Septafar® 1,5mg / ml + 5mg / ml Spray KRKA 30ml

Septafar 1,5mg / ml + 5mg / ml KRKA Spray For Oral Mucosa

Septafar 30ml Spray 1,5mg / 5mg is the oral mucosal spray, indicated for adults and children over 6 years of age. Suitable for the anti-inflammatory, analgesic and antiseptic treatment in irritation of the throat, mouth and gums, in gingivitis, pharyngitis and laryngitis and before and after tooth extractions.

Active principles

Each ml of oral mucosal spray solution contains 1.5 mg of benzydamine hydrochloride and 5 mg of cetylpyridinium chloride. One dispensing contains 0.1 ml of oral mucosal spray, solution, containing 0.15 mg of benzydamine hydrochloride and 0.5 mg of cetylpyridinium chloride. Excipient (s) with known effects : • Ethanol: 26 mg / for each actuation.

Excipients

Ethanol (96 percent) Glycerol (E422) Macrogolglycerol hydroxystearate Sodium saccharinate (E954) Peppermint oil Purified water

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

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Children under 6 years of age as the pharmaceutical form is not suitable for this age group.

Dosage

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 optimal effect, it is recommended not to use the product immediately before or after brushing your teeth. Do not exceed the recommended dose. Septafar can be used for up to 7 days. Elderly patients The recommended dose is the same as for 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 6 to 12 years of age : Septafar should only be used in this age group 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 the first use of Septafar Oromucosal Spray, to obtain a regular delivery, press the spray several times. If the spray has not been used for a long time (at least a week) press the dispenser once to obtain a regular delivery. Remove the plastic cap before use. Open your mouth wide, point the spray nozzle towards your throat and press the nozzle 1-2 times. Hold your breath while delivering. After each use, put the plastic cap back on the dispenser. When the dispenser is pressed once, 0.1 ml of oral mucosal spray is released, which contains 0.15 mg of benzydamine hydrochloride and 0.5 mg of cetylpyridinium chloride.

storage

Do not store above 25 ° C. For storage conditions after first opening the medicine.

Warnings

Septafar should not be used for more than 7 days. If no appreciable results are seen after 3 days, consult your doctor. The use, especially if prolonged, of topical preparations can give rise to sensitization phenomena, in which case it is necessary to suspend the treatment and institute suitable therapy. Septafar should not be used in conjunction with anionic compounds, such as those found for example in toothpastes, therefore it is recommended not to use the product immediately before or after brushing your teeth. Avoid direct contact of Septafar Oromucosal Spray, solution with the eyes. The product must not be inhaled. This medicine contains small amounts of ethanol (alcohol) less than 100 mg per dose.

Effects

• Very common (≥1 / 10) • Common (≥1 / 100 to <1/10) • Uncommon (≥1 / 1,000 to <1/100) • Rare (≥1 / 10,000 to <1 / 1,000) • Very rare (<1 / 10,000), • Not known (frequency cannot be estimated from the available data)

Tabulated list of adverse reactions

Reporting of suspected adverse reactions

Reporting 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 national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Overdose

Symptoms Toxic manifestations of benzydamine overdose consist of excitement, convulsions, sweating, ataxia, tremors and vomiting. Since there is no specific antidote, treatment of acute benzydamine intoxication is purely symptomatic. Signs and symptoms of intoxication following the ingestion of large quantities of cetylpyridinium chloride include nausea, vomiting, dyspnoea, cyanosis, asphyxia, resulting from paralysis of the respiratory muscles, CNS depression, hypotension and coma. In humans, the lethal dose is approximately 1–3 grams. Management Since there is no specific antidote, treatment of acute overdose is purely symptomatic.

Pregnancy

There are no or limited amounts of data on the use of benzydamine hydrochloride and cetylpyridinium chloride in pregnant women. Septafar is not recommended during pregnancy . Breastfeeding It is not known whether benzydamine hydrochloride / and metabolites are excreted in human milk. A risk to the newborns / infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue / abstain from Septafar therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Format

30ml spray.