Histallay 120 mg Film-Coated Tablets
Each film-coated tablet contains 120 mg of fexofenadine hydrochloride; which is equivalent to 112 mg of fexofenadine.
Histallay 120 mg is indicated in adults and children 12 years and older for the relief of symptoms associated with seasonal allergic rhinitis.
Posology
Adults
The recommended dose of fexofenadine hydrochloride for adults is 120 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 120 mg once daily taken before a meal.
? Children under 12 years of age
The efficacy and safety of fexofenadine hydrochloride 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.
As with most new medicinal products there is only limited data in the elderlyand renally or hepatically impaired patients. Histallay should be administered with care in these special groups on the advice of a doctor.
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) and should use Histallay 120 mg only on the advice of their doctor.
Histallay 120 mg should not be used in children under 12 years of age.
In children from 6 to 11 years of age: fexofenadine hydrochloride 30 mg tablet (prescription only medicine) is the appropriate formulation for administration and dosing in this population.
Histallay 120 mg Film-Foated Tablets also contain Allura Red AC Lake, which may cause allergic reactions.
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 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.
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 (see section 5.3). Histallay 120 mg should not be used during pregnancy unless unless on the advice of a doctor.
Lactation
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 Histallay is not recommended for mothers breastfeeding their babies. Breast-feeding women should only use Histallay 120 mg if advised to do so by a doctor.
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 (see section 5.3).
On the basis of the pharmacodynamic profile and reported adverse reactions it is unlikely that fexofenadine hydrochloride tablets 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.
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| Value | Weight | Delivery Charge |
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