Febuxostat

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Febuxostat 80mg (as febuxostat hemihydrate)

Tilgjengelig fra:

Teva Pharma (New Zealand) Limited

Dosering :

80 mg

Legemiddelform:

Film coated tablet

Sammensetning:

Active: Febuxostat 80mg (as febuxostat hemihydrate) Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 85F32645 Purified water

Resept typen:

Prescription

Indikasjoner:

Treatment of chronic hyperuricaemia in patients with gout (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat is indicated in adults.

Produkt oppsummering:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/aluminium in cardboard carton - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/aluminium in cardboard carton - 84 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with silica gel desiccant and LDPE cap - 28 tablets - 36 months from date of manufacture stored at or below 25°C

Autorisasjon dato:

2018-12-06

Informasjon til brukeren

CONSUMER MEDICINE INFORMATION
FEBUXOSTAT (TEVA)
Febuxostat hemihydrate 80 mg & 120 mg tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Febuxostat
(Teva).
This leaflet answers some common questions about Febuxostat (Teva). It
does not contain all the available information. It does not take the
place of
talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of
you using Febuxostat (Teva) against the benefits they expect it will
have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT FEBUXOSTAT (TEVA) IS USED FOR
Febuxostat (Teva) is 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 (Teva) works by reducing uric acid levels. Keeping uric
acid levels
low by taking Febuxostat (Teva)
tablets 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 (Teva) 80 mg tablets are 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 in the blood accordingly, unless the formation of uric acid
is
prevented.
Your doctor may have prescribed Febuxostat (Teva) for another reason.
Ask your doctor if you have any questions about why Febuxostat (Teva)
has
been prescr

Preparatomtale

Version 2.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Febuxostat (Teva), film coated tablets, 80 mg
Febuxostat (Teva), film coated tablets, 120 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains febuxostat 80 mg or 120 mg as febuxostat
hemihydrate.
Excipient with known effect:
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet, film coated, 80 mg: Capsule-shaped, biconvex, yellow coloured
tablet, approximately
16 x 7 mm, with logo A275 on one side and 80 on the other side.
Tablet, film coated, 120 mg: Capsule-shaped, biconvex, yellow coloured
tablet, approximately
19 x 8.2 mm, with logo A265 on one side and 120 on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Febuxostat (Teva) film coated tablets are indicated for use in adults.
Febuxostat (Teva) film coated tablets 80 mg and 120 mg are indicated
for the treatment of chronic
hyperuricaemia in patients with gout (including a history, or presence
of, tophus and/or gouty
arthritis).
Febuxostat (Teva) film coated tablets 120 mg are also 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).
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
GOUT
The recommended oral dose of Febuxostat (Teva) is 80 mg once daily
with or without food. If serum
uric acid is > 6 mg/dl (357 µmol/L) after 2-4 weeks, Febuxostat
(Teva) 120 mg once daily may be
considered.
Febuxostat (Teva) 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.
TUMOR LYSIS SYNDROME
The recommended oral dose of Febuxostat (Teva) is 120 mg once daily
without regard to food.
Febuxostat (Teva) should be started two days before the beginning of
cytotoxic therapy and continued
for a minimum of 7 days, however treatment may be prol