Tonzihelp

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TONZIHELP (TONZIHELP)

Composition:

Active substance: benzydamine;

1 ml of solution contains benzidamine hydrochloride 3.0 mg;

Excipients: methyl p-hydroxybenzoate (E 218), ethanol (96%), glycerol, macrogol 40 glyceryl hydroxystearate, sodium saccharin, levomenthol, purified water.

Pharmaceutical form. Oral spray, solution.

Main physicochemical properties: colorless clear liquid with a characteristic odor.

Pharmacotherapeutic group.

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

Pharmacological properties.

Pharmacodynamics.

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

Clinical studies have demonstrated that benzydamine is effective in relieving symptoms associated with localized inflammatory conditions of the oral cavity and pharynx. In addition, benzydamine exerts anti-inflammatory and local analgesic action, producing a local anesthetic effect 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 benzydamine in human plasma. However, this is insufficient to produce any systemic pharmacological effect. Excretion occurs mainly via urine, primarily in the form of inactive metabolites or conjugated compounds.

It has been demonstrated that topical application leads to accumulation of effective concentrations of benzydamine 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;
• age under 18 years;
• pregnancy or breastfeeding period.

Interaction with other medicinal products and other types of interactions.

No interaction studies have been conducted.

Special precautions for use

If sensitivity occurs during prolonged use, treatment should be discontinued and medical advice should be sought to initiate appropriate therapy.

In some patients, ulcers of the buccal mucosa/pharynx 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, where appropriate, a dentist.

Benzidamine should not be used in patients with hypersensitivity to acetylsalicylic acid or to other NSAIDs.

This medicinal product may cause bronchospasm in patients suffering from bronchial asthma or with a history of bronchial asthma. Such patients must be warned accordingly.

This medicinal product contains a small amount of ethanol (alcohol), not more than 21 mg/dose.

This medicinal product contains methylparahydroxybenzoate, which may cause allergic reactions (possibly delayed).

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

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 medicinal product to pass into breast milk has not been studied. Animal studies are insufficient to draw any conclusions regarding the effects of this medicinal product during pregnancy or breastfeeding. The potential risk to humans is unknown.

This medicinal product should not be used during pregnancy or breastfeeding.

Effect on ability to drive and use machines

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

Method of administration and dosage.

To use the spray, raise the atomizer nozzle, insert it into the oral cavity, and direct it toward the inflamed area; press the cap.

Pressing the cap releases an aerosol containing 1 spray dose – 0.17 mL, corresponding to 0.51 mg of benzidamine hydrochloride.

Adults should use 2–4 doses 2–6 times daily.

Do not exceed the recommended dose.

Benzidamine adheres to the mucous membrane, thereby providing a sustained effect. Therefore, the medication should be used after eating.

If the medication needs to be used for more than 7 days, consult a physician. If no improvement occurs after treatment or if new symptoms appear, consult a doctor.

Use the medication only as directed in the instructions and in the specified doses. If necessary, consult a doctor before using the medication.

Children.

This medication must not be used in children under 18 years of age.

Overdose.

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

In case of accidental ingestion of a large amount of benzidamine (> 300 mg), poisoning may occur. Typical signs of overdose following oral intake include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system symptoms (such as 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.

Side effects.

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

Adverse reactions are classified by 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 from 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, pruritus, urticaria.

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

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze. Keep out of reach of children.

Packaging.

30 ml of solution in a bottle with a dosing device and spray pump.

1 bottle with the instruction for medical use in a carton.

Classification of supply.

Over-the-counter.

Manufacturer. JSC "STOMA", Ukraine.

Manufacturer's address and location of its business activities.

3, Newton Street, Kharkiv, 61105, Ukraine.

Marketing Authorisation Holder.

Ananta Medikear Ltd.

Address of the Marketing Authorisation Holder and/or its representative.

Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, London, United Kingdom.