Febuxostat Pinewood 80 mg film-coated tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Febuxostat

Saatavilla:

Pinewood Laboratories Ltd

ATC-koodi:

M04AA03

INN (Kansainvälinen yleisnimi):

Febuxostat

Annos:

80 milligram(s)

Lääkemuoto:

Film-coated tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

febuxostat

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2018-11-30

Pakkausseloste

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

Valmisteyhteenveto

Health Products Regulatory Authority
22 March 2023
CRN00CWWX
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Febuxostat Pinewood 80 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of febuxostat (as magnesium salts).
_Excipient(s) 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
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 is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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. 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).
_ _
_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).
The recommended dose in patients with mild hepatic impairment