INSTRUCTION

for medical use of medicinal product

TONZIHELP

Composition:

active substance: benzydamine;

1 ml of solution contains benzydamine hydrochloride – 3.0 mg;

excipients: methylparahydroxybenzoate (E 218), ethanol (96%), glycerine, macrogol 40 glyceryl hydroxystearate, sodium saccharin, levomenthol, purified water.

Pharmaceutical form. Oral spray solution.

Basic physical and chemical properties: a clear colourless liquid with a specific odor.

Pharmacotherapeutic group.

Agents for use in dentistry. Other agents for local application 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 shown that benzydamine is effective in relieving symptoms that accompany localized irritating pathological processes in the oral cavity and pharynx. In addition, benzydamine exerts anti-inflammatory and local analgesic effects, exhibits a local anaesthetic effect on the mucous membrane of the oral cavity.

Pharmacokinetics.

The fact of absorption through the mucous membrane of the oral cavity and pharynx was proven by the presence of measurable amounts of benzydamine in human blood plasma. However, this is insufficient to produce any systemic pharmacological effect. Excretion occurs mainly with urine, predominantly in the form of inactive metabolites or conjugated compounds.

It has been proven that with topical application, accumulation of effective concentration of benzydamine in inflamed tissues is achieved due to its ability to penetrate through the mucous membrane.

Clinical particulars

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;
• - paediatric age under 18 years;
• - pregnancy or lactation period.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been performed.

Precautions for use.

If sensitivity occurs during prolonged use, treatment should be discontinued and a physician should be consulted for appropriate treatment.

In some patients, ulcers of the mucous membrane of the cheeks/pharynx may be caused by serious pathological processes. In this regard, patients whose symptoms have worsened or have not decreased within 3 days or who have developed fever or other symptoms should consult a therapist or dentist in appropriate cases.

It is not recommended to use benzydamine in patients with hypersensitivity to acetylsalicylic acid or to other NSAIDs.

Use of the preparation may cause bronchospasm in patients with bronchial asthma or with a history of bronchial asthma. Such patients must be warned about this.

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 give a positive result in anti-doping test analysis, considering the limits established by some sports federations.

Pregnancy and lactation.

To date, there are no adequate available data regarding the use of benzydamine in pregnant women and women who are breastfeeding. The ability of this agent to penetrate into breast milk has not been studied. Animal study data are insufficient to draw any conclusions regarding the effect of this medicinal product during pregnancy or lactation. The potential risk to humans is unknown.

The medicinal product should not be used during pregnancy or lactation.

Effects on ability to drive and use machines.

When used in recommended doses, the medicinal product has no effect on the ability to drive vehicles and other machinery.

Method of administration and dosage.

To use the spray, lift the spray cannula, insert it into the oral cavity and direct it to the area of inflammation; press the cap.

When pressing the cap, an aerosol is formed that contains 1 dose of spray – 0.17 ml, which corresponds to 0.51 mg of benzydamine hydrochloride.

Adults are prescribed 2-4 doses 2-6 times per day.

Do not exceed the recommended dose.

Benzydamine adheres to the mucous membrane and, due to this, provides a lasting effect. In connection with this, the preparation should be used after meals.

If it is necessary to use the preparation for more than 7 days, it is necessary to consult your doctor. If after treatment no improvement occurs or new symptoms appear, it is necessary to consult your doctor.

Use this preparation only according to the method of administration and dosage indicated in the instructions. If necessary, consult your doctor before using the medicinal product.

Children.

The medicinal product cannot be used in children under 18 years of age.

Overdose.

No cases of benzydamine overdose have been reported with topical application.

With accidental oral ingestion of large amounts of benzydamine (> 300 mg), toxicity may occur. Characteristic signs of overdose after internal administration are gastroenterological symptoms (most often nausea, vomiting, abdominal pain, oesophageal irritation) and symptoms from the central nervous system (possible dizziness, hallucinations, agitation, convulsions, tremor, increased sweating, ataxia, anxiety and irritability).

Such acute overdose requires immediate gastric lavage, treatment of water-electrolyte balance disorders and symptomatic treatment, and adequate hydration.

Adverse reactions.

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 (from ≥ 1/100 to < 1/10); uncommon (from ≥ 1/1000 to < 1/100); rare (from ≥ 1/10,000 to < 1/1,000); very rare (<1/10,000); unknown (cannot be assessed based on available data).

Gastrointestinal disorders: rare – burning sensation in the mouth, dry mouth; unknown – oral cavity hypoesthesia, nausea, vomiting, tongue swelling and discoloration, taste alteration.

Immune system disorders: rare – hypersensitivity reaction; unknown – anaphylactic reaction.

Respiratory, thoracic and mediastinal disorders: very rare – laryngospasm; unknown – bronchospasm.

Skin and subcutaneous tissue disorders: uncommon – photosensitivity; very rare – angioneurotic oedema; unknown – rash, itching, urticaria.

Neurological disorders: unknown – 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 dosing device and spray.

1 bottle together with instructions for medical use in a box.

Terms of dispensing.

Without prescription.

Date of last update.

23.02.2022