Febuxostat Aurovitas

Package Leaflet: Information for the Patient

Febuxostat Aurovitas, 80 mg, Film-Coated Tablets

Febuxostat Aurovitas, 120 mg, Film-Coated Tablets

Febuxostat

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

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

Febuxostat Aurovitas tablets contain the active substance febuxostat and are used to treat gout, which is associated with an excess of a chemical compound called uric acid (urate) in the body. In some people, the amount of uric acid in the blood increases and can become too high to remain dissolved. In such cases, urate crystals can form inside and around the joints and kidneys. The resulting crystals can cause sudden, severe pain, redness, warmth, and swelling of the joint (so-called gout attack). If the disease is untreated, larger deposits called tophi can form inside and around the joints. Tophi can cause joint and bone damage. Febuxostat Aurovitas works by reducing uric acid levels. Maintaining low uric acid levels by taking Febuxostat Aurovitas once daily prevents the formation of crystals and over time reduces symptoms. Maintaining sufficiently low uric acid levels for a long enough period can also lead to a reduction in tophi. Febuxostat Aurovitas 120 mg tablets are also used to treat and prevent high uric acid levels in the blood that can occur when starting chemotherapy for blood cancer. When chemotherapy is used, cancer cells are destroyed, and uric acid levels in the blood increase unless uric acid production 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Febuxostat Aurovitas, tell your doctor:

• if you have or have had heart failure, heart disease, or stroke;
• if you currently have or have had kidney or liver disease, 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 tests;
• if you are being treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare inherited disease in which there is too much uric acid in the blood);
• if you have thyroid disease.

If you experience an allergic reaction to Febuxostat Aurovitas, stop taking this medicine immediately and contact your doctor or pharmacist (see also section 4). Possible symptoms of an allergic reaction are:

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

Rare cases of potentially life-threatening skin rashes (Stevens-Johnson syndrome) have been reported with the use of Febuxostat Aurovitas, initially appearing as red, concentric patches or circular patches often with blisters on the trunk. Symptoms may also include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling around the eyes). The rash may spread and cause skin peeling and separation. If you experience Stevens-Johnson syndrome while taking Febuxostat Aurovitas, do not restart treatment with febuxostat. If a rash or the above skin symptoms occur, contact your doctor immediately and inform them that you are taking febuxostat. If you have a gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling of the joint): before starting treatment with Febuxostat Aurovitas, wait until the attack has subsided. In some people, gout attacks may worsen when starting treatment with certain uric acid-lowering medicines. Worsening may not occur in everyone, but it may occur, even if you are taking Febuxostat Aurovitas, especially during the first few weeks or months of treatment. It is essential to continue taking Febuxostat Aurovitas even if you experience worsening, as Febuxostat Aurovitas is still lowering uric acid levels. Over time, gout attacks will become less frequent and less painful if Febuxostat Aurovitas is taken daily. Your doctor may prescribe other medicines if necessary to help prevent or treat worsening symptoms (such as pain and swelling of the joint). In patients with very high uric acid levels (e.g., those undergoing chemotherapy for blood cancer), treatment with uric acid-lowering medicines may lead to the accumulation of xanthine in the urinary tract, with the possibility of stone formation, although this has not been observed in patients treated with Febuxostat Aurovitas due to tumor lysis syndrome. Your doctor may recommend blood tests to check if your liver is working properly.

Children and adolescents

Do not use this medicine in children under 18 years of age, as the safety and efficacy of febuxostat have not been established.

Febuxostat Aurovitas and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription. It is particularly 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 need to take necessary measures:

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

Pregnancy, breastfeeding, and fertility

It is not known whether Febuxostat Aurovitas can harm an unborn baby. 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 plan to breastfeed. If you are pregnant or breastfeeding, 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

Remember that during treatment, dizziness, drowsiness, blurred vision, and numbness or tingling may occur. If you experience these symptoms, do not drive or operate machinery.

Febuxostat Aurovitas contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Febuxostat Aurovitas contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 80 mg/120 mg film-coated tablet, which is essentially 'sodium-free'.

3. How to take Febuxostat Aurovitas

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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 suitable dose for you. Take Febuxostat Aurovitas once daily, even if you do not have a gout attack. Prevention and treatment of high uric acid levels in patients undergoing chemotherapy for cancer. Febuxostat Aurovitas is available as 120 mg tablets. Start taking Febuxostat Aurovitas two days before chemotherapy and continue as directed by your doctor. Treatment is usually short-term.

Overdose of Febuxostat Aurovitas

If you accidentally take too much, ask your doctor for advice or contact the nearest hospital emergency department.

Missed dose of Febuxostat Aurovitas

If you miss a dose, take it as soon as you remember, unless it is time for your next dose, in which case skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for a missed dose.

Stopping treatment with 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 in the joints and kidneys. If you have any further questions on the use of this product, 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 or go to the nearest emergency department immediately if you experience the following rare (affecting 1 in 1000 people) side effects, as they can 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 peeling of the skin and mucous membranes (e.g., mouth, genitals) with possible systemic involvement (Stevens-Johnson syndrome, toxic epidermal necrolysis) or lymph node enlargement, liver enlargement, hepatitis (up to liver failure), increased white blood cell count (drug reaction with eosinophilia and systemic symptoms - DRESS) (see section 2);
• generalized skin rashes.

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

• abnormal liver function tests,
• diarrhea,
• headache,
• rash (including various types of rash, see below "uncommon" and "rare"),
• nausea,
• worsening of gout symptoms,
• localized swelling due to fluid accumulation in tissues (edema),
• dizziness,
• shortness of breath,
• itching,
• limb pain, muscle pain, or joint pain
• fatigue.

Other side effects not listed above are listed below.
Uncommon side effects(may affect up to 1 in 100 people):

• decreased appetite, changes in blood sugar levels (diabetes), which may cause excessive thirst, increased fat levels in the blood, weight gain;
• decreased sex drive;
• sleep disturbances, drowsiness;
• numbness, tingling, weakness, or changes in touch sensation (hypoesthesia, paresis, or paresthesia), taste disturbances, decreased sense of smell (hyposmia);
• abnormal ECG, irregular or rapid heartbeat, palpitations;
• hot flashes or flushing of the skin (e.g., facial flushing), increased blood pressure, bleeding (hemorrhage, observed only in patients undergoing chemotherapy for blood cancer);
• cough, discomfort or pain in the chest, nasal congestion or throat infection (upper respiratory tract infection), bronchitis, lower respiratory tract infection;
• dry mouth, abdominal pain or discomfort, gas, upper abdominal pain, heartburn or indigestion, constipation, frequent bowel movements, vomiting, abdominal discomfort;
• pruritic rash, hives, skin inflammation, 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, localized redness and spots on the skin, excessive sweating, night sweats, hair loss, skin redness (erythema), psoriasis, eczema, other skin disorders;
• muscle spasms, muscle weakness, tendonitis or bursitis (tendon or joint inflammation, usually accompanied by pain, swelling, and stiffness), back pain, muscle cramps, muscle stiffness and joint stiffness;
• blood in urine, abnormal frequent urination, abnormal urine test results (increased protein in urine), decreased kidney function, urinary tract infection;
• chest pain, discomfort in the chest;
• gallstones or bile duct stones (cholelithiasis);
• increased TSH levels;
• changes in blood chemistry or blood cell count (abnormal blood test results);
• kidney stones;
• erectile dysfunction;
• hypothyroidism;
• blurred vision, changes in vision;
• ringing in the ears;
• nasal congestion;
• mouth ulcers;
• pancreatitis: frequent symptoms include abdominal pain, nausea, and vomiting;
• sudden urge to urinate;
• pain;
• malaise;
• increased INR;
• injury;
• lip swelling.

Rare side effects(may affect up to 1 in 1000 people):

• muscle damage, a condition that can be severe in isolated cases. Muscle disorders may occur, with associated malaise or high fever, caused by muscle damage. Contact your doctor immediately if you experience muscle pain, tenderness, or weakness;
• severe swelling of the deep skin layers, particularly around the eyes, genitals, hands, feet, or tongue, with possible sudden breathing difficulties;
• high fever with a rash, lymph node enlargement, liver enlargement, hepatitis (up to liver failure), increased white blood cell count (leukocytosis with or without eosinophilia);
• rashes of various types (e.g., with white spots, blisters, pus-filled blisters, peeling skin, rash), widespread redness, necrosis, blisters on the skin and mucous membranes causing peeling and possible sepsis (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• nervousness;
• thirst;
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia);
• abnormal low blood cell count (white or red blood cells or platelets);
• changes in urine or decreased urine output related to kidney inflammation (interstitial nephritis);
• hepatitis;
• jaundice;
• urinary tract infection;
• liver damage;
• increased creatine phosphokinase activity in the blood (indicator of muscle damage);
• sudden cardiac death;
• low red blood cell count (anemia);
• depression;
• sleep disturbances;
• loss of smell;
• burning sensation;
• vertigo;
• circulatory collapse;
• lung infection (pneumonia);
• mouth ulcers; mouth inflammation;
• perforation of the digestive tract;
• rotator cuff syndrome;
• polymyalgia rheumatica;
• feeling of heat;
• sudden loss of vision due to blockage of an artery in the eye.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Pharmacovigilance Department, 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 You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this 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 that month. There are no special precautions for storage. Medicines should 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, yellow iron oxide (E 172).

What Febuxostat Aurovitas looks like and contents of the pack

Febuxostat Aurovitas, 80 mg, film-coated tablets
Light yellow or yellow, biconvex, oval film-coated tablets with "FEB" debossed on one side and "80" debossed on the other side of the tablet. Tablet size 14.7 mm x 8.7 mm.
Febuxostat Aurovitas, 120 mg, film-coated tablets
Light yellow or yellow, biconvex, capsule-shaped film-coated tablets with "FEB" debossed on one side and "120" debossed on the other side of the tablet. Tablet size 19.2 mm x 8.7 mm.
Febuxostat Aurovitas 80 mg and 120 mg are packaged in transparent blisters containing 14, 28, 30, 42, 56, 84, and 98 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

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 authorized in the Member States of 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

Date of last revision of the package leaflet: 04/2022