Fenofex 300mg. 20mg / 1ml FC tablet

FENOFEX 120 is indicated for the relief of symptoms associated with seasonal allergic rhinitis (SAR). FENOFEX 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): One 180 mg tablet daily.
• Seasonal Allergic Rhinitis (SAR): One 120 mg tablet daily.

Children under 12 years of age

The efficacy and safety of FENOFEX has not been studied in children under 12 years of age.

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.

Method of administration

Oral

• Hypersensitivity to fexofenadine or to any of the excipients listed in section 6.1.
• Safety in pregnancy and lactation has not been established (See section 4.6).
• The safety and efficacy of FENOFEX has not been studied in children under the age of 12 years.

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

FENOFEX does not undergo hepatic biotransformation. Co-administration of FENOFEX with erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of FENOFEX 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.

The increase in plasma levels of FENOFEX observed after co-administration of erythromycin or ketoconazole appears to be due to an increase in gastro-intestinal absorption and either a decrease in biliary excretion or gastro-intestinal secretion, respectively. No interaction between FENOFEX and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to FENOFEX caused a reduction in bioavailability, most likely due to binding in the gastro-intestinal tract. It is advisable to leave 2 hours between administration of FENOFEX and aluminium and magnesium hydroxide containing antacids.

Pregnancy

There is no experience with FENOFEX in pregnant women. FENOFEX should not be taken during pregnancy (see section 4.3).

Breastfeeding

FENOFEX has been detected in breast milk. FENOFEX should not be taken during breastfeeding (see section 4.3).

FENOFEX may affect the ability to drive or operate machinery. FENOFEX 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. This effect may be compounded by simultaneous intake of alcohol or other central nervous system depressants. (See section 5.2).

Tabulated list of adverse reactions

MedDRA System organ class Frequency Adverse reactions

• Infections and infestations Less frequent Sinusitis and viral infections such as cold or flu.
• 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 Headache, drowsiness and dizziness.
• Cardiac disorders Frequency unknown Tachycardia, palpitations
• Gastrointestinal disorders Frequent Nausea Less frequent Dyspepsia Frequency unknown Diarrhoea
• Hepatobiliary disorders Less frequent Hepatitis either cytolytic or cholestatic.
• Skin and subcutaneous tissue disorders Less frequent Rash, urticaria and 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. 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.

See section 4.8.

Symptoms of overdose

Most reports of FENOFEX overdose contain limited information. However, dizziness, drowsiness and dry mouth have been reported.

Treatment of overdose

Standard measures should be considered to remove any unabsorbed drug. Haemodialysis does not effectively remove FENOFEX from blood.