CORSODYL ORIGINAL Mouthwash (2020)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | GlaxoSmithKline Consumer Healthcare |
|---|---|
| Διεύθυνση | 980 Great West Road, Brentford, Middlesex, TW8 9GS |
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Περιεχόμενα
Name of the medicinal product
Corsodyl Original Mouthwash. Corsodyl Mouthwash Original.
Qualitative and quantitative composition
Chlorhexidine Digluconate 0.2% w/v. (equivalent to Chlorhexidine Digluconate Solution Ph Eur 1.0% v/v).
Pharmaceutical form
Oromucosal solution.
Therapeutic indications
Corsodyl Mouthwash is an antimicrobial solution which inhibits the formation of dental plaque. It is indicated as an aid in the treatment and prevention of gingivitis and in the maintenance of oral hygiene, ...
Posology and method of administration
Adults Thoroughly rinse the mouth for about one minute with 10 ml twice daily. Spit out after use. In the dental surgery the patient should be instructed to rinse the mouth for one minute prior to treatment. ...
Contraindications
Corsodyl is contraindicated for patients who have previously shown a hypersensitivity reaction to Chlorhexidine or to any of the excipients in the formulation.
Special warnings and precautions for use
For oral (external) 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 ...
Interaction with other medicinal products and other forms of interaction
Chlorhexidine is incompatible with anionic agents.
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.
Effects on ability to drive and use machines
None have been reported or are known.
Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); ...
Overdose
Due to the alcohol content (7.0 % v/v) ingestion of large amounts by children requires attention. Seek medical advice for appropriate action. Accidental ingestion: Chlorhexidine taken orally is poorly ...
Pharmacodynamic properties
Chlorhexidine 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 ...
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.
Preclinical safety data
No information further to that contained in other sections of the SPC is included.
List of excipients
Ethanol (96 per cent) Macrogolglycerol Hydroxystearate Ponceau 4R (E124) Aniseed Flavouring Oil Peppermint oil Purified water
Incompatibilities
Hypochlorite bleaches may cause brown stains to develop in fabrics that have previously been in contact with preparations containing chlorhexidine.
Shelf life
Three years.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Oriented amber polyethylene terephthalate bottle with plastic screw cap made from white food grade polypropylene. Each bottle contains 300 ml or 600 ml.
Special precautions for disposal and other handling
None.
Marketing authorization holder
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
Marketing authorization number(s)
PL 44673/0061
Date of first authorization / renewal of the authorization
10 February 1994 / 09 September 2008
Date of revision of the text
17/6/20
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