Zurampic 200 mg Film coated tablet

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Lesinurad 200 mg

Tilgjengelig fra:

AstraZeneca Limited

INN (International Name):

Lesinurad 200 mg

Dosering :

200 mg

Legemiddelform:

Film coated tablet

Resept typen:

Prescription

Produsert av:

Hovione Limited

Autorisasjon dato:

2015-06-26

Informasjon til brukeren

Zurampic
TM
CMI 250118
Copyright
1(5)
Zurampic
TM
Lesinurad 200 mg Film Coated Tablets.
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some of the common questions people ask about
Zurampic. It does not contain
all the information that is known about Zurampic.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking
Zurampic 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 Zurampic is used for
Zurampic contains the active ingredient lesinurad and belongs to a
group of medicines called
selective uric acid reabsorption inhibitors that help the kidneys
remove uric acid from your body.
Zurampic is used to treat gout in adult patients. It will lower the
levels of uric acid in your blood.
Zurampic is used in combination with allopurinol or febuxostat, which
are other medicines called
xanthine oxidase inhibitors. Allopurinol and febuxostat decrease the
amount of uric acid your body
makes.
Your doctor will prescribe Zurampic if your current medicine is not
controlling your gout. You must
use Zurampic together with either allopurinol or febuxostat.
Gout is a type of arthritis. It happens when there is too much uric
acid in your blood.
In some people, uric acid builds up in the blood and may form crystals
in and around the joints. This
can cause a gout attack (gout flare).
The signs include a sudden, severe pain, redness, warmth and swelling
in a joint. If this is not
treated, over time your joints and bones can become damaged by large
amounts of crystals called
‘tophi’.
Keeping uric acid levels low enough for a long enough time can also
shrink ‘tophi’.
Ask your doctor if you have any questions about why this medicine has
been prescribed for you.
Your doctor may have prescribed it for another reason.
Zurampic is only availabl

Preparatomtale

Z
URAMPIC
Data Sheet 250118
Copyright
1
NEW ZEALAND DATA SHEET
1.
NAME OF MEDICINE
Z
URAMPIC
TM
200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of lesinurad.
Excipient with known effect: Each 200 mg lesinurad tablet contains
55.75 mg of lactose
monohydrate.
For a full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet. Oval, 5.7 x 12.9 mm, blue tablets. Tablets are
debossed with “LES200”
on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Z
URAMPIC
is
indicated
for
the
treatment
of
hyperuricaemia
associated
with
gout
in
combination with a xanthine oxidase inhibitor.
For use in adults 18 years of age or older.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage
The recommended dose of Z
URAMPIC
is 200 mg once daily. Z
URAMPIC
should be taken by
mouth, in the morning with food and water.
Z
URAMPIC
tablets must be co-administered with a xanthine oxidase inhibitor,
i.e.
allopurinol or febuxostat.
The target serum uric acid level is less than 0.36 mmol/L (6 mg/dL).
In patients with tophi or
persistent symptoms, the target is less than 0.30 mmol/L (5 mg/dL).
Testing for the target
serum uric acid level may be performed as early as 4 weeks after
initiating Z
URAMPIC
treatment.
Gout flare prophylaxis is recommended for at least 5 months when
starting therapy (see
Section 4.4).
Z
URAMPIC
Data Sheet 250118
Copyright
2
Special Populations
Renal impairment
No dose adjustment is necessary in patients with mild or moderate
renal impairment. No
overall differences in safety and effectiveness were observed in
patients with mild or
moderate renal impairment (CrCL
r
of 30-89 mL/min) compared to patients with normal renal
function (see Section 5.2).
There
are insufficient
data in
patients with
severe
renal
impairment (CrCL
r
less than
30 ml/min.).
Hepatic impairment
No dose adjustment is necessary in patients with mild or moderate
hepatic impairment
(Child-Pugh classes A and B) (see Section 5.2). Lesinurad has not been
studied in pa