FEBURIC 80 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

FEBUXOSTAT

Commercializzato da:

NEOPHARM LTD, ISRAEL

Codice ATC:

M04AA03

Forma farmaceutica:

FILM COATED TABLETS

Composizione:

FEBUXOSTAT 80 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

PATHEON FRANCE S.A.S.,FRANCE

Area terapeutica:

FEBUXOSTAT

Indicazioni terapeutiche:

Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).Feburic is indicated in adults.

Data dell'autorizzazione:

2019-04-30

Foglio illustrativo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is to be supplied upon a doctor's prescription only
FEBURIC
 80 MG
FILM-COATED TABLETS
Active ingredient and its quantity:
Each film-coated tablet contains:
febuxostat 80 mg
For the excipients in this product, please see section 6:
“Additional information” and section 2:
“Important information regarding some of the ingredients of this
medicine”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. This leaflet contains
concise information about the medicine. 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 you think that their illness is the same as yours.
Do not give this medicine to children under 18 years of age since
the safety and efficacy have
not been proven.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of gout in adults, which is
characterized by chronic
increase of uric acid in the blood (chronic
_ _
hyperuricemia) and is accompanied with urate
deposition (including formation of crystals and/or gouty arthritis).
THERAPEUTIC GROUP:
Medicines which inhibit production of uric acid.
2. BEFORE YOU TAKE THE MEDICINE:
DO NOT USE THE MEDICINE IF:
•
You are hypersensitive (allergic) to the active ingredient
(Febuxostat) or to any of
the other ingredients of this medicine (listed in section 6).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
TALK TO YOUR DOCTOR BEFORE TAKING FEBURIC IF:
•
you have or have had heart failure, heart problems or stroke.
•
you have or have had renal disease and/or serious allergic reaction to
Allopurinol (a
medication used for the treatment of Gout).
•
you have or have had liver disease or liver function test
abnormalities.
•
you are being treated for high uric acid levels as a result of cancer
disease or Lesch-
Nyhan syndrome (a rare inherited condition in which there is too muc

Scheda tecnica

_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FEBURIC
® 80 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of febuxostat.
Excipient(s) with known effects:
Each tablet contains 76.50 mg of lactose (as monohydrate).
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 and a break-
line on the other side.
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).
FEBURIC is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended oral dose of FEBURIC is 80 mg once daily without
regard to food. If serum uric acid
is > 6 mg/dL (357 µmol/L) after 2-4 weeks, FEBURIC 120 mg once daily
may be considered.
FEBURIC 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 µmol/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 has not been studied in patients
with severe hepatic impairment
(Child Pugh Class C).
The recommended dose in patients with mild hepatic impairment is 80
mg. Limited information is
available in patients with moderate hepatic impairment.
_ _
_Paediatric population_
The safety and the efficacy of FEBURIC in children aged below the age
of 18 years have not been
established. No data are available.
Method of ad