Adenuric film-coated tablets 80 mg 28 pcs.

Active ingredient: febuxostat;

1 film-coated tablet contains 80 mg or 120 mg of febuxostat;

Excipients: lactose, hydroxypropylcellulose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, silicon dioxide, polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol, talc, iron oxide yellow (E 172).

Hypersensitivity to the active substance or any other excipient of the drug.

For oral use.

Adenuric is administered orally, regardless of meals.

Gout. The recommended dose of Adenuric is 80 mg once daily orally, without regard to meals. If serum uric acid levels exceed 6 mg/dL (357 μmol/L) after 2 to 4 weeks of treatment, an increase in the dose of Adenuric to 120 mg once daily should be considered. The onset of action is rapid, allowing for repeat uric acid levels after 2 weeks. The goal of treatment is to reduce uric acid levels and maintain them below 6 mg/dL (357 μmol/L).

The duration of prevention of gout attacks is at least 6 months.

Tumor Lysis Syndrome (TLS): The recommended dose of Adenuric is 120 mg once daily orally, without regard to meals.

Adenuric should be started two days before the start of cytotoxic therapy and continued for at least 7 days; however, the duration of therapy may be extended to 9 days depending on the duration of chemotherapy and clinical assessment.

Pregnant women

Febuxostat should not be used during pregnancy.

Drivers

With caution.

In case of overdose, symptomatic and supportive therapy is indicated.

The most common adverse reactions in clinical trials (4072 patients receiving doses of 10 to 300 mg) and post-marketing surveillance in patients with gout were gout flares, liver dysfunction, diarrhea, nausea, headache, rash, and edema. These reactions were mostly mild to moderate in severity. During post-marketing surveillance, isolated cases of serious hypersensitivity reactions to febuxostat have been reported, some of which were accompanied by systemic reactions.

Glucuronidation inducers.

Strong inducers of UDP-glucuronyltransferase may increase the metabolism and reduce the efficacy of febuxostat. In patients taking strong inducers of glucuronidation, it is recommended to monitor the level of uric acid in the blood plasma after 1-2 weeks of concomitant therapy. When the inducer of glucuronidation is canceled, an increase in the level of febuxostat in the blood plasma is possible.

No special storage conditions are required.

Keep out of reach of children.

Shelf life – 3 years.