Patient Information Leaflet: Information for the User

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

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Never give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Febuxostat Aurobindo is and what it is used for
What you need to know before taking Febuxostat Aurobindo
How to take Febuxostat Aurobindo
Possible side effects
How to store Febuxostat Aurobindo
Contents of the pack and other information

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

Febuxostat Aurobindo tablets contain the active substance febuxostat and are 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 accumulating in the blood may become too high to remain dissolved. In this case, urate crystals may
form within and around joints and kidneys. These crystals can cause sudden, severe pain, redness, warmth, and swelling in a joint (gout attack). If left untreated, larger deposits called tophi may form
within and around joints. Tophi can damage joints and bones.
Febuxostat Aurobindo works by reducing uric acid levels. Maintaining low uric acid levels by taking
Febuxostat Aurobindo once daily prevents the accumulation of crystals and, over time, helps reduce symptoms. If uric acid levels are kept low for a sufficiently long period, tophi may even gradually resolve.
Febuxostat Aurobindo 120 mg tablets are also used to treat and prevent high blood levels of uric acid that
may occur during chemotherapy for blood cancers.
During chemotherapy, cancer cells are destroyed and uric acid levels in the blood rise, unless the formation of this acid is prevented.
Febuxostat Aurobindo is for use in adults.

2. What you need to know before taking Febuxostat Aurobindo

Do not take Febuxostat Aurobindo:

If you are allergic to febuxostat or to 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 have or have had heart failure, heart problems, or a 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 thyroid problems.

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

Skin rash, including severe forms (e.g. blisters, nodules, itchy rash, exfoliative rash), itching;
Swelling of limbs or face;
Difficulty breathing;
Fever with swollen lymph nodes;
Or even severe, life-threatening allergic conditions with cardiac and circulatory arrest. Your doctor may decide to permanently discontinue treatment with Febuxostat Aurobindo.

Rare, life-threatening skin reactions (Stevens-Johnson syndrome) have been reported with the use of Febuxostat Aurobindo, initially appearing on the trunk as reddish spots or circular lesions, often with central blisters. These may also include mouth, throat, nose, genital ulcers, and conjunctivitis (red and swollen eyes). The rash may progress to widespread blistering or skin peeling.
If you have developed Stevens-Johnson syndrome while taking febuxostat, treatment with Febuxostat Aurobindo must not be restarted. If you develop a rash or these skin symptoms, contact your doctor immediately and inform them that you are being treated with this medicine.
If you are currently experiencing a gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling in a joint), wait until the gout attack has resolved before starting treatment with Febuxostat Aurobindo.
In some people, gout attacks may recur at the beginning of certain treatments used to control uric acid levels. Not everyone experiences recurrences, but you may still have a flare-up even while taking Febuxostat Aurobindo, especially during the first weeks or months of treatment. It is important that you continue taking Febuxostat Aurobindo even during a flare-up, as it continues to work to lower uric acid levels. If you continue taking Febuxostat Aurobindo daily, flare-ups will become less frequent and less painful over time.
Your doctor may prescribe additional medicines, if needed, to help prevent or treat flare-up symptoms (such as pain and swelling in a joint).
In patients with very high urate levels (e.g. patients undergoing chemotherapy), treatment with medicines that lower uric acid levels may lead to xanthine accumulation in the urinary tract, potentially causing kidney stones, although this has not been observed in patients treated with Febuxostat Aurobindo for Tumor Lysis Syndrome.
Your doctor may order blood tests to monitor your liver function.
Children and adolescents
Do not administer this medicine to children under 18 years of age, as safety and efficacy have not been established.
Other medicines and Febuxostat Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
It is very important that you inform your doctor or pharmacist if you are taking a medicine containing any of the following substances, as they may interact with Febuxostat Aurobindo and your doctor may consider appropriate measures:

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

Pregnancy and breastfeeding
It is not known whether Febuxostat Aurobindo may harm the unborn baby. Febuxostat Aurobindo must not be used during pregnancy. It is not known whether Febuxostat Aurobindo passes into breast milk. You must not take Febuxostat Aurobindo if you are breastfeeding or planning to breastfeed.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Be aware that you may experience dizziness, drowsiness, blurred vision, numbness, or tingling during treatment; if so, do not drive or operate machinery.
Febuxostat Aurobindo contains lactose
If your doctor has diagnosed you with an 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 80 mg or 120 mg film-coated tablet, i.e. it is essentially 'sodium-free'.

3. How to take Febuxostat Aurobindo

Always take this medicine exactly as instructed by your doctor. If you have any doubts, you must consult your doctor or pharmacist.

The usual dose is one tablet per day.
The tablets should be taken orally and can be taken with or without food.

Gout
Febuxostat Aurobindo is available as 80 mg or 120 mg tablets. Your doctor will prescribe the dosage most suitable for you.
Continue taking Febuxostat Aurobindo every day, even in the absence of flare-ups or a gout attack.

Prevention and treatment of high uric acid levels in patients undergoing chemotherapy
Febuxostat Aurobindo is available as 120 mg tablets.
Start taking Febuxostat Aurobindo two days before chemotherapy begins and continue taking it as advised by your doctor. Usually, treatment is short-term.

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

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 the forgotten dose.

If you stop taking Febuxostat Aurobindo
Do not stop treatment with Febuxostat Aurobindo without consulting your doctor, even if you feel better. If you stop taking Febuxostat Aurobindo, your uric acid levels may start to rise again, and your symptoms may worsen due to the formation of new urate crystals in and around your joints and kidneys.

If you have any questions about how to use this medicine, consult 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 department if you experience any of the following rare side effects (may affect up to 1 in 1,000 people), as they could lead to a severe allergic reaction:

anaphylactic reactions, hypersensitivity to the drug (see also section 2 “Warnings and Precautions”);
life-threatening skin rashes characterized by blistering and peeling of the skin and internal body surfaces, 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 swollen lymph nodes, enlarged liver, hepatitis (up to liver failure), increased white blood cell count (Drug Reaction with Eosinophilia and Systemic Symptoms - DRESS) (see section 2);
generalized skin rash.

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

abnormalities in liver function tests;
diarrhoea;
headache;
rash (including various types of skin eruptions, see below in the sections “uncommon” and “rare”);
nausea;
worsening of gout symptoms;
localized swelling due to fluid retention in tissues (oedema).
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 paraesthesia), reduced or altered sense of taste (hypogeusia);
abnormalities in ECG tracings, irregular or rapid heartbeat, awareness of heartbeat (palpitations);
hot flushes or redness (e.g. redness of face or neck), increased blood pressure, bleeding (haemorrhage, observed only in patients undergoing chemotherapy for blood disorders);
cough, shortness of breath, chest pain, inflammation of nasal passage and/or throat (respiratory tract infection), bronchitis;
dry mouth, abdominal pain or discomfort, excess intestinal gas, heartburn/dyspepsia, constipation, more frequent defecation, vomiting, gastric discomfort;
itching, hives, skin inflammation, change in skin colour, small red or purple spots on the skin, small flat red spots on the skin, red area of skin covered with small confluent swellings, skin rashes, areas of redness and spots on the skin, other skin disorders;
muscle cramps, muscle weakness, muscle or joint pain, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), limb pain, back pain, muscle spasms;
blood in urine, increased frequency of urination, abnormalities in urine test results (increased levels of protein in urine), reduced kidney function;
fatigue, chest pain, chest discomfort;
gallstones or bile duct stones (cholelithiasis);
increased blood levels of thyroid-stimulating hormone (TSH);
changes in blood biochemical test values or red blood cell or platelet count (abnormal blood test results);
kidney stones;
difficulty achieving erection.

Rare side effects (may affect up to 1 in 1,000 people) are:

muscle damage, a condition which in rare cases may be serious. Muscle problems may develop and, in particular, if you also feel unwell or have high fever, this could be a consequence of abnormal breakdown of muscle cells. Contact your doctor immediately if you experience muscle pain, tenderness or weakness;
marked swelling of deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet or tongue, possibly causing sudden difficulty in breathing;
high fever associated with measles-like skin rash, swollen lymph nodes, enlarged liver, hepatitis (up to liver failure), increased white blood cell count (leucocytosis, with or without eosinophilia);
skin redness (erythema), skin eruptions of various types (e.g. itching, white spots, blisters, pustule-containing blisters, skin peeling, measles-like rash), widespread erythema, necrosis and blistering detachment of the epidermis and mucous membranes, leading to 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, uncontrolled loss of appetite (anorexia);
muscle and/or joint stiffness;
abnormally low levels of blood cells (white blood cells, red blood cells or platelets);
urgency to urinate;
changes or decreased amount of urine due to kidney inflammation (tubulo-interstitial nephritis);
liver inflammation (hepatitis);
yellowing of the skin (jaundice);
liver damage;
increased blood levels of creatine phosphokinase (a marker of muscle damage);
sudden cardiac death.

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the carton and blister after "Exp". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Febuxostat Aurobindo contains
The active substance is febuxostat.
Each tablet contains 80 mg or 120 mg of febuxostat.
The other ingredients are:
Tablet core: monohydrate lactose, microcrystalline cellulose (grade 101), sodium croscarmellose,
hydroxypropylcellulose, microcrystalline cellulose (grade 102), anhydrous colloidal silica, magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

Description of the appearance of Febuxostat Aurobindo and the 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. 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. 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)

Manufacturers
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 European Economic Area countries under the following names:
Belgium: Febuxostat AB 80 mg/120 mg filmomhulde tabletten/comprimés pélliculés/Filmtabletten
Czech Republic: Febuxostat Aurovitas
France: Fébuxostat Arrow 80 mg/120 mg comprimé pelliculé
Germany: Febuxostat PUREN 80 mg/120 mg Filmtabletten
Italy: Febuxostat Aurobindo
Poland: Febuxostat Aurovitas
Portugal: Febuxostate Aurobindo
Romania: Febuxostat Aurobindo 80 mg/120 mg comprimate filmate
Spain: Febuxostat Aurovitas 80 mg/120 mg comprimidos recubiertos con película EFG