Fexxtab 120 mg and 180 mg FC tablets

FEXXTAB 120 is indicated for the relief of symptoms associated with seasonal allergic rhinitis (SAR). FEXXTAB 180 is indicated for the relief of symptoms associated with chronic idiopathic urticaria (CIU).

Posology:
Adults and children aged 12 years and over:
Seasonal allergic rhinitis (SAR): One 120 mg tablet daily.
Chronic idiopathic urticaria (CIU): One 180 mg tablet daily.
Children under 12 years of age: The efficacy and safety of FEXXTAB has not been studied in children under the age of 12.
Special risk groups: See sections 4.4 and 5.2.
Method of administration: FEXXTAB is for oral administration. The tablets should be swallowed with liquid and should not be chewed. FEXXTAB should not be broken because the coating is intended to ensure a prolonged release.

• FEXXTAB is contraindicated in patients with known hypersensitivity to fexofenadine hydrochloride or any of the excipients of FEXXTAB (see section 6.1).
• There is no experience with FEXXTAB in pregnant women. FEXXTAB should not be taken during pregnancy or by mothers breastfeeding their babies.

There is only limited data for the use of FEXXTAB in elderly and renally or hepatically impaired patients. FEXXTAB should be administered with care in these special risk 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).

Paediatric population: The efficacy and safety of FEXXTAB has not been studied in children under the age of 12 years.

Excipient warnings: FEXXTAB contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take FEXXTAB.

Fexofenadine, as in FEXXTAB does not undergo hepatic biotransformation and therefore will not interact with other medicines through hepatic mechanisms. Co-administration of fexofenadine as in FEXXTAB with erythromycin or ketoconazole has been found to result in 2 u2013 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 events compared to the medicines given individually.

A 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 area under the curve (AUC) of fexofenadine. It was reported that animal studies have shown that the increase in plasma levels of fexofenadine as in FEXXTAB, observed after co-administration of erythromycin or ketoconazole, appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary excretion or gastrointestinal secretion, respectively.

No interaction between fexofenadine, as in FEXXTAB, and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride, as in FEXXTAB, caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of FEXXTAB and aluminium and magnesium hydroxide containing antacids.

Pregnancy: There is no experience with fexofenadine as in FEXXTAB in pregnant women. Therefore, FEXXTAB should not be taken during pregnancy (see section 4.3). 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).

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, FEXXTAB should not be taken by mothers breastfeeding their babies (see section 4.3).

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 treatment (see section 5.3).

Fexofenadine as in FEXXTAB lacks significant sedative effects. Patients should, however, be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by simultaneous intake of alcohol or other central nervous system depressants.

Tabulated list of adverse reactions:

Reporting of suspected adverse reactions: Reporting of suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

Symptoms: Most reports of fexofenadine hydrochloride, as in FEXXTAB overdose contain limited information. However, dizziness, drowsiness, and dry mouth have been reported.

Treatment: Standard measures should be considered to remove any unabsorbed medicine. Symptomatic and supportive treatment is recommended. Haemodialysis does not effectively remove fexofenadine hydrochloride from blood.