FORTESA

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

Composition:

Active ingredient: benzidamine hydrochloride;

15 ml of solution contain 22.5 mg of benzidamine hydrochloride;

Excipients: sodium saccharin, ethanol 96%, methylparaben (E 218), glycerol, polysorbate 20, peppermint essence, quinoline yellow (E 104), patent blue V (E 131), purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: green transparent liquid with a minty odor.

Pharmacotherapeutic group. Agents for use in dentistry. Other locally acting agents in the oral cavity.

ATC code A01AD02.

Pharmacological properties.

Pharmacodynamics.

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

Clinical studies have demonstrated that benzidamine is effective in relieving symptoms associated with localized inflammatory conditions of the oral cavity and pharynx.

In addition, when applied locally, benzidamine acts as a disinfectant and exerts a local anesthetic effect on the mucous membrane of the oral cavity.

Pharmacokinetics.

The efficacy of benzidamine 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, benzidamine is absorbed by the mucous membrane; however, its plasma concentration is so low that it does not produce any systemic pharmacological effect.

Benzidamine 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.

No studies on interactions have been conducted.

Special precautions for use

If sensitivity occurs during prolonged use, treatment should be discontinued and medical advice should be sought to prescribe 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 physician or dentist, as appropriate.

Benzidamine is not recommended for 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 result in a positive anti-doping test, depending on the thresholds established by certain sports federations.

Fortesa should be used in the oral cavity without dilution. The solution should not be swallowed after application but should be spat out. If the patient experiences burning or stinging, dilution of the preparation is recommended (see section "Dosage and method of administration").

Use during pregnancy or breastfeeding

There are currently insufficient available data on the use of benzidamine in pregnant or breastfeeding women. It is not known whether this agent is excreted in breast milk. Animal studies are insufficient to allow conclusions regarding the effects of this agent during pregnancy or breastfeeding. The potential risk to humans is unknown.

Fortesa oral solution should not be used during pregnancy or breastfeeding.

Effect on the ability to drive or operate machinery

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

Method of Administration and Dosage

Use only for rinsing the oral cavity. Do not exceed the recommended dose.

Adults and children aged 12 years and older should rinse the mouth for 20–30 seconds using one measuring cap (15 mL) of the rinse solution, then spit out the liquid without swallowing. The rinse dose (15 mL) may be diluted with an equal amount of water if necessary.

Repeat the procedure 2–3 times daily, with intervals of 3–4 hours, unless otherwise directed by a physician. If needed, the number of rinses may be increased up to 5 times per day.

The duration of treatment should be determined individually by a physician. It is recommended not to use the medication for more than 7 days without consulting a doctor.

Children

The medication should not be used in children under 12 years of age due to the risk of accidentally swallowing the solution during mouth rinsing.

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 effects (dizziness, hallucinations, excitement, anxiety, irritability, seizures, tremor, excessive sweating, ataxia). Acute overdose requires immediate gastric lavage, correction of fluid and electrolyte imbalances, symptomatic treatment, and adequate hydration.

Adverse reactions.

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

Adverse reactions are classified according to 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 hypaesthesia, 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, oral solution contains methylparaben (E218), which may cause allergic reactions (possibly delayed).

Shelf life.

For 60 ml bottles: 2 years.

For 120 ml bottles: 3 years.

Storage conditions.

Store at temperatures not exceeding 25 °C, in a light-protected and child-resistant place.

Packaging.

60 ml or 120 ml of solution in a glass bottle. 1 bottle with a measuring cap in a cardboard box.

Classification.

Over-the-counter (without prescription).

Manufacturer.

ABDI IBRAHIM Ilac Sanai ve Ticaret A.S.

Manufacturer's address and location of operations.

Orhan Gazi Mahallesi, Tunc Jadeesi No:3, Esenyurt, Istanbul, Turkey.