Sensafex 120 Mg Film-Coated Tablets

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

Posology

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

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

Special risk groups: See sections 4.4 and 5.2.

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

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

There is only limited data for the use of SENSAFEX 120 mg in elderly and renally or hepatically impaired patients. SENSAFEX 120 mg 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 SENSAFEX 120 mg, has not been studied in children under the age of 12 years.

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

Fexofenadine, as in SENSAFEX 120 mg 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 SENSAFEX 120 mg 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 SENSAFEX 120 mg and omeprazole was observed. However, the administration of antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride, as in SENSAFEX 120 mg caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of SENSAFEX 120 mg and aluminium and magnesium hydroxide containing antacids.

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