Febuxostat Teva

Package leaflet: Information for the patient

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

Generic medicine
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Febuxostat Teva is and what it is used for
2. What you need to know before taking Febuxostat Teva
3. How to take Febuxostat Teva
4. Possible side effects
5. How to store Febuxostat Teva
6. Contents of the pack and other information

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

Febuxostat Teva contains the active substance febuxostat and is used to treat gout, a condition
associated with an excess of a chemical substance called uric acid (urate) in the body. In some
individuals, the amount of uric acid accumulating in the blood may become too high to remain
in solution. In such cases, urate crystals may form within and around the joints and kidneys.
These crystals can cause sudden, intense pain, redness, warmth, and swelling in a joint (an event known as a gout attack). If left untreated, larger deposits called tophi may form within and around the joints. Tophi can damage joints and bones.
Febuxostat Teva works by reducing uric acid levels. Maintaining low uric acid levels by taking Febuxostat Teva once daily prevents the accumulation of crystals and, over time, reduces symptoms. If uric acid levels are kept low for a sufficiently long period, existing tophi may even gradually dissolve.
Febuxostat Teva 120 mg is 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 and uric acid levels in the blood rise, unless the formation of this acid is prevented.
Febuxostat is for use in adults.

2. What you need to know before taking Febuxostat Teva

Do not take Febuxostat Teva:

• 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 Teva

• if you have or have had heart failure or other heart problems
• 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 allergic reactions to Febuxostat Teva occur, stop taking the medicine (see also section 4). Possible symptoms of allergic reactions may include:
• skin rash, including severe forms (e.g. blisters, nodules, itchy rash, exfoliative 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 Teva.

Rare, life-threatening skin rashes (Stevens-Johnson syndrome) have been reported during febuxostat treatment, initially appearing on the trunk as red, target-like spots or circular lesions, often with central blisters. These may also include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). The rash may progress to widespread blistering or skin peeling.
If you have developed Stevens-Johnson syndrome while taking febuxostat, treatment with febuxostat must not be restarted. If you develop a rash or these skin symptoms, consult your doctor immediately and inform them that you are being treated with this medicine.
If you are currently experiencing 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.
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 flare-ups even while taking febuxostat, especially during the first weeks or months of treatment. It is important that you continue taking febuxostat even during a flare-up, as febuxostat continues to work to lower your uric acid levels. If you continue taking febuxostat daily, over time flare-ups will occur less frequently and become less painful.
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 could cause xanthine accumulation in the urinary tract, potentially leading to kidney stones, although this has not been observed in patients treated with febuxostat for Tumor Lysis Syndrome.
Your doctor may order blood tests to monitor your 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 Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring 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 they may interact with Febuxostat Teva and your doctor may 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 are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is not known whether febuxostat may harm the fetus. Febuxostat must not be used during pregnancy. It is not known whether febuxostat passes into human breast milk. Do not take febuxostat if you are breastfeeding or intend to breastfeed.

Driving and use of machines
Be aware that you may experience dizziness, drowsiness, blurred vision, or numbness or tingling during treatment. If you experience these symptoms, do not drive or operate machinery.

Febuxostat Teva contains lactose
Febuxostat Teva contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Febuxostat Teva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Gout
Febuxostat Teva is available as 80 mg or 120 mg film-coated tablets. Your doctor will prescribe the dose most suitable for you.
The usual dose is one tablet daily.
Continue taking Febuxostat Teva every day, even if you do not have flare-ups or an attack of gout.

Prevention and treatment of high uric acid levels in patients undergoing chemotherapy
The usual dose is one 120 mg film-coated tablet daily.
Start taking Febuxostat Teva two days before starting chemotherapy and continue taking it as prescribed by your doctor. This is usually a short-term treatment.

Method of administration
Febuxostat Teva is for oral use.
The tablets can be taken regardless of food intake.

If you take more Febuxostat Teva than you should
In case of accidental overdose, contact your doctor or the nearest emergency department for advice.

If you forget to take Febuxostat Teva
If you forget to take a dose of Febuxostat Teva, 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 forgotten dose.

If you stop taking Febuxostat Teva
Do not stop treatment with Febuxostat Teva without consulting your doctor, even if you feel better. If you stop treatment with Febuxostat Teva, 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 further questions about the use of 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.

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, hypersensitivity to the drug (see also section 2 "Warnings and Precautions")
• potentially life-threatening skin rashes characterized by blistering and peeling of the skin and internal body surfaces, e.g. mouth and genitals, painful mouth and/or genital ulcers, 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
• rash (including various types of skin eruptions, see below under "uncommon" and "rare" sections)
• nausea
• worsening of gout symptoms
• localized swelling due to fluid retention in tissues (oedema)

Other side effects not mentioned above are listed below.
Uncommon side effects (may affect up to 1 in 100 people) are:

• decreased appetite, changes in blood sugar levels (diabetes), one symptom of which may be excessive thirst, increased blood lipid levels, weight gain
• loss of libido (sexual desire)
• difficulty sleeping, drowsiness
• dizziness, numbness, tingling, reduced or altered sense of touch (hypoesthesia, hemiparesis or paraesthesia), reduced or altered sense of taste (hypogeusia)
• abnormalities in 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, shortness of breath, chest pain or discomfort, inflammation of the nasal passage and/or throat (upper respiratory tract infection), bronchitis
• dry mouth, abdominal pain or discomfort or intestinal gas, heartburn/indigestion, constipation, more frequent defecation, vomiting, gastric discomfort
• itching, hives, skin inflammation, change in skin colour, small red or purple spots on the skin, small flat red spots on the skin, flat red area on the skin covered with small confluent bumps, skin rashes, areas of redness and spots on the skin, other skin disorders
• muscle cramps, muscle weakness, muscle or joint pain, bursitis or arthritis (inflammation of the joints usually accompanied by pain, swelling and/or stiffness), limb pain, back pain, muscle spasms
• blood in urine, increased frequency of urination, abnormal urine test results (elevated protein levels in urine), reduced kidney function
• fatigue, 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

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

• muscle damage, a condition which in rare cases may be severe. Muscle problems may develop and, in particular, if you also feel unwell or have a high fever, this could 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 lips, 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 redness (erythema), various types of skin eruptions (e.g. itching, with white spots, with blisters, with pus-filled blisters, with 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
• ringing in the ears
• blurred vision, double vision
• hair loss
• oral mucosal ulcers
• inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting
• increased sweating
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
• muscle and/or joint stiffness
• abnormally low levels of blood cells (white blood cells or red blood cells or platelets)
• urgency to urinate
• changes or reduced amount of urine due to kidney inflammation (tubulo-interstitial nephritis)
• liver inflammation (hepatitis)
• yellowing of the skin (jaundice)
• liver damage
• increased levels of creatine phosphokinase in the blood (an indicator of muscle damage)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Febuxostat Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle or blister pack, following "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 Teva contains

• The active substance is febuxostat.
  Febuxostat Teva 80 mg: Each film-coated tablet contains 80.00 mg of febuxostat (as febuxostat hemihydrate).
  Febuxostat Teva 120 mg: Each film-coated tablet contains 120.00 mg of febuxostat (as febuxostat hemihydrate).
• The other components are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, hydroxypropylcellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.
  Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

Description of the appearance of Febuxostat Teva and contents of the pack
The film-coated tablets of Febuxostat Teva are yellow, biconvex and capsule-shaped.
The 80 mg film-coated tablets are marked with the code "80" on one side and "A275" on the other side.
The 120 mg film-coated tablets are marked with the code "120" on one side and "A265" on the other side.
Pack sizes
PVC/PVDC//Al blisters
PVC/PCTFE/PVC//Al blisters
HDPE bottles with LDPE closure and desiccant (HDPE container containing silica gel).
10, 14, 28, 30, 42, 56, 84, 98 and 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturers
Actavis Ltd, BLB 016 Bulebel Industrial Estate, Zejtun, ZTN 3000, Malta
Teva Gyógyszerkészítő Zrt., Pallagi út 13, Debrecen, H-4042, Hungary
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg, 89143, Germany
Teva Pharma SLU, C/C, n. 4, Poligono Industrial Malpica, Zaragoza, 50016, Spain