Sanofi Fexallegra 10 Tablets Coated 120mg
- Brand:SANOFI Srl
- Product Code: 042554042
- Availability: In Stock
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Symptomatic treatment of seasonal allergic rhinitis.
Fexallegra is used to counter allergy symptoms, sneezing, nasal itching, runny nose, itching and watery eyes. It works for 24 hours, so only one tablet a day is enough.
Fexallegra fights allergy symptoms with 3 characteristics:
- it is effective: it acts quickly against all symptoms of allergy;
- it is safe: it does not give drowsiness, in fact its use is authorized for the pilots of the American Army Aviation;
- It's practical: you take one tablet a day, the effect lasts 24 hours.
Antihistamines for systemic use.
Tablet core: microcrystalline cellulose; elatinized preg corn starch; croscarmellose sodium; magnesium stearate Film coating: hypromellose; povidone; titanium dioxide (E171); colloidal anhydrous silica; macrogol 400; iron oxide (E172).
The drug is indicated in adults and children 12 years of age and over for the symptomatic treatment of seasonal allergic rhinitis.
The product is contraindicated in patients with hypersensitivity to the active substance or to any of the listed excipients.
Method of use or Posology
Adults: the recommended dose of fexofenadine hydrochloride for adults is 120 mg once a day, before meals. Fexofenadine is a pharmacologically active metabolite of terfenadine. Children 12 years of age and above: the recommended dose of fexofenadine hydrochloride for children 12 years of age and older is 120 mg once a day, 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 dosage in this population. Studies in groups of at-risk patients (elderly, patients with renal or hepatic impairment) indicate that no dose of fexofenadine hydrochloride needs to be adjusted in these patients.
The medicine does not require special precautions for storage.
As with most new medicines, data on elderly subjects and patients with renal or hepatic impairment are limited. Fexofenadine hydrochloride should be given carefully to these groups of subjects. Patients with prior or ongoing cardiovascular disease should be advised that antihistamines, as a class of medicinal products, have been associated with undesirable reactions such as tachycardia and palpitations.
Fexofenadine does not undergo liver biotransformation and therefore will not interact with other drugs in the liver. The concomitant administration of fexofenadine hydrochloride with erythromycin or ketoconazole has been shown to increase the 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 drugs 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 respectively by a decrease in both biliary excretion and gastrointestinal secretion. No interaction between fexofenadine and omeprazole was observed. 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 links in the gastrointestinal tract. A 2 hour interval between the administration of fexofenadine hydrochloride and antacids containing aluminum and magnesium hydroxide is recommended.
Unwanted Effects or Side Effects
The following frequency class was 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. In adults, the following side effects have been reported in clinical trials, with similar incidence reported with placebo. Nervous system disorders. Common: headache, drowsiness, 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. Immune system disorders: hypersensitivity reactions with manifestations such as angioedema, thoracic oppression, dyspnea, flushing and systemic anaphylaxis. Psychiatric disorders: insomnia, nervousness, sleep disorders or nightmares / excess dreams (paroniria). Cardiac disorders: tachycardia, palpitations. Gastrointestinal disorders: diarrhea. Skin and subcutaneous tissue disorders: rash, urticaria and pruritus. The reporting of suspected adverse reactions occurring after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk balance of the medicinal product.
Use during pregnancy and lactation
There are no adequate data on the use of fexofenadine hydrochloride in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonal / fetal development, childbirth or post-natal development. Fexofenadine hydrochloride should not be used during pregnancy unless absolutely necessary.There are no data on concentration in breast milk after administration of fexofenadine hydrochloride. However, when terfenadine was given to nursing mothers, it was found that fexofenadine passes into breast milk. Therefore the use of fexofenadine hydrochloride is not recommended during lactation.
Pack of 10 film-coated tablets