Corsodyl 200 mg/100 ml 150 ml oral mucosal solution

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Disinfectant action of the oral cavity, even before and after tooth extractions or minor operations. Anti-plaque action, adjuvant in the prevention of gingivitis and periodontitis secondary to the formation of dental plaque. Protective action against infections in wearers of fixed or removable prostheses, for its antiseptic activity on teeth and gums.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

WARNINGS AND PRECAUTIONS FOR USE

Do not exceed the indicated doses. Avoid contact with eyes and ears. If the product comes into contact with your eyes or ears, wash promptly with water. The product is for external oral use only; do not ingest. If you experience pain, swelling or irritation in your mouth, stop treatment and consult your doctor or dentist. If you experience a rash, swelling or difficulty breathing, discontinue use of the product and contact a doctor immediately. Initially, transient changes in taste and transient sensations of numbness, tingling or burning of the tongue may occur. These effects usually diminish with continued use. If they persist, consult your doctor or dentist. The use, especially prolonged, of products for topical use can give rise to sensitization phenomena; in this case, stop treatment and consult your doctor to institute suitable therapy. Do not use for prolonged treatments; after a short period of treatment without appreciable results, consult your doctor. Chlorhexidine gluconate can cause surface discoloration of the tongue, teeth and some materials used for fillings and dentures. The stains are not permanent and can largely be prevented by reducing the consumption of food chromogens, such as tea, coffee and red wine. As regards teeth and orthodontic material, this staining can be prevented with the daily use of a common toothpaste or before the use of Corsodyl solution, spray for oral mucosa and dental gel, taking care to rinse the mouth with water in the interval between the two treatments, or at another time of the day. These precautions are necessary as chlorhexidine gluconate is incompatible with anionic compounds generally found in common toothpastes. In some cases, the coloring can be eliminated by resorting to professional cleaning. In the case of anterior prostheses and fillings that have infiltrated edges and/or rough surfaces, the pigmentation could remain even after professional cleaning. A professional cleaning intervention may be required following treatments such as jaw fixation or application of orthodontic appliances which have not made it possible to carry out normal mechanical oral hygiene (e.g. brushing). Important information about some excipients CORSODYL oral mucosa solution, oral mucosa spray and dental gel contain hydrogenated polyoxyethylene-castor oil which may cause localized skin reactions. CORSODYL solution and spray for oral mucosa contain mint essence, an aroma which in turn contains d-limonene, eugenol and linalool, which may cause allergic reactions. CORSODYL dental gel contains mint essence, an aroma which itself contains d-limonene which can cause allergic reactions.

INTERACTIONS

There are no known clinically significant interactions with other drugs. Avoid the simultaneous use of other antiseptics.

SIDE EFFECTS

Undesirable effects arising from clinical trial data and post-marketing data are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), frequency not known (cannot be estimated from the available data). Data from clinical studies Gastrointestinal disorders. Very common: coated tongue; Common: dry mouth. Nervous system disorders. Common: ageusia/dysgeusia, glossodynia, paraesthesia/hypoesthesia of the oral cavity. Post-marketing data Gastrointestinal disorders. Frequency not known: superficial discoloration of the tongue and teeth (see “Special warnings and precautions for use”), pain/irritation of the mouth, scaling/pain/swelling of the oral mucosa (see “Special warnings and precautions for use”), swelling of the parotid glands. Pathologies of the skin and subcutaneous tissue. Frequency not known: idiosyncratic skin reactions. Immune system disorders. Frequency not known: hypersensitivity, allergic reactions and anaphylaxis (see “Contraindications”, “Special warnings and precautions for use”). The side effects noted are generally mild and local in nature. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at Error! Hyperlink reference not valid. https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.