Febuxostat Krka

Patient Information Leaflet: Information for the Patient

Febuxostat Krka 80 mg film-coated tablets, 120 mg film-coated tablets

febuxostat

Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Febuxostat Krka is and what it is used for
  2. What you need to know before taking Febuxostat Krka
  3. How to take Febuxostat Krka
  4. Possible side effects
  5. How to store Febuxostat Krka
  6. Contents of the pack and other information

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

Febuxostat Krka tablets contain the active substance febuxostat and are used to treat
gout, a condition associated with excess uric acid (urate) in the body. In some individuals,
the amount of uric acid accumulating in the blood may become so high that it can no longer remain
in solution. In such cases, urate crystals may form within and around joints and
in the kidneys. These crystals can cause sudden, severe pain, redness, warmth, and swelling in a joint (a gout attack). If left untreated, larger deposits called tophi may develop
within and around the joints. Tophi can damage joints and bones.
Febuxostat Krka works by reducing uric acid levels. Maintaining low uric acid levels by taking
Febuxostat Krka once daily prevents the accumulation of crystals and, over time, helps reduce symptoms. If uric acid levels are kept low for a sufficiently long period, existing tophi may even gradually dissolve.
Febuxostat Krka 120 mg tablets are also used to treat and prevent high blood levels of uric acid that may occur during chemotherapy for blood cancers.
During chemotherapy, cancer cells are destroyed, leading to increased levels of uric acid in the blood, unless the formation of this acid is prevented.
Febuxostat Krka is for use in adults.

2. What you need to know before taking Febuxostat Krka

Do not take Febuxostat Krka

• If you are allergic to febuxostat or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor before taking Febuxostat Krka:
• If you have or have had heart failure, heart problems, or heart attack
• If you have or have had kidney disease and/or severe allergic reactions to allopurinol (a medicine used to treat gout)
• If you have or have had liver disease or abnormal liver function tests
• If you have high levels of uric acid due to Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood)
• If you have any thyroid problems. If you experience allergic reactions to Febuxostat Krka, stop treatment with this medicine (see also section 4). Possible symptoms of allergic reactions may include:
• Skin rash, including severe forms (e.g. blisters, nodules, itchy rash, exfoliative skin rash), itching
• Swelling of limbs or face
• Difficulty breathing
• Fever with swollen lymph nodes
• Or even severe, life-threatening allergic conditions with cardiac and circulatory arrest. Your doctor may decide to permanently discontinue treatment with Febuxostat Krka. Rare, life-threatening skin rashes (Stevens-Johnson syndrome) have been reported with the use of Febuxostat Krka, initially appearing on the trunk as reddish spots resembling targets or circular lesions, often with central blisters. These may also include mouth, throat, nose, genital ulcers, and conjunctivitis (red, swollen eyes). The rash may progress to widespread blistering or skin peeling. If you have developed Stevens-Johnson syndrome while taking febuxostat, you must not restart treatment with Febuxostat Krka. If you develop a skin rash or these skin symptoms, consult your doctor immediately and inform them that you are being treated with this medicine. If you currently have a gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling in a joint), wait until the gout attack has resolved before starting treatment with Febuxostat Krka. In some people, gout attacks may recur at the beginning of certain treatments used to control uric acid levels. Not everyone experiences recurrences, but you may have a flare-up even while taking Febuxostat Krka, especially during the first weeks or months of treatment. It is important that you continue taking Febuxostat Krka even during a flare-up, as Febuxostat Krka continues to work in lowering your uric acid levels. If you continue taking Febuxostat Krka daily, flare-ups will become less frequent and less painful over time. Often, your doctor may prescribe additional medicines, if needed, to help prevent or treat symptoms of flare-ups (such as pain and swelling in a joint). In patients with very high urate levels (e.g. patients 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 for Tumor Lysis Syndrome. Your doctor may prescribe blood tests to monitor normal liver function. Children and adolescents Do not give this medicine to children under 18 years of age, as safety and efficacy have not been established. Other medicines and Febuxostat Krka Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

It is very important that you inform your doctor or pharmacist if you are taking a medicine containing
any of the following substances, as these may interact with Febuxostat Krka and your doctor
may need to consider appropriate measures:

• Mercaptopurine (used to treat cancer)
• Azathioprine (used to reduce immune response)
• Theophylline (used to treat asthma) Pregnancy and breastfeeding If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. It is not known whether Febuxostat Krka could harm the unborn child. Febuxostat Krka must not be used during pregnancy. It is not known whether Febuxostat Krka passes into breast milk. You must not take Febuxostat Krka if you are breastfeeding or intend to breastfeed. Driving and using machines Be aware that you may experience dizziness, drowsiness, blurred vision, numbness, or tingling during treatment with this medicine, and in such cases you must not drive or operate machinery. Febuxostat Krka contains lactose and sodium If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Febuxostat Krka

Take this medicine exactly as prescribed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.

• The usual dose is one tablet per day. The score line is intended only to help you break the tablet if you have difficulty swallowing it whole.
• The tablets should be taken by mouth. They can be taken with or without food. Gout Febuxostat Krka is available as 80 mg or 120 mg tablets. Your doctor will prescribe the most appropriate dosage for you. Continue taking Febuxostat Krka 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 Febuxostat Krka is available as 120 mg tablets. Start taking Febuxostat Krka two days before beginning chemotherapy and continue taking it as directed by your doctor. Treatment is usually short-term. If you take more Febuxostat Krka than you should In case of accidental overdose, contact your doctor or go to the nearest emergency department immediately. If you forget to take Febuxostat Krka If you forget to take a dose of Febuxostat Krka, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

If you stop taking Febuxostat Krka
Do not stop treatment with Febuxostat Krka without consulting your doctor, even if you feel better. If you stop treatment with Febuxostat Krka, your uric acid levels may start to rise again, and your symptoms may worsen due to the formation of new urate crystals in and around your joints and kidneys.
If you have any questions about the use of 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 immediately or go to the nearest emergency department if you experience any of the following rare side effects (may affect up to 1 in 1,000 people), as they may indicate a serious allergic reaction:

• anaphylactic reactions, drug hypersensitivity (see also section 2 “Warnings and precautions”)
• life-threatening skin rashes characterized by blistering and peeling of the skin and internal body surfaces, e.g. mouth and genitals, painful ulcers in the mouth and/or genital areas, accompanied by fever, sore throat and fatigue (Stevens-Johnson syndrome/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 rash

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

• abnormal liver function test results
• diarrhoea
• headache
• skin rash (including various types of rashes, see below in the “uncommon” and “rare” sections)
• nausea
• worsening of gout symptoms
• localized swelling due to fluid retention in tissues (oedema)
• dizziness
• shortness of breath
• itching
• limb pain, muscle pain or joint pain
• fatigue

Other side effects not mentioned above are listed below.

Uncommon (may affect up to 1 in 100 people):

• decreased appetite, changes in blood glucose levels (diabetes), one symptom of which may be excessive thirst, increased blood lipid levels, weight gain
• loss of sexual desire
• difficulty sleeping, drowsiness
• numbness, tingling, reduced or altered sense of touch (hypoesthesia, hemiparesis or paraesthesia), altered sense of taste, reduced sense of smell (hyposmia)
• abnormal ECG tracings, irregular or rapid heartbeat, awareness of heartbeat (palpitations)
• hot flushes or flushing (e.g. redness of the face or neck), increased blood pressure, bleeding (haemorrhage, observed only in patients undergoing chemotherapy for blood disorders)
• cough, chest pain, inflammation of the nasal passage and/or throat (respiratory tract infection), bronchitis, lower respiratory tract infections
• dry mouth, abdominal pain or discomfort, excessive intestinal gas, upper abdominal pain, heartburn/indigestion, constipation, more frequent bowel movements, vomiting, gastric discomfort
• itchy skin rash, urticaria, skin inflammation, skin colour changes, small red or purple spots on the skin, flat red spots on the skin, red area on the skin covered with small confluent bumps, skin rashes, areas of redness and spots on the skin, increased sweating, night sweats, alopecia, skin redness (erythema), psoriasis, eczema, other skin disorders
• muscle cramps, muscle weakness, bursitis or arthritis (joint inflammation usually accompanied by pain, swelling and/or stiffness), back pain, muscle spasms, muscle and/or joint stiffness
• blood in urine, increased frequency of urination, abnormal urine test results (elevated protein levels in urine), reduced kidney function, urinary tract infections
• chest pain, chest discomfort
• gallstones or bile duct stones (cholelithiasis)
• increased blood levels of thyroid-stimulating hormone (TSH)
• changes in blood biochemical test values or red blood cell or platelet counts (abnormal blood test results)
• kidney stones
• difficulty achieving erection
• reduced thyroid gland activity, blurred vision, changes in vision
• ringing in the ears
• runny nose
• oral ulceration
• pancreatitis: common symptoms are abdominal pain, nausea and vomiting
• urgency to urinate
• pain
• malaise
• increased INR (blood coagulation index)
• bruising
• swelling of the lips

Rare (may affect up to 1 in 1,000 people):

• muscle damage, a condition which in rare cases may be serious. Muscle problems may develop, and particularly if you also feel unwell or have a high fever, this may be due to abnormal breakdown of muscle cells. Contact your doctor immediately if you experience muscle pain, tenderness or weakness
• marked swelling of deeper layers of the skin, especially around the eyes, genitals, hands, feet or tongue, possibly with sudden difficulty breathing
• high fever associated with a measles-like skin rash, swollen lymph nodes, liver enlargement, hepatitis (up to liver failure), increased white blood cell count (leucocytosis, with or without eosinophilia)
• skin rashes of various types (e.g. with white spots, blisters, pustules, skin peeling, measles-like rash), widespread erythema, necrosis and blistering detachment of the epidermis and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• nervousness
• thirst
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
• abnormally low levels of blood cells (white blood cells or red blood cells or platelets)
• changes or reduced urine output due to kidney inflammation (tubulointerstitial nephritis)
• liver inflammation (hepatitis)
• yellowing of the skin (jaundice)
• bladder infection
• liver damage
• increased blood levels of creatine phosphokinase (a marker of muscle damage)
• sudden cardiac death
• low number of red blood cells (anaemia)
• depression
• sleep disorders
• loss of taste
• burning sensation
• dizziness
• circulatory failure
• lung infection (pneumonia)
• mouth ulcers; mouth inflammation
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• sensation of warmth
• sudden loss of vision due to blockage of an artery in the eye

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Febuxostat Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Febuxostat Krka contains

• The active substance is febuxostat. Each film-coated tablet contains 80 mg of febuxostat. Each film-coated tablet contains 120 mg of febuxostat.
• The other components are: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, hydrated colloidal silica and magnesium stearate in the tablet core; and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, yellow iron oxide (E172) – only in the 120 mg film-coated tablets, and red iron oxide (E172) – only in the 80 mg film-coated tablets. See section 2 “Febuxostat Krka contains lactose and sodium”.

What Febuxostat Krka looks like and contents of the pack

Febuxostat Krka 80 mg film-coated tablets are pink, oval, biconvex, film-coated tablets with a score line on one side. Tablet size: approximately 16 mm x 8 mm. The score line on the tablet is intended to facilitate breaking for easier swallowing and is not intended for dividing the tablet into equal doses.

Febuxostat Krka 120 mg film-coated tablets are yellow-brown, slightly biconvex, capsule-shaped, film-coated tablets with a score line on both sides. Tablet size: approximately 19 mm x 8 mm. The score line on the tablet is intended to facilitate breaking for easier swallowing and is not intended for dividing the tablet into equal doses.

Febuxostat Krka is available in packs containing 14, 28, 56 or 84 film-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Norge
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 80

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom (Northern Ireland)
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu