Angi.net® spray

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ANG.I.NET® SPRAY

Composition:

Active ingredient: benzidamine hydrochloride;

1 ml of solution contains 1.5 mg of benzidamine hydrochloride;

Excipients: glycerol 85 %; ethanol 96 %; polyethylene glycol hydrogenated castor oil; methylparahydroxybenzoate (E 218); sodium saccharin; sodium hydrogencarbonate; cherry flavoring; purified water.

Pharmaceutical form. Oral spray, 1.5 mg/ml.

Main physicochemical properties: clear, colorless solution with a cherry odor and taste.

Pharmacotherapeutic group.

Agents for use in dentistry. Other agents for local application in the oral cavity. ATC code A01AD02.

Pharmacological properties.

Pharmacodynamics.

Benzidamine is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-exudative properties.

Clinical studies have demonstrated that benzidamine is effective in relieving symptoms associated with localized inflammatory conditions of the oral cavity and pharynx. In addition, benzidamine exerts anti-inflammatory and local analgesic effects, producing a local anesthetic action on the mucous membranes of the oral cavity.

Pharmacokinetics.

Absorption through the mucous membranes of the oral cavity and pharynx has been confirmed by the presence of measurable amounts of benzidamine in human plasma. However, this is insufficient to produce any systemic pharmacological effect. Elimination occurs primarily via the urine, mainly in the form of inactive metabolites or conjugated compounds.

It has been shown that topical application leads to accumulation of an effective concentration of benzidamine in inflamed tissues due to its ability to penetrate through the mucous membrane.

Clinical characteristics.

Indications.

For symptomatic treatment of irritations and inflammations of the oropharynx; pain caused by gingivitis, stomatitis, pharyngitis; in dentistry — after tooth extraction or for prophylactic purposes.

Contraindications.

Hypersensitivity to the active substance or to other components of the medicinal product.

Interaction with other medicinal products and other types of interactions.

Interaction studies have not been conducted.

Special precautions for use.

The use of the medicinal product may cause adverse reactions; in such cases, its use should be discontinued. In cases of increased sensitivity during prolonged use, treatment should be stopped and medical advice should be sought so that appropriate therapy can be prescribed.

In some patients, ulcers of the oral or pharyngeal mucosa may be caused by serious underlying pathological conditions. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop fever or other symptoms, should consult a physician or dentist, as appropriate.

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

The use of this product may cause bronchospasm in patients with bronchial asthma or a history of bronchial asthma. Such patients must be warned accordingly — ANGI.NET® SPRAY should be used with caution in such cases. Prolonged therapy with this medicinal product is not recommended, as it may adversely affect the bacterial flora of the oral cavity.

Avoid contact with the eyes.

ANGI.NET® SPRAY contains methylparahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed-type), and in some cases bronchospasm.

The product contains hydrogenated polyoxyl castor oil, which may cause gastrointestinal disturbances and diarrhea.

This medicinal product contains a small amount of ethanol (alcohol) — less than 100 mg per 0.5 ml.

Warning for athletes: The use of medicinal products containing ethyl alcohol may result in a positive anti-doping test, depending on the threshold limits established by certain sports federations.

Use during pregnancy or breastfeeding.

Currently, there are no adequate data available on the use of benzidamine in pregnant or breastfeeding women. It is not known whether this product passes into breast milk. Animal studies are insufficient to draw conclusions regarding the effects of this product during pregnancy or breastfeeding. The potential risk to humans is unknown.

ANGI.NET® SPRAY should not be used during pregnancy or breastfeeding.

Effect on the ability to drive vehicles or operate machinery.

When used at recommended doses, this medicinal product has no effect on the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

The medicinal product ANG.NET® SPRAY should not be used immediately before eating or drinking. Before the first use of the bottle, press the spray nozzle several times until a uniform spray appears. One spray dose — 0.17 ml — contains 0.255 mg of benzydamine hydrochloride.

Before application, it is necessary to:

1. Lift the applicator;
2. Insert the tip of the applicator into the oral cavity and direct it toward the affected area. Press the spray nozzle with a finger. The patient should hold their breath during spraying. Do not exceed the recommended dose. Continuous treatment should not last longer than 7 days. If there is no improvement after 3 days of using the medicinal product, or if symptoms (sore throat and oral pain) worsen, consult a physician.

Dosage

Adults and children aged 12 years and older: 4–8 sprays 2–6 times daily (every 1.5–3 hours).

Children (6–12 years): 4 sprays 2–6 times daily (every 1.5–3 hours).

Children. The use of the medicinal product ANG.NET® SPRAY is not recommended in children who are unable to hold their breath during spraying.

Elderly patients. There are no special dosage recommendations for elderly patients. Unless otherwise prescribed by a dentist or physician, the doses indicated for adults should be used.

Children.

The medicinal product can be used in children aged 6 years and older.

Overdose.

There have been no reports of benzydamine overdose with local application.

In case of accidental ingestion of a large amount of benzydamine (> 300 mg), especially in children, poisoning may occur. Characteristic signs of overdose after ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system symptoms (possible dizziness, hallucinations, excitement, seizures, tremor, excessive sweating, ataxia, anxiety, and irritability).

Such acute overdose requires immediate gastric lavage, correction of fluid and electrolyte imbalances, symptomatic treatment, and adequate hydration.

Adverse Reactions

Adverse reactions are classified according to frequency of occurrence: 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); frequency not known (cannot be estimated based on available data). Within each frequency group, adverse effects are listed in order of decreasing severity.

Gastrointestinal disorders:
Rare: burning sensation in the mouth, dry mouth, hypoaesthesia of the oral cavity;
Frequency not known: nausea, vomiting, swelling and discoloration of the tongue, taste alterations.

Immune system disorders:
Rare: hypersensitivity reaction, anaphylactic reaction.

Respiratory, thoracic and mediastinal disorders:
Very rare: laryngospasm, bronchospasm.

Skin and subcutaneous tissue disorders:
Uncommon: photosensitivity;
Very rare: angioedema;
Frequency not known: rash, pruritus, urticaria.

Nervous system disorders:
Frequency not known: dizziness, headache.

ANGI.NET® SPRAY contains methylparaben, which may cause allergic reactions (possibly delayed).

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua/.

Shelf life: 3 years.

Storage conditions.
Store at temperatures not exceeding 25°C.
Keep out of reach and sight of children.

Packaging.
30 ml in a bottle with a metered pump and cap. One bottle with a spray nozzle is packaged in a cardboard box.

Supply category: Over-the-counter (without prescription).

Manufacturer: LABORATORIUM SANITATIS S.L. / LABORATORIUM SANITATIS S.L.

Manufacturer's address and location of operations:
C/ Leonardo da Vinci, 11 (Parque Tecnologico de Alava), Minano, 01510 Alava, Spain / Street Leonardo da Vinci, 11 (Technology Park of Alava), Minano, 01510 Alava, Spain.