FEBURIC® FILM COATED TABLETS 80MG

4.1 Therapeutic indications

Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).

Feburic is indicated in adults.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.8) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.2 Posology and method of administration

Posology

The recommended oral dose of Feburic is 40 mg or 80 mg once daily without regard to food. The recommended starting dose of Feburic is 40 mg once daily. If serum uric acid is >6 mg/dL (357 micromole/L) after 2–4 weeks, Feburic 80 mg once daily is recommended.

The 80 mg tablet can be divided into equal halves. In order to provide a 40 mg dose, the tablet should be split just before use. Prescribers should advise patients on how to break the tablets in half and to keep the other half for the next dose.

Feburic works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 6.0 mg/dL (357 micromole/L).

Gout flare prophylaxis of at least 6 months is recommended (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly

No dose adjustment is required in the elderly (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment

The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance <30 mL/min, see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

No dose adjustment is necessary in patients with mild or moderate renal impairment.

Hepatic impairment

The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C).

No dose adjustment is necessary in patients with mild hepatic impairment. Limited information is available in patients with moderate hepatic impairment.

Paediatric population

The safety and efficacy of Feburic in children aged below the age of 18 years have not been established. No data are available.

Method of administration

Oral use

Feburic should be taken by mouth and can be taken with or without food.