FEBUXOSTAT 120 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Febuxostat Accord, 120 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Febuxostat Accord and what is it used for
4. Important information before taking Febuxostat Accord
   1. When not to take Febuxostat Accord:
   2. Warnings and precautions
   3. Children and adolescents
   4. Febuxostat Accord and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Febuxostat Accord contains lactose
   8. Febuxostat Accord contains sodium
5. How to take Febuxostat Accord
   1. Prevention and treatment of high uric acid levels in patients undergoing chemotherapy for cancer
   2. Overdose of Febuxostat Accord
   3. Missed dose of Febuxostat Accord
   4. Discontinuation of Febuxostat Accord
6. Possible side effects
   1. Frequent side effects (may affect up to 1 in 10 people):
   2. Uncommon side effects (may affect up to 1 in 100 people):
   3. Rare side effects (may affect up to 1 in 1000 people):
   4. Reporting side effects
7. How to store Febuxostat Accord
8. Contents of the pack and other information
   1. What Febuxostat Accord contains
   2. What Febuxostat Accord looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

Febuxostat Accord, 120 mg, coated tablets

Febuxostatum

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

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

Febuxostat Accord tablets contain the active substance febuxostat, used to treat gout - a disease related to an excessive amount of a substance called uric acid (urate) in the body. In some people, uric acid builds up in the blood to such an extent that it can no longer dissolve. In such cases, urate crystals may form inside or around the joints and kidneys. These crystals can cause sudden, severe pain, redness, heat, and swelling of the joint (so-called gout attack). If left untreated, this condition can lead to the formation of larger deposits (called tophi) in the joints or around them, which can damage the joint and bone.
The action of Febuxostat Accord is to reduce the concentration of uric acid in the blood. Taking the medicine once a day maintains this concentration within normal limits, preventing the formation of crystals and, over time, reducing the symptoms of the disease. Maintaining a low uric acid concentration for a sufficient period can also reduce tophi.
Febuxostat Accord 120 mg, coated tablets are also used to treat and prevent high uric acid concentrations in the blood that may occur when starting chemotherapy for blood cancer. When chemotherapy is used, cancer cells are destroyed, and uric acid concentration in the blood increases accordingly, unless uric acid formation is prevented.
Febuxostat Accord is intended for use in adults.

2. Important information before taking Febuxostat Accord

When not to take Febuxostat Accord:

Warnings and precautions

Before starting to take Febuxostat Accord, the patient should discuss it with their doctor if they:

• have or have had heart failure, heart disease, or stroke;
• have or have had kidney disease and (or) have had a severe allergic reaction to allopurinol (a medicine used to treat gout);
• have or have had liver disease or abnormal liver function test results;
• are being treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare inherited disorder characterized by excessive uric acid in the blood);
• have thyroid function disorders.

If the patient experiences an allergic reaction to Febuxostat Accord, they should stop taking the medicine (see also section 4). The symptoms of allergic reactions may include:

• rash, including severe rash (e.g., with blistering, nodules, itching, peeling);
• swelling of limbs or face;
• breathing difficulties;
• fever with lymph node enlargement;
• a severe, life-threatening condition with cardiac arrest and circulatory failure.

The doctor may decide to permanently discontinue the use of Febuxostat Accord.
During febuxostat treatment, rare cases of potentially life-threatening skin rashes (Stevens-Johnson syndrome) have been reported, which initially looked like red, target-like patches or round patches on the torso, often with a central blister. Mouth sores, throat, nose, genital, and eye inflammation (conjunctivitis) may also occur. The rash may progress, turning into generalized blisters or skin peeling.
If the patient develops Stevens-Johnson syndrome while taking febuxostat, they should never take Febuxostat Accord again. If a rash or the described skin symptoms occur, the patient should immediately consult their doctor and inform them about taking this medicine.
If the patient is currently experiencing a gout attack (sudden onset of severe pain, tenderness, redness, heat, and swelling of the joint), they should wait until the attack has subsided before starting to take Febuxostat Accord.
In some people, gout attacks may worsen when starting certain uric acid-lowering therapies. This is not true for all patients, but worsening may occur, even if the patient is taking Febuxostat Accord, especially in the first few weeks or months of treatment. It is essential to continue taking Febuxostat Accord even if the symptoms of gout worsen, as Febuxostat Accord still reduces uric acid levels. If the patient takes Febuxostat Accord daily, gout attacks will become less frequent and less painful over time.
Doctors often prescribe other medicines if necessary to 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 therapies 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 Accord due to tumor lysis syndrome.
The doctor may order blood tests to check the patient's liver function.

Children and adolescents

The medicine should not be given to children under 18 years of age, as its safety and efficacy have not been established in this age group.

Febuxostat Accord and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
It is particularly important to inform the doctor or pharmacist about taking medicines containing any of the following substances, as they may interact with Febuxostat Accord, and the doctor may consider taking necessary actions:

• mercaptopurine (a medicine used to treat cancer);
• azathioprine (a medicine used to weaken the immune system);
• theophylline (a medicine used to treat asthma).

Pregnancy and breastfeeding

It is not known whether the medicine can harm the fetus. Febuxostat Accord should not be taken during pregnancy. It is not known whether the medicine passes into breast milk. If the patient is breastfeeding or plans to breastfeed, they should not take Febuxostat Accord.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

During treatment, dizziness, drowsiness, blurred vision, and a feeling of numbness or tingling may occur. If these effects occur, the patient should not drive or operate machinery.

Febuxostat Accord contains lactose

Febuxostat Accord tablets contain lactose (a type of sugar). If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Febuxostat Accord contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Febuxostat Accord

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

• The usual dose is one tablet per day. The back of the blister pack has the days of the week printed on it to help the patient keep track of their daily dose.
• The tablets can be taken with or without food.

Gout
Febuxostat Accord is available in 80 mg and 120 mg tablet strengths. The doctor will prescribe the dose that is right for the patient.
The medicine should be taken every day, even if the patient does not have a gout attack or worsening symptoms.

Prevention and treatment of high uric acid levels in patients undergoing chemotherapy for cancer

Febuxostat Accord is available in 120 mg tablet strength.
Treatment with Febuxostat Accord should be started 2 days before chemotherapy and continued as prescribed by the doctor. The treatment is usually short-term.

Overdose of Febuxostat Accord

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

Missed dose of Febuxostat Accord

If a dose is missed, the patient should take it as soon as possible, unless it is almost time for the next dose. In this case, the patient should not take the missed tablet, but take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Discontinuation of Febuxostat Accord

The patient should not stop taking Febuxostat Accord without their doctor's advice, even if they feel better. Stopping the medicine may cause uric acid levels to rise, leading to worsening symptoms due to the formation of new urate crystals inside and around the joints and kidneys.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Febuxostat Accord can cause side effects, although not everybody gets them.
If the patient experiences any of the following rare side effects (may affect up to 1 in 1000 people), they should stop taking the medicine and contact their doctor or the nearest emergency department immediately, as they may lead to severe 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, as well as mucous membrane lesions (e.g., oral and genital), painful mouth sores, and (or) genital ulcers, with fever, sore throat, and fatigue (Stevens-Johnson syndrome or 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.

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

• abnormal liver function test results;
• diarrhea;
• headache;
• rash (including various types of rash, see below "uncommon" and "rare");
• nausea;
• worsening of gout symptoms;
• local swelling due to fluid accumulation in tissues (edema);
• dizziness;
• shortness of breath;
• itching;
• limb pain;
• muscle 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, increased blood sugar levels (diabetes), which may cause excessive thirst, increased blood fat levels, weight gain;
• decreased libido;
• difficulty sleeping, drowsiness;
• numbness, tingling, altered or decreased sensation (hypoesthesia, paresis, or paresthesia), altered or decreased taste, decreased sense of smell;
• abnormal ECG, irregular or rapid heartbeat, palpitations;
• hot flashes or skin redness (e.g., face or neck), increased blood pressure; bleeding (hemorrhage, observed only in patients undergoing chemotherapy for blood cancer),
• cough, feeling of discomfort or pain in the chest, inflammation of the nasal and (or) throat mucosa (upper respiratory tract infection), bronchitis, lower respiratory tract infection
• dry mouth, abdominal pain and (or) discomfort, gas, heartburn and (or) indigestion, constipation, frequent bowel movements, vomiting, stomach discomfort;
• itchy rash, hives, skin inflammation, skin discoloration, appearance of small red or purple spots on the skin, appearance of small, flat, red spots on the skin, appearance of flat, red areas on the skin covered with small, merging nodules, rash, appearance of reddened areas and spots on the skin, excessive sweating, night sweats, hair loss, skin redness (erythema), psoriasis, eczema other types of skin lesions;
• muscle cramps, muscle weakness, bursitis or tendonitis (tendonitis, usually with pain, swelling, and (or) stiffness), back pain, muscle spasms, muscle stiffness and (or) joint stiffness;
• blood in urine, frequent urination, abnormal urine test results (increased protein in urine), kidney function disorders; urinary tract infection;
• chest pain, feeling of discomfort in the chest;
• presence of gallstones or bile duct stones (cholelithiasis);
• increased thyroid-stimulating hormone (TSH) levels in the blood;
• changes in blood chemistry or changes in blood cell or platelet count (abnormal blood test results);
• kidney stones;
• erectile dysfunction;
• hypothyroidism;
• blurred vision, changes in vision;
• ringing in the ears;
• runny nose;
• mouth sores;
• pancreatitis: frequent symptoms include abdominal pain, nausea, and vomiting;
• sudden need 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 rare cases. Muscle disorders may occur, and if accompanied by malaise or high fever, they may be caused by muscle damage. If muscle pain, tenderness, or weakness occurs, the patient should contact their doctor immediately.
• severe swelling of the deeper 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);
• various types of rashes (e.g., with white spots, blisters, pus-filled blisters, skin peeling), widespread redness, necrosis, blisters on the skin and mucous membranes, leading to peeling and possible sepsis (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• nervousness;
• feeling of thirst;
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia);
• abnormal low blood cell count (white, red, or platelet);
• changes in urine or decreased urine output due to kidney inflammation (interstitial nephritis);
• hepatitis;
• jaundice;
• urinary tract infection;
• liver damage;
• increased creatine kinase 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 sores; 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.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urzędowy Rejestr Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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, more information can be collected on the safety of the medicine.

5. How to store Febuxostat Accord

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP.
The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Febuxostat Accord contains

The active substance of the medicine is febuxostat.
Each coated tablet contains 120 mg of febuxostat (as magnesium salt).

• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, light magnesium oxide, colloidal anhydrous silica, magnesium stearate. Opadry II Yellowcoating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172).

What Febuxostat Accord looks like and contents of the pack

Febuxostat Accord 120 mg: pale yellow or yellow, coated tablets in the shape of a capsule, with the inscription "120" on one side and smooth on the other.
Length: 19.2 ± 0.2 mm; Width: 8.2 ± 0.2 mm; Thickness: 6.1 mm ± 0.2 mm.
The tablets are packaged in PVC/PCTFE/Aluminum blisters in a cardboard box.
Pack sizes:
Febuxostat Accord 120 mg: 14, 28, 56, and 84 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warszawa
Tel: +48 22 577 28 00

Manufacturer:

Pharmathen S.A.
6, Dervenakion strasse
15351 Pallini, Attiki, Greece
Pharmathen International S.A.
Industrial Park Sapes, Block No 5,
69300 Rodopi Prefecture
Greece
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola PLA 3000, Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:January 2023