Zeroflog 0.074g / 100ml Diclofenac Mouthwash Bottle 200 ml

ZEROFLOG * COLLUT 1FL 200ML

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.

Dosage and method of use

Dosage MouthwashThe 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.Oral mucosal sprayThe 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.

Contraindications

Hypersensitivity to the active substance, or substances closely related from a chemical point of view to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs or to any of the excipients listed in section 6.1

Side effects

Undesirable effects listed by frequency are reported, using the following convention: Very common (≥1 / 10); common (≥1 / 100 to Gastrointestinal disorders Not known: Burning sensation in the mouthRespiratory, thoracic and mediastinal disordersCough In clinical studies with ZEROFLOG oral mucosal spray solution, the following undesirable effects were observed only in a small number of treated patients: a) Mild in severityGastrointestinal disorders:nausea, dyspepsiaVascular disorders:hypotensionMusculoskeletal and connective tissue disorders:chillsEye disorders:vision changes b) ModerateCentral nervous system disorders:headacheSkin and subcutaneous tissue disorders:changes in the mucous membranesReporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the address: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

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).

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.

Expiration and retention

Mouthwash (bottle and sachets)Store below 25 ° CSpray solution for oral mucosaStore below 25 ° C

Interactions with other drugs

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

Overdose

There have been no reports of overdosage with ZEROFLOG.

Active principles

ZEROFLOG 0.074 g / 100 ml mouthwash, 1 bottle100 ml of mouthwash contain: active ingredient: Diclofenac acid (acid 2-[(2,6-diclorofenil)amino]benzenacetic) g 0.074Excipient (s) with known effects:sodium benzoateZEROFLOG 0.011 g / 15 ml mouthwash, 12 sachetsEach 15 ml sachet contains: active ingredient: Diclofenac acid (acid 2-[(2,6-diclorofenil)amino]benzenacetic) g 0.011Excipient (s) with known effects:sodium benzoateZEROFLOG 0.022g / 15ml solution, oral mucosal spray15 ml of solution contain: active ingredient: Diclofenac acid (acid 2-[(2,6-diclorofenil)amino]benzenacetic) g 0.022Excipient (s) with known effects:sodium benzoate, ethanol For a 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 peach flavoring, Ponceau red dye (E 124), 96% ethanol, sodium hydroxide, purified water.