Fexogen 120mg/180mg FC tablets

Fexogen 120 is indicated for the symptomatic relief of allergic conditions including seasonal allergic rhinitis (SAR). Fexogen 180 is indicated for the relief of symptoms associated with chronic idiopathic urticaria.

Posology

Adults and children aged 12 years and over: Symptomatic relief of allergic conditions: One 120 mg tablet daily. Symptomatic relief of chronic idiopathic urticaria: One 180 mg tablet daily.

Special populations

See section 4.4. For patients with decreased renal function, a lower starting dose of 60 mg once daily, is recommended.

Paediatric population

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

Method of administration

For oral use.

• Hypersensitivity to fexofenadine hydrochloride or to any of the ingredients of Fexogen tablets (see section 6.1).
• Children under the age of 12.
• Pregnancy and lactation (see section 4.6).

As there is limited data for the use in elderly and renally or hepatically impaired patients, care must be taken when administering fexofenadine in these special risk groups (see section 4.2). Performance of skilled tasks maybe affected (see section 4.7).

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. Plasma concentrations of fexofenadine have been increased 2 - 3 fold after the concomitant administration of fexofenadine hydrochloride with P-gp inhibitors erythromycin or ketoconazole, but this was not associated with any adverse effects on the QT interval or any increase in adverse effects compared to the medicines given singly. 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 was observed between fexofenadine and omeprazole. However, antacids containing aluminium and magnesium hydroxide have reduced the absorption of fexofenadine, and it is therefore advisable to administer the two medicines 2 hours apart.

Pregnancy

Safety and efficacy has not been established in pregnancy, therefore fexofenadine hydrochloride should not be taken by pregnant women.

Lactation

Safety and efficacy has not been established in lactation, therefore fexofenadine hydrochloride should not be taken by women that are breastfeeding.

Fertility

No data on the effect of FEXOGEN on fertility are available.

In the case of non-sedating antihistamines like fexofenadine, although drowsiness is rare, it can occur and may affect the performance of skilled tasks.

a. Summary of the safety profile

No data is available.

b. Tabulated summary of adverse reactions

MedDRA system organ class Frequency Adverse reactions

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, sleep disorders or paroniria.

Nervous system disorders Frequent Headache, drowsiness, dizziness

Eye disorder Frequency not known Blurred vision

Respiratory, thoracic and mediastinal disorders Less frequent Chest tightness, dyspnoea

Gastrointestinal disorders Frequent Nausea

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

Musculoskeletal and connective tissue disorders 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

Information on overdosage is limited. However, dizziness, drowsiness and dry mouth have been reported. Haemodialysis does not effectively remove fexofenadine hydrochloride from the blood. Treatment is symptomatic and supportive.