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SANOFI SpA

FEXALLEGRA*10CPR RIV 120MG

FEXALLEGRA*10CPR RIV 120MG

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EAN

042554042

MINSAN

042554042

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


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Therapeutic indications

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

Dosage and method of use

Posology Adults The recommended dose of fexofenadine hydrochloride for adults is 120 mg once daily, before meals. Fexofenadine is a pharmacologically active metabolite of terfenadine. Pediatric population Children 12 years of age and older The recommended dose of fexofenadine hydrochloride for children 12 years of age and older is 120 mg once daily, before meals. Children under 12 years of age The efficacy and safety of fexofenadine hydrochloride 120 mg has not been studied in children under 12 years of age. In children 6 to 11 years of age: fexofenadine hydrochloride 30 mg tablets is the appropriate formulation for administration and dosing in this population. Special populations Studies performed in groups of patients at risk (elderly, patients with renal or hepatic insufficiency) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients.

Contraindications

The medicinal product is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Side effects

The following frequency grouping 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 undesirable effects were reported in clinical trials, with an incidence similar to that seen with placebo : nervous system Common: headache, somnolence, dizziness. Gastrointestinal disorders Common: nausea. General disorders and administration site conditions Uncommon: Fatigue. In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occur is not known (cannot be estimated from 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 dreams (paroniria). Cardiac disorders Tachycardia, palpitations. Gastrointestinal disorders Diarrhoea. Skin and subcutaneous tissue disorders Rash, urticaria and pruritus. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Special warnings

As with most new medicines, data in elderly subjects and in patients with impaired renal or hepatic function are limited. Fexofenadine hydrochloride should be administered with caution to these groups of individuals. Patients with a history of or current cardiovascular disease should be advised that antihistamines, as a class of medicinal products, have been associated with adverse reactions such as tachycardia and palpitations (see section 4.8).

Pregnancy and breastfeeding

Pregnancy There are no adequate data from the use of fexofenadine hydrochloride in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary. Breast -feeding There are no data on the concentration in breast milk after administration of fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers, fexofenadine was found to pass into breast milk. Therefore the use of fexofenadine hydrochloride is not recommended during breastfeeding. Fertility There are no data on the effect of fexofenadine hydrochloride on human fertility. In mice, treatment with fexofenadine hydrochloride showed no effect on fertility (see section 5.3).

Expiration and conservation

The medicinal product does not require any special storage precautions.

Interactions with other drugs

Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products by hepatic mechanisms. Concomitant administration of fexofenadine hydrochloride and erythromycin or ketoconazole has been found to increase plasma levels of fexofenadine by 2-3 times. These alterations were not accompanied by any effect on the QT interval and were not associated with any increase in adverse reactions compared to what was observed with the same medicinal products given individually. Studies in animals 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 between fexofenadine and omeprazole has been observed. However, administration of an aluminum and magnesium hydroxide-containing antacid 15 minutes prior to fexofenadine hydrochloride administration resulted in decreased bioavailability, most likely due to binding in the gastrointestinal tract. An interval of 2 hours between the administration of fexofenadine hydrochloride and antacids containing aluminum and magnesium hydroxide is advisable.

Overdose

Dizziness, drowsiness, fatigue and dry mouth have been reported following an overdose of fexofenadine hydrochloride. Single doses up to 800 mg and doses up to 690 mg twice daily for one month or 240 mg once daily for one year have been administered to healthy volunteers without clinically significant adverse reactions compared with placebo. The maximum tolerated dose of fexofenadine hydrochloride has not been established. Standard measures to remove unabsorbed drug should be considered. Symptomatic and supportive treatment is recommended. Hemodialysis does not effectively remove fexofenadine hydrochloride from the blood.

Active principles

One tablet contains : Active ingredient : 120 mg of fexofenadine hydrochloride, equal to 112 mg of fexofenadine. For the full list of excipients, see section 6.1

Excipients

Tablet core microcrystalline cellulose; pregelatinized corn starch; croscarmellose sodium; magnesium stearate Hypromellose film coating ; povidone K30; titanium dioxide (E171); colloidal anhydrous silica; macrogol 400; red iron oxide (E172), yellow iron oxide (E172).

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