Febuxostat Rowa 80 mg film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Febuxostat

Tilgjengelig fra:

Rowa Pharmaceuticals Limited

ATC-kode:

M04AA; M04AA03

INN (International Name):

Febuxostat

Dosering :

80 milligram(s)

Legemiddelform:

Film-coated tablet

Terapeutisk område:

Preparations inhibiting uric acid production; febuxostat

Autorisasjon dato:

2021-04-30

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FEBUXOSTAT ROWA 80 MG FILM-COATED TABLETS
FEBUXOSTAT ROWA 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 Rowa is and what it is used for
2.
What you need to know before you take Febuxostat Rowa
3.
How to take Febuxostat Rowa
4.
Possible side effects
5.
How to store Febuxostat Rowa
6.
Contents of the pack and other information
1.
WHAT FEBUXOSTAT ROWA IS AND WHAT IT IS USED FOR
Febuxostat Rowa 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 Rowa works by reducing uric acid levels. Keeping uric acid
levels low by taking
Febuxostat Rowa 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 Rowa 120 mg tablets is also used to treat and prevent high
blood levels of uric acid that
may occur when you start to receive chemotherapy for blood cancers.
When

Preparatomtale

Health⋅Products⋅Regulatory⋅Authority
22⋅June⋅2023
CRN00DLJC
Page⋅1⋅of⋅14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Febuxostat⋅Rowa⋅80⋅mg⋅film-coated⋅tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each⋅film-coated⋅tablet⋅contains⋅febuxostat⋅hemihydrate⋅equivalent⋅to⋅80⋅mg⋅of⋅febuxostat.⋅
Excipient with known effect
Each⋅film-coated⋅tablet⋅contains⋅72.68⋅mg⋅of⋅lactose⋅(as⋅monohydrate)
For⋅the⋅full⋅list⋅of⋅excipients,⋅see⋅section⋅6.1.
3 PHARMACEUTICAL FORM
Film-coated⋅tablet.
Pale⋅yellow⋅coloured⋅round⋅shaped⋅film-coated⋅tablet⋅approximately⋅11⋅mm⋅in⋅diameter,⋅debossed⋅with⋅"80"⋅on⋅one⋅side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment⋅of⋅chronic⋅hyperuricaemia⋅in⋅conditions⋅where⋅urate⋅deposition⋅has⋅already⋅occurred⋅(including⋅a⋅history,⋅or⋅
presence⋅of,⋅tophus⋅and/or⋅gouty⋅arthritis).
Febuxostat⋅Rowa⋅is⋅indicated⋅in⋅adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The⋅recommended⋅oral⋅dose⋅of⋅Febuxostat⋅Rowa⋅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⋅Rowa⋅120⋅mg⋅once⋅daily⋅may⋅be⋅considered.
Febuxostat⋅Rowa⋅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).