Febuxostat Accord

Package Leaflet: Information for the Patient

Febuxostat Accord, 80 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 package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 film-coated tablets contain the active substance febuxostat, which is used to treat gout - a disease associated with an excessive amount 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 dissolve. In this case, urate crystals may form inside or around the joints and kidneys. Such 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 in turn can lead to joint and bone damage. 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 lead to a reduction in tophi. 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 treatment with Febuxostat Accord, discuss with your doctor if you:

• 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 tests;
• 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 you experience an allergic reaction to Febuxostat Accord, stop taking the medicine (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;
• breathing difficulties;
• fever with lymph node enlargement;
• life-threatening condition with cardiac arrest and circulatory failure.

Your doctor may decide to permanently stop treatment with Febuxostat Accord. During treatment with febuxostat, rare cases of potentially life-threatening skin rashes (Stevens-Johnson syndrome) have been reported, which initially looked like red spots resembling target marks or round spots on the torso, often with a centrally located blister. Oral, throat, nasal, genital, and eye ulcers may also occur, as well as conjunctivitis (redness and swelling of the eyes). The rash may progress, turning into generalized blisters or peeling of the skin. If you experience Stevens-Johnson syndrome while taking febuxostat, you should never take Febuxostat Accord again. If a rash or skin symptoms occur, seek medical attention immediately and inform your doctor that you are taking this medicine. If you are currently experiencing a gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling of the joint), you should wait until the attack has subsided before starting treatment with Febuxostat Accord. In some people, gout attacks may worsen at the start of treatment with certain medicines that control uric acid levels. This does not apply to all patients, but worsening may occur even if you are taking Febuxostat Accord, especially in the first few weeks or months of treatment. It is essential to continue taking Febuxostat Accord even if gout symptoms worsen, as Febuxostat Accord still reduces uric acid levels. If you take Febuxostat Accord daily, gout attacks will become less frequent and less painful over time. Your doctor may prescribe other medicines if necessary to prevent or treat symptoms of worsening (such as joint pain and swelling). Your doctor may order blood tests to check your 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

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. 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 Accord, and your doctor may need to take 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 you are breastfeeding or plan to breastfeed, you should not take Febuxostat Accord. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Dizziness, drowsiness, blurred vision, and a feeling of numbness or tingling may occur during treatment. If you experience these effects, do not drive or operate machinery.

Febuxostat Accord contains lactose

Febuxostat Accord tablets contain lactose (a type of sugar). If you have been told that you have an intolerance to some sugars, consult your 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• The usual dose is one tablet per day. The back of the blister pack has the days of the week marked to help you keep track of your daily dose.
• The tablets can be taken with or without food.

Gout
Febuxostat Accord is available in 80 mg and 120 mg tablet strengths. Your doctor will prescribe the dose that is right for you.
Take the medicine every day, even if you do not have a gout attack.

If you take more Febuxostat Accord than you should

If you have taken more than the prescribed dose, ask your doctor what to do 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 you remember, unless it is almost time for your next dose. In this case, do not take the missed dose, just take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Febuxostat Accord

Do not stop taking Febuxostat Accord without your doctor's advice, even if you feel better. Stopping treatment may cause uric acid levels to rise, leading to worsening of the disease due to the formation of new urate crystals in and around the joints and kidneys. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following rare side effects (may affect up to 1 in 1000 people), stop taking the medicine and contact your doctor or the emergency department of your nearest hospital immediately, as they can 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 (e.g., mouth and genitals) and the formation of painful mouth 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.

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;
• local 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, increased blood sugar levels (diabetes), which may cause excessive thirst, increased blood lipid levels, weight gain;
• decreased libido;
• difficulty sleeping, drowsiness;
• numbness, tingling, decreased or altered sensation (hypoesthesia, hemiparesis, or paresthesia), altered or decreased taste, decreased sense of smell;
• abnormal ECG, irregular or rapid heartbeat, feeling of heartbeat (palpitations);
• hot flashes or flushing of the skin (e.g., face or neck), increased blood pressure;
• 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, upper abdominal pain, heartburn and (or) indigestion, constipation, frequent bowel movements, vomiting, stomach discomfort;
• pruritic 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 red and spotted areas on the skin, excessive sweating, night sweats, hair loss, skin redness (erythema), psoriasis, other types of skin changes;
• muscle cramps, muscle weakness, bursitis or joint inflammation (joint inflammation 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 infections;
• chest pain, feeling of discomfort in the chest;
• gallstones or gallstones in the bile ducts (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, vision changes;
• ringing in the ears;
• common cold;
• mouth ulcers;
• pancreatitis: common 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, may be due to muscle damage. If you experience muscle pain, tenderness, or weakness, contact your 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 resembling measles, 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, peeling), widespread redness, necrosis, blisters on the skin and mucous membranes causing 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 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 of labyrinthine origin;
• circulatory collapse;
• lung infection (pneumonia);
• mouth ulcers; mouth inflammation;
• perforation of the digestive tract;
• rotator cuff syndrome;
• polymyalgic syndrome;
• feeling of heat;
• sudden loss of vision due to occlusion of the artery in the eye.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 Accord

Keep the medicine out of the 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 stated. There are no special storage instructions for this medicine. 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 pack and other information

What Febuxostat Accord contains

The active substance of the medicine is febuxostat. Each film-coated tablet contains 80 mg of febuxostat (as magnesium salt).

• Other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, light magnesium oxide, silicon dioxide, magnesium stearate. Film coating Opadry II Yellow: polyvinyl alcohol, partially hydrolyzed, 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, film-coated, capsule-shaped tablets with "80" engraved on one side and smooth on the other. Length: 17.2 ± 0.2 mm; Width: 6.2 ± 0.2 mm; Thickness: 5.6 mm ± 0.2 mm. The tablets are packaged in PVC/PCTFE/Aluminum blisters in a cardboard box. Pack sizes: Febuxostat Accord 80 mg: 14, 28, 30, 56, and 84 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw, 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 package leaflet:January 2023