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FEBUXOSTAT DR. REDDYS 120 MG FILM-COATED TABLETS

Active substance(s): FEBUXOSTAT HEMIHYDRATE / FEBUXOSTAT HEMIHYDRATE

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165 mm

Package leaflet: Information for the user
36 mm

Febuxostat 80 mg Film-Coated Tablets
Febuxostat 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.

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, and especially during the
first weeks or months of treatment. It is
important to keep taking Febuxostat even if
you have a flare, as Febuxostat is still
working to lower uric acid. Over time, gout
flares will occur less often and be less painful
if you keep taking Febuxostat every day.

What is in this leaflet
1. What Febuxostat is and what it is used for
2. What you need to know before you take
Febuxostat
3. How to take Febuxostat
4. Possible side effects
5. How to store Febuxostat
6. Contents of the pack and other information

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 for Tumor Lysis Syndrome.

1. What Febuxostat is and what it is
used for

Your doctor may ask you to have blood tests
to check that your liver is working normally.

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.

Children and adolescents
Do not give this medicine to children under
the age of 18 because the safety and
efficacy have not been established.

Febuxostat works by reducing uric acid
levels. Keeping uric acid levels low by taking
Febuxostat 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 is for adults.
2. What you need to know before you
take Febuxostat
Do not take Febuxostat:
• if you are allergic to febuxostat or any of
the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor before taking Febuxostat:
• 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, 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.
Your doctor might decide to permanently
stop treatment with Febuxostat.
There have been rare reports of potentially
life-threatening skin rashes (Stevens-Johnson
Syndrome) with the use of febuxostat,
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 re-started on Febuxostat at any
time. If you developed a rash or these skin
symptoms, seek immediate advice from a
doctor and tell them 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.

Other medicines and Febuxostat
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
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 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 may harm your
unborn child. Febuxostat should not be used
during pregnancy. It is not known if Febuxostat
may pass into human breast milk. You should
not use Febuxostat 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 by your doctor
that you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.
3. How to take Febuxostat
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
• The recommended dose is one tablet daily.
The back of the blister pack is marked with
the days of the week to help you check
that you have taken a dose each day.
• The tablets should be taken with or
without food.
Gout
Febuxostat is 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 every day even
when you are not experiencing gout flare or
attack.
Febuxostat 120 mg:
Prevention and treatment of high uric acid
levels in patients undergoing cancer
chemotherapy
Febuxostat is available as a 120 mg tablet.
Start taking Febuxostat two days before
chemotherapy and continue its use according
to your doctor’s advice. Usually treatment is
short-term.
If you take more Febuxostat 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
If you miss a dose of Febuxostat take it as
soon as you remember 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.
If you stop taking Febuxostat
Do not stop taking Febuxostat without the advice
of your doctor even if you feel better. If you stop
taking Febuxostat 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.

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Febuxostat 120 mg:
Febuxostat 120 mg film-coated 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.

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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).

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4. Possible side effects

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
(Stevens-Johnson 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
Common side effects (may affect up to
1 in 10 people):
• 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)

Uncommon side effects (may affect up to
1 in 100 people):
• 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):
• 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
increased level of creatine phosphokinase
in blood (an indicator of muscle damage)

If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
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 the 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
• 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
blister after EXP. The expiry date refers to
the last day of that month.
• This medicinal product 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.
Febuxostat 80 mg film-coated tablets:
Each film-coated tablet contains 80 mg
febuxostat (as febuxostat hemihydrate).
Febuxostat 120 mg film-coated tablets:
Each film-coated tablet contains 120 mg
febuxostat (as febuxostat hemihydrate).
- The other ingredients are:
Tablet core: lactose monohydrate,
cellulose, microcrystalline (E460),
hydroxypropylcellulose (E463),
croscarmellose sodium, silica, colloidal
anhydrous (E551), magnesium stearate
(E470b).
Film-coating: poly (vinyl alcohol) (E1203),
talc (E553b), titanium dioxide (E171),
macrogol 3350 (E1521), methacrylic acid ethyl acrylate copolymer (1:1) (Type A),
iron oxide yellow (E172), sodium hydrogen
carbonate (E500(ii)).
What Febuxostat tablets look like and
contents of the pack
Febuxostat 80 mg film-coated tablets: Pale
yellow to yellow, film-coated, capsule shaped
tablets, engraved with “80” on one side and
plain on the other, with dimensions 16.5 mm
x 7.0 mm ± 5%.
Febuxostat 120 mg film-coated tablet: Pale
yellow to yellow, film-coated, capsule shaped
tablets, engraved with “120” on one side and
plain on the other, with dimensions 18.5 mm
x 9.0 mm ± 5%.
Febuxostat 80 mg and 120 mg film-coated
tablets are packed in
Aluminium-OPA/Alu/PVC or Aluminium-PVC/
PE/PVDC blisters.
Febuxostat 80 mg and 120 mg are available
in packs containing 7, 14, 28, 30, 42, 56, 80
and 84 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dr. Reddy’s Laboratories (UK) Ltd.,
6 Riverview Road, Beverley, East Yorkshire,
HU17 0LD, United Kingdom
Manufacturer
Rontis Hellas Medical and Pharmaceutical
Products S.A., P.O. Box 3012 Larisa
Industrial Area, Larisa, 41004, Greece
This leaflet was last revised in 06/2017

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60 mm

Other side effects which are not mentioned
above are listed below.









36 mm

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

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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