CORSODYL GEL DENT 30G 1G/100G

CORSODYL

active ingredients

CORSODYL solution and spray for oral mucosa 1 ml of solution contains: Active ingredient chlorhexidine gluconate 2 mg Excipients with known effects: polyoxyethylene- hydrogenated castor oil, mint essence CORSODYL dental gel 1 g gel contains: Active ingredient chlorhexidine glucon 10 mg Excipients with known effects: polyoxyethylene- hydrogenated castor oil, mint essence For full list of excipients see paragraph 6.1.

Excellent

CORSODYL solution and spray for oral mucosa: polyxyethylene- hydrogenated castor oil, 70% non crystallized sorbitol, mint essence, ethyl alcohol (96%), purified water.CORSODYL dental gel: polyxyethylene- hydrogenated castor oil, hydroxypropylcellulose, acetate sodium, menthol, mint essence, isopropyl alcohol, purified water.

Therapeutic indications

Disinfecting oral cavity action, even before and after tooth extractions or small interventions. Antiplaque action, adjuvant in the prevention of gums and secondary periodontitis to the formation of dentaria plaque. Protective action against infections in wearers of fixed or mobile prostheses, for antiseptic activity on teeth and gums.

Contraindications

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

Population

Solution for oral mucosa Adults Pour 10 ml of Corsodyl in the appropriate glass and rinse your mouth for about 1 minute twice a day until complete remission of symptomatology; in case of ulcers or candidiasis continue treatment for another 48 hours once the clinical resolution is completed. The product should not be diluted. Sputate after use. Oral Mucosa Spray Adults Spray on teeth and gums 2 times a day. The maximum daily dosage is 12 sprays (about 0.14 ml/per spray) twice a day, in the morning and in the evening. Dental gel Adults Apply on teeth and gums 2 cm of gel for a minute, one or twice a day, using a soft toothbrush or fingers. In the wearers of mobile prostheses, after cleaning, apply a small amount of gel on the surfaces that come in contact with the gums. Sputate the excess product. Do not rinse your mouth after applying the gel. Suggested doses for adults are also suitable for use in elderly patients and children from 12 years on, except for different prescription of the doctor or dentist. In children under the age of 12, Corsodyl should only be used on a doctor's or dentist's prescription.

Conservation

CORSODYL oral mucosa spray: none. CORSODYL dental gel: Store at a temperature not exceeding 25°C. CORSODYL oral mucosa solution: do not store at temperature above 25°C.

Warnings

Do not exceed the doses indicated. Avoid contact with eyes and ears. If the product comes in contact with the eyes or ears, wash quickly with water. The product is only for external oral use; don't swallow. In case of pain, swelling or irritation of the mouth, stop treatment and consult your doctor or dentist. In case of appearance of rash, swelling or difficulty breathing, suspend the use of the product and immediately contact a doctor. Initially, transient alterations of taste and transient sensations of numbness, pinch or burning of the tongue may occur. These effects usually decrease with continued use. If they persist, consult your doctor or dentist. Prolonged use of topical products can give rise to awareness-raising phenomena; in this case interrupt treatment and consult your doctor to establish suitable therapy. Do not use for prolonged treatments; after short period of treatment without appreciable results consult your doctor. Chlorhexidine gluconate can cause a superficial coloration of the tongue, teeth and some materials used for fillings and prostheses. The stains are not permanent and can be largely prevented by reducing the consumption of food chromogens, such as tea, coffee and red wine. As for teeth and orthodontic material, such coloring can be prevented with the daily use of a common toothpaste or before the use of Corsodyl solution, oral mucosa spray and dental gel, taking care to rinse the mouth with water in the range between the two treatments, or at another time of the day. These precautions are necessary as chlorhexidine gluconate is incompatible with anionic compounds typically present in common toothpastes. In some cases, the coloring can be eliminated using professional cleaning. In the case of anterior prosthesis and fillings with infiltrated edges and/or rough surfaces, pigmentation may remain even after professional cleaning. A professional cleaning procedure may be required as a result of treatments such as maxillary fixing or application of orthodontic appliances which have not made possible the implementation of normal mechanical oral hygiene (e.g. brushing). Important information about some excipients CORSODYL oral mucosa solution, oral mucosa spray and dental gel contain polyoxethylene-oil of hydrogenated castor which can cause reactions on the localized skin. CORSODYL oral mucosal solution and spray contain mint essence, an aroma in turn containing d-limonene, eugenol and linalol, which can cause allergic reactions. CORSODYL dental gel contains mint essence, an aroma in turn containing d-limonene which can cause allergic reactions.

Interactions

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

Effects

The undesirable effects of clinical studies and post-marketing data are listed below according to system and organ classification and frequency. The frequencies are defined as: very common (≥1/10), common (≥1/100, Data from clinical studies Gastrointestinal diseases Very common: patinate language. Municipality: dry mouth Diseases of the nervous system Municipality: ageusia/disgeusia, glossodinia, paresthesia/hypoesthesia of the oral cable. Post-marketing data Gastrointestinal diseases Frequency not known: superficial coloring of the tongue and teeth (see “Special warnings and precautions of use”), pain/irritation of the mouth, desquamation/dolor/inflator of the oral mucosa (see “Special warnings and precautions of use”), swelling of the parotidee glands. Pathologies of skin and subcutaneous tissue Frequency not known: skin reactions of idiosyncrasic type. Immune system pathologies Frequency not known: hypersensitivity, allergic reactions and anaphylaxis (see “Controindications”, “Special warnings and precautions of use”). The undesirable effects are generally of a mild and local nature. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address Error! Hyperlink reference not valid. https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Chlorhexidine is poorly absorbed by mouth. The ingestion of Corsodyl, even in high quantities, should not produce systemic effects, however in such eventuality it is advisable to contact the doctor to establish suitable therapy. Lecturedyl solution and oral mucosa spray contain 6.72% of ethyl alcohol, therefore taking high doses by children requires attention and possible use of the doctor to establish suitable therapy.

There is no evidence of any adverse reactions to the fetus attributable to the use of the product during pregnancy, or to the burden of infants during breastfeeding. Therefore, no precautions other than those already mentioned in the paragraph are necessary 4.4.

Source: Farmadati