Febuxostat Aurovitas

Leaflet accompanying the packaging: patient information

Febuxostat Aurovitas, 80 mg, film-coated tablets

Febuxostat Aurovitas, 120 mg, film-coated tablets

Febuxostat

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging 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 for the compound to remain dissolved. In such cases, urate crystals may 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 not treated, larger deposits called tophi may 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 a day 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 may occur during cancer chemotherapy. When chemotherapy is used, cancer cells are destroyed, and uric acid levels in the blood increase accordingly, unless uric acid formation is prevented.
Febuxostat Aurovitas is intended for use in adults.

2. Important information before taking Febuxostat Aurovitas

When not to take Febuxostat Aurovitas

• if the patient is 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, consult a doctor:

• if the patient has or has had heart failure, heart disease, or stroke;
• if the patient currently has or has had kidney disease and (or) severe allergic reactions to allopurinol (a medicine used to treat gout)
• if the patient currently has or has had liver disease or abnormal liver function test results;
• if the patient is 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 the patient has thyroid disease.

In case of an allergic reaction to Febuxostat Aurovitas, stop taking this medicine immediately (see also section 4).
Possible symptoms of an allergic reaction are:

• rash, including severe forms of rash (e.g., blisters, nodules, itching, flaking rash), itching;
• swelling of limbs or face;
• breathing difficulties;
• fever and lymph node enlargement;
• severe, life-threatening allergic reactions with cardiac arrest and circulatory collapse. The 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 red, concentric spots or round spots, often with blisters on the torso.
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 peeling and separation of the skin.
In case of Stevens-Johnson syndrome during treatment with Febuxostat Aurovitas, treatment with febuxostat should not be restarted. In case of rash or the mentioned skin symptoms, immediately contact a doctor and inform them about taking febuxostat.
If the patient experiences 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 subsides.
In some people, gout attacks may worsen when starting treatment with certain uric acid-controlling medicines. Worsening may not occur in everyone, but worsening may occur, even if the patient is taking Febuxostat Aurovitas, especially during the first few weeks or months of treatment. It is essential to continue taking Febuxostat Aurovitas even if the patient experiences worsening, as Febuxostat Aurovitas still reduces uric acid levels. Over time, gout attacks will become less frequent and less painful if Febuxostat Aurovitas is taken daily.
Doctors often prescribe other medicines if necessary to help prevent or treat worsening symptoms (such as joint pain and swelling).
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.
The doctor may recommend blood tests to check if liver function is normal.

Children and adolescents

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

Febuxostat Aurovitas and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without 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 the immune system's response),
• theophylline (used to treat asthma).

Pregnancy, breastfeeding, and fertility

It is not known whether Febuxostat Aurovitas can harm an unborn child. Febuxostat Aurovitas should not be used during pregnancy. It is not known whether Febuxostat Aurovitas can pass into breast milk. Febuxostat Aurovitas should not be used if the patient is breastfeeding or plans to breastfeed.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

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

Febuxostat Aurovitas contains lactose

If the patient has been diagnosed with intolerance to certain sugars, they should consult a 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, 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, consult your doctor or pharmacist.

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

Gout
Febuxostat Aurovitas is available in 80 mg and 120 mg tablets. The doctor will prescribe the most suitable dose for the patient.
Febuxostat Aurovitas should be taken daily, even if there is no worsening or gout attack.
Prevention and treatment of high uric acid levels in patients undergoing chemotherapy due to cancer.
Febuxostat Aurovitas is available in 120 mg tablets.
Treatment with Febuxostat Aurovitas should be started two days before chemotherapy and continued as recommended by the doctor. Treatment is usually short-term.

Taking a higher dose of Febuxostat Aurovitas than recommended

In case of accidental overdose, ask your doctor how to proceed or contact the nearest hospital emergency department.

Missing a dose of Febuxostat Aurovitas

If a dose of Febuxostat Aurovitas is missed, take it as soon as you remember, unless it is close to the time for the next dose, in which case skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the 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 doubts about taking 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 or go to the nearest emergency department immediately if you experience the following rare (occurring in 1 in 1000 patients) side effects, 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 peeling of the skin and mucous membranes, e.g., mouth and genitals, painful ulcers in the mouth and (or) genitals with fever and lymph node enlargement (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);
• widespread skin rashes.

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

• abnormal liver test results,
• 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, changed blood sugar levels (diabetes), which may cause excessive thirst, increased blood fat levels, weight gain;
• decreased libido;
• sleep disorders, drowsiness;
• numbness, tingling, weakness, or changed sensation (hypoesthesia, paresis, or paresthesia), taste disorders, decreased sense of smell (hyposmia);
• ECG abnormalities, irregular or rapid heartbeat, palpitations;
• hot flashes or skin redness (e.g., facial redness), increased blood pressure, bleeding (hemorrhage, observed only in patients undergoing chemotherapy for blood diseases);
• cough, discomfort or pain in the chest, nasal congestion or throat inflammation (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, urticaria, 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, bursitis or tendonitis (tendon inflammation, which is usually accompanied by pain, swelling, and (or) stiffness), back pain, muscle cramps, muscle stiffness and (or) 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, changed vision;
• ringing in the ears;
• runny nose;
• 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, especially 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 disorders;
• loss of smell;
• burning sensation;
• vertigo;
• circulatory collapse;
• lung infection (pneumonia);
• mouth ulcers; mouth inflammation;
• gastrointestinal perforation;
• 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, consult 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 any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported 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 the 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 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Febuxostat Aurovitas contains

• The active substance of the medicine is febuxostat. Each film-coated tablet contains 80 mg or 120 mg of febuxostat (as febuxostat hemihydrate).
• 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
Pale yellow or yellow, biconvex, oval film-coated tablets with "FEB" embossed on one side 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 with "FEB" embossed on one side 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 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 leaflet: 04/2022