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CORSODYL SPRAY

Active substance(s): CHLORHEXIDINE DIGLUCONATE SOLUTION

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Corsodyl Spray

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Chlorhexidine Digluconate 0.2% w/v (equivalent to Chlorhexidine Digluconate Solution Ph Eur 1.0% v/v)

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PHARMACEUTICAL FORM Oromucosal spray

4 4.1.

CLINICAL PARTICULARS 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 tooth brushing cannot be adequately employed (eg following oral surgery, in physically or mentally handicapped patients, the terminally ill or immunocompromised patients). Also for use in a post-peridontal surgery or treatment* regimen to promote gingival healing. *N.B: Use as part of a post-periodontal treatment regimen has only been adequately studied over the short term and following standard root surface instrumentation It is useful in the management of aphthous ulceration and oral candidal infections (eg denture stomatitis and thrush).

4.2.

Posology and method of administration

Adults: Corsodyl spray should be applied as required to the tooth and gingival surfaces, ulcers or other sore areas, using up to a maximum of twelve actuations of the spray (0.14 ml/actuation) twice daily. The spray should be applied once in the morning and once in the evening. Corsodyl is incompatible with anionic agents which are usually present in conventional dentifrices. These should therefore be used before Corsodyl (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 Corsodyl 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 External (oral) use only

4.3.

Contraindications Corsodyl 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 oral (external) use only. Do not swallow. Keep out of the eyes and ears. If the spray 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.

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 Corsodyl 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 spray. 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 spray. These effects usually diminish with continued use. Oral desquamation: In cases where oral desquamation occurs it may be necessary to discontinue treatment. Parotid gland swelling: Very occasionally, swelling of the parotid glands during the use of chlorhexidine has been reported. In all cases spontaneous resolution has occurred on discontinuation of treatment. Irritative skin reactions: Irritative skin reactions to chlorhexidine preparations can occasionally occur. Generalised reactions: Allergic reactions, hypersensitivity & anaphylaxis to chlorhexidine have also been reported but are extremely rare.

4.9.

Overdose This has not been reported. Due to the alcohol content (7.0 % v/v) ingestion of large amounts by children requires attention. Seek medical advice for appropriate action.

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5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Corsodyl Spray 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 No information further to that contained in other sections of the SPC is included.

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PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients Ethanol, Macrogolglycerol Hydroxystearate, Sorbitol 70 per cent (noncrystallising), Peppermint oil, 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 Three years.

6.4.

Special Precautions for Storage Store below 25C, protect from light.

6.5

Nature and contents of container
A clear sodaglass bottle, externally coated with opaque white polyvinylchloride (PVC) of nominal capacity 75 ml. The closure is a polypropylene, polyethylene, stainless steel pump dispenser incorporating a seal made of polyether ketone (PEK) and mounted in an aluminium cap, which is manually actuated and non-removable. It can be fitted with a detachable polyethylene actuator/spray head. Each bottle contains 60 ml.

6.6.

Instructions for Use, Handling and Disposal None.

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MARKETING AUTHORISATION HOLDER Beecham Group plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

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MARKETING AUTHORISATION NUMBER(S) PL 00079/0311

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/09/2008

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DATE OF REVISION OF THE TEXT
06/05/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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