Febuxostat Rontis 80mg film coated tablet

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

FEBUXOSTAT

Verfügbar ab:

Rontis Hellas Medical and Pharmaceutical Products S.A. 38, Sorou Str., Athens, Maroussi, 15125, Greece

ATC-Code:

M04AA03

INN (Internationale Bezeichnung):

FEBUXOSTAT 80 mg

Darreichungsform:

FILM-COATED TABLET

Zusammensetzung:

FEBUXOSTAT 80 mg

Verschreibungstyp:

POM

Therapiebereich:

ANTIGOUT PREPARATIONS

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2017-08-21

Gebrauchsinformation

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

Fachinformation

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Febuxostat Rontis 80 mg film-coated tablets
Febuxostat Rontis 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Febuxostat Rontis 80 mg_
_film-coated tablets: _
Each film-coated tablet contains 80 mg of febuxostat (as hemihydrate)
_Febuxostat Rontis 120 mg film-coated tablets: _
Each film-coated tablet contains 120 mg of febuxostat (as hemihydrate)
Excipient(s) with known effect:
_Febuxostat Rontis 80 mg film-coated tablets: _
Each film-coated tablet contains 72.68 mg of lactose (as monohydrate).
_Febuxostat Rontis 120 mg film-coated tablets: _
Each film-coated tablet contains 109.02 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
_Febuxostat Rontis 80 mg film-coated tablets (tablets): _
Pale yellow to yellow, film-coated, capsule shaped tablets, engraved
with “80” on one side
and plain on the other, with dimensions 16.5 mm x 7.0 mm
_Febuxostat Rontis 120 mg film-coated tablets (tablets): _
Pale yellow to yellow, film-coated, capsule shaped tablets, engraved
with “120” on one side
and plain on the other, with dimensions 18.5 mm x 9.0 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Febuxostat Rontis 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 Rontis 120 mg: _
Febuxostat Rontis 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 Rontis is indicated in adults.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Gout: _
The recommended oral dose of Febuxostat Rontis 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 Rontis 120
mg once d