Febuxostat Accord 120mg Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Febuxostat

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

M04AA03

INN (International Name):

Febuxostat

Dosage:

120 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

febuxostat

Authorization status:

Marketed

Authorization date:

2019-02-08

Patient Information leaflet

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Febuxostat Accord 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 120 mg of febuxostat (as magnesium salts).
_Excipient with known effect: _
Each tablet contains 114.70 mg lactose monohydrate.
Each tablet contains 0.25 mmol (5.86 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pale yellow to yellow, film-coated, capsule shaped tablets, engraved
with “120” on one side, 19.2 ±
0.2 mm in length, 8.2 ± 0.2 mm in width, 6.1 ± 0.2 mm in thickness.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Febuxostat Accord is indicated for the treatment of chronic
hyperuricaemia in conditions where urate
deposition has already occurred (including a history, or presence of,
tophus and/or gouty arthritis).
Febuxostat Accord is indicated for the prevention and treatment of
hyperuricaemia in adult patients
undergoing chemotherapy for haematologic malignancies at intermediate
to high risk of Tumor Lysis
Syndrome (TLS).
Febuxostat Accord is indicated in adults.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Gout: The recommended oral dose of Febuxostat Accord is 80 mg once
daily without regard to food.
If serum uric acid is > 6 mg/dL (357 μmol/L) after 2-4 weeks,
Febuxostat Accord 120 mg once daily
may be considered.
Febuxostat Accord 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 mg/dL (357 μmol/L).
Gout flare prophylaxis of at least 6 months is recommended (see
section 4.4).
_ _
Tumor Lysis Syndrome: The recommended oral dose of Febuxostat Accord
is 120 mg once daily
without regard to food.
2
Febuxostat Accord should be started two days before the beginning of
cytotoxic therapy and continued
for a minimum of 7 days; however, treatment may be prolonged up to 9
days according to
chemotherapy duration as per clinical judgment.
_El

Summary of Product characteristics

Health Products Regulatory Authority
26 January 2023
CRN00CZRX
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Febuxostat Accord 120mg Film Coated Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 120 mg of febuxostat (as magnesium salts).
_Excipient with known effect:_
Each tablet contains 114.70 mg lactose monohydrate.
Each tablet contains 0.25 mmol (5.86 mg) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pale yellow to yellow, film-coated, capsule shaped tablets, engraved
with “120” on one side, 19.2 ± 0.2 mm in length, 8.2 ± 0.2
mm in width, 6.1 ± 0.2 mm in thickness.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Febuxostat Accord is indicated for thetreatment of chronic
hyperuricaemia in conditions where urate deposition has already
occurred (including a history, or presence of, tophus and/or gouty
arthritis).
Febuxostat Accord is indicated for the prevention and treatment of
hyperuricaemia in adult patients undergoing chemotherapy
for haematologic malignancies at intermediate to high risk of Tumor
Lysis Syndrome (TLS).
Febuxostat Accord is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Gout: The recommended oral dose of Febuxostat Accord is 80 mg once
daily without regard to food. If serum uric acid is > 6
mg/dL (357 μmol/L) after 2-4 weeks, Febuxostat Accord 120 mg once
daily may be considered.
Febuxostat Accord 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 mg/dL (357 μmol/L).
Gout flare prophylaxis of at least 6 months is recommended (see
section 4.4).
Tumour Lysis Syndrome: The recommended oral dose of febuxostat is 120
mg once daily without regard to food.
Febuxostat should be started two days before the beginning of
cytotoxic therapy and continued for a minimum of 7 days;
however, treatment may be prolonged up to 9 days according to
chemothe