Febuxostat Pinewood 120 mg film-coated tablets

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Febuxostat

MAH:

Pinewood Laboratories Ltd

ATC_code:

M04AA03

INN:

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:

2018-11-30

PIL

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

SPC

HealthProductsRegulatoryAuthority
22March2023
CRN00CWWX
Page1of15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
FebuxostatPinewood120mgfilm-coatedtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachtabletcontains120mgoffebuxostat(asmagnesiumsalts).
_Excipient(s) 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Pinewood120mgfilm-coatedtablets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Pinewood120mgfilm-coatedtablets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Pinewoodisindicatedinadults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Gout:TherecommendedoraldoseofFebuxostatPinewood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Pinewood120mgoncedailymaybeconsidered.
FebuxostatPinewoodworkssufficientlyquicklytoallowretestingoftheserumuricacidafter2
weeks.�