Febuxostat aurovitas

Package leaflet: Information for the user

Febuxostat Aurovitas, 80 mg, film-coated tablets
Febuxostat Aurovitas, 120 mg, film-coated tablets
Febuxostatum
Please read this leaflet carefully before 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 a specific individual. Do not give it to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Febuxostat Aurovitas is and what it is used for
2. Important information before taking Febuxostat Aurovitas
3. How to take Febuxostat Aurovitas
4. Possible side effects
5. How to store Febuxostat Aurovitas
6. Contents of the pack and other information

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

Febuxostat Aurovitas tablets contain the active substance febuxostat and are used to treat
gout, a condition associated with excess of a chemical substance called uric acid (urate) in the
body. In some people, the level of uric acid in the blood increases and may become too high for the
substance to remain dissolved. In such cases, urate crystals may form inside and around joints and
kidneys. These crystals can cause sudden, severe pain, redness, warmth and swelling of a joint
(called a gout attack). If the disease is left untreated, larger deposits called tophi may form inside
and around the joints. Tophi may cause joint and bone damage.
Febuxostat Aurovitas works by reducing the level of uric acid. Maintaining a low uric acid level by
taking Febuxostat Aurovitas once daily stops the formation of crystals and over time reduces
symptoms. Maintaining sufficiently low uric acid levels for a long enough period may also lead to a
reduction in tophi.
Febuxostat Aurovitas 120 mg tablets are also used to treat and prevent high levels of uric acid in the
blood that may occur when starting chemotherapy for blood cancer. When chemotherapy is used,
cancer cells are destroyed and the level of uric acid in the blood increases accordingly, unless the
formation of uric acid is prevented.
Febuxostat Aurovitas is intended for use in adults.

2. Important information before taking Febuxostat Aurovitas
When not to take Febuxostat Aurovitas

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

Warnings and precautions
Before starting Febuxostat Aurovitas, talk to your doctor:

• if you have or have had heart failure, heart disease or stroke;
• if you currently have or have had kidney disease and (or) severe allergic reactions to allopurinol (a medicine used to treat gout);
• if you currently have or have had liver disease or abnormal liver function test results;
• if you are being treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare inherited disorder in which there is too much uric acid in the blood);
• if you have a thyroid disorder.

If you experience an allergic reaction to Febuxostat Aurovitas, you must stop taking this medicine
immediately (see also section 4).
Possible symptoms of an allergic reaction include:

• skin rash, including severe forms of rash (e.g. blisters, nodules, itchy, peeling rash), itching;
• swelling of limbs or face;
• difficulty breathing;
• fever and swollen lymph nodes;
• severe, life-threatening allergic reactions with cardiac arrest and circulatory collapse. Your doctor may decide to permanently discontinue treatment with Febuxostat Aurovitas.

Rare cases of potentially life-threatening skin rashes (Stevens-Johnson syndrome) have been reported
during treatment with Febuxostat Aurovitas, initially presenting as reddish, concentric or circular
patches, often with blisters, on the trunk. Symptoms may also include ulceration of the mouth, throat,
nose, genitals and conjunctivitis (redness and swelling around the eyes). The rash may spread and
cause peeling and detachment of the outer layer of skin.
If Stevens-Johnson syndrome occurs during treatment with Febuxostat Aurovitas, febuxostat therapy
must not be restarted. If a rash or the above-mentioned skin symptoms occur, contact your doctor
immediately and inform them that you are taking febuxostat.

If you are experiencing a gout attack (sudden onset of severe pain, tenderness, redness, warmth and
swelling of a joint): wait until the gout attack subsides before starting treatment with Febuxostat
Aurovitas.
In some people, gout attacks may worsen when starting treatment with certain medicines that
control uric acid levels. Flare-ups do not occur in everyone, but they may occur even if you are taking
Febuxostat Aurovitas, especially during the first weeks or months of treatment. It is important to
continue taking Febuxostat Aurovitas even if you have a flare-up, because Febuxostat Aurovitas still
reduces uric acid levels. Over time, gout attacks will occur less frequently and be less painful if
Febuxostat Aurovitas is taken daily.
Your doctor may often prescribe other medicines, if necessary, to help prevent or treat flare-up
symptoms (such as joint pain and swelling).
In patients who have very high uric acid levels (e.g. those undergoing chemotherapy), treatment with
medicines that lower uric acid levels may lead to xanthine accumulation in the urinary tract with a
risk of stone formation, although this has not been observed in patients treated with Febuxostat
Aurovitas due to tumour lysis syndrome.
Your doctor may recommend blood tests to check whether liver function is normal.
Children and adolescents
Do not use this medicine in children under 18 years of age, as efficacy and safety have not been
established.
Febuxostat Aurovitas and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those not requiring a prescription.
It is especially important to inform your doctor or pharmacist if you are taking medicines containing
any of the following substances, as they may interact with Febuxostat Aurovitas and your doctor may
consider taking necessary measures:

• mercaptopurine (used to treat cancer),
• azathioprine (used to reduce immune system response),
• theophylline (used to treat asthma).

Pregnancy, breastfeeding and fertility
It is not known whether Febuxostat Aurovitas may harm the unborn child. Febuxostat Aurovitas
should not be used during pregnancy. It is not known whether Febuxostat Aurovitas passes into
breast milk. Do not use Febuxostat Aurovitas if you are breastfeeding or planning to breastfeed.
If you are pregnant, breastfeeding, think you may be pregnant or are planning to have a child, you
should consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
Be aware that dizziness, drowsiness, blurred vision, and numbness or tingling may occur during
treatment. If you experience such symptoms, do not drive or operate machinery.
Febuxostat Aurovitas contains lactose
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking
this medicine.
Febuxostat Aurovitas contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 80 mg/120 mg film-coated tablet,
i.e. essentially "sodium-free".
3. How to take Febuxostat Aurovitas
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or
pharmacist.

• The usual dose is one tablet per day.
• Take the tablets orally; the medicine can be taken with or without food.

Gout
Febuxostat Aurovitas is available as 80 mg and 120 mg tablets. Your doctor will prescribe the most
appropriate dose for you.
Febuxostat Aurovitas should be taken daily, even if you do not have a flare-up or gout attack.
Prevention and treatment of high uric acid levels in patients undergoing chemotherapy due to
cancer.
Febuxostat Aurovitas is available as 120 mg tablets.
Treatment with Febuxostat Aurovitas should be started two days before chemotherapy and
continued as directed by your doctor. Treatment is usually short-term.
Taking more Febuxostat Aurovitas than prescribed
If you accidentally take too much medicine, consult your doctor or go to the nearest hospital
emergency department.
If you forget to take Febuxostat Aurovitas
If you miss a dose of Febuxostat Aurovitas, 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 usual time. Do
not take a double dose to make up for a missed dose.
Stopping Febuxostat Aurovitas
Do not stop taking Febuxostat Aurovitas without consulting your doctor, even if you feel better.
Stopping treatment with Febuxostat Aurovitas may cause uric acid levels to rise again, and symptoms
may worsen due to the formation of new urate crystals around or within joints and in the kidneys.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should stop taking this medicine and contact your doctor immediately or go to
the nearest emergency department if any of the following rare (occurring in 1 in 1,000
patients) adverse reactions occur, as they may lead to serious allergic reactions:

• anaphylactic reactions, hypersensitivity to the medicine (see also section 2 "Warnings and precautions");
• potentially life-threatening skin rashes characterized by blistering and skin peeling, including internal mucosal surfaces such as the oral cavity and genital organs, painful oral ulcers and (or) genital area ulcers, accompanied by fever, sore throat, and fatigue (Stevens-Johnson syndrome, toxic epidermal necrolysis) or swollen lymph nodes, liver enlargement, hepatitis (progressing to liver failure), increased white blood cell count (drug reaction with eosinophilia and systemic symptoms - DRESS) (see section 2);
• generalized skin rashes.

Common adverse effects (may occur in 1 in 10 people):

• abnormal liver function tests,
• diarrhoea,
• headache,
• rash (including various types of rashes, see below under "not very common" and "rare"),
• nausea,
• exacerbation of gout symptoms,
• localized swelling due to fluid accumulation in tissues (oedema),
• dizziness,
• dyspnoea,
• itching,
• limb pain, muscle or joint pain,
• fatigue.

Other adverse effects not listed above are listed below.
Not very common adverse effects (may occur in 1 in 100 people):

• decreased appetite, change in blood sugar concentration (diabetes), which may manifest as excessive thirst, increased blood lipid levels, weight gain;
• loss of libido;
• sleep disorders, somnolence;
• numbness, tingling, weakness, or altered touch sensation (hypoesthesia, paresis, or paraesthesia), taste disturbances, reduced sense of smell (hyposmia);
• abnormalities in ECG recording, irregular or rapid heartbeat, palpitations;
• hot flushes or skin redness (e.g. redness of face or neck), elevated blood pressure, bleeding (haemorrhage, observed only in patients receiving chemotherapy for blood disorders);
• cough, discomfort or pain in the chest, inflammation of nasal and (or) throat mucosa (upper respiratory tract infection), bronchitis, lower respiratory tract infection;
• dry mouth, abdominal pain or discomfort or flatulence, upper abdominal pain, heartburn or indigestion, constipation, increased frequency of bowel movements, vomiting, gastric discomfort;
• itchy rash, urticaria, dermatitis, skin discoloration, small red or purple spots on the skin, small flat red spots on the skin, flat red areas on the skin covered with small bumps, rash, local redness and skin spots, excessive sweating, night sweats, alopecia, skin redness (erythema), psoriasis, eruption, other types of skin disorders;
• muscle cramps, muscle weakness, tenosynovitis or arthritis (joint inflammation, usually accompanied by pain, swelling and (or) stiffness), back pain, muscle spasms, stiffness of muscles and (or) joints;
• blood in urine, abnormal frequent urination, abnormal urine test results (increased protein in urine), reduced kidney function, urinary tract infection;
• chest pain, discomfort in the chest;
• gallstones in the gallbladder or bile ducts (cholelithiasis);
• increased TSH concentration;
• changes in blood chemical composition or blood cell or platelet count (abnormal blood test results);
• nephrolithiasis;
• erectile dysfunction;
• hypothyroidism;
• blurred vision, change in vision;
• tinnitus;
• rhinitis;
• oral ulceration;
• pancreatitis: common symptoms include abdominal pain, nausea and vomiting;
• sudden urge to urinate;
• pain;
• malaise;
• increased INR;
• injury;
• lip oedema.

Rare adverse effects (may occur in 1 in 1,000 people):

• muscle injury, a condition which in isolated cases may be severe. Muscle-related disorders may occur, accompanied by malaise or high fever, caused by muscle damage. You should contact your doctor immediately if you experience muscle pain, tenderness or weakness;
• severe swelling of the deep layers of skin, particularly around the eyes, genital organs, hands, feet or tongue, possibly with sudden breathing difficulties;
• high fever with rash resembling measles, swollen lymph nodes, enlarged liver, hepatitis (progressing to liver failure), increased white blood cell count (leukocytosis with or without eosinophilia);
• various types of rashes (e.g. with white spots, blisters, pustular blisters, skin peeling, measles-like rash), widespread erythema, necrosis, blisters on skin and mucous membranes leading to separation and risk of sepsis (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• nervousness;
• feeling thirsty;
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia);
• abnormal low number of blood cells (white or red blood cells or platelets);
• changes in urine or reduced urine output related to kidney inflammation (tubulointerstitial nephritis);
• hepatitis;
• yellowing of the skin (jaundice);
• urinary bladder infection;
• liver damage;
• increased creatine phosphokinase activity in blood (a marker of muscle damage);
• sudden cardiovascular death;
• low number of red blood cells (anaemia);
• depression;
• sleep disorders;
• loss of smell;
• burning sensation;
• vestibular dizziness;
• circulatory collapse;
• lung infection (pneumonia);
• oral ulcers; oral inflammation;
• gastrointestinal tract perforation;
• rotator cuff syndrome;
• polymyalgia rheumatica;
• feeling of warmth;
• sudden loss of vision due to blockage of an artery in the eye.

If any adverse effects occur, you should consult your doctor or pharmacist.
This includes any possible adverse effects not listed in this leaflet.
Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible entity. Reporting adverse effects helps to collect more information on the safety of using the medicine.

5. How to store Febuxostat Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the stated month.
No special precautions for storage are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Febuxostat Aurovitas contains

• The active substance is febuxostat. Each film-coated tablet contains 80 mg or 120 mg of febuxostat (as febuxostat hemihydrate).
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose (Type 101), sodium croscarmellose, hydroxypropyl cellulose, microcrystalline cellulose (Type 102), colloidal anhydrous silica, magnesium stearate. Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide yellow (E 172).

What Febuxostat Aurovitas looks like and contents of the pack
Febuxostat Aurovitas, 80 mg, film-coated tablets
Pale yellow or yellow, biconvex, oval film-coated tablets, embossed on one side with the symbol "FEB" and "80" on the other side of the tablet. Tablet size: 14.7 mm x 8.7 mm.
Febuxostat Aurovitas, 120 mg, film-coated tablets
Pale yellow or yellow, biconvex, capsule-shaped film-coated tablets, embossed on one side with the symbol "FEB" and "120" on the other side of the tablet. Tablet size: 19.2 mm x 8.7 mm.
Febuxostat Aurovitas 80 mg and 120 mg is packed in transparent blisters containing 14, 28, 30, 42, 56, 84, and 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
Poland
Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France
This medicinal product is authorised for sale in the European Economic Area 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, comprimé pelliculé
FÉBUXOSTAT ARROW 120 mg, comprimé pelliculé
Germany: Febuxostat PUREN 80 mg/ 120 mg Filmtabletten
Italy: Febuxostat Aurobindo
Poland: Febuxostat Aurovitas
Portugal: Febuxostat Generis
Romania: Febuxostat Aurobindo 80 mg / 120 mg comprimate filmate
Spain: Febuxostat Aurovitas 80 mg / 120 mg comprimidos recubiertos con película EFG