Fexallegra 10 Coated Tablets 120 mg

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Fexallegra is indicated in adults and children from 12 years of age for the symptomatic treatment of allergic rhinitis.

CONTRAINDICATIONS

The medicine is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

WARNINGS AND PRECAUTIONS FOR USE

Data in elderly subjects and patients with impaired renal or hepatic function are limited. Fexofenadine hydrochloride should be administered with caution to these groups of subjects (see section 4.2). Patients with previous or current cardiovascular disease should be informed that antihistamines, as a class of medicinal products, have been associated with adverse reactions such as tachycardia and palpitations (see section 4.8). Fexallegra contains sodium This medicinal product contains less than 1 mmol (23 mg) sodium per tablet, i.e. essentially 'sodium-free'.

INTERACTIONS

Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products at the level of hepatic mechanisms. Coadministration of fexofenadine hydrochloride and erythromycin or ketoconazole has been found to increase plasma levels of fexofenadine 2-3-fold. These alterations were not accompanied by any effect on the QT interval and were not associated with any increase in adverse reactions compared to that observed with the same medicinal products administered individually. Animal studies have shown that the increase in plasma levels of fexofenadine observed after concomitant treatment with erythromycin or ketoconazole appears to be caused by an increase in gastrointestinal absorption and a decrease in both biliary excretion and gastrointestinal secretion, respectively. No interaction was observed between fexofenadine and omeprazole. However, administration of an antacid containing aluminum and magnesium hydroxide 15 minutes before administration of fexofenadine hydrochloride resulted in a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. An interval of 2 hours is advisable between the administration of fexofenadine hydrochloride and antacids containing aluminum and magnesium hydroxide.

SIDE EFFECTS

The following frequency class has been used when applicable: very common (≥ 1/10); common (≥ 1/100 and < 1/10); uncommon (≥ 1/1000 and < 1/100); rare (≥ 1/10,000 and < 1/1,000); very rare (< 1/10,000) and not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. In adults, the following side effects were reported in clinical trials, with an incidence similar to that observed with placebo: Nervous system disorders. Common: headache, drowsiness, dizziness. Gastrointestinal disorders. Common: nausea. Systemic pathologies and conditions relating to the administration site. Uncommon: fatigue. In adults, the following side effects have been reported during post-marketing surveillance. The frequency with which they occur is not known (an estimate cannot be made based on the available data): Immune system disorders: Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, hot flushes and systemic anaphylaxis. Psychiatric disorders: Insomnia, nervousness, sleep disturbances or nightmares/excessive dreaming (paronyria). Cardiac disorders: Tachycardia, palpitations. Gastrointestinal disorders: Diarrhoea. Skin and subcutaneous tissue disorders: Rash, urticaria and itching. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.