Document: spc-doc_PL 44673-0063 change

• spc-doc_PL 00079-0677
• spc-doc_PL 44673-0063

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Corsodyl Mint Flavour 0.2% w/v Mouthwash

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Chlorhexidine Digluconate 0.2% w/v

(equivalent to Chlorhexidine Digluconate Solution 1.028% w/w)

Also contains macrogolglycerol hydroxystearate. For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Mouthwash

A clear to slightly opalescent, transparent solution with an odour of peppermint.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For inhibition of the formation of dental plaque.

As an aid in the treatment and prevention of gingivitis and in the maintenance of oral hygiene, particularly in situations where toothbrushing cannot be adequately employed (e.g. following oral surgery, in mentally or physically handicapped patients).

Also for use in a post-peridontal surgery or treatment¹ regimen to promote gingival healing.

It is useful in the management of aphthous ulceration and oral candidal infections (e.g. denture stomatitis and thrush).

4.2 Posology and method of administration

Adults:

Thoroughly rinse the mouth for about one minute with 10 ml twice daily. In the dental surgery the patient should be instructed to rinse the mouth for one minute prior to treatment.

The mouthwash is incompatible with anionic agents which are usually present in conventional dentifrices. These should therefore be used before the mouthwash (rinsing the mouth between applications) or at a different time of day.

For the treatment of gingivitis a course of about one month is advisable although some variation in response is to be expected. In the case of aphthous ulceration and oral candidal infections treatment should be continued for 48 hours after clinical resolution. For the treatment of dental stomatitis the dentures should be cleansed and soaked in the mouthwash for fifteen minutes twice daily.

Children and the Elderly:

The normal adult dose is appropriate for elderly patients and children of 12 years and over unless otherwise recommended by the dentist or the physician.

Children under 12 years of age should not use the product unless recommended by a healthcare professional.

Route of administration

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

4.3 Contraindications

The product is contraindicated for patients who have previously shown a hypersensitivity reaction to Chlorhexidine or to any of the excipients in the formulation. However, such reactions are extremely rare.

4.4 Special warnings and precautions for use

For oromucosal use only. Do not swallow. Keep out of the eyes and ears.

If the mouthwash comes into contact with the eyes, wash out promptly and thoroughly with water.

In case of soreness, swelling or irritation of the mouth, stop using the product and consult a healthcare professional.

Macrogolglygerol hydroxystearate may cause skin reactions.

4.5 Interaction with other medicinal products and other forms of interaction

Chlorhexidine is incompatible with anionic agents.

4.6 Pregnancy and lactation

There is no evidence of any adverse effects on the foetus arising from the use of chlorhexidine digluconate during pregnancy or on infants during lactation. Therefore no special precautions are recommended.

4.7 Effects on ability to drive and use machines

None have been reported or are known.

4.8 Undesirable effects

Discoloration: A superficial discoloration of the dorsum of the tongue may occur. This disappears after treatment is discontinued. Discoloration of the teeth and silicate or composite restorations may also occur. This stain is not permanent and can largely be prevented by reducing the consumption of tea, coffee and red wine and brushing with a conventional toothpaste daily before using the mouthwash, or, in the case of dentures, cleaning with a conventional denture cleaner. 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, for example with intermaxillary fixation, or with extensive orthodontic appliances, scaling and polishing may also be required once the underlying condition has been resolved.

Taste: Transient disturbance 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.

Oral desquamation: In cases where oral desquamation occurs dilution of the mouthwash with an equal volume of tap water, freshly mixed, will often allow continued use of the mouthwash.

Parotid gland swelling: Very occasionally, swelling of the parotid glands during the use of chlorhexidine mouthrinses have been reported. In all cases spontaneous resolution has occurred on discontinuing treatment.

Irritative skin reactions: Irritative skin reactions to chlorhexidine preparations can occasionally occur.

Generalised reactions: allergic reactions, hypersensitivity and anaphylaxis to chlorhexidine have also been reported but are extremely rare.

4.9 Overdose

This has not been reported.

Accidental ingestion: Chlorhexidine taken orally is poorly absorbed. Systemic effects are unlikely even if large volumes are ingested. However, gastric lavage may be advisable using milk, raw egg, gelatin or mild soap. Employ supportive measures as appropriate.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC code: A01A B03

Pharmacotherapeutic group: anti-infectives and antiseptics for local oral treatment

The mouthwash contains 0.2% w/v chlorhexidine digluconate which is an antimicrobial preparation for external use. It is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is active against a wide range of important oral pathogens and is therefore effective in the treatment of many common dental conditions.

5.2 Pharmacokinetic properties

Because of its cationic nature, chlorhexidine binds strongly to skin, mucosa and tissues and is thus very poorly absorbed. No detectable blood levels have been found following oral use.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Glycerol

Macrogolglycerol Hydroxystearate Sorbitol liquid (non-crystallising)

Peppermint flavour Purified water.

6.2    Incompatibilities

Hypochlorite bleaches may cause brown stains to develop in fabrics that have previously been in contact with preparations containing chlorhexidine.

6.3    Shelf Life

300 ml - 30 months

Shelf life after opening: 3 months

6.4    Special precautions for storage

Store below 25 °C

6.5    Nature and contents of container

Oriented amber polyethylene terephthalate bottle with plastic screw cap made from white food grade polypropylene.

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NB: Use as part of a post-periodontal treatment regimen has only been adequately studied over the short term and following standard root surface instrumentation.