Vertum Lor external spray 0.255mg/dose bottle, 40ml

Composition

1 dose of spray contains:

Active ingredient: benzydamine hydrochloride-0.255 mg

. excipients: ethanol (95% ethyl alcohol) – 13.6 mg, glycerol (glycerol)

– 8.5 mg; methylparahydroxybenzoate (methylparaben) – 0.17 mg; natural food flavor MINT* – 0.051 mg; sodium saccharinate-0.0408 mg; polysorbate 20-0.0085 mg; purified water-up to 0.17 ml.

*Ingredients: natural food flavor, propylene glycol. The content of propylene glycol in 1 ml of the solution is less than 0.3 mg

Pharmacological action

Pharmacotherapy group

Nonsteroidal anti-inflammatory drug.

ATX code

A01AD02

Pharmacological properties

Pharmacodynamics

Benzydamine is a nonsteroidal anti-inflammatory drug that belongs to the indazole group. It has an anti-inflammatory and local analgesic effect, has an antiseptic effect against a wide range of microorganisms.

The mechanism of action of the drug is associated with the stabilization of cell membranes and inhibition of prostaglandin synthesis.

Benzydamine has an antibacterial and specific antimicrobial effect due to the rapid penetration of microorganisms through the membranes, followed by damage to cellular structures, disruption of metabolic processes and cell lysosomes.

It has an antifungal effect against Candida albicans. It causes structural modifications of the cell wall of fungi and their metabolic chains, thus preventing their reproduction, which was the basis for the use of benzydamine in inflammatory processes in the oral cavity, including infectious etiology. Pharmacokinetics

When applied topically, benzydamine is well absorbed through the mucous membranes and penetrates into inflamed tissues, and is found in the blood plasma in an amount insufficient to produce systemic effects.

Benzydamine is mainly excreted by the kidneys as inactive metabolites or conjugation products.

Indications

Symptomatic therapy of pain syndrome of inflammatory diseases of the oral cavity and ENT organs (of various etiologies):

• pharyngitis, laryngitis, tonsillitis;
• gingivitis, glossitis, stomatitis (including after radiation and chemotherapy);
• periodontal disease;
• calculous inflammation of the salivary glands;
• after treatment or removal of teeth;
• after surgical interventions and injuries (tonsillectomy, jaw fractures);
• candidiasis of the oral mucosa (as part of combination therapy).

For infectious and inflammatory diseases that require systemic treatment, VERTUM ENT is used as part of a combination therapy.

Use during pregnancy and lactation

The use of benzydamine during pregnancy and lactation is not recommended.

Contraindications

• Hypersensitivity to benzydamine or any other component of the drug;
• children under 3 years of age.

With caution

• , hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;
• bronchial asthma (including in the anamnesis).

Side effects

Classification of the frequency of side effects according to the recommendations of the World Health Organization (WHO): very common ≥ 1/10; common ≥ 1/100 to < 1/10; uncommon ≥ 1/1000 to < 1/100; rare ≥ 1/10000 to < 1/1000;very rare

Immune system disorders: infrequently-photosensitization; rarely-hypersensitivity reactions, skin rash, pruritus; very rarely-angioedema, laryngospasm;frequency unknown – anaphylactic reactions.

General disorders and reactions at the injection site: rarely-dry mouth, burning sensation in the oral cavity; frequency unknown-feeling of numbness in the oral cavity. If any of the side effects listed in the instructions get worse, or any other side effects that are not listed in the instructions are noted, you should immediately inform your doctor.

Interaction

Interaction studies with other drugs have not been conducted.

How to take, course of use and dosage

Spray for topical application dosed 0,255 mg / dose:

Locally. After a meal. One dose (one injection) corresponds to 0.255 mg of benzydamine. Adults (including elderly patients) and children over 12 years of age,4-8 injections 2-6 times a day.

Children from 6 to 12 years,4 injections 2-6 times a day.

Children from 3 to 6 years of age: 1 injection for every 4 kg of body weight, but no more than 4 injections (maximum dose) 2-6 times a day.

Instructions for use

• Turn the cannula (the tube that is part of the spray nozzle) in either direction by 90 degrees to the bottle.
• Insert the cannula into your mouth and point it at inflamed areas in your mouth or throat.

Press the dosage pump on the top of the bottle as many times as the prescribed doses. One tap corresponds to one dose. Hold your breath during the injection.

Do not exceed the recommended dose.

The duration of treatment should not exceed 7 days. If there is no improvement after treatment for 7 days or new symptoms appear, you should consult your doctor.

Use the drug only according to the method of use and in the doses indicated in the instructions. If necessary, please consult your doctor before using the medicine.

Overdose

No cases of benzydamine overdose have been reported. When using the drug in accordance with the instructions for use, overdose is unlikely.

Symptoms If the drug is accidentally swallowed, the following symptoms may occur: vomiting, abdominal cramps, anxiety, fear, hallucinations, convulsions, ataxia, fever, tachycardia, respiratory depression.

treatment The treatment is symptomatic. Clear the stomach by inducing vomiting or flush the stomach using a gastric tube (under the supervision of a doctor); provide medical supervision, supportive therapy, and adequate hydration. The antidote is not known.

Description

Transparent colorless solution with a characteristic odor.

Special instructions

Hypersensitivity reactions may occur when benzydamine is used. In this case, it is recommended to stop treatment and consult a doctor to prescribe appropriate therapy.

In a limited number of patients, the presence of ulcers in the throat and oral cavity may indicate the presence of a more serious pathology. If symptoms persist for more than 3 days, you should consult your doctor.

Benzydamine is not recommended in patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.

The drug should be used with caution in patients with a history of bronchial asthma due to the possibility of developing bronchospasm while taking benzydamine.

The drug contains parahydroxybenzoates, which can cause allergic reactions.

Influence on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and engage in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Spray for topical application dosed 0.255 mg / dose. 40 ml (235 doses) in vials made of high-density polyethylene, equipped with a dosing device (pump) and a protective cap. The bottle together with the spray nozzle (actuator) and together with the instructions for use in a pack of cardboard.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Benzydamine

Dosage form

spray for external use