Febuxostat accord

Package leaflet: Information for the patient

Febuxostat Accord, 80 mg, coated tablets
Febuxostatum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Febuxostat Accord is and what it is 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 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 of a substance called uric acid (urate) in the body.
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 (so-called gout attack). If left untreated, this condition may lead to the formation of larger deposits (called tophi) in or around joints, which in turn may cause joint and bone damage.
Febuxostat Accord works by reducing the concentration of uric acid in the blood. Taking the medicine once daily maintains this concentration at normal levels, prevents crystal deposition, and gradually reduces disease symptoms. Maintaining uric acid levels at an appropriately low level for a sufficiently long period may also lead to a reduction in tophi.
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) has 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 function disorders.

If the patient experiences an allergic reaction to Febuxostat Accord, the medicine should be discontinued 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 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.
During treatment with febuxostat, rare cases of potentially life-threatening skin rashes ( Stevens-Johnson syndrome ) have been reported, initially appearing as red, target-like spots or circular lesions on the trunk, often with a central blister. There may also be ulceration in the mouth, throat, nose, genital organs, and conjunctivitis (redness and swelling of the eyes). The rash may progress to widespread blistering or skin peeling.
If Stevens-Johnson syndrome occurs during treatment with febuxostat, the patient must never take Febuxostat Accord again. In case of rash or the described skin symptoms, immediate medical advice should be sought and the doctor informed about the use of this medicine.
If the patient is currently experiencing an attack of gout (sudden onset of severe pain, tenderness, redness, warmth, and swelling in a joint), treatment with Febuxostat Accord should be delayed until the gout attack has subsided.
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 during gout flare-ups, as it 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 may prescribe additional medicines, if necessary, to prevent or treat flare-up symptoms (such as joint pain and swelling).
The doctor may order blood tests to monitor 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.
Febuxostat Accord and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is especially important to inform the doctor or pharmacist about 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 to treat cancer);
• azathioprine (a medicine used to suppress immune system responses);
• theophylline (a medicine used to treat asthma).

Pregnancy and breastfeeding
It is unknown whether the medicine may harm the unborn child. Febuxostat Accord should not be used during pregnancy. It is not known whether the medicine passes into breast milk. If the patient is breastfeeding or planning to breastfeed, she should not use Febuxostat Accord.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, 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 these symptoms 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 an intolerance to certain sugars, consultation with a doctor is recommended 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 use Febuxostat Accord

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.

• The usual dose is one tablet per day. The days of the week are printed on the reverse side of the blister 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 suitable for you.
The medicine should be taken every day, even if you do not currently have a flare-up or gout attacks.
Taking more Febuxostat Accord than prescribed
In case of accidental overdose, consult your doctor for advice or contact the emergency department of your nearest hospital immediately.
Missing a dose of 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
Do not stop taking Febuxostat Accord without your doctor's advice, even if you feel better. Stopping treatment may lead to increased uric acid levels and worsening of disease 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 not everyone will experience them.
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 blistering and peeling of the skin and mucous membranes lining body cavities (e.g. mouth and genital organs), development of painful oral ulcers and (or) genital area with fever, sore throat and fatigue (Stevens-Johnson syndrome or toxic epidermal necrolysis), or swollen 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 (affecting 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;
• shortness of breath;
• itching;
• limb pain, muscle or joint pain;
• fatigue.

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

• decreased appetite, increased blood sugar levels (diabetes), which may manifest as excessive thirst, increased blood lipid levels, weight gain;
• reduced libido;
• difficulty sleeping, drowsiness;
• numbness, tingling, impaired or altered sensation (hypoesthesia, hemiparesis or paraesthesia), altered or impaired taste sensation, reduced sense of smell;
• abnormal ECG findings, irregular or rapid heartbeat, sensation of heart palpitations;
• hot flushes or skin redness (e.g. face or neck), increased blood pressure;
• 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, 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, hair loss, skin redness (erythema), psoriasis, eruption, other types of skin lesions;
• muscle cramps, muscle weakness, tenosynovitis or arthritis (joint inflammation usually with pain, swelling and/or stiffness), back pain, muscle spasms, 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 concentration of thyroid-stimulating hormone (TSH);
• changes in blood chemistry or changes in blood cell or platelet count (abnormal blood test results);
• kidney stones;
• erectile dysfunction;
• hypothyroidism;
• blurred vision, change in vision;
• tinnitus;
• catarrh;
• oral ulceration;
• pancreatitis: common symptoms include abdominal pain, nausea and vomiting;
• sudden urge to urinate;
• pain;
• malaise;
• increased INR;
• injury;
• swelling of the lips.

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

• muscle damage – a condition which in rare cases may be severe. Muscle disorders may occur, and if accompanied by malaise or high body temperature, may be due to muscle damage. If muscle pain, tenderness or weakness occur, contact your doctor immediately.
• severe swelling of deeper skin layers, especially around the eyes, genital organs, hands, feet or tongue, possibly leading to sudden breathing difficulties;
• high fever combined with a measles-like rash, swollen lymph nodes, enlarged liver, 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, pustular blisters, skin peeling, measles-like), extensive erythema, necrosis, blisters on the skin and mucous membranes leading to sloughing and possible sepsis (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• nervousness;
• sensation of thirst;
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia);
• abnormally low blood cell count (white blood cells, red blood cells or platelets);
• changes or reduction in urine output 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 death due to cardiovascular causes;
• low red blood cell count (anaemia);
• depression;
• sleep disorders;
• loss of smell;
• burning sensation;
• vestibular dizziness;
• circulatory collapse;
• lung infection (pneumonia);
• oral ulceration; inflammation of the mouth;
• 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 conditions apply for this medicine.
Medicines must not be disposed of via the sewage system 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 coated tablet contains 80 mg of febuxostat (in the form of magnesium salt).

• Other ingredients are:
  Tablet core: monohydrate lactose, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, light magnesium oxide, anhydrous colloidal silicon dioxide, magnesium stearate.
  Coating Opadry II Yellow: 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 80 mg: pale yellow or yellow, capsule-shaped coated tablets,
with "80" embossed on one side and smooth on the other side.
Length: 17.2 ± 0.2 mm; Width: 6.2 ± 0.2 mm; Thickness: 5.6 mm ± 0.2 mm.
Tablets are packed in PVC/PCTFE/Aluminium blisters in cardboard boxes.
Pack sizes:
Febuxostat Accord 80 mg: 14, 28, 30, 56 and 84 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Poland
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: