FORTESSA

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

Composition:

Active substance: benzidamine hydrochloride;

15 ml of solution contains 0.0225 g of benzidamine hydrochloride;

30 ml of solution contains 0.045 g of benzidamine hydrochloride;

Excipients: sodium saccharin, ethanol 96%, methylparaben (E 218), glycerol, polysorbate 20, peppermint flavor, purified water.

The amount of one dose is 0.18 ml, corresponding to 0.270 mg of benzidamine hydrochloride.

Pharmaceutical form. Oral spray.

Main physicochemical properties: colorless, clear solution with a minty 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. In addition, when applied locally, benzydamine acts as a disinfectant and exerts a local anesthetic effect on the oral mucosa.

Pharmacokinetics.

The efficacy of benzydamine upon local application is due to its ability to penetrate the epithelial layer and reach effective concentrations in inflamed tissues.

When applied locally at the indicated concentration, benzydamine is absorbed by the mucous membrane; however, its plasma concentration remains so low that no systemic pharmacological effects occur.

Benzydamine is excreted from the body mainly in the urine as inactive metabolites or conjugation products.

Clinical characteristics.

Indications.

Symptomatic treatment of:

• pain caused by gingivitis, stomatitis, pharyngitis;
• irritations and inflammations of the oropharynx;
• in dentistry, after tooth extraction or for prophylactic purposes.

Contraindications.

Hypersensitivity to the active substance or to any of the other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted.

Special precautions for use

If symptoms of the disease do not improve within 3 days, the continuation of treatment with the medicinal product should be determined by a physician.

In cases of hypersensitivity reactions occurring during prolonged use, treatment should be discontinued and medical advice should be sought to initiate appropriate therapy.

In some patients, oral or pharyngeal mucosal ulcers 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 general practitioner or, where appropriate, a dentist.

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

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

For athletes: Medicinal products containing ethanol may lead to a positive result in anti-doping tests, depending on the thresholds established by certain sports federations.

Contact of the product with the eyes should be avoided.

Use during pregnancy or breastfeeding

There are currently insufficient adequate data on the use of benzidamine in pregnant or breastfeeding women. The ability of this product to pass into breast milk has not been studied. Animal studies are insufficient to allow any conclusions regarding the effects of this product during pregnancy or breastfeeding. The potential risk to humans is unknown.

Fortesa oral spray 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 does not affect the ability to drive or operate machinery.

Method of Administration and Dosage.

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 drug 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 is possible, 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, anxiety, irritability, seizures, tremor, excessive sweating, ataxia). Such acute overdose requires immediate gastric lavage, treatment of fluid and electrolyte imbalances, symptomatic therapy, and adequate hydration.

Adverse Reactions.

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

Adverse reactions are classified according to the frequency of 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, pruritus, urticaria.

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

Fortesa contains methylparahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).

Shelf life.

For 15 mL bottles – 2 years.

For 30 mL bottles – 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in a place inaccessible to children.

Packaging.

15 mL or 30 mL of solution in a glass bottle with a spray pump. One bottle per cardboard box.

Classification of supply.

Over-the-counter.

Manufacturer.

ABDI IBRAHIM Ilac Sanai ve Ticaret A.S.

Manufacturer's address and location of its business activity.

Orhan Gazi Mahallesi, Tunc Jadde Street No. 3, Esenyurt, Istanbul, Turkey.