Pollofex 120 mg or 180 mg FC tablets

Pollofex 120 is indicated for the relief of symptoms associated with seasonal allergic rhinitis (SAR). Pollofex 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 Pollofex have not been studied in children under 12.

Special risk groups: (see section 4.4) Based on increases of bioavailability and half-life, a dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function.

Pollofex is contraindicated in patients with known hypersensitivity to fexofenadine hydrochloride or to any of the excipients of Pollofex (see section 6.1). Safety in pregnancy and lactation has not been established. Pollofex should not be taken during pregnancy or lactation (see section 4.6). The safety and efficacy of Pollofex have not been studied in children under the age of 12 years.

There is only limited data for the use in elderly and renally or hepatically impaired patients. Pollofex should be administered with care in these special risk groups. Patients with a history of or ongoing cardiovascular disease should be warned that antihistamines, such as Pollofex, have been associated with the adverse reactions tachycardia and palpitations (see section 4.8).

Lactose intolerance

Patients with the rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take Pollofex.

Pollofex does not undergo hepatic biotransformation. Fexofenadine as contained in Pollofex is a P-glycoprotein (P-gp) and organic-anion-transporting polypeptide (OATP) substrate. Concomitant use of Pollofex with P-gp inhibitors or inducers can affect the exposure to Pollofex. Co-administration of Pollofex with P-gp inhibitors, erythromycin or ketoconazole has been found to result in 2 to 3 times increase in the level of Pollofex 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 medicine-medicine interaction study showed that co-administration of apalutamide (a weak inducer of P-gp) and a single oral dose of 30 mg fexofenadine as contained in Pollofex resulted in a 30 % decrease in AUC of fexofenadine. No interaction between Pollofex and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to Pollofex, causes a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of Pollofex and aluminium and magnesium hydroxide containing antacids.

Pregnancy

Safety in pregnancy has not been established. Pollofex should not be taken during pregnancy (see section 4.3).

Breastfeeding

Safety in lactation has not been established. Pollofex has been detected in breast milk. Pollofex should not be taken during lactation (see section 4.3).

Pollofex lacks 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. The effect may be compounded by simultaneous intake of alcohol or other central nervous system depressants.

System Organ Class Frequency

• Immune system disorders Less frequent Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing, and systemic anaphylaxis
• Psychiatric disorders Less frequent Insomnia, nervousness and sleep disorders or nightmares/ excessive dreaming (paroniria)
• Nervous system disorders Frequent Headaches, drowsiness, dizziness
• Eye disorders Frequency unknown Blurred vision
• Cardiac disorders Frequency unknown Tachycardia, palpitations
• Respiratory, thoracic and mediastinal disorders Less frequent Sinusitis and viral infections such as cold or flu
• Gastrointestinal disorders Frequent Nausea
• Less frequent Dyspepsia
• Skin and subcutaneous tissue disorders Less frequent Rash, urticaria, pruritus
• Reproductive system and breast disorders Less frequent Dysmenorrhoea
• General disorders and administration site conditions Less frequent Fatigue

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 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.

Most reports of Pollofex overdose contain limited information. However, dizziness, drowsiness and dry mouth have been reported. Standard measures should be considered to remove any unabsorbed medicine. Haemodialysis does not effectively remove Pollofex from blood.