Fexofenadine 120 Mg Film-Coated Tablets

FEXOFENADINE 120 mg MEDREICH is indicated for the relief of symptoms associated with seasonal allergic rhinitis (SAR).

Posology

Adults and children aged 12 years and over : FEXOFENADINE 120 mg MEDREICH: One 120 mg tablet daily.

Paediatric population: Children under 12 years of age : The efficacy and safety of FEXOFENADINE 120 mg MEDREICH has not been studied in children under the age of 12.

Special risk groups: See sections 4.4 and 5.2.

Method of administration: FEXOFENADINE 120 mg MEDREICH should be taken orally. The tablets should be swallowed with liquid and should not be chewed. FEXOFENADINE 120 mg MEDREICH should not be broken because the coating is intended to ensure a prolonged release.

• FEXOFENADINE 120 mg MEDREICH is contraindicated in patients with known hypersensitivity to fexofenadine hydrochloride or any of the excipients of FEXOFENADINE 120 mg MEDREICH listed in section 6.1.
• There is no experience with FEXOFENADINE 120 mg MEDREICH in pregnant women. FEXOFENADINE 120 mg MEDREICH should not be taken during pregnancy or by mothers breastfeeding their babies.

There is only limited data for the use of FEXOFENADINE 120 mg MEDREICH in elderly and renally or hepatically impaired patients. FEXOFENADINE 120 mg MEDREICH should be administered with care in these special risk groups.

Patients with a history of or ongoing cardiovascular disease should be warned that antihistamines, has been associated with the adverse reactions, tachycardia and palpitations (see section 4.8).

Paediatric population: The safety and efficacy of fexofenadine, as in FEXOFENADINE 120 mg MEDREICH, has not been studied in children under the age of 12 years.

FEXOFENADINE 120 mg MEDREICH contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take FEXOFENADINE 120 mg MEDREICH.

Fexofenadine, as in FEXOFENADINE 120 mg MEDREICH does not undergo hepatic biotransformation. 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. Co-administration of FEXOFENADINE 120 mg MEDREICH with P-gp inhibitors erythromycin or ketoconazole has been found to result in 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 events compared to the medicines given individually.

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, as in FEXOFENADINE 120 mg MEDREICH and omeprazole was observed. However, the administration of antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride, as in FEXOFENADINE 120 mg MEDREICH 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 120 mg MEDREICH and aluminium and magnesium hydroxide containing antacids.

Pregnancy: There is no experience with fexofenadine, as in FEXOFENADINE 120 mg MEDREICH, in pregnant women. FEXOFENADINE 120 mg MEDREICH 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.

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. FEXOFENADINE 120 mg MEDREICH 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 FEXOFENADINE 120 mg MEDREICH 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.

System Organ Class Adverse reaction Frequency

• Immune system disorders Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis Less frequent
• Psychiatric disorders Insomnia, nervousness and sleep disorders or nightmares/excessive dreaming (paroniria). Less frequent
• Nervous system disorders Headache, drowsiness, dizziness Frequent
• Eye disorders Blurred vision Frequency unknown
• Cardiac disorders Tachycardia, palpitations Frequency unknown
• Gastrointestinal disorders Nausea Frequent
• Diarrhoea Frequency unknown
• Skin and subcutaneous tissue disorder Rash, urticaria, pruritus Less frequent
• General disorders and administrative site conditions Fatigue Less frequent

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. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Medicine Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

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

Treatment: Standard measures should be considered to remove any unabsorbed medicine. Haemodialysis does not effectively remove fexofenadine hydrochloride from blood.