmful effects in human pregnancy have been

reported.

However as with all drugs, caution should be exercised.

Chlorhexidine Gluconate Antiseptic Mouthwash

should be used only when the benefit to the mother has been assessed by a clinician.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Immune disorders

Frequency not known: hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4)

Skin disorders

Frequency not known:

Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticarial, skin irritation, and

blisters, following topical application.

Chemical burns in neonates and infants, following topical application.

Gastrointestinal disorders

Uncommon:

A superficial discolouration of the dorsum of the tongue may occur.

This disappears after treatment is

discontinued.

Discolouration of the teeth and silicate or composite restorations may also occur.

This stain is not

permanent and can largely be prevented by brushing with a conventional toothpaste daily before using the mouthwash.

However, in certain cases, a professional prophylaxis (scaling and polishing) may be required to remove this stain

completely.

Stained anterior tooth-coloured restorations with poor margins or rough surfaces which are not adequately

cleaned by professional prophylaxis may require replacement.

Similarly where normal toothbrushing is not possible, as

for example with intermaxillary fixation or with extensive orthodontic appliances, scaling and polishing may also be

required once the underlying conditions have been resolved.

Very rare:

In cases where oral desquamation occurs it may be necessary to discontinue treatment.

Very occasionally,

swelling of the parotid glands during the use of oral chlorhexidine has been reported.

In all cases spontaneous

resolution has occurred on discontinuing treatment.

Nervous System disorders:

Common:

Transient disturbances of taste sensation and a burning sensation of the tongue may occur on initial use of the

mouthwash.

These effects usually diminish with continued use.

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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 HPRA Pharmacovigilance, Earlsfort Terrace,

IRL – Dublin 2; Tel: +353 1 6764971;

System Organ

Class

Very

Common

(

1/10)

Common

(

1/100 <

1/10)

Uncommon

(

1/1,000 <

1/100)

Rare

(

1/10,000

< 1/1,000)

Very Rare

(< 1/10,000)

Not known

(cannot be

estimated from

available data)

Gastrointestinal

Disorders

Tooth

discolouration

Tongue

discolouration

Oral mucosal

exfoliation

(desquamation)

Parotid gland

enlargement

Immune

System

Disorders

Hypersensitivity

Anaphylactic

shock

Nervous System

Disorder

Dysgeusia

(taste

altered)

Skin and

Subcutaneous

Tissue

Disorders

Allergic skin

reactions

Chemical Burns

(Neonates and

infants)

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Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

Chlorhexidine is poorly absorbed by the oral route, therefore systematic effects are unlikely even if large volumes are

swallowed.

However, gastric lavage followed by supportive measures may be used as appropriate.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Chlorhexidine gluconate is a bisguanide antiseptic and disinfectant which is bactericidal or bacteriostatic against a wide

range of gram negative and gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophylic viruses.

antimicrobial activity covers most of the important species occuring in the oral microflora.

5.2 Pharmacokinetic properties

Because of its cationic nature, chlorhexidine (gluconate) binds strongly to skin, mucosa and other tissues and is thus

very poorly absorbed.

No detectable blood levels have been found following oral use.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Chlorhexidine Gluconate Antiseptic Mouthwash contains the following inactive ingredients:

Ethanol

Sorbitol

Macrogol glycerol hydroxystearate

Original Flavour: E2309 10 N1

Ponceau 4R

Purified Water

6.2 Incompatibilities

Chlorhexidine Gluconate Antiseptic Mouthwash is incompatible with anionic agents which are often present in

toothpastes.

Therefore these should be used before the mouthwash, rinsing the mouth between applications, or at a

different time of day.

Hypochlorite bleaches may cause brown stains to develop in fabrics previously in contact with chlorhexidine.

6.3 Shelf life

Two years.

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original container in order to protect from light.

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6.5 Nature and contents of container

Amber PET bottle with a polypropylene screw cap. The cap is conical in shape and has “10 ml” and a level line

engraved on the inside. The pack contains 300 ml.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Ecolab Ltd

Lotherton Way

Garforth

Leeds LS25 2JY

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA 1110/011/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 18 February 2000

Date of last renewal:

12 March 2008

10 DATE OF REVISION OF THE TEXT

October 2015

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