Adenuric 120mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Febuxostat

Available from:

A. Menarini Farmaceutica Internazionale SRL

ATC code:

M04AA03

INN (International Name):

Febuxostat

Dosage:

120mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010400; GTIN: 5038227000362

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADENURIC 80 MG FILM-COATED TABLETS
ADENURIC 120 MG FILM-COATED TABLETS
Febuxostat
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
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 their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What ADENURIC is and what it is used for
2.
What you need to know before you take ADENURIC
3.
How to take ADENURIC
4.
Possible side effects
5
How to store ADENURIC
6.
Contents of the pack and other information
1.
WHAT ADENURIC IS AND WHAT IT IS 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 works by reducing uric acid levels. Keeping uric acid levels
low by taking ADENURIC
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 is 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
level

Summary of Product characteristics

OBJECT 1
ADENURIC 120 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 10-Apr-2018 | A. Menarini
Farmaceutica Internazionale
SRL
1. Name of the medicinal product
ADENURIC 120 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 120 mg of febuxostat.
Excipient(s) with known effects:
Each tablet contains 114.75 mg of lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablets).
Pale yellow to yellow, film-coated, capsule shaped tablets, engraved
with “120“ on one side.
4. Clinical particulars
4.1 Therapeutic indications
ADENURIC is indicated for the treatment of chronic hyperuricaemia in
conditions where urate deposition
has already occurred (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 Posology and method of administration
Posology
_Gout: _The recommended oral dose of ADENURIC is 80 mg once daily
without regard to food. If serum
uric acid is > 6 mg/dL (357 µmol/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 (357μmol/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 without regard
to food.
ADENURIC should be started two days before the beginning of cytotoxic
therapy and continued for a
minimum of 7 days; however treatment may be prolonged up to 9 days
according to chemotherapy
duration as per clinical judgment.
_Elderly_
No dose adjustment is required in the elderly (see section 5.2).
_Renal impairment_
The efficacy and safety have