DICLOMED COLLUT 1FL 200ML

DICLOMED

active ingredients

DICLOMED 0.74 mg/ml Collutory. 100 ml of collutory contain: Active ingredient: Diclofenac Acid (acid 2-[(2,6-diclorofenil)amino] benzenacetic): 0.074 g. DICLOMED 0.3 mg/spruzzo Spray for oral mucosa. A spray (corresponding to 0.2 ml) contains: Diclofenac Acid (acid 2-[(2,6-diclorofenil)amino] benzenacetic): 0.3 mg. Excipients with known effects: benzoate sodium (E211). For the full list of excipients, see paragrafo6.1.

Excellent

DICLOMED 0,74 mg/ml Collutory: Sorbitol, choline, benzoate sodium (E211), sodium edetato, potassium acesulfame, natural aroma mint, natural aroma fishing, E124, purified water. DICLOMED 0.3 mg/spruzzo spray for oral mucosa:Sorbitol, choline chloride, sodium edetato, sodium benzoate (E211), potax acesulfame, mint essential oil, natural aroma fishing, E129, Ethanol, sodium hydroxide, purified water.

Therapeutic indications

Symptomatic treatment of irritative-inflammatory states also associated with pain of the oropharyngeal cable (e.g. gums, stomatitis, pharyngitis), also as a result of conservative or extractive dentaria therapy.

Contraindications

Hypersensitivity to the product components or substances closely related to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs

Population

Collumination: The recommended dose is 2-3 shawls or gargarisms per day with 15 ml (1 scoop) pure or diluted in little water. Oral Mucosa Spray: The recommended dose is 2 sprays three times a day directly on the affected part. Each spray dispenses 0.2 ml of solution equivalent to 0.3 mg of active ingredient.

Conservation

Do not store above 25°C

Warnings

Any involuntary swallowing of the collutory dose used for casks and gargles does not entail any damage to the patient as it is equivalent to a fifth/sixth of the dose provided by systemic dosage. The use, especially if the topical preparations are prolonged, can give rise to awareness-raising phenomena, in which case it is necessary to stop the treatment and establish, if necessary, suitable therapy. Diclomed contains benzoate sodium (E211), which can cause local irritation. Diclomed 0.74 mg/ml Collutory contains 2000 mg of benzoate sodium (E211) in 200 ml, equivalent to 10 mg/ml. Diclomed 0.3 mg/spruzzo, oral mucosa spray contains 150 mg benzoate sodium (E211) in 15 ml, equivalent to 10 mg/ml.

Interactions

Negative interactions with other common drugs used in relevant therapy have not been detected.

Effects

Diclofenac is generally well tolerated and undesirable effects Clinical studies conducted with DICLOMED 0,74 mg/ml Collutory have shown, especially for prolonged treatments, the appearance of the following side effects. Small:

Classification for systems and organs	Undesirable effects
Gastrointestinal diseases	irritative phenomena due to oral mucosa
Other side effects:
Classification for systems and organs	Undesirable effects
Respiratory, chest and mediastinic pathologies	Tosses

In clinical studies with DICLOMED 0.3 mg/spruzzo oral mucosa spray in a small number of treated patients were observed the following side effects. Small:

Classification for systems and organs	Undesirable effects
Pathologies of the eye	Alterations of vision
Heart disease	Hypotension
Gastrointestinal disorders	Nausea, dispepsia
Systemic pathologies and conditions for administration	Brilliant

Moderate:

Classification for systems and organs	Undesirable effects
Disorders of the nervous system	Cefa
Systemic pathologies and conditions for administration	alteration of mucous membranes

Other side effects:

Classification for systems and organs	Undesirable effects
Gastrointestinal disorders	Frequency not known: burning sensation in the mouth

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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

Hyperdose cases with DICLOMED have not been reported

In pregnant women and during breastfeeding the product should be used in cases of actual need, under the direct control of the doctor.

Source: Farmadati