Adenuric 80mg 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:

80mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010400; GTIN: 5038227000348

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 80 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 10-Apr-2018 | A. Menarini
Farmaceutica Internazionale
SRL
1. Name of the medicinal product
ADENURIC 80 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 80 mg of febuxostat.
Excipient(s) with known effects:
Each tablet contains 76.50 mg of lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Pale yellow to yellow, film-coated, capsule shaped tablets, engraved
with “80“ on one side.
4. Clinical particulars
4.1 Therapeutic indications
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 in adults.
4.2 Posology and method of administration
Posology
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).
_Elderly_
No dose adjustment is required in the elderly (see section 5.2).
_Renal impairment_
The efficacy and safety have not been fully evaluated in patients with
severe renal impairment (creatinine
clearance <30 mL/min, see section 5.2).
No dose adjustment is necessary in patients with mild or moderate
renal impairment.
_Hepatic impairment_
The efficacy and safety of febuxostat has not been studied in patients
with severe hepatic impairment
(Child Pugh Class C).
The recommended dose in patients with mild hepatic impairment is 80
mg. Limited information is
available in patients with moderate hepatic impairment.
_Paediatric population_
The safety and the efficacy of ADENURIC in children aged bel