Febuxostat Rowex 120 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Febuxostat

Available from:

Rowex Ltd

ATC code:

M04AA; 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:

Preparations inhibiting uric acid production; febuxostat

Authorization status:

Marketed

Authorization date:

2017-07-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
FEBUXOSTAT ROWEX 80 MG FILM-COATED TABLETS
FEBUXOSTAT ROWEX 120 MG FILM-COATED TABLETS
febuxostat
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
1.
What Febuxostat Rowex is and what it is used for
2.
What you need to know before you take Febuxostat Rowex
3.
How to take Febuxostat Rowex
4.
Possible side effects
5.
How to store Febuxostat Rowex
6.
Contents of the pack and other information
1.
WHAT FEBUXOSTAT ROWEX IS AND WHAT IT IS USED FOR
Febuxostat Rowex tablets contain the active substance febuxostat and
are used to treat gout, which is
associated with an excess of a chemical called uric acid (urate) in
the body. In some people, the
amount of uric acid builds up in the blood and may become too high to
remain soluble. When this
happens, urate crystals may form in and around the joints and kidneys.
These crystals can cause
sudden, severe pain, redness, warmth and swelling in a joint (known as
a gout attack). Left untreated,
larger deposits called tophi may form in and around joints. These
tophi may cause joint and bone
damage.
Febuxostat Rowex works by reducing uric acid levels. Keeping uric acid
levels low by taking
Febuxostat Rowex once every day stops crystals building up, and over
time it reduces symptoms.
Keeping uric acid levels sufficiently low for a long enough period can
also shrink tophi.
_Febuxostat Rowex 120 mg: _
Febuxostat Rowex 120 mg Film-coated tablets are also used to treat and
prevent high blood levels of
uric acid that may occur when

Summary of Product characteristics

Health Products Regulatory Authority
16 January 2024
CRN00DV0Q
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Febuxostat Rowex 120 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 120 mg of febuxostat (as hemihydrate)
Excipient(s) with known effect:
Each film-coated tablet contains 109.01 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Pale yellow to yellow, film-coated, capsule shaped tablets, engraved
with “120” on one side and plain on the other, with
dimensions 18.5 mm x 9.0 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Febuxostat Rowex 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 Rowex 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 Rowex is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Gout: _The recommended oral dose of Febuxostat Rowex 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 Rowex 120 mg once
daily may be considered.
Febuxostat Rowex 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 Rowex
is 120 mg once daily without regard to food.
Febuxostat Rowex 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.
_E