Adenuric

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Febuxostat 80mg;  

Available from:

A. Menarini New Zealand Pty Ltd

INN (International Name):

Febuxostat 80 mg

Dosage:

80 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Febuxostat 80mg   Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 85F42129

Units in package:

Blister pack, PVC/Aclar/Aluminium, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Esteve Quimica SA

Therapeutic indications:

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

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Aclar/Aluminium - 28 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2012-11-13

Patient Information leaflet

ADENURIC
®
T
ABLETS
_febuxostat 80 mg and 120 mg _
_tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ADENURIC
®
Tablets.
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 taking
ADENURIC
®
Tablets against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ADENURIC
® TABLETS ARE USED FOR
ADENURIC
®
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.
ADENURIC
®
Tablets work by reducing uric acid levels. Keeping uric acid levels
low by
taking ADENURIC
®
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.
ADENURIC 120 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.
BEFORE YOU TAKE ADENURIC
® TABLETS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ADENURIC
® TABLETS IF:
•
you have ever had an allergy to febuxostat or any of the ingredients
listed at the en

Summary of Product characteristics

NEW ZEALAND DATASHEET
1
PRODUCT NAME
ADENURIC
®
80 mg, 120 mg film coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains either 80 mg or 120 mg of febuxostat.
Excipient(s) with known effects:
Each 80 mg tablet contains 76.50 mg of lactose (as monohydrate).
Each 120 mg tablet contains 114.75 mg of lactose (as monohydrate).
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
ADENURIC
®
80 mg and 120 mg tablets are pale yellow to yellow, film-coated,
capsule
shaped
tablets,
with
“80”
or “120” on
one
side. They
are
immediate
release
tablets
containing 80 mg or 120 mg of febuxostat as the active substance.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
ADENURIC
®
80 mg
ADENURIC
®
is indicated for the treatment of chronic hyperuricaemia in patients
with gout
(including a history, or presence of, tophus and/or gouty arthritis).
ADENURIC
®
is indicated in adults.
ADENURIC
®
120 mg
ADENURIC
®
is indicated for the treatment of chronic hyperuricaemia in patients
with gout
(including a history, or presence of, tophus and/or gouty arthritis).
ADENURIC
®
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).
ADENURIC
®
is indicated in adults.
4.2
Dose and method of administration
_Gout _
The recommended oral dose of ADENURIC
®
is 80 mg once daily with or without food. If
serum uric acid is > 6 mg/dL (357 micromole/L) after 2-4 weeks,
ADENURIC
®
120 mg once
daily may be considered.
ADENURIC
®
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
(357micromole/L).
Gout flare prophylaxis of at least 6 months is recommended (see
section 4.4).
_Tumor Lysis Syndrome _
The recommended oral dose of ADENURIC
®
is 120 mg once daily with or without food.
ADENURIC
®
should be started two days before the beginning of cytot