BENZIVERDE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BЕНZИVERDE (BENZYVERDE)

Composition:

Active substance: benzidamine hydrochloride;

1 ml of solution contains benzidamine hydrochloride 1.5 mg;

Excipients: ethanol 96 %, glycerol, methylparahydroxybenzoate (E 218), menthol (levomenthol), sodium saccharin, sodium hydrogencarbonate, polysorbate 20, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: colorless clear or slightly opalescent liquid with a menthol odor.

Pharmacotherapeutic group

Agents used 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. Additionally, 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 measurable concentrations of benzidamine in human plasma. However, these levels are insufficient to produce any systemic pharmacological effect. Excretion 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

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 forms of interactions

Interaction studies have not been performed.

Special precautions for use

In case of hypersensitivity occurring during prolonged use, treatment should be discontinued and medical advice should be sought for appropriate management.

In some patients, ulcers of the buccal mucosa/pharynx may be caused by serious pathological processes. 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 other NSAIDs.

The medicinal product contains a small amount of ethanol, less than 100 mg per dose.

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.

For athletes: the use of medicinal products containing ethanol may result in a positive anti-doping test, considering the thresholds established by certain sports federations.

Benziverde, oral spray, contains the flavor menthol (levomenthol), which may cause allergic reactions.

Use during pregnancy or breastfeeding

There are currently insufficient available data on the use of benzidamine in pregnant or breastfeeding women. The ability of this agent to pass into breast milk has not been studied.

Pregnancy

Clinical data on the use of Benziverde during pregnancy are lacking.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may cause cardiovascular and renal toxicity in the fetus. Towards the end of pregnancy, prolonged bleeding time may occur in both mother and newborn, and onset of labor may be delayed.

It is unknown whether systemic exposure to Benziverde following local administration could be harmful to the embryo/fetus.

Therefore, Benziverde should not be used during pregnancy unless the use is considered clinically justified. If used, the dose should be as low as possible and the duration of treatment kept to a minimum.

Effect on ability to drive or operate machinery

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

Method of Administration and Dosage

Pressing the spray pump produces an aerosol containing 1 spray dose – 0.17 mL, corresponding to 0.255 mcg of benzidamine hydrochloride.

Dosage

Adults: 4–8 sprays 2–6 times daily.

Children (6–12 years): 4 sprays 2–6 times daily.

Children (4–6 years): 1 spray per 4 kg of body weight, up to a maximum dose equivalent to 4 sprays 2–6 times daily.

Do not exceed the recommended dosage.

Children

The drug can be used in children aged 4 years and older.

Overdose

There have been no reports of overdose with benzidamine following topical application.

However, accidental ingestion of a large amount of benzidamine (> 300 mg), especially in children, may lead to poisoning. Characteristic signs of overdose after ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system effects (such as dizziness, hallucinations, excitement, convulsions, tremor, excessive sweating, ataxia, anxiety, and irritability).

In cases of acute overdose, immediate gastric lavage is required, along with correction of fluid and electrolyte imbalances, symptomatic treatment, and adequate hydration.

Side effects

Within each frequency group, adverse effects are listed in order of decreasing severity.

Adverse reactions are classified according to the frequency of their occurrence: very common (≥ 1/10); common (from ≥ 1/100 to < 1/10); uncommon (from ≥ 1/1000 to < 1/100); rare (from ≥ 1/10000 to < 1/1000); very rare (<1/10000); frequency not known (cannot be estimated based on available data).

Gastrointestinal disorders: rare – burning sensation in the mouth, dry mouth; frequency not known – oral hypoaesthesia, nausea, vomiting, swelling and discoloration of the tongue, taste alteration.

Immune system disorders: rare – hypersensitivity reaction; frequency not known – anaphylactic reaction.

Respiratory, thoracic and mediastinal disorders: very rare – laryngospasm; frequency not known – bronchospasm.

Skin and subcutaneous tissue disorders: uncommon – photosensitivity; very rare – angioneurotic edema; frequency not known – rash, itching, urticaria.

Nervous system disorders: frequency not known – dizziness, headache.

Benziverde contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

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

Shelf life. 2 years.

Do not use after the expiry date.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging

30 ml in a bottle with a spray pump and a rotating nozzle. One bottle per carton.

Prescription status

Over-the-counter.

Manufacturer

JSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA".

Manufacturer's address and location of business activity

1, Gordiyenkivska Street, Kharkiv, Kharkiv region, 61010, Ukraine.