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FEBUXOSTAT 80MG FILM-COATED TABLETS

Active substance(s): FEBUXOSTAT / FEBUXOSTAT

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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.
2.
3.
4.
5.
6.

What Febuxostat tablets are and what they are used for
What you need to know before you take Febuxostat tablets
Eplerenone tablets
How to take Febuxostat tablets
Possible side effects
How to store Febuxostat tablets
Contents of the pack and other information

1.

WHAT FEBUXOSTAT TABLETS ARE AND WHAT THEY ARE USED FOR

The full name of your medicine is Febuxostat 80 or 120 mg film-coated
tablets. In this leaflet the shorter name Febuxostat tablets is used.
Febuxostat 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.
Febuxostat tablets work by reducing uric acid levels. Keeping uric acid
levels low by taking Febuxostat 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.
Febuxostat 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.
Febuxostat tablets are for adults.
2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEBUXOSTAT
TABLETS

Do not take Febuxostat tablets


If you are allergic to febuxostat or any of the other
ingredients of this medicine (listed in section 6).

Warnings and precautions

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Talk to your doctor before taking Febuxostat tablets:
• If you have or have had heart failure or heart problems
• If you have or have had renal disease and/or serious allergic reaction
to Allopurinol (a medication used for the treatment of Gout)
• If you have or have had liver disease or liver function test
abnormalities
• If you are being treated for high uric acid levels as a result of
Lesch-Nyhan syndrome (a rare inherited condition in which there is
too much uric acid in the blood)
• If you have thyroid problems.
Should you experience allergic reactions to Febuxostat tablets, stop taking
this medicine (see also section 4). Possible symptoms of allergic reactions
might be:
- rash including severe forms (e.g. blisters, nodules, itchy-, exfoliative
rash), itchiness
- swelling of limbs or face
- difficulties in breathing
- fever with enlarged lymph nodes
- but also serious life threatening allergic conditions with cardiac and
circulatory arrest.

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Your doctor might decide to permanently stop treatment with Febuxostat
tablets.
There have been rare reports of potentially life-threatening skin rashes
(Stevens-Johnson- Syndrome) with the use of Febuxostat tablets, appearing
initially as reddish target-like spots or circular patches often with central
blister on the trunk. It may also include ulcers in the mouth, throat, nose,
genitals and conjunctivitis (red and swollen eyes). The rash may progress to
widespread blistering or peeling of the skin. If you have developed
Stevens-Johnson-Syndrome with the use of febuxostat, you must not be
restarted on Febuxostat tablets at any time. If you developed a rash or
these skin symptoms, seek immediate advice from a doctor and tell that
you are taking this medicine.

If you are having a gout attack at the moment (a sudden onset of severe
pain, tenderness, redness, warmth and swelling in a joint), wait for the gout
attack to subside before first starting treatment with Febuxostat tablets.

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Febuxostat 80 mg film-coated tablets
Febuxostat 120 mg film-coated tablets

For some people, gout attacks may flare up when starting certain
medicines that control uric acid levels. Not everyone gets flares, but you
could get a flare-up even if you are taking Febuxostat tablets, and
especially during the first weeks or months of treatment. It is important to
keep taking Febuxostat tablets even if you have a flare, as Febuxostat
tablets are still working to lower uric acid. Over time, gout flares will occur
less often and be less painful if you keep taking Febuxostat tablets every
day.
Your doctor will often prescribe other medicines, if they are needed, to help
prevent or treat the symptoms of flares (such as pain and swelling in a
joint).
In patients with very high urate levels (e.g. those undergoing cancer
chemotherapy), treatment with uric acid-lowering medicines could lead to
the build-up of xanthine in the urinary tract, with possible stones, even
though this has not been observed in patients being treated with
Febuxostat tablets for Tumor Lysis Syndrome.
Your doctor may ask you to have blood tests to check that your liver is
working normally.
Children and adolescents
Do not give this medicine to children under the age of 18 because the
safety and efficacy have not been established.
Other medicines and Febuxostat tablets
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, including medicines obtained without a
prescription. It is especially important to tell your doctor or pharmacist if
you are taking medicines containing any of the following substances as
they may interact with Febuxostat tablets and your doctor may wish to
consider necessary measures:
• Mercaptopurine (used to treat cancer)
• Azathioprine (used to reduce immune response)
• Theophylline (used to treat asthma)
Pregnancy and breast-feeding
It is not known if Febuxostat tablets may harm your unborn child.
Febuxostat tablets should not be used during pregnancy. It is not known if
Febuxostat tablets may pass into human breast milk. You should not use
Febuxostat tablets if you are breast feeding, or if you are planning to
breastfeed.
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Be aware that you may experience dizziness, sleepiness, blurred vision and
numbness or tingling sensation during treatment and should not drive or
operate machines if affected.
Febuxostat tablets contain lactose
Febuxostat tablets contain lactose (a type of sugar). If you have been told
that you have an intolerance to some sugars contact your doctor before
taking this medicine.
contact your doctor before taking this medicine
3.

HOW TO TAKE FEBUXOSTAT TABLETS

Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.



The recommended dose is one tablet daily.
The tablets should be taken by mouth and can be taken with or
without food.

Gout
Febuxostat tablets are available as either an 80 mg tablet or a 120 mg
tablet. Your doctor will have prescribed the strength most suitable for you.
Continue to take Febuxostat tablets every day even when you are not
experiencing gout flare or attack.
Prevention and treatment of high uric acid levels in patients undergoing cancer
chemotherapy - Febuxostat 120 mg tablets
Febuxostat tablets are available as a 120 mg tablet. Start taking Febuxostat
tablets two days before chemotherapy and continue its use according to
your doctor’s advice. Usually treatment is short-term.
If you take more Febuxostat tablets than you should
In the event of an accidental overdose ask your doctor what to do, or
contact your nearest accident and emergency department.
If you forget to take Febuxostat tablets
If you miss a dose of Febuxostat tablets take it as soon as you remember

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Package leaflet: Information for the user

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If you stop taking Febuxostat tablets
Do not stop taking Febuxostat tablets without the advice of your doctor
even if you feel better. If you stop taking Febuxostat tablets your uric acid
levels may begin to rise and your symptoms may worsen due to the
formation of new crystals of urate in and around your joints and kidneys.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking this medicine and contact your doctor immediately or go to an
emergency department nearby if the following rare (may affect up to 1 in
1,000 people) side effects occur, because a serious allergic reaction might
follow:
• anaphylactic reactions, drug hypersensitivity (see also section 2
“Warnings and precautions”)
• potentially life-threatening skin rashes characterized by formation of
blisters and shedding of the skin and inner surfaces of body cavities,
e.g. mouth and genitals, painful ulcers in the mouth and/or genital
areas, accompanied by fever, sore throat and fatigue (StevensJohnson Syndrome/ Toxic Epidermal Necrolysis), or by enlarged lymph
nodes, liver enlargement, hepatitis (up to liver failure), raising of the
white-cells count in the blood (drug reaction with eosinophilia and
systemic symptoms- DRESS) (see section 2)
• generalised skin rashes
The common side effects (may affect up to 1 in 10 people) are:
• abnormal liver test results
• diarrhoea
• headache
• rash (including various types of rash, please see below under
“uncommon” and “rare” sections)
• nausea
• increase in gout symptoms
• localized swelling due to retention of fluids in tissues (oedema)
Other side effects which are not mentioned above are listed below.

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Uncommon side effects (may affect up to 1 in 100 people) are:
• decreased appetite, change in blood sugar levels (diabetes) of which a
symptom may be excessive thirst, increased blood fat levels, weight
increase
• loss of sex drive
• difficulty in sleeping, sleepiness
• dizziness, numbness, tingling, reduced or altered sensation
(hypoesthesia, hemiparesis or paraesthesia), altered or reduced
sense of taste (hyposmia)
• abnormal ECG heart tracing, irregular or rapid heartbeats, feeling your
heart beat (palpitation)
• hot flushes or flushing (e.g. redness of the face or neck), increased
blood pressure, bleeding (hemorrhage, seen only in patients taking
chemotherapy for blood disorders)
• cough, shortness of breath, chest discomfort or pain, inflammation of
nasal passage and/or throat (upper respiratory tract infection),
bronchitis
• dry mouth, abdominal pain/discomfort or wind, heartburn/
indigestion, constipation, more frequent passing of stools, vomiting,
stomach discomfort
• itching, hives, skin inflammation, skin discoloration, small red or
purple spot on the skin, small, flat red spots on the skin, flat, red
area on the skin that is covered with small confluent bumps, rash,
areas of redness and spots on the skin, other type of skin conditions
• muscle cramp, muscle weakness, pain/ache in muscles/joints,
bursitis or arthritis (inflammation of joints usually accompanied by
pain, swelling and/or stiffness), pain in extremity, back pain, muscle
spasm
• blood in the urine, abnormal frequent urination, abnormal urine tests
(increased level of proteins in the urine), a reduction in the ability of
the kidneys to function properly
• fatigue, chest pain, chest discomfort
• stones in the gallbladder or in bile ducts (cholelithiasis)
• increase in blood thyroid stimulating hormone (TSH) level
• changes in blood chemistry or amount of blood cells or platelets
(abnormal blood test results)
• kidney stones
• erectile difficulties
Rare side effects (may affect up to 1 in 1,000 people) are:
• muscle damage, a condition which on rare occasions can be serious.
It may cause muscle problems and particularly, if at the same time, you
feel unwell or have a high temperature it may be caused by an
abnormal muscle breakdown. Contact your doctor immediately if you
experience muscle pain, tenderness or weakness
• severe swelling of the deeper layers of the skin, especially around
the lips, eyes, genitals, hands, feet or tongue, with possible sudden
difficult breathing
• high fever in combination with measles-like skin rash, enlarged lymph
nodes, liver enlargement, hepatitis (up to liver failure), raising of the
white-cells count in the blood (leukocytosis, with or without


















eosinophilia)
reddening of the skin (erythema), rash in various types (e.g. itchy,
with white spots, with blisters, with blisters containing pus, with
shedding of the skin, measles-like rash), widespread erythema,
necrosis, and bullous detachment of the epidermis and mucous
membranes, resulting in exfoliation and possible sepsis
(Stevens-Johnson Syndrome/Toxic epidermal necrolysis)
nervousness
feeling thirsty
ringing in the ears
blurred vision, change in vision
hair loss
mouth ulceration
inflammation of the pancreas: common symptoms are abdominal
pain, nausea and vomiting
increased sweating
weight decrease, increased appetite, uncontrolled loss of appetite
(anorexia)
muscle and/or joint stiffness
abnormally low blood cell counts (white or red blood cells or
platelets)
urgent need to urinate
changes or decrease in urine amount due to inflammation in the
kidneys (tubulointerstitial nephritis)
inflammation of the liver (hepatitis)
yellowing of the skin (jaundice)
liver damage

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5.

HOW TO STORE FEBUXOSTAT TABLETS




Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton and the tablet blister foil after ‘EXP.’ The expiry date refers to the
last day of that month.
This medicine does not require any special storage conditions.



Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Febuxostat tablets contain
The active substance is febuxostat.
Each tablet contains 80 mg or 120 mg of febuxostat.
The other ingredients are:
Tablet core: lactose monohydrate, cellulose, microcrystalline,
croscarmellose sodium, hydroxypropylcellulose, poloxamer 407, silica,
colloidal anhydrous, magnesium stearate
Film-coating: Opadry II yellow, containing: polyvinyl alcohol – part.
hydrolyzed, titanium dioxide (E171), macrogol/polyethyleneglycol,
talc, iron oxide yellow (E172)
What Febuxostat tablets look like and contents of the pack
Febuxostat film-coated tablets are yellow, oblong biconvex film-coated
tablets. The 80 mg film-coated tablets are marked on one side with ‘80’.
The 120 mg film-coated tablets are marked on one side with ‘120’.
Febuxostat 80 mg and 120 mg tablets are packed in PVC/PVDC –Aluminium
blister of 14 tablets.
Febuxostat 80 mg and 120 mg tablets are available in packs containing 28
and 84 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Rivopharm UK Ltd.
30th Floor, 40 Bank Street, Canary Wharf
London, E14 5NR
United Kingdom
Manufacturer
Bluepharma Indústria Farmacêutica, S.A.
S. Martinho do Bispo
3045-016 Coimbra
Portugal
This leaflet was last revised in 06/2017

R/MA/0070-0071/PIL/001

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unless it is almost time for your next dose, in which case miss out the
forgotten dose and take your next dose at the normal time. Do not take a
double dose to make up for a forgotten dose.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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