Fortalor

INSTRUCTIONS for medical use of the medicinal product FORTALOR (FORTALOR)

Composition:

Active ingredient: benzidamine hydrochloride;

1 ml of oral spray contains 1.5 mg of benzidamine hydrochloride;

Excipients: saccharin, sodium bicarbonate, polysorbate 20, "Mint" flavouring, methylparaben (E 218), glycerin, ethanol 96%, purified water.

Pharmaceutical form. Oral spray.

Basic physico-chemical properties: clear, colourless liquid with a characteristic odour and taste of mint.

Pharmacotherapeutic group. Agents used in dentistry. Other local preparations for 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 in 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 measurable concentrations of benzydamine in human plasma. However, these levels are insufficient to produce any systemic pharmacological effect. Excretion occurs mainly via the urine, primarily in the form of inactive metabolites or conjugated compounds.

It has been shown that topical application leads to accumulation of an effective concentration 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.

Interaction with other medicinal products and other types of interactions.

Interaction studies have not been conducted.

Special precautions for use

If sensitivity occurs during prolonged use, treatment should be discontinued and medical advice should be sought so that appropriate therapy can be prescribed.

In some patients, ulcers of the buccal 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 new symptoms, should consult a physician or dentist, as appropriate.

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

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

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

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

The medicinal product contains methylparahydroxybenzoate (methylparaben), which may cause allergic reactions (possibly delayed), and in individual cases, bronchospasm.

Use during pregnancy or breastfeeding

Pregnancy

There are no clinical data on the use of benzidamine during pregnancy.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may cause cardiopulmonary and renal toxicity in the fetus. Towards the end of pregnancy, prolonged bleeding time may occur in both mother and child, and there may also be a delay in the onset of labor.

It is unknown whether systemic exposure to benzidamine achieved after local application could be harmful to the embryo/fetus.

Therefore, benzidamine should not be used during pregnancy unless absolutely necessary. If used, the dose should be as low as possible and the duration of treatment as short as possible.

Breastfeeding period

Currently, there are insufficient data available on the use of benzidamine in breastfeeding women. The ability of this medicinal product to pass into breast milk has not been studied. Animal studies are insufficient to draw conclusions regarding the effects of this medicinal product during breastfeeding. The potential risk to humans is unknown.

The medicinal product FORATALOR should not be used during breastfeeding.

Effect on ability to drive and use machines

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

Method of Administration and Dosage

Before use, a spray device must be attached to the container with the medicinal product.

Pressing the spray device produces a spray containing 1 dose — 0.17 mL, corresponding to 0.255 mg of benzidamine hydrochloride.

Dosing

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 dosages.

Children

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

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, especially in children. Characteristic signs of overdose following ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system symptoms (dizziness, hallucinations, excitation, seizures, tremor, excessive sweating, ataxia, anxiety, and irritability). Such acute overdose requires immediate gastric lavage, treatment of fluid and electrolyte imbalances, symptomatic therapy, and adequate hydration.

Adverse reactions.

The table below lists the drug's adverse reactions by organ systems.

The frequency of adverse reactions is classified as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated based on available data). Within each frequency group, adverse effects are listed in order of decreasing severity.

Reporting of suspected adverse reactions

Reporting adverse reactions after marketing authorization of a medicinal product is of great importance. It allows continuous 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 effectiveness of the medicinal product via the Automated Information System for Pharmacovigilance 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 polyethylene container with cap and dropper, together with a nebulizing device, in a cardboard box.

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

Manufacturer. Ukrainian-Spanish joint venture "Sperko Ukraine".

Manufacturer's address and location of operations. 25, 600-richchia St., Vinnytsia, Ukraine, 21027.