SEPTAFAR SPRAY 1FL 30ML 250ER

SEPTAFAR 1.5 MG/ML + 5,0 MG/ML SPRAY FOR ORAL MUCOSA, DEVELOPMENT

active ingredients

Each ml of oral mucosa spray, solution contains 1.5 mg of benzidamine hydrochloride and 5 mg of cetilpiridinium chloride. A dispensing contains 0.1 ml oral mucosa spray, solution, containing 0.15 mg of benzidamine hydrochloride and 0.5 mg of cetilpiridinium chloride. Excipient(s) with known effects: - Ethanol: 26 mg/ for each delivery For the full list of excipients, see paragraph 6.1.

Excellent

Ethanol (96 percent) Glicerol (E422) Hydroxystearate Macrogolglycerol Sodium saccharin (E954) Peppermint Oil Purified Water

Therapeutic indications

Septafar oral mucosa spray, solution is indicated in adults and children over 6 years of age for anti-inflammatory, analgesic and antiseptic treatment in throat, mouth and gum irritations, gums, pharyngitis and laryngitis and before and after tooth extractions.

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. Children under the age of 6 because the pharmaceutical form is not suitable for this age group.

Population

Population Adults: for a single dose, press the dispenser once or twice. This operation can be repeated every 2 hours, 3-5 times a day. For an optimal effect, it is recommended not to use the product immediately before or after washing the teeth. Do not exceed the recommended doses. Septafar can be used up to 7 days. Senior Patients The recommended dose is the same as adults. Pediatric population Children over 12 years of age: for a single dose, press the dispenser once or twice. This operation can be repeated every 2 hours, 3-5 times a day. Children from 6 to 12 years old: Septafar must be used in this age group only under medical advice. For a single dose, press the dispenser once. This operation can be repeated every 2 hours, 3-5 times a day. Septafar is contraindicated in children under 6 years of age. Method of administration Before using Septafar spray for oral mucosa, to obtain a regular dispensing, press the spray several times. If the spray has not been used for a long time (at least one week) press the dispenser once to obtain a regular delivery.

	Remove the plastic cap before use.
	Open your mouth well, point the spray spout to the throat and press the dispenser 1-2 times. Hold your breath during delivery.

After each use, put the plastic cap on the dispenser. When you press the dispenser once, 0.1 ml of oral mucosa spray is released, a solution containing 0.15 mg of benzidamine hydrochloride and 0.5 mg of cetilpiridinium chloride.

Conservation

Do not store at temperature above 25°C. For conditions of conservation after the first opening of the medicinal product see paragraph 6.3.

Warnings

Septafar should not be used for more than 7 days. If you do not notice appreciable results after 3 days, consult your doctor. The use of species if prolonged preparations by topical means can give rise to awareness-raising phenomena, in which case it is necessary to suspend treatment and establish suitable therapy. Septafar should not be used together with anionic compounds, such as those present for example in toothpastes, so it is recommended not to use the product immediately before or after washing the teeth. Avoid direct contact of Septafar oral mucosa spray, eye solution. The product should not be inhaled. This medicine contains small amounts of ethanol (alcohol) less than 100 mg per dose.

Interactions

Septafar should not be used simultaneously with other antiseptics.

Effects

- Very common (≥1/10) - Common (≥1/100, Tabulated list of adverse reactions

	Rare	Very rare	Notable
Immune system disorders			Anaphylactic reactions, Reaction of hypersensitivity
Diseases of the nervous system			Mucosa burning, oral mucosa anesthesia
Respiratory, chest and mediastinic pathologies	Broncospasmo
Gastrointestinal diseases		Irritation of the oral mucosa, Feeling of burning in the mouth
Pathologies of skin and subcutaneous tissue	Orticaria, Fotosensitivity

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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

SynonymsIntoxication is expected only in case of accidental ingestion of high quantities of benzidamine (> 300 mg). Symptoms associated with overdose by ingestion of benzidamine are mainly of gastrointestinal nature and dependent on the central nervous system. The most frequent gastrointestinal symptoms are nausea, vomiting, abdominal pain and esophageal irritation. Symptoms to the central nervous system include dizziness, hallucinations, agitation, anxiety and irritability. In case of acute overdose, only a symptomatic treatment can be performed. Patients should be kept under close observation and should receive support treatment. An adequate hydration must be maintained. Signs and symptoms of intoxication resulting from ingestion of significant amounts of cetilpiridinium chloride include nausea, vomiting, dispnea, cyanosis, asphyxiation, resulting in paralysis of respiratory muscles, SNC depression, hypotension and coma. In man the lethal dose is about 1-3 grams. Management Since there is no specific antidote, the treatment of acute overdose is purely symptomatic.

Pregnancy

There are no limited amounts of data on the use of benzidamine hydrochloride and cetilpiridinium chloride in pregnant women. Septafar is not recommended during pregnancy.

Food

It is not known whether benzidamine hydrochloride/and metabolites are excreted in human milk. There is no risk for infants or infants. It is necessary to decide whether to stop breastfeeding or to stop/abstain from Septafar therapy taking into consideration the benefit of breastfeeding for the child and the benefit of the therapy for the woman

Source: Farmadati