Fortesa

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

Composition:

Active ingredient: benzidamine hydrochloride;

1 lozenge contains 3 mg of benzidamine hydrochloride (equivalent to 2.68 mg of benzidamine);

Excipients: isomalt (E 953); citric acid monohydrate; aspartame (E 951); quinoline yellow (E 104); lemon flavoring; peppermint oil.

Pharmaceutical form. Lozenges.

Main physicochemical properties: yellow, round lozenges, 19 mm in diameter, with lemon flavor.

Pharmacotherapeutic group.

Medicinal products used in throat disorders. Benzidamine. ATC code R02AX03.

Pharmacological properties.

Pharmacodynamics.

Clinical studies have demonstrated that benzydamine is effective in reducing pain caused by localized irritation processes of the oral and pharyngeal mucosa. In addition, benzydamine exerts a moderate local anesthetic effect.

Pharmacokinetics.

Absorption

The absorption through the oral and pharyngeal mucosa has been confirmed by measurable amounts of benzydamine in human plasma. Approximately 2 hours after administration of a 3 mg lozenge, the maximum plasma concentration of benzydamine reaches 37.8 ng/mL, and the AUC value is 367 ng/mL∗h. However, these concentrations are too low to produce systemic pharmacological effects.

Distribution

It has been established that when applied locally, benzydamine accumulates in inflamed tissues, where it reaches effective concentrations due to its ability to penetrate the epithelial lining.

Metabolism and elimination

The drug is primarily excreted in the urine, mainly as inactive metabolites or conjugated compounds.

Clinical characteristics.

Indications.

For symptomatic local treatment of sore throat in adults and children aged 6 years and older.

Contraindications.

Hypersensitivity to the active substances or to any of the excipients.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted; clinically significant interactions with other medicinal products have not been reported.

Special precautions for use

Benzidamine is not recommended for patients with hypersensitivity to salicylates (e.g., acetylsalicylic acid and salicylic acid) or other nonsteroidal anti-inflammatory drugs (NSAIDs).

In patients with bronchial asthma, including a history of asthma, benzidamine may provoke bronchospasm. Therefore, the drug should be used with caution in such patients.

In some patients, oral 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 seek medical advice.

The medicinal product contains aspartame, which is a source of phenylalanine. It may be harmful for patients with phenylketonuria.

The medicinal product contains isomalt and therefore should not be used in patients with rare hereditary fructose intolerance.

Use during pregnancy or breastfeeding

There are currently insufficient adequate data on the use of benzidamine in pregnant or breastfeeding women. It has not been studied whether this medicinal product is excreted in breast milk. Animal data are insufficient to draw conclusions regarding the effect of this drug on pregnancy and lactation. There are no data available on the potential risk during pregnancy or breastfeeding.

The medicinal product Forteza should not be used during pregnancy and breastfeeding.

Ability to influence reaction rate while driving or operating machinery

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

Method of Administration and Dosage

The lozenges should be slowly dissolved in the mouth; do not swallow or chew them.

Adults and children aged 6 years and older: 1 lozenge 3 times a day.

The duration of treatment should not exceed 7 days.

If symptoms persist for more than 3 days or if a high fever develops, consult a physician.

Children.

The Forteza medicinal product is intended for children aged 6 years and older.

Children aged 6–11 years should use the Forteza medicinal product under adult supervision.

Overdose.

There have been no reports of benzidamine overdose with topical administration. However, it is known that benzidamine, when ingested in large quantities (doses hundreds of times higher than the possible doses of this medicinal form), especially in children, may cause excitation, seizures, tremor, nausea, increased sweating, ataxia, and vomiting. Such acute overdose requires immediate gastric lavage, treatment of water-electrolyte imbalances, symptomatic therapy, and adequate hydration.

Adverse reactions.

Undesirable effects are classified by frequency of occurrence as follows: very common (≥ 1/10); common (from ≥ 1/100 to < 1/10); uncommon (from ≥ 1/1000 to < 1/100); rare (from ≥ 1/10 000 to < 1/1000); very rare (< 1/10 000); frequency not known (cannot be estimated from available data).

Gastrointestinal disorders — rare: burning sensation in the mouth, dry mouth; frequency not known: oral hypoaesthesia.

Immune system disorders — rare: hypersensitivity reaction; frequency not known: anaphylactic reaction.

Respiratory, thoracic and mediastinal disorders — very rare: laryngospasm or bronchospasm.

Skin and subcutaneous tissue disorders — uncommon: photosensitivity; very rare: angioneurotic edema.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of the reach of children.

Packaging.

12 lozenges in a blister, 1 or 2 blisters per cardboard box.

Availability.

Over-the-counter.

Manufacturer.

LOZIS FARMACEUTICA S.L.;

INFARMED, S.L.

Manufacturer's address and location of business activity.

Campus Imperial, Lecaroz, Navarra, 31795, Spain;

C/ Torre de los Herberos, 35, R.I. Carretera de la Isla, Dos Hermanas, Seville, 41703, Spain.