Febuxostat accord

Package leaflet: Information for the user

Febuxostat Accord, 120 mg, film-coated tablets
Febuxostatum
Please read all of 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 you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Febuxostat Accord is and what it is used for
2. What you need to know 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 Febuxostat Accord is and what it is used for

Febuxostat Accord tablets contain the active substance febuxostat, used in the treatment of
gout – a disease associated with excessive levels in the body of a substance called uric acid (urate).
In some people, uric acid accumulates in the blood to such an extent that it can no longer remain dissolved.
In such cases, urate crystals may form within or around joints and kidneys. These crystals can cause sudden,
severe pain, redness, warmth and swelling of a joint (known as a gout attack). If left untreated, this condition
may lead to the formation of larger deposits (called tophi) in or around the joints, which in turn may cause
joint and bone damage.
Febuxostat Accord works by lowering the concentration of uric acid in the blood. Taking the medicine
once daily maintains this concentration at a normal level, prevents the deposition of crystals, and over
time reduces disease symptoms. Maintaining uric acid levels sufficiently low for a prolonged period may
also lead to a reduction in tophi.
Febuxostat Accord 120 mg film-coated tablets are also used in the treatment and prevention of high blood
uric acid levels that may occur when starting chemotherapy for blood cancer. During chemotherapy,
cancer cells are destroyed, leading to a rise in blood uric acid levels unless uric acid formation is prevented.
Febuxostat Accord is intended for use in adults.

2. Important information before using Febuxostat Accord

When not to use Febuxostat Accord:

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

Warnings and precautions
Before starting treatment with Febuxostat Accord, discuss with the doctor if the patient:

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

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

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

The doctor may decide to permanently discontinue treatment with Febuxostat Accord.
Rare cases of potentially life-threatening skin rashes (Stevens-Johnson syndrome) have been reported during treatment with febuxostat. These initially appear as red, target-like or circular spots on the trunk, often with a centrally located blister. Ulceration in the mouth, throat, nose, or genital area, as well as conjunctivitis (redness and swelling of the eyes), may also occur. The rash may progress to generalized blistering or skin peeling.
If Stevens-Johnson syndrome occurs during treatment with febuxostat, the patient must never take Febuxostat Accord again. If a rash or the described skin symptoms occur, the patient should immediately contact a doctor and inform them about taking this medicine.
If the patient is currently experiencing an attack of gouty arthritis (sudden onset of severe pain, tenderness, redness, warmth, and swelling in a joint), they should wait until the gout attack subsides before starting treatment with Febuxostat Accord.
In some people, gout attacks may worsen at the beginning of treatment with certain medicines that control uric acid levels. This does not affect all patients, but flare-ups may occur even when taking Febuxostat Accord, particularly during the first weeks or months of treatment. It is important to continue taking Febuxostat Accord even if gout symptoms flare up, because Febuxostat Accord continues to reduce uric acid levels. With regular daily use of Febuxostat Accord, gout attacks will become less frequent and less painful over time.
The doctor often prescribes additional medicines, if necessary, to prevent or treat flare-up symptoms (such as joint pain and swelling).
In patients who have very high levels of uric acid (e.g. those 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 Accord due to tumor lysis syndrome.
The doctor may order blood tests to check the patient's liver function.

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

Febuxostat Accord and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
It is particularly important to inform the doctor or pharmacist if the patient is taking medicines containing any of the following active substances. These may interact with Febuxostat Accord, so the doctor may consider taking necessary actions:

• mercaptopurine (a medicine used in cancer treatment);
• azathioprine (a medicine used to suppress immune system responses);
• theophylline (a medicine used in the treatment of asthma).

Pregnancy and breastfeeding
It is unknown whether the medicine may harm the unborn baby. Febuxostat Accord should not be used during pregnancy. It is unknown whether the medicine passes into human breast milk. If the patient is breastfeeding or planning to breastfeed, they should not use Febuxostat Accord.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Dizziness, drowsiness, blurred vision, and sensations of numbness or tingling may occur during treatment. If such 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 certain 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, i.e. it is essentially "sodium-free".

3. How to take Febuxostat Accord

This medicine should always be taken according to the doctor's or pharmacist's instructions. If you have any doubts,
please consult your doctor or pharmacist.

• The usual dose is one tablet per day. The days of the week are printed on the back of the blister pack to help you keep track of daily dosing.
• Tablets may be taken regardless of meals.

Gout
Febuxostat Accord is available as 80 mg tablets and 120 mg tablets. Your doctor will prescribe the dose most appropriate for you.
You should take this medicine every day, even if you do not currently have a flare-up or gout attack.
Prevention and treatment of high uric acid levels in patients undergoing chemotherapy for cancer
Febuxostat Accord is available as 120 mg tablets.
Treatment with Febuxostat Accord should be started two days before chemotherapy and continued as directed by your doctor. Treatment is usually short-term.
Taking more Febuxostat Accord than prescribed
If you accidentally take too much medicine, consult your doctor immediately or contact the emergency department of your nearest hospital.
If you forget to take Febuxostat Accord
If you miss a dose, take it as soon as possible unless it is almost time for your next dose. In that case, do not take the missed tablet; instead, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Febuxostat Accord treatment
Do not stop taking Febuxostat Accord without your doctor's advice, even if you feel better. Stopping treatment may cause an increase in uric acid levels and worsening of symptoms due to formation of new urate crystals inside and around joints and in the kidneys.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If any of the following rare adverse reactions (may affect up to 1 in 1,000 people) occur, stop taking the medicine immediately and contact your doctor or the nearest emergency department, 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 blister formation and peeling of the skin and mucous membranes lining body cavities (e.g. mouth and genital organs), painful ulceration of the oral cavity and (or) genital area accompanied by fever, sore throat, and fatigue (Stevens-Johnson syndrome or toxic epidermal necrolysis), or enlarged lymph nodes, 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 adverse reactions (in up to 1 in 10 people):

• abnormal liver function test results;
• diarrhoea;
• headache;
• rash (including various types of rashes, see below under “not common” and “rare”);
• nausea;
• worsening of gout symptoms;
• localised swelling due to fluid accumulation in tissues (oedema);
• dizziness;
• dyspnoea;
• itching;
• limb pain;
• muscle or joint pain;
• fatigue.

Other adverse reactions not listed above are listed below.
Not common adverse reactions (in up to 1 in 100 people):

• decreased appetite, increased blood glucose levels (diabetes mellitus), which may manifest as excessive thirst, increased blood lipid levels, weight gain;
• decreased libido;
• difficulty sleeping, drowsiness;
• numbness, tingling, impaired or reduced sensation (hypoesthesia, hemiparesis or paraesthesia), altered or reduced taste sensation, impaired sense of smell;
• abnormal ECG findings, irregular or rapid heartbeat, palpitations;
• hot flushes or skin redness (e.g. face or neck), increased blood pressure; bleeding (haemorrhage, observed only in patients receiving chemotherapy due to blood disorders);
• cough, discomfort or chest pain, inflammation of the nasal and (or) throat mucosa (upper respiratory tract infection), bronchitis, lower respiratory tract infection;
• dry mouth, abdominal pain and (or) discomfort or gas in the abdominal cavity, upper abdominal pain; heartburn and (or) indigestion, constipation, more frequent bowel movements, vomiting, stomach discomfort;
• itchy rash, urticaria, dermatitis, skin discolouration, 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 coalescing papules, rash, appearance of red areas and spots on the skin, excessive sweating, night sweats, alopecia, skin redness (erythema), psoriasis, eruption, other types of skin changes;
• muscle cramps, muscle weakness, tenosynovitis or joint inflammation (arthritis usually with pain, swelling and (or) stiffness), back pain, muscle cramps, muscle and (or) joint stiffness;
• presence of blood in urine, abnormally frequent urination, abnormal urine test results (increased protein in urine), kidney function disorders; urinary tract infection;
• chest pain, discomfort in the chest;
• presence of gallstones in the gallbladder or bile ducts (cholelithiasis);
• increased blood levels of thyroid-stimulating hormone (TSH);
• changes in blood chemical composition or changes in blood cell or platelet counts (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 swelling.

Rare adverse reactions (in up to 1 in 1,000 people):

• muscle injury – a condition which in rare cases may be severe. Muscle disorders may occur, and if accompanied by malaise or high body temperature, may be caused by muscle damage. If muscle pain, tenderness to pressure or weakness occur, contact your doctor immediately.
• significant swelling of deeper skin layers, especially around the eyes, genital organs, hands, feet or tongue, with possible sudden breathing difficulty;
• high fever combined with measles-like rash, enlarged lymph nodes, 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, measles-like), extensive erythema, necrosis, blisters on the skin and mucous membranes leading to separation and possible sepsis (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• nervousness;
• sensation of thirst;
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia);
• abnormally low number of blood cells (white, red or platelets);
• changes or reduced amount of urine due to kidney inflammation (tubulointerstitial nephritis);
• hepatitis;
• yellowing of the skin (jaundice);
• urinary bladder infection;
• liver damage;
• increased creatine kinase 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;
• vertigo of labyrinthine origin;
• circulatory collapse;
• lung infection (pneumonia);
• oral ulceration; inflammation of the oral cavity;
• gastrointestinal tract perforation;
• rotator cuff syndrome;
• polymyalgia syndrome;
• sensation of heat;
• sudden loss of vision due to occlusion of an artery in the eye.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Febuxostat Accord

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

6. Contents of the pack and other information

What Febuxostat Accord contains
The active substance is febuxostat.
Each film-coated tablet contains 120 mg of febuxostat (in the form of magnesium salt).

• Other ingredients are:
  Tablet core: monohydrate lactose, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, light magnesium oxide, colloidal anhydrous silica, magnesium stearate.
  Film coating Opadry II Yellow: partially hydrolysed 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, capsule-shaped, film-coated tablets,
with the inscription "120" embossed on one side and smooth on the other side.
Length: 19.2 ± 0.2 mm; Width: 8.2 ± 0.2 mm; Thickness: 6.1 mm ± 0.2 mm.
Tablets are packed in PVC/PCTFE/Aluminium blisters in cardboard boxes.
Pack sizes:
Febuxostat Accord 120 mg: 14, 28, 56 and 84 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names: