Febuxostat Clonmel 120 mg Film-coated tablets

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Febuxostat

Доступно од:

Clonmel Healthcare Ltd

АТЦ код:

M04AA; M04AA03

INN (Међународно име):

Febuxostat

Дозирање:

120 milligram(s)

Фармацеутски облик:

Film-coated tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

Preparations inhibiting uric acid production; febuxostat

Статус ауторизације:

Marketed

Датум одобрења:

2018-04-27

Информативни летак

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
Febuxostat Clonmel 80mg Film-coated Tablets
Febuxostat Clonmel 120mg 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 Clonmel is and what it is used for
2. What you need to know before you take Febuxostat Clonmel
3. How to take Febuxostat Clonmel
4. Possible side effects
5. How to store Febuxostat Clonmel
6. Contents of the pack and other information
1. WHAT FEBUXOSTAT CLONMEL IS AND WHAT IT IS USED FOR
Febuxostat Clonmel 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 Clonmel works by reducing uric acid levels. Keeping uric
acid levels low by taking
Febuxostat Clonmel 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 Clonmel 120 mg tablets is also used to treat and prevent
high blood levels of uric acid that
may occur when you start to rec

Карактеристике производа

Health⋅Products⋅Regulatory⋅Authority
04⋅July⋅2022
CRN00CTRY
Page⋅1⋅of⋅14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Febuxostat⋅Clonmel⋅120⋅mg⋅Film-coated⋅tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each⋅film-coated⋅tablet⋅contains⋅120
mg⋅of⋅febuxostat⋅(as⋅hemihydrate).
For⋅the⋅full⋅list⋅of⋅excipients,⋅see⋅section⋅6.1.
3 PHARMACEUTICAL FORM
Film-coated⋅tablet.
Yellow,⋅oblong,⋅biconvex,⋅18⋅mm⋅x⋅8⋅mm⋅film-coated⋅tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Febuxostat⋅Clonmel⋅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⋅Clonmel⋅is⋅indicated⋅for⋅the⋅prevention⋅and⋅treatment⋅of⋅hyperuricaemia⋅in⋅adult⋅patients⋅undergoing⋅
chemotherapy⋅for⋅haematologic⋅malignancies⋅at⋅intermediate⋅to⋅high⋅risk⋅of⋅Tumour⋅Lysis⋅Syndrome⋅(TLS).
Febuxostat⋅Clonmel⋅is⋅indicated⋅in⋅adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Gout_
The⋅recommended⋅oral⋅dose⋅of⋅Febuxostat⋅Clonmel is⋅80
mg⋅once⋅daily⋅without⋅regard⋅to⋅food.⋅If⋅serum⋅uric⋅acid⋅is⋅>
6 mg/dl⋅
(357 micromol/l)⋅after⋅2-4 weeks,⋅Febuxostat⋅Clonmel⋅120
mg⋅once⋅daily⋅may⋅be⋅considered.
Febuxostat⋅Clonmel
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 micromol/l).
Gout⋅flare⋅prophylaxis⋅of⋅at⋅least⋅6
months⋅is⋅recommended⋅(see⋅section⋅4.4).
_Tumour Lysis Syndrome_
The⋅recommended⋅oral⋅dose⋅of⋅Febuxostat⋅Clonmel⋅is⋅120
mg⋅once⋅daily⋅without⋅regard⋅to⋅food.
Febuxostat⋅Clonmel⋅should⋅be⋅started�