ZEROFLOG COLLUT 1FL 200ML

ZEROFLOG

active ingredients

ZEROFLOG 0.074 g /100 ml collutory, 1 bottle 100 ml of collutory contain: active ingredient: Diclofenac Acid (acid 2-[(2,6-diclorofenil)amino] benzenacetic) g 0.074 Excipient(s) with known effects: sodium benzoate ZEROFLOG 0.011 g/15 ml collutory, 12 bags Each 15 ml bag contains: active ingredient: Diclofenac Acid (acid 2-[(2,6-diclorofenil)amino] benzenacetic) g 0.011 Excipient(s) with known effects:sodium benzoate ZEROFLOG 0.022g /15 ml solution, oral mucosa spray 15 ml of solution contain: active ingredient: Diclofenac Acid (acid 2-[(2,6-diclorofenil)amino] benzenacetic) g 0.022 Excipient(s) with known effects:benzoate sodium, ethanol For the full list of excipients see section 6.1

Excellent

ZEROFLOG Collutorio (flacone and sachets) Non crystallized liquid Sorbitol, choline (base), benzoate sodium, disodium edetato, potax acesulfame, natural aroma mint, natural aroma fishing, Ponceau red colorant (E124), purified water. ZEROFLOG oral mucosa spray solution Non crystallized liquid Sorbitol, choline chloride, disodium edetate, sodium benzoate, potassium acesulfame, mint essential oil, natural aroma fishing, red coloring Ponceau (E 124), Ethanol 96%, 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 active ingredient, or substances strictly related to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs or any of the excipients listed in paragraph 6.1

Population

Population Collumination The recommended dose is 2-3 shawls or gargles per day with 15 ml (1 scoop or 1 sachet) of pure or diluted collutory 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

Collutorio (flacone and sachets) Store at a temperature below 25°C Oral Mucosa Spray Solution Store at a temperature below 25°C

Warnings

Any involuntary swallowing of the collutory dose used for casks and gargles does not entail any harm 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. Although systemic absorption is limited, Zeroflog must be administered with caution in patients with a history of gastrointestinal hemorrhage or perforation related to previous active treatments or history of hemorrhage/recurring peptic ulcer (two or more distinct episodes of proven ulceration or bleeding).

Interactions

Since systemic absorption is limited in normal conditions of use, interactions with other medicines are unlikely.

Effects

The desired effects listed by frequency are reported using the following convention: Very common (≥1/10); common (from ≥1/100 to gastrointestinal pathologies) Notable: Feeling of burning in the mouth Respiratory, chest and mediastinic pathologies Toxes In clinical studies with ZEROFLOG oral mucosa spray solution, only in a small number of treated patients were observed the following side effects: (a) Small Gastrointestinal diseases: nausea, dispepsia Vascular pathologies: hypotension Skeletal muscle system and connective tissue pathologies: smooths Eye pathologies: b) Moderate entity Central nervous system pathologies: headache Pathologies of skin and subcutaneous tissue: alterations of mucous membranes 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 address: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No hyperdosage cases have been reported with ZEROFLOG.

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