INSTRUCTIONS

for medical use of the medicinal product

TONZIHELP

Composition:

active substance: benzydamine;

1 ml of the solution contains benzydamine hydrochloride 3.0 mg;

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

Pharmaceutical form. Oral spray, solution.

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

Pharmacotherapeutic group.

Dental products. Other products for local use in the oral cavity. ATC code А01А D02.

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 alleviating symptoms associated with localized irritative pathological processes in the oral cavity and pharynx. Additionally, benzydamine has anti-inflammatory and local analgesic effects, providing local anaesthetic action on the mucous membrane of the oral cavity.

Pharmacokinetics.

Absorption through the mucous membranes of the oral cavity and pharynx has been confirmed by measurable amounts of benzydamine in human plasma. However, this is insufficient to exhibit any systemic pharmacological effects. Excretion occurs primarily via the urine, predominantly in the form of inactive metabolites or conjugated compounds. Local application achieves an effective concentration of benzydamine in inflamed tissues due to its ability to penetrate the mucosa.

Clinical characteristics.

Indications.

Symptomatic treatment of irritation and inflammation of the oropharynx; pain caused by gingivitis, stomatitis, pharyngitis; post-dental extraction or as a preventive measure in dentistry.

Contraindications.

• – Hypersensitivity to the active substance or other components of the product;
• – Children under 18 years of age.
• – Pregnancy and breastfeeding.

Interactions with other medicinal products and other forms of interaction.

No interaction studies have been carried out.

Special precautions.

If sensitivity occurs during prolonged use, discontinue treatment and consult a doctor for proper care.

In some patients, mucosal ulcers in the cheeks/pharynx may be caused by serious underlying pathological processes. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop fever or other symptoms, should consult a general practitioner or dentist.

Benzydamine is not recommended for patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.

Application may cause bronchospasm in patients with asthma or a history of asthma. These patients must be warned.

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

It also contains methylparahydroxybenzoate, which may cause allergic reactions (possibly delayed).

For athletes: Use of medicinal products containing ethanol may yield a positive result in anti-doping tests, depending on the limits established by certain sport federations.

Pregnancy and breastfeeding.

There is no sufficient data on the use of benzydamine in pregnant and breastfeeding women. The ability of this medicinal product to pass into breast milk has not been studied. Animal studies are insufficient to make conclusions regarding the impact during pregnancy or breastfeeding. The potential risk to humans is unknown.

Do not use during pregnancy or breastfeeding.

Effects on ability to drive and use machines.

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

Method of administration and dosage.

To use the spray, raise the spray nozzle, insert it into the oral cavity, and direct it to the inflamed area. Press the cap to release the aerosol, which contains 1 dose (0.17 ml), equivalent to 0.51 mg of benzydamine hydrochloride.

For adults: 2–4 doses, 2–6 times per day.

Do not exceed the recommended dose.

Benzydamine adheres to the mucous membrane, providing a prolonged effect. Therefore, it should be used after meals.

If treatment lasts longer than 7 days, it is recommended to consult a doctor. If there is no improvement or if new symptoms develop, seek medical advice.

Use only as directed in the instructions. If needed, consult a doctor before using this medicinal product.

Children.

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

Overdose.

There have been no reported cases of benzydamine overdose with topical use..

If a large amount of benzydamine is ingested (> 300 mg), poisoning may occur. Symptoms of overdose after ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, oesophageal irritation) and central nervous system symptoms (dizziness, hallucinations, agitation, seizures, tremors, excessive sweating, ataxia, anxiety, irritability).

Acute overdose requires immediate gastric lavage, correction of water-electrolyte balance, symptomatic treatment, and adequate hydration.

Adverse reactions.

Adverse reactions within each frequency group are listed in descending order of severity.

Adverse reactions are classified according to the frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (<1/10,000); unknown frequency (cannot be estimated from available data).

Gastrointestinal disorders: rare – burning sensation in the mouth, dry mouth; unknown frequency – oral hypaesthesia, nausea, vomiting, swelling and discoloration of the tongue, taste change.

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

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

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

Nervous system disorders: unknown frequency – 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 nozzle.

1 bottle with instructions for medical use in a box.

Terms of dispensing.

Over-the-counter.

Manufacturer. STOMA JSC, Ukraine.

Manufacturer’s registered address.

3, Newtona str., Kharkiv, 61105, Ukraine.

Applicant.

Ananta Medicare Ltd.

Applicant’s and/or the applicant's representative registered address.

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