FEBUXOSTAT 80 mg Film-Coated Tablets

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1. Febuxostat Aurobindo 80 mg film-coated tablets, 120 mg film-coated tablets
   1. What is Febuxostat Aurobindo and what it is used for
   2. What you need to know before taking Febuxostat Aurobindo
   3. How to take Febuxostat Aurobindo
   4. Possible side effects
   5. How to store Febuxostat Aurobindo
   6. Contents of the pack and other information

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

Generic medicine

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Febuxostat Aurobindo and what it is used for

Febuxostat Aurobindo tablets contain the active ingredient febuxostat and is used to treat gout, a
disease associated with an excess of uric acid (urate) in the body. In some people, the amount of uric
acid that accumulates in the blood can become too high to remain in solution. In this case,
crystals of urate can form inside and around the joints and kidneys. These crystals can
cause intense and sudden pain, redness, a feeling of heat and swelling in a
joint (gout attack). If left untreated, larger deposits, called tophi, can
form inside and around the joints. Tophi can damage the joints and bones.
Febuxostat Aurobindo works by reducing uric acid levels. Maintaining low levels of uric acid
by taking Febuxostat Aurobindo once a day prevents the accumulation of crystals, and over
time reduces symptoms. If uric acid levels are kept low for a sufficiently long time,
tophi can also be reabsorbed.
Febuxostat Aurobindo 120 mg tablets is also used for the treatment and prevention of high
blood levels of uric acid that can occur during chemotherapy for blood cancers.
During chemotherapy, cancer cells are destroyed and uric acid levels in the
blood increase, unless the formation of this acid can be prevented.
Febuxostat Aurobindo is for adults.

2. What you need to know before taking Febuxostat Aurobindo

Do not take Febuxostat Aurobindo:

• 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 Aurobindo:

• If you suffer from or have suffered from heart failure, heart problems or heart attack.
• If you have or have had kidney disease and/or severe allergic reactions to allopurinol (a medicine used to treat gout).
• If you have or have had liver disease or abnormal liver function tests.
• If you have high levels of uric acid due to Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood).
• If you have any problems with your thyroid.

If you experience allergic reactions to Febuxostat Aurobindo, stop taking the medicine (see also section 4).
Possible symptoms of allergic reactions may be:

• skin rash including severe forms (e.g. blisters, nodules, itchy rash, exfoliating rash), itching;
• swelling of the limbs or face;
• difficulty breathing;
• fever with enlarged lymph nodes;
• but also severe life-threatening allergic conditions with cardiac and circulatory arrest. Your doctor may decide to permanently discontinue treatment with Febuxostat Aurobindo.

Rare skin rashes (Stevens-Johnson syndrome) that put the patient's life at risk have been reported with the use of Febuxostat Aurobindo
which initially appeared on the trunk as reddish spots or circular spots often with central blisters. They may also include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). The rash may progress to widespread blisters or
skin shedding.
If you develop Stevens-Johnson syndrome with the use of febuxostat, treatment with Febuxostat
Aurobindo should no longer be resumed. If you develop a rash or these skin symptoms, consult
your doctor immediately and tell them that you are taking this medicine.
If you currently have a gout attack (sudden onset of intense pain, tenderness, redness,
warmth and swelling in a joint), wait for the gout attack to end before starting
therapy with Febuxostat Aurobindo.
In some people, gout attacks may worsen at the beginning of certain therapies used for
controlling uric acid levels. Not all people experience exacerbations, but you may
experience an exacerbation even when taking Febuxostat Aurobindo, especially during the first
weeks or months of therapy. It is important that you continue to take Febuxostat Aurobindo even in
the presence of an exacerbation, as Febuxostat Aurobindo continues to work to lower uric acid levels.
If you continue to take Febuxostat Aurobindo every day, over time, the
exacerbations will occur less frequently and will be less painful.
Your doctor will often prescribe other medicines, if necessary, to help prevent or treat the symptoms
of exacerbations (such as pain and swelling in a joint).
In patients with very high uric acid levels (e.g. patients undergoing chemotherapy), treatment with drugs
that lower uric acid levels may cause xanthine to accumulate in the urinary tract with possible
formation of stones, although this has not been observed in patients treated with Febuxostat Aurobindo for
Tumor Lysis Syndrome.
Your doctor may prescribe blood tests to check that your liver is functioning normally.

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

Other medicines and Febuxostat Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.
It is very important that you tell your doctor or pharmacist if you are taking a medicine that contains
any of the following substances, as these may interact with Febuxostat Aurobindo and your doctor
may want to take appropriate measures:

• Mercaptopurine (used to treat cancer).
• Azathioprine (used to reduce the immune response).
• Theophylline (used to treat asthma).

Pregnancy and breastfeeding
It is not known whether Febuxostat Aurobindo can harm the fetus. Febuxostat Aurobindo should not be
used during pregnancy. It is not known whether Febuxostat Aurobindo passes into breast milk. Do not
take Febuxostat Aurobindo if you are breastfeeding or intend to do so.
If you are pregnant, suspect or are planning a pregnancy, or are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Be aware that you may experience dizziness, drowsiness, blurred vision, numbness or
tingling during treatment and in such cases, if you experience these symptoms, you should not drive vehicles or
use machines.

Febuxostat Aurobindo contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this
medicine.

Febuxostat Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet of 80 mg or
120 mg, i.e. it is essentially ‘sodium-free’.

3. How to take Febuxostat Aurobindo

Always take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.

• The usual dose is one tablet a day. .
• The tablets must be taken by mouth and can be taken with or without food.

Gout
Febuxostat Aurobindo is available in 80 mg or 120 mg tablets. Your doctor will prescribe the dosage most
suitable for you.
Continue to take Febuxostat Aurobindo every day, even if you do not have flares or a gout
attack.

Prevention and treatment of high uric acid levels in patients undergoing chemotherapy
Febuxostat Aurobindo is available in 120 mg tablets.
Start taking Febuxostat Aurobindo two days before chemotherapy and continue to take it according to
your doctor's advice. Usually the use is short-term.

If you take more Febuxostat Aurobindo than you should
In case of accidental overdose, contact your doctor for advice or go to the nearest emergency
room.

If you forget to take Febuxostat Aurobindo
If you forget to take a dose of Febuxostat Aurobindo, take it as soon as you remember, unless
it is almost time for your next dose. In that case, skip the missed dose and take the
next dose at the scheduled time. Do not take a double dose to make up for a missed
dose.

If you stop taking Febuxostat Aurobindo
Do not stop taking Febuxostat Aurobindo without your doctor's consent, even if you feel
better. If you stop taking Febuxostat Aurobindo, your uric acid levels may start to rise and your symptoms may worsen due to the formation of new urate crystals inside and
around your joints and kidneys.
If you have any questions about the use of the 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 the medicine and contact your doctor immediately or go to the nearest emergency room
if you experience the following rare side effects (may affect up to 1 in 1,000 people),
as a severe allergic reaction may follow:

• anaphylactic reactions, hypersensitivity to the drug (see also section 2 “Warnings and Precautions”);
• skin rashes that can be life-threatening, characterized by blister formation and peeling of the skin and internal surfaces of body cavities, such as the mouth and genitals, painful sores in the mouth and/or genitals, accompanied by fever, sore throat and fatigue (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis), or enlarged lymph nodes, enlarged liver, hepatitis (up to hepatic failure), increased white blood cell count (Drug Reaction with Eosinophilia and Systemic Symptoms-DRESS) (see section 2);
• widespread rash.

Common side effects(may affect up to 1 in 10 people) are:

• abnormalities in liver function tests;
• diarrhea;
• headache;
• rash (including various types of skin eruptions, see below in the “uncommon” and “rare” sections);
• nausea;
• increased gout symptoms;
• localized swelling due to fluid retention in the tissues (edema). Other side effects not mentioned above are listed below.

Uncommon side effects(may affect up to 1 in 100 people) are:

• decreased appetite, changes in blood sugar levels (diabetes), one symptom of which may be excessive thirst, increased levels of fats in the blood, weight gain;
• loss of sexual desire;
• difficulty sleeping, drowsiness;
• dizziness, numbness, tingling, reduced or altered sense of touch (hypoesthesia, hemiparesis or paresthesia), reduced or altered sense of taste (hyposmia);
• abnormalities in ECG tracings, irregular or rapid heartbeat, perception of heartbeat (palpitations);
• hot flashes or redness (e.g. flushing of the face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients undergoing chemotherapy for blood disorders);
• cough, shortness of breath, chest pain, inflammation of the nasal passage and/or throat (upper respiratory tract infection), bronchitis;
• dry mouth, abdominal pain or discomfort, excessive intestinal gas, heartburn/indigestion, constipation, more frequent bowel movements, vomiting, gastric discomfort;
• itching, hives, skin inflammation, changes in skin color, small red spots

or purple spots on the skin, small flat red spots on the skin, a red area on the skin covered with small
confluent bumps, skin eruptions, areas of redness and spots on the skin, other skin disorders;

• muscle cramps, muscle weakness, muscle pain or joint pain, bursitis or arthritis (inflammation of the joints usually accompanied by pain, swelling and/or stiffness), pain in the extremities, back pain, muscle spasms;
• blood in the urine, increased frequency of urination, abnormalities in urine tests (increased levels of protein in the urine), decreased ability of the kidneys to function properly;
• fatigue, chest pain, chest discomfort;
• gallstones or bile duct stones (cholelithiasis);
• increased levels in the blood of thyroid-stimulating hormone (TSH);
• changes in biochemical blood tests or red blood cell or platelet counts (alteration of blood test results);
• kidney stones;
• difficulty achieving an erection. Rare side effects(may affect up to 1 in 1,000 people) are:
• muscle damage, a condition that can occasionally be severe. Muscle problems may develop, and in particular, if you simultaneously do not feel well or have a high fever, this could be a consequence of an abnormal breakdown of muscle cells. Contact your doctor immediately if you experience muscle pain, soreness or weakness;
• marked swelling of the deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet or tongue, with possible sudden difficulty breathing;
• high fever associated with measles-like rash, enlarged lymph nodes, enlarged liver, hepatitis (up to hepatic failure), increased white blood cell count (leukocytosis, associated or not with eosinophilia);
• redness of the skin (erythema), rash in various types (e.g. itching, with white spots, with blisters, with blisters containing pus, with peeling of the skin, measles-like rash), widespread erythema, necrosis and blistering detachment of the epidermis and mucous membranes, resulting in exfoliation and possible sepsis (Stevens-Johnson Syndrome/toxic epidermal necrolysis);
• nervousness;
• thirst;
• 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 loss, increased appetite, loss of appetite (anorexia);
• muscle and/or joint stiffness;
• abnormally low level of blood cells (white blood cells, red blood cells or platelets);
• urgent need to urinate;
• changes or decrease in amount in urine due to inflammation in the kidneys (tubulo-interstitial nephritis);
• inflammation of the liver (hepatitis);
• jaundice (yellowing of the skin);
• liver damage;
• increased level of creatine phosphokinase in the blood (an indicator of muscle damage);
• sudden cardiac death.

If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Febuxostat Aurobindo

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 package and on the blister after “Exp”. The expiry
date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Febuxostat Aurobindo contains
The active ingredient is febuxostat.
Each tablet contains 80 mg or 120 mg of febuxostat.
The other excipients are:

Tablet core: lactose monohydrate, microcrystalline cellulose (grade 101), croscarmellose sodium,
hydroxypropylcellulose, microcrystalline cellulose (grade 102), anhydrous colloidal silicon dioxide, magnesium stearate.

Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172).

Description of the appearance of Febuxostat Aurobindo and contents of the pack

Febuxostat Aurobindo 80 mg film-coated tablets
Film-coated tablets, light yellow to yellow in colour, oval shaped, biconvex with “FEB” imprinted on one side and “80” on the other side. The dimensions are 14.7 mm x 8.7 mm.

Febuxostat Aurobindo 120 mg film-coated tablets
Film-coated tablets, yellow to light yellow in colour, capsule shaped, with “FEB” imprinted on one side and “120” on the other side. The dimensions are 19.2 mm x 8.7 mm.
Febuxostat Aurobindo 80 mg and 120 mg is available in blister packs containing 14, 28, 30, 42, 56, 84 and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 – 21047, Saronno (VA)

Manufacturer
APL Swift Services (Malta) Ltd, HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia BBG 3000 - Malta
Generis Farmacêutica, S.A., Rua João de Deus, 19, Amadora, 2700-487 - Portugal
Arrow Génériques-Lyon, 26 avenue Tony Garnier, Lyon, 69007 - France

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Belgium: Febuxostat AB 80 mg/120 mg film-coated tablets/comprimés
pélliculés/Filmtabletten
Czech Republic: Febuxostat Aurovitas
France: Fébuxostat Arrow 80 mg/120 mg film-coated tablet
Germany: Febuxostat PUREN 80 mg/120 mg Filmtabletten
Italy: Febuxostat Aurobindo
Poland: Febuxostat Aurovitas
Portugal: Febuxostate Aurobindo
Romania: Febuxostat Aurobindo 80 mg/120 mg film-coated tablets
Spain: Febuxostat Aurovitas 80 mg/120 mg film-coated tablets EFG