FEXODINE (Fexofenadine hydrochloride 180mg) Hard gelatin CAPSULE 1 NAME OF THE MEDICINAL PRODUCT FEXODINE 180 mg Hard gelatin CAPSULE. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Fexodine 180mg capsule contains: Active ingredient: Fexofenadine hydrochloride 180 mg Excipient with known effect: Lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard gelatin capsule of opaque blue cap/opaque white body containing white granular powder. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Fexofenadine hydrochloride 180 mg is indicated in adults and children 12 years and older for the relief of symptoms associated with chronic idiopathic urticaria. 4.2 Posology and method of administration Posology Adults The recommended dose of fexofenadine hydrochloride for adults is 180 mg once daily taken before a meal. Fexofenadine is a pharmacologically active metabolite of terfenadine. Paediatric population *Children aged 12 years and over The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 180 mg once daily taken before a meal. *Children under 12 years of age The efficacy and safety of fexofenadine hydrochloride 180 mg has not been studied in children under 12. Special populations Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients (listed in section 6.1). 4.4 Special warnings and precautions for use As with most new medicinal products there is only limited data in the elderly and renally or hepatically impaired patients. Fexofenadine hydrochloride should be administered with care in these special groups. Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, have been associated with the adverse reactions, tachycardia and palpitations (see section 4.8). 4.5 Interaction with other medicinal products and other forms of interaction Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms. Fexofenadine is a P-glycoprotein (P-gp) and organic-anion-transporting polypeptide (OATP) substrate. Concomitant use of fexofenadine with P-gp inhibitors or inducers can affect the exposure to fexofenadine. Coadministration of fexofenadine hydrochloride with P-gp inhibitors erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse reactions compared to the medicinal products given singly. A clinical drug-drug interaction study showed that co-administration of apalutamide (a weak inducer of P-gp) and a single oral dose of 30 mg fexofenadine resulted in a 30 % decrease in AUC of fexofenadine. No interaction between fexofenadine and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids. 4.6 Fertility, pregnancy and lactation 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 effects on pregnancy, embryonal/foetal development, parturition or postnatal development. Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary. Breastfeeding There are no data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers fexofenadine was found to cross into human breast milk. Therefore fexofenadine hydrochloride is not recommended for mothers breastfeeding their babies. Fertility No human data on the effect of fexofenadine hydrochloride on fertility are available. In mice, there was no effect on fertility with fexofenadine hydrochloride treatments. 4.7 Effects on ability to drive and use machines On the basis of the pharmacodynamic profile and reported adverse reactions it is unlikely that fexofenadine hydrochloride capsules will produce an effect on the ability to drive or use machines. In objective tests, fexofenadine hydrochloride has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to medicinal products, it is advisable to check the individual response before driving or performing complicated tasks. 4.8 Undesirable effects The following frequency rating has been used, when applicable. Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 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 have been reported in clinical trials, with an incidence similar to that observed with placebo: Nervous system disorders Common: headache, drowsiness, dizziness Eye disorders: Not known: Vision blurred. Gastrointestinal disorder Common: nausea General disorders and administration site conditions Uncommon: fatigue
