Zeroflog

Mouthwash

Composition:

ZEROFLOG Mouthwash 100 ml of mouthwash contain: active ingredient: Diclofenac acid (2 - [(2,6 – dichlorophenyl) amino] benzenacetic acid) 0.074 g. Excipients: sodium benzoate. A 15 ml sachet contains: active ingredient: Diclofenac acid (2 - [(2,6 – dichlorophenyl) amino] benzenacetic acid) 0.011 g. excipients: sodium benzoate. For the full list of excipients see section 6.1 ZEROFLOG 0.022g / 15 ml spray solution for oral mucosa 15 ml of solution contain: active ingredient: Diclofenac acid (2 - [(2,6-dichlorophenyl) amino] benzenacetic acid) 0.022 g. excipients: sodium benzoate. For the full list of excipients see section 6.1.

Excipients

ZEROFLOG Mouthwash (bottle and sachets) Non crystallizable liquid sorbitol, choline (base), sodium benzoate, disodium edetate, acesulfame potassium, mint natural flavoring, natural peach flavoring, Ponceau red dye (E124) purified water. ZEROFLOG spray solution for oral mucosa Non-crystallizable liquid sorbitol, choline chloride, disodium edetate, sodium benzoate, acesulfame potassium, essential oil of mint, natural flavoring peach, Ponceau red dye (E 124), 96% ethanol, sodium hydroxide, purified water.

Therapeutic indications

Symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.

Contraindications

Hypersensitivity to product components or substances closely related chemically to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs

Dosage

Mouthwash The recommended dose is 2–3 rinses or gargles per day with 15 ml (1 scoop or 1 sachet) of pure or diluted mouthwash in a little water. Oromucosal spray The recommended dose is 2 sprays three times a day addressed directly to the affected area. Each spray delivers 0.2 ml of solution equivalent to 0.3 mg of active ingredient.

Warnings and Precautions

Any involuntary swallowing of the dose of mouthwash used for rinsing and gargling does not cause any harm to the patient as it is equivalent to one fifth / sixth of the dose prescribed by the systemic dosage. The use, especially if prolonged, of topical preparations can give rise to sensitization phenomena, in which case it is necessary to interrupt the treatment and institute, if necessary, suitable therapy. Although systemic absorption is limited, Zeroflog should be administered with caution to patients with a history of gastrointestinal bleeding or perforation related to previous active treatments or a history of recurrent peptic haemorrhage / ulcer (two or more distinct episodes of proven ulceration or bleeding).

Interactions

As systemic absorption is limited under normal conditions of use, interactions with other medicinal products are unlikely.

Side effects

Diclofenac is generally well tolerated and side effects rarely occur. Clinical studies conducted with ZEROFLOG Collutorio have shown, especially for prolonged treatments, the onset of the following undesirable effects: Gastrointestinal disorders Irritative phenomena affecting the oral mucosa, generally mild. Respiratory disorders Cough. In clinical studies with ZEROFLOG oromucosal spray solution, the following undesirable effects were observed in only a small number of patients treated: a) mild in severity Gastrointestinal disorders nausea, dyspepsia Vascular disorders Hypotension Musculoskeletal and connective tissue disorders chills Disorders vision disturbances in vision b) moderate Central nervous system disorders headache Skin and subcutaneous tissue disorders mucous membrane disorders.

Pregnancy and breastfeeding

In pregnant and lactating women, the product should be used in cases of real need, under the direct supervision of the doctor.