Оралсепт

Оралсепт – the non-steroidal anti-inflammatory drug (NPVP) having the antiinflammatory and local anesthetizing effect, possessing antiseptic (against a wide range of microorganisms), and also antifungal action.

The reference to the website of the producer is oralsept.ru

Form of release and structure

Dosage form of Oralsept – spray for topical administration the dosed, transparent solution of flavovirent color with aroma of a peppermint. On 30 ml (176 doses) in a plastic white opaque container with the doser and the developing tip. Each container together with the application instruction is located in a cardboard pack.

Structure on one dose of drug:

• Active agent: benzydamine a hydrochloride – 0,255 mg;
• Excipients: methylparahydroxybenzoate – 0,17 mg; ethanol of 96% – 17,00 mg; glycerin (глицерол) – 8,50 mg; fragrance of a peppermint 27198/14 – 0,17 mg; sodium saccharinate – 0,0408 mg; polysorbate-60 – 0,0085 mg; Natrii hydrocarbonas – 0,0034 mg; dye quinolinic yellow 70 (Е 104) – 0,0034 mg; dye indigotin of 85% (Е 132) – 0,00017 mg; the purified water to 170 мкл.

Indications to use

Symptomatic therapy of a pain syndrome of inflammatory diseases of an oral cavity and ENT organs (various etiology):

• Pharyngitis, laryngitis, tonsillitis;
• Ulitis, glossitis, periodontosis, stomatitis (including after beam and chemotherapy);
• Calculous inflammation of sialadens;
• State after treatment or an exodontia;
• State after operative measures and injuries (a tonsilectomy, jaw fractures);
• Candidiasis of a mucous membrane of an oral cavity (as a part of a combination therapy).

At the infectious and inflammatory diseases demanding system treatment, drug of Oralsept is used as a part of a combination therapy.

Contraindications

• Hypersensitivity to benzydamine or other components of drug;
• Children's age up to 3 years.

Take Oralsept at hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, and also bronchial asthma with caution (including in the anamnesis).

Data on a research on animals of use of benzydamine during pregnancy and in the period of a lactation (breastfeeding) are not enough. Whether adequate and strictly controlled researches at pregnant women it is not conducted, besides, it is unknown benzydamine gets into breast milk. Therefore, the potential risk for the person cannot be defined.

At pregnancy and during breastfeeding drug is used only after consultation with the attending physician if the estimated advantage for mother exceeds potential risk for a fruit and the child.

Route of administration and dosage

Spray of Oralsept is applied locally. One dose of spray corresponds to one pressing (one breath) and is equivalent to 0,17 ml of solution.

Depending on age it is recommended:

• Children of 3-6 years – on 1 dose on 4 kg of body weight (as much as possible – 4 doses) 2-6 times a day;
• Children of 6-12 years – on 4 doses of 2-6 times a day;
• Adults and children are more senior than 12 years – on 4-8 doses of 2-6 times a day.

Course of treatment depending on a disease:

• Inflammatory diseases of an oral cavity and throat – from 4 to 15 days;
• Odonto-stomatologichesky pathologies – from 6 to 25 days;
• After operative measures and injuries (a tonsilectomy, jaw fractures) – from 4 to 7 days.

At use of drug during long terms consultation of the doctor is necessary.

Instructions on use of a container with the doser and the developing tip:

1. To hold a bottle vertically, to lift a cap nozzle at an angle 90 ° to a bottle;
2. To enter a nozzle into an oral cavity and to press a cap several times, according to the recommended dose. The period between two pressing has to be not less than 5 seconds;
3. To return a nozzle to initial situation.

Obligatory before the first use several times to press the sprayer in air.

Not to exceed the recommended dosage.

Prior to therapy it is necessary to consult with the doctor.

Side effects

• Local reactions: dryness in a mouth, feeling of numbness, burning in an oral cavity;
• Allergic reactions: hypersensitivity reactions, including skin rash, a skin itch, a small tortoiseshell, a photosensitization, a Quincke's disease, anaphylactic reactions;
• Others: laryngospasm.

If any of the side effects specified in the instruction are aggravated, or you noticed other side effects which are not specified in the instruction, report about it to the doctor.

About overdose cases by drug of Oralsept it was not reported. However it is known that benzydamine at accidental hit inside in a high dose (in hundreds of times exceeding therapeutic), especially at children, can cause excitement, spasms, a tremor, the increased sweating, an ataxy and vomiting. Such acute overdose demands an immediate gastric lavage, recovery of water and electrolytic balance, a symptomatic treatment, adequate hydration.

At overdose it is necessary to rinse a mouth enough water, and at emergence of side reactions to see the attending physician.

Special instructions

At use of drug of Oralsept development of reactions of hypersensitivity is possible. In this case it is recommended to stop treatment and to consult with the doctor for purpose of the corresponding therapy.

In case of a canker of a mucous membrane of a stomatopharynx the patient has to see a doctor if symptoms remain more than three days.

Use of spray is not recommended at patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

Drug needs to be used with care at patients with bronchial asthma as in this case development of a bronchospasm is possible.

It is necessary to avoid hit of spray in eyes if it occurred, eyes need to be washed out a large amount of water.

Drug does not exert impact on ability to drive the car, performance of potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Medicinal interaction

Interaction with other drugs was not studied. It is not established to pharmaceutical incompatibility of Oralsept with other medicines.

Terms and storage conditions

To store at a temperature not above 25 °C, in the place, unavailable to children.

Period of validity – 4 years.