ADENURIC febuxostat 80 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

febuxostat, Quantity: 80 mg

Available from:

A Menarini Australia Pty Ltd

INN (International Name):

febuxostat

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: microcrystalline cellulose; hyprolose; croscarmellose sodium; magnesium stearate; silicon dioxide; lactose monohydrate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

4 tablets (sample pack), 28 tablets, 8 tablets (sample pack)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of chronic symptomatic hyperuricaemia in conditions where urate deposition has already occurred (gouty arthritis and/or tophus formation) in adults with gout.

Product summary:

Visual Identification: Pale yellow to yellow, film-coated rectangle shaped tablets with a breakline on one side and "80" engraved on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-12-18

Patient Information leaflet

ADENURIC
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I TAKING ADENURIC?
ADENURIC contains the active ingredient febuxostat. ADENURIC is used
in the treatment of gout, a type of arthritis associated with
high uric acid levels. For more information, see Section 1. Why am I
taking ADENURIC? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE ADENURIC?
Do not use if you have ever had an allergic reaction to febuxostat or
any of the ingredients listed at the end of the CMI. Talk to
your doctor if you have any other medical conditions, take any other
medicines, are pregnant, plan to become pregnant or are
breastfeeding. For more information, see Section 2. What should I know
before I take ADENURIC? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ADENURIC and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I TAKE ADENURIC?
•
The usual dose is 40 mg (half a tablet) or 80 mg (1 whole tablet) once
daily with a full glass of water. This depends on your
condition and whether or not you are taking any other medicines.
•
This medicine helps to control your condition, but does not cure it.
It is important to keep taking your medicine even if you feel
well.
More instructions can be found in Section 4. How do I take ADENURIC?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING ADENURIC?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
ADENURIC.
•
Stop taking ADENURIC and contact your doctor if you experience any
allergy symptoms listed in Section
5 in the full CMI. Notify your doctor of any side effects or symptoms
that worry you.
•
Keep your doctor's appointments so your progre

Summary of Product characteristics

WARNING - Cardiovascular Death - Gout patients with established
cardiovascular (CV)
disease treated with febuxostat had a higher rate of CV death compared
to those treated
with allopurinol in a CV outcomes study. Treatment with febuxostat in
patients with pre-
existing major CV disease is not recommended. Prescribers should
consider patients’ CV
risk
factors
before
initiating
febuxostat (see Section 4.4
SPECIAL WARNINGS
AND
PRECAUTIONS FOR USE – Cardiovascular disorders).
AUSTRALIAN PRODUCT INFORMATION
ADENURIC
 FEBUXOSTAT TABLETS
ADENURIC PI vA8.0
1
1. NAME OF THE MEDICINE
Febuxostat
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of febuxostat.
Excipients with known effect: Contains lactose. For the full list of
excipients, see Section
6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
ADENURIC 80 mg tablets are pale yellow to yellow, film-coated,
rectangular shaped
tablets, with a break line on one side and “80” engraved on the
other side. They are
immediate-release tablets containing 80 mg of febuxostat as the active
substance.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of chronic symptomatic hyperuricaemia in conditions where
urate deposition
has already occurred (gouty arthritis and/or tophus formation) in
adults with gout.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended oral dose of ADENURIC is 40 mg or 80 mg once daily
with or without
food. The recommended starting dose of ADENURIC is 40 mg once daily.
If serum uric
acid (sUA) is greater than 357 micromole/L (6 mg/dL) after 2-4 weeks,
ADENURIC
80 mg once daily is recommended. The 80 mg tablet can be split into
two equal halves in
order to provide a 40 mg dose. Prescribers should advise patients on
how to break the
tablets in half.
Testing for the target serum uric acid level of less than 357
micromole/L (6 mg/dL) may
be performed as early as two weeks after initiating ADENURIC therapy.
Gout flare prophylaxis of up to 6 months is recommended (see Section
4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE, Ac