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FEXALLEGRA * 10CPR RIV 120MG

  • Farma 1000 S.r.l.
  • 048373017
Fexallegra is a drug based on the active ingredient fexofenadine hydrochloride, belonging to the category of antiallergic antihistamines and specifically Other antihistamines for systemic use. Fexallegra can be prescribed with OTC Recipe - self-medication. Fexallegra is indicated in adults and children from 12 years of age for the symptomatic treatment of seasonal allergic rhinitis.
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FEXALLEGRA * 10CPR RIV 120MG

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

Dosage AdultsThe recommended dose of fexofenadine hydrochloride for adults is 120 mg once a day, before meals. Fexofenadine is a pharmacologically active metabolite of terfenadine.Pediatric population Children aged 12 years and overThe recommended dose of fexofenadine hydrochloride for children from 12 years of age is 120 mg once a day, before meals.Children under 12 years of ageThe efficacy and safety of fexofenadine hydrochloride 120 mg have not been studied in children below 12 years of age. In children 6 to 11 years of age: fexofenadine hydrochloride 30 mg tablets is the appropriate formulation for administration and dosage in this population.Special populationsStudies 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 class was used when applicable: very common ≥ 1/10; common ≥ 1/100 eNervous system disorders.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 (an estimate cannot be made based on the available data): Immune system disorders: Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, hot flashes and systemic anaphylaxis. Psychiatric disorders: Insomnia, nervousness, sleep disturbances or nightmares / excess of dreams (paronyria). Cardiac disorders: Tachycardia, palpitations. Gastrointestinal disorders: Diarrhea. Skin and subcutaneous tissue disorders: Rash, hives and itching.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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 medicinal products, data in elderly subjects and in patients with impaired renal or hepatic function are limited. Fexofenadine hydrochloride should be administered with caution to such groups of subjects. Patients with previous 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

PregnancyThere 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 / fetal development, parturition or postnatal development (see section 5.3). Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary.Feeding timeThere 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.FertilityThere 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 retention

The medicinal product does not require special storage conditions.

Interactions with other drugs

Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products at the level of hepatic mechanisms. Co-administration of fexofenadine hydrochloride and erythromycin or ketoconazole was found to increase the plasma levels of fexofenadine by 2-3 fold. These changes 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 prior to 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 recommended between the administration of fexofenadine hydrochloride and antacids containing aluminum and magnesium hydroxide.

Overdose

Dizziness, somnolence, fatigue and dry mouth have been reported following overdose with 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 causing clinically significant adverse reactions when compared to placebo. The maximum tolerated dose of fexofenadine hydrochloride has not been established. Standard measures should be considered to remove unabsorbed drug. Supportive and symptomatic treatment is recommended. Hemodialysis does not effectively remove fexofenadine hydrochloride from the blood.

Active principles

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

Excipients

Core of the tabletmicrocrystalline cellulose; pregelatinised maize starch; croscarmellose sodium; magnesium stearateFilm coatinghypromellose; povidone K30; titanium dioxide (E171); anhydrous colloidal silica; macrogol 400; red iron oxide (E172), yellow iron oxide (E172).

048373017

Data sheet

Packaging
120 mg 10 film-coated tablets (imported from Poland)
Product Type
HUMAN DRUG
ATC code
R06AX26
ATC description
Fexofenadine
Therapeutic Group
Anti-allergic antihistamines
Active principle
fexofenadine hydrochloride
Class
C.
Pharmaceutical form
coated tablets
Type of Administration
oral
Container
cpr / cps / pills / confetti in blister packs
Quantity
10 tablet
Quantity of the Active Ingredient
120MG
Recipe required
OTC - self-medication medicine
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