Doluric 120mg film coated tablet

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

FEBUXOSTAT

Commercializzato da:

Meditop Pharmaceutical Ltd. Pilisborosjeno, Ady Endre utca 1., 2097,, Hungary

Codice ATC:

M04AA03

INN (Nome Internazionale):

FEBUXOSTAT 120 mg

Forma farmaceutica:

FILM-COATED TABLET

Composizione:

FEBUXOSTAT 120 mg

Tipo di ricetta:

POM

Area terapeutica:

ANTIGOUT PREPARATIONS

Stato dell'autorizzazione:

Withdrawn

Data dell'autorizzazione:

2017-08-21

Foglio illustrativo

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_ _
DOLURIC 80 MG FILM-COATED TABLETS
DOLURIC 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 Doluric is and what it is used for
2.
What you need to know before you take Doluric
3.
How to take Doluric
4.
Possible side effects
5.
How to store Doluric
6.
Contents of the pack and other information
1.
WHAT DOLURIC IS AND WHAT IT IS USED FOR
Doluric 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.
Doluric works by reducing uric acid levels. Keeping uric acid levels
low by taking Doluric 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.
_Doluric 120 mg: _
Doluric120 mg film-coated 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 chemotherapy is given, cancer cells are destroyed, and uric acid
levels increase

Scheda tecnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Doluric 80 mg film-coated tablets
Doluric 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Doluric 80 mg_
_film-coated tablets: _
Each film-coated tablet contains 80 mg of febuxostat (as hemihydrate)
_Doluric 120 mg film-coated tablets: _
Each film-coated tablet contains 120 mg of febuxostat (as hemihydrate)
Excipient(s) with known effect:
_Doluric 80 mg film-coated tablets: _
Each film-coated tablet contains 72.68 mg of lactose (as monohydrate).
_Doluric 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.
_Doluric 80 mg film-coated 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
_Doluric 120 mg film-coated 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
Doluric 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).
_Doluric 120 mg: _
Doluric 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).
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Doluric is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Gout: _
The recommended oral dose of Doluric is 80 mg once daily without
regard to food. If serum
uric acid is > 6 mg/dL (357 μmol/L) after 2-4 weeks, Doluric 120 mg
once daily may be considered.
Doluric works sufficiently quickly to allow retesting of the serum
uric acid after 2 weeks. The
therapeutic target is to decrease and maintain se