Febuxostat Sandoz

Patient Information Leaflet

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

Generic medicine
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. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Febuxostat Sandoz tablets contain the active substance febuxostat and are used to treat
gout, a condition associated with an excess of 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 joints and 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 joints.
Tophi can damage joints and bones.
Febuxostat Sandoz works by reducing uric acid levels. Maintaining low uric acid levels
by taking Febuxostat Sandoz 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 resolve.

Febuxostat Sandoz 120 mg:
Febuxostat Sandoz 120 mg film-coated tablets are also used for the treatment and
prevention of elevated 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 formation of this acid is prevented.
Febuxostat Sandoz is for use in adults.

2. What you should know before taking Febuxostat Sandoz

Do not take Febuxostat Sandoz:
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 Sandoz:

• • 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 thyroid problems.

If you experience allergic reactions to Febuxostat Sandoz, stop treatment with 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 Sandoz.
Rare, life-threatening skin rashes (Stevens-Johnson syndrome) have been reported with the use of febuxostat,
initially appearing on the trunk as reddish 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 using febuxostat, treatment with
Febuxostat Sandoz 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 Sandoz.
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 still have a flare-up even while taking Febuxostat Sandoz, especially during the first weeks or months of treatment. It is important that you continue taking Febuxostat Sandoz even during a flare-up, as Febuxostat Sandoz continues to work to lower your uric acid levels. If you continue taking Febuxostat Sandoz daily, over time, flare-ups will occur less frequently and become less painful.
Often, your doctor will 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, possibly leading to stone formation, although this has not been observed in patients treated with Febuxostat Sandoz for Tumor Lysis Syndrome.
Your doctor may prescribe blood tests to monitor that your liver is functioning normally.

Children and adolescents
Do not administer this medicine to children under 18 years of age, as safety and efficacy have not been established.

Other medicines and Febuxostat Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 Sandoz and your doctor may wish to consider appropriate measures:

• • Mercaptopurine (used to treat cancer)
• • Azathioprine (used to reduce immune response)
• • Theophylline (used to treat asthma)

Pregnancy and breastfeeding
It is unknown whether Febuxostat Sandoz may harm the fetus. Febuxostat Sandoz must not be
used during pregnancy. It is unknown whether Febuxostat Sandoz passes into breast milk. You must not
take Febuxostat Sandoz if you are breastfeeding or plan to breastfeed.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Be aware that you may experience dizziness, drowsiness, blurred vision,
numbness or tingling during treatment; in such cases, you must not drive or operate machinery.

Febuxostat Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.

Febuxostat Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Febuxostat Sandoz

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

• • The usual dose is one tablet daily. The back of the blister shows the days of the week to help you keep track of having taken your daily dose.
• • The tablets are taken orally and may be taken with or without food.

For the treatment of gout
Febuxostat Sandoz is available as 80 mg or 120 mg tablets. Your doctor will have prescribed the most appropriate dose for you.
Continue taking Febuxostat Sandoz every day, even if you are not experiencing flare-ups or a gout attack.

Febuxostat Sandoz 120 mg:
For the prevention and treatment of high levels of uric acid in patients undergoing
chemotherapy
Febuxostat Sandoz is available as 120 mg tablets.
Start taking Febuxostat Sandoz two days before beginning chemotherapy and continue taking it as advised by your doctor. Treatment is usually of short duration.

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

If you forget to take Febuxostat Sandoz
If you forget to take a dose of Febuxostat Sandoz, 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 one at the scheduled time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Febuxostat Sandoz
Do not stop treatment with Febuxostat Sandoz without consulting your doctor, even if you feel better. If you stop taking Febuxostat Sandoz, your uric acid levels may begin 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 how to use 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 room if you experience any of the following rare side effects (may affect up to 1 in 1,000 people), as they may indicate a severe allergic reaction:

• • anaphylactic reactions, drug hypersensitivity (see also section 2 "Warnings and Precautions")
• • skin rashes that may be life-threatening, 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, enlarged liver, 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):

• • abnormal liver function test results
• • diarrhea
• • headache
• • rash (including various types of skin rashes, see below in the "uncommon" and "rare" sections)
• • nausea
• • worsening of gout symptoms
• • localized swelling due to fluid retention in tissues (edema)

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

• • decreased appetite, changes in blood glucose levels (diabetes), of which a symptom may be excessive thirst, increased blood fat levels, weight gain
• loss of libido (sexual desire)
• • difficulty sleeping, drowsiness
• • dizziness, numbness, tingling, reduced or altered tactile sensation (hypoesthesia, hemiparesis or paresthesia), reduced or altered sense of taste, reduced sense of smell (hyposmia)
• • abnormal ECG readings, irregular or rapid heartbeat, awareness of heartbeat (palpitations)
• • hot flushes or flushing (e.g. redness of face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients undergoing chemotherapy for blood disorders)
• • cough, shortness of breath, inflammation of nasal passage and/or throat (respiratory tract infection), bronchitis
• • dry mouth, abdominal pain or discomfort, excessive intestinal gas, heartburn/indigestion, constipation, more frequent defecation, vomiting, gastric discomfort
• • itching, hives, skin inflammation, skin color changes, small red or purple spots on the skin, small flat red spots on the skin, red areas of 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 (joint inflammation 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):

• • muscle damage, a condition which in rare cases may be serious. 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 causing sudden breathing difficulties
• • high fever associated with a measles-like skin rash, swollen lymph nodes, enlarged liver, hepatitis (up to liver failure), increased white blood cell count (leukocytosis, with or without eosinophilia)
• • skin redness (erythema), various types of skin rash (e.g. itching, white spots, blisters, pustular blisters, skin peeling, measles-like rash), diffuse 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, change in vision
• • hair loss
• • oral ulceration
• • 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 decreased urine output due to kidney inflammation (tubulo-interstitial nephritis)
• • liver inflammation (hepatitis)
• • yellowing of the skin (jaundice)
• • liver damage
• • increased blood levels of creatine phosphokinase (a marker of muscle damage)

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 national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Febuxostat Sandoz

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 Sandoz contains

• The active substance is febuxostat.
  Febuxostat Sandoz 80 mg film-coated tablets
  Each film-coated tablet contains 80 mg of febuxostat (as hemihydrate).

Febuxostat Sandoz 120 mg film-coated tablets
Each film-coated tablet contains 120 mg of febuxostat (as hemihydrate).

• The other ingredients (excipients) are:
  Core: lactose monohydrate, microcrystalline cellulose (E460), hydroxypropylcellulose (E463), sodium croscarmellose, anhydrous colloidal silica (E551), magnesium stearate (E470b).

Coating:
polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol 3350 (E1521), copolymer of methacrylic acid and ethyl acrylate (1:1) (Type A), yellow iron oxide (E172), sodium hydrogen carbonate (E500(ii)).

Description of the appearance of Febuxostat Sandoz and contents of the pack
Febuxostat Sandoz 80 mg film-coated tablet:
Pale yellow to yellow, film-coated, capsule-shaped tablet, marked “80” on one side and flat on the other, with dimensions of 16.5 mm x 7.0 mm.

Febuxostat Sandoz 120 mg film-coated tablet:
Pale yellow to yellow, film-coated, capsule-shaped tablet, marked “120” on one side and flat on the other, with dimensions of 18.5 mm x 9.0 mm.

Febuxostat Sandoz 80 mg and 120 mg film-coated tablets are packaged in blisters made of Aluminium-OPA/Al/PVC or Aluminium-PVC/PE/PVDC.

Febuxostat Sandoz 80 mg and 120 mg are available in the following pack sizes: 14, 28, 30, 42, 56, 84 and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturers
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area,
Larisa, 41004, Greece
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
Sachsen-Anhalt, 39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana, Slovenia

This medicinal product is authorized in the European Economic Area countries under the following names:

Febuxostat Sandoz 80 mg – Filmtabletten
Austria
Febuxostat Sandoz 120 mg – Filmtabletten

Febuxostat Sandoz 80 mg filmomhulde tabletten
Belgium
Febuxostat Sandoz 120 mg filmomhulde tabletten

FEBUXOSTAT SANDOZ 80 mg, comprimé pelliculé
France
FEBUXOSTAT SANDOZ 120 mg, comprimé pelliculé

Febuxostat HEXAL 80 mg Filmtabletten
Germany
Febuxostat HEXAL 120 mg Filmtabletten

Greece Febuxostat/Sandoz

Ireland Febuxostat Rowex 80 mg & 120 mg Film-coated tablets

Italy Febuxostat Sandoz

Febuxostat Sandoz 80 mg, filmomhulde tabletten
Netherlands
Febuxostat Sandoz 120 mg, filmomhulde tabletten

Czech Republic
Febuxostat Sandoz

Slovakia
Febuxostat Sandoz 80 mg
Febuxostat Sandoz 120 mg

Febuxostat Sandoz 80 mg comprimidos recubiertos con película EFG
Spain
Febuxostat Sandoz 120 mg comprimidos recubiertos con película EFG

Febuxostat Sandoz 80 mg filmtabletta
Hungary
Febuxostat Sandoz 120 mg filmtabletta