Febuxostat Accord 80mg Film Coated Tablet

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Febuxostat

제공처:

Accord Healthcare Ireland Ltd.

ATC 코드:

M04AA03

INN (International Name):

Febuxostat

복용량:

80 milligram(s)

약제 형태:

Film-coated tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

febuxostat

승인 상태:

Marketed

승인 날짜:

2019-02-08

환자 정보 전단

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FEBUXOSTAT TABLETS 80 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 Tablets is and what it is used for
2.
What you need to know before you take Febuxostat Tablets
3.
How to take Febuxostat Tablets
4.
Possible side effects
5.
How to store Febuxostat Tablets
6.
Contents of the pack and other information
1.
WHAT FEBUXOSTAT TABLETS IS AND WHAT IT IS USED FOR
Febuxostat Tablets 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 Tablets works by reducing uric acid levels. Keeping uric
acid levels low by taking
Febuxostat Tablets 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 Tablets is for adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEBUXOSTAT TABLETS
DO NOT
TAKE FEBUXOSTAT TABLETS:
-
if you are allergic to febuxostat or any of the other ingredi

제품 특성 요약

Health Products Regulatory Authority
26 January 2023
CRN00CZRX
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Febuxostat Accord 80mg Film Coated Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of febuxostat (as magnesium salts).
_Excipient with known effect:_
Each tablet contains 76.50 mg lactose monohydrate.
Each tablet contains 0.17 mmol (3.9 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 “80” on one side, 17.2 ± 0.2 mm in length, 6.2 ± 0.2
mm in width, 5.6 ± 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 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).
_ _
_Elderly_
No dose adjustment is required in the elderly (see section 5.2).
_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).
No dose adjustment is necessary in patients with mild or moderate
renal impairment.
_ _
_Hepatic impairment_
The efficacy and safety of febuxostat have not been studied in
patients with severe hepatic impairment (Child-Pugh Class C).
Gout: The recommended dose in patie