Fexo 120 mg, 180 mg FC tablets.

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

Posology

Adults and children aged 12 years and over:

• Chronic idiopathic urticaria (CIU): Take one 180 mg tablet once a day.
• Seasonal allergic rhinitis (SAR): Take one 120 mg tablet once a day.

Children below 12 years of age: The safety and efficacy of FEXO has not been studied in children under 12. (see section 4.3 and section 4.4).

Special populations (See section 4.4).

Renal impairment: Because of the increases in bioavailability and half-life, a single dose of 60 mg daily is recommended as the starting dose in patients with renal impairment.

Paediatric population: The safety and efficacy of FEXO in children younger than 12 years has not yet been established.

Method of administration: For oral administration.

FEXO is contraindicated in:

• Patients with known hypersensitivity to fexofenadine hydrochloride or to any of the excipients used in the formulation of FEXO (see section 6.1)
• FEXO should not be taken during pregnancy or by mothers breastfeeding their babies (see section 4.6)

Data on the use in the elderly and in renally or hepatically impaired patients is limited. FEXO should be administered with care in these special risk groups or special populations (see section 4.2). FEXO is excreted in breast milk (see section 4.6). Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, such as FEXO, have been associated with the adverse reactions, tachycardia and palpitations (see section 4.8). The ability to drive or operate machinery may be affected by FEXO.

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

FEXO is not metabolised in the liver. 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. A two- or three-fold increase in plasma levels of FEXO result from co-administration of FEXO with P-gp inhibitors erythromycin or ketoconazole. These changes do not coincide with changes in the QT-interval and are not accompanied by any increase in adverse reactions compared to the medicines administered 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. An increase in gastrointestinal absorption together with either a decrease in biliary excretion or a decrease in gastrointestinal secretion, appears to be responsible for the increase in plasma levels of FEXO following co-administration with either erythromycin or ketoconazole. There is no interaction between FEXO and omeprazole. However, the bioavailability of FEXO is reduced when an antacid containing aluminium and magnesium hydroxide gels is administered 15 minutes prior to FEXO. This most likely results from binding in the gastrointestinal tract. Therefore, the administration of FEXO and aluminium and magnesium hydroxide containing antacids should be spaced two hours apart.

Pregnancy: There is no data on the use of FEXO in pregnant women. Therefore, FEXO should not be taken during pregnancy (see section 4.3).

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, FEXO should not be taken by mothers breastfeeding their babies.

Fertility: No human data on the effect of fexofenadine hydrochloride on fertility are available.

The ability to drive or operate machinery may be affected by FEXO. FEXO lacks significant sedative effects but since a small number of individuals may experience sedation, patients should be warned of this. Each individualu2019s response to FEXO should therefore be determined prior to driving or performing complicated tasks. The sedative effects may be enhanced by the concomitant intake of other central nervous system depressants or alcohol (see section 4.8).

Tabulated summary of adverse reactions

The following adverse reactions have been classified according to the following categories, frequent, less frequent and frequency unknown.

MedDRA system organ class

Frequency

Side effects

• General disorders and administration site conditions
• Less frequent: Fatigue

• Nervous system disorders
• Frequent: Drowsiness, dizziness, headache
• Less frequent: Insomnia

• Gastrointestinal disorders
• Frequent: Nausea
• Frequency unknown: Diarrhoea

• Skin and subcutaneous tissue disorders
• Less frequent: Rash, urticaria, pruritus

• Immune system disorders
• Less frequent: Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, angioedema, flushing, systemic anaphylaxis

• Cardiac disorders
• Frequency unknown: Tachycardia, palpitations.

Reporting of suspected adverse reactions

Reporting 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 Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website, or to Cipla Medpro (Pty) Ltd. at [email protected] or telephone 080 222 6662 (toll free).

There is limited information on FEXO overdoses. However, available data have reported drowsiness, dizziness and a dry mouth. Any unabsorbed drug should be removed by standard measures. Haemodialysis is not an effective measure to remove FEXO from the circulation.