Febuxostat Tillomed 120 mg film-coated tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Febuxostat

Disponibil de la:

Laboratorios Tillomed Spain, S.L.U.

Codul ATC:

M04AA03

INN (nume internaţional):

Febuxostat

Dozare:

120 milligram(s)

Forma farmaceutică:

Film-coated tablet

Zonă Terapeutică:

febuxostat

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2020-06-26

Prospect

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

Caracteristicilor produsului

Health Products Regulatory Authority
14 November 2022
CRN00D5M5
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Febuxostat Tillomed 120 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 120 mg of febuxostat (as febuxostat hemihydrate).
Excipient(s) with known effects:
Each tablet contains 430.80 mg of lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablets).
Pale yellow to yellow, capsule shaped, film coated tablet debossed
with "EM 48" on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Febuxostat Tillomed 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 Tillomed 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 Tillomed 120 mg film-coated tablets is indicated in adults.
Febuxostat Tillomed 120 mg film-coated tablets is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Gout: The recommended oral dose of Febuxostat Tillomed 80 mg
film-coated tablets 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 Tillomed 120 mg film-coated tablets once daily
may be considered.
Febuxostat 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 (357μmol/L).
Gout flare prophylaxis of at least 6 months is recommended (see
section 4.4).
Tumor Lysis Syndrome: The recommended oral dose of Febuxostat Tillomed
120 mg film-coated tablets is 120 mg once daily
without regard to food.
Febuxostat Tillomed 120 mg film-coate