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1. FEBUXOSTAT DOC Generici 80 mg film-coated tablets
   1. What is FEBUXOSTAT DOC Generici and what it is used for
   2. What you need to know before taking FEBUXOSTAT DOC Generici
   3. How to take FEBUXOSTAT DOC Generici
   4. Possible side effects
   5. How to store FEBUXOSTAT DOC Generici
   6. Contents of the pack and other information
2. FEBUXOSTAT DOC Generici is available in packs of 28 film-coated tablets.

FEBUXOSTAT DOC Generici 80 mg film-coated tablets

FEBUXOSTAT DOC Generici 120 mg film-coated tablets
Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is FEBUXOSTAT DOC Generici and what it is used for

FEBUXOSTAT DOC Generici tablets contain the active ingredient febuxostat and
are used to treat gout, a disease associated with an excess of uric acid (urate)
in the body. In some people, the amount of uric acid that accumulates in the blood can
become too high to remain in solution. In this case, urate crystals can form
inside and around the joints and kidneys. These crystals can cause intense and sudden pain,
redness, a feeling of heat and swelling in a
joint (gout attack). If left untreated, larger deposits, called tophi, can form
inside and around the joints. Tophi can damage the joints and the
bones.
FEBUXOSTAT DOC Generici works by reducing uric acid levels. Maintaining
low levels of uric acid by taking FEBUXOSTAT DOC Generici once a
day prevents the accumulation of crystals, and over time reduces symptoms. If uric acid
levels are kept low for a sufficient length of time, tophi can also
be reabsorbed.

FEBUXOSTAT DOC Generici 120 mg
FEBUXOSTAT DOC Generici 120 mg film-coated tablets are also used for the
treatment and prevention of elevated blood uric acid levels that can occur in
the case of chemotherapy for blood cancers.
During chemotherapeutic treatment, cancer cells are destroyed and uric acid levels in the blood increase, unless the formation of this acid can be prevented.
FEBUXOSTAT DOC Generici is for adults.

2. What you need to know before taking FEBUXOSTAT DOC Generici

Do not take FEBUXOSTAT DOC Generici:
If you are allergic to febuxostat or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor before taking FEBUXOSTAT DOC Generici:

• If you suffer from or have suffered from 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 problems with your thyroid.

If you experience allergic reactions to FEBUXOSTAT DOC Generici, stop
taking the medicine (see also section 4). Possible symptoms of allergic reactions may be:

• skin rash including severe forms (e.g. blisters, nodules, itchy rash, exfoliating skin rash), itching
• swelling of the limbs or face
• difficulty breathing
• fever with enlarged lymph nodes
• but also severe life-threatening allergic conditions with cardiac and circulatory arrest. Your doctor may decide to permanently discontinue treatment with FEBUXOSTAT DOC Generici.

With the use of FEBUXOSTAT DOC Generici, rare skin rashes (Stevens-Johnson syndrome) have been reported that have put the patient's life in danger, which appeared on the
trunk initially as reddish spots or circular spots often with central blisters.
They may also include ulcers in the mouth, throat, nose, genitals and conjunctivitis
(red and swollen eyes). The rash may progress to widespread blisters or peeling of the
skin.
If you develop Stevens-Johnson syndrome with the use of febuxostat, treatment with
FEBUXOSTAT DOC Generici should no longer be resumed. If you develop a rash or these
skin symptoms, consult your doctor immediately and tell them that you are taking this
medicine.
If you currently have a gout attack (sudden onset of intense pain, tenderness,
redness, heat and swelling in a joint), wait for the end of the gout attack before starting therapy with FEBUXOSTAT DOC Generici.
In some people, gout attacks may worsen at the beginning of certain therapies used
to control uric acid levels. Not everyone experiences exacerbations, but you
may experience an exacerbation even while taking FEBUXOSTAT DOC Generici,
especially during the first weeks or months of therapy. It is important that you continue to
take FEBUXOSTAT DOC Generici even in the presence of an exacerbation, as
FEBUXOSTAT DOC Generici continues to work to lower your uric acid level. If
you continue to take FEBUXOSTAT DOC Generici every day, over time, the
exacerbations will occur less frequently and will be less painful.
Your doctor will often prescribe other medicines, if necessary, to help prevent or treat
the symptoms of exacerbations (such as pain and swelling in a joint).
In patients with very high urate levels (e.g. patients undergoing chemotherapy), treatment
with drugs that lower uric acid levels may cause xanthine to accumulate in the
urinary tract with possible formation of stones, although this has not been observed in
patients treated with FEBUXOSTAT DOC Generici for Tumor Lysis Syndrome.
Your doctor may prescribe blood tests to check that your liver is functioning
normally.

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

Other medicines and FEBUXOSTAT DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken, or may
take any other medicines, including those available without a prescription.
It is very important that you tell your doctor or pharmacist if you are taking a medicine that
contains any of the following substances, as these may interact with
FEBUXOSTAT DOC Generici and your doctor may want to take appropriate
measures:

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

Pregnancy and breastfeeding
It is not known whether FEBUXOSTAT DOC Generici can harm the fetus. FEBUXOSTAT DOC
Generici should not be used during pregnancy. It is not known whether FEBUXOSTAT DOC
Generici passes into breast milk. Do not take FEBUXOSTAT DOC Generici if you are
breastfeeding or intend to do so.
If you are pregnant, suspect or are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

Driving and operating machinery
Be aware that you may experience dizziness, drowsiness, blurred vision
numbness or tingling during treatment and in such cases, in the presence of these symptoms,
you should not drive vehicles or operate machinery.

FEBUXOSTAT DOC Generici contains lactose
The tablets of FEBUXOSTAT DOC Generici contain lactose (a type of sugar). If your
doctor has told you that you are intolerant to some sugars, talk to your doctor before
taking this medicine.

3. How to take FEBUXOSTAT DOC Generici

Always take this medicine exactly as your doctor has told you. If you have any
doubts, ask your doctor or pharmacist.

• The usual dose is one tablet a day. The back of the blister shows the days of the week to help you check that you have taken the dose each day.
• The tablets can be taken with or without food.

Gout
FEBUXOSTAT DOC Generici is available as 80 mg or 120 mg tablets.
Your doctor will have prescribed the dosage most suitable for you.
Continue to take FEBUXOSTAT DOC Generici every day, even if you do not have
flare-ups or a gout attack.

FEBUXOSTAT DOC Generici 120 mg.

Prevention and treatment of high uric acid levels in patients undergoing

chemotherapy
FEBUXOSTAT DOC Generici is available in 120 mg tablets.
Start taking FEBUXOSTAT DOC Generici two days before chemotherapy and
continue to take it as advised by your doctor. Usually, the use is short-term.

If you take more FEBUXOSTAT DOC Generici than you should
If you accidentally take too much, contact your doctor for advice or go to the nearest
emergency room.

If you forget to take FEBUXOSTAT DOC Generici
If you forget to take a dose of FEBUXOSTAT DOC Generici, take it as soon as you
remember, unless it is almost time for your next dose. In this case, skip the missed dose and
take your next dose at the usual time. Do not take a double dose to make up for a forgotten
dose.

If you stop taking FEBUXOSTAT DOC Generici
Do not stop taking FEBUXOSTAT DOC Generici without your doctor's consent, even if you
feel better. If you stop taking FEBUXOSTAT DOC Generici, your uric acid levels may start to
rise and your symptoms may worsen due to the formation of new urate crystals inside and
around your joints and kidneys.
If you have any further questions on 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 everyone will experience them.
Stop treatment with the medicine and immediately contact your doctor or go to the nearest
emergency room if you experience the following rare side effects (may affect up to 1 in 1,000 people), as a serious allergic reaction may follow:

• anaphylactic reactions, hypersensitivity to the drug (see also section 2 "Warnings and Precautions")
• skin rashes that can be life-threatening, characterized by the formation of blisters and peeling of the skin and internal surfaces of the body cavities, such as the mouth and genitals, painful ulcers in the mouth and/or genital area, accompanied by fever, sore throat and fatigue (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis), or enlarged lymph nodes, enlarged liver, hepatitis (up to liver failure), increased white blood cell count in the blood (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):

• abnormalities in liver function tests
• diarrhea
• headache
• rash (including various types of skin eruptions, see below in the "uncommon" and "rare" paragraphs)
• nausea
• increased gout symptoms
• localized swelling due to fluid retention in the tissues (edema)

Other side effects that are not mentioned above are listed below.

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 levels of fats in the blood, weight gain
• loss of libido (sexual desire)
• difficulty sleeping, drowsiness
• dizziness, numbness, tingling, reduced or altered sense of touch (hypoesthesia, hemiparesis or paresthesia), reduced or altered sense of taste (hyposmia)
• abnormalities in ECG traces, irregular or rapid heartbeat, perception of heartbeat (palpitations)
• hot flashes or redness (e.g. flushing of the face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients undergoing chemotherapy for blood disorders)
• cough, shortness of breath, chest pain, inflammation of the nasal passage and/or throat (upper respiratory tract infection), bronchitis
• dry mouth, abdominal pain or discomfort, excessive intestinal gas, heartburn/indigestion, constipation, more frequent bowel movements, vomiting, gastric discomfort
• itching, urticaria, skin inflammation, change in skin color, small red or purple spots on the skin, small 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, 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), pain in the extremities, back pain, muscle spasms
• blood in urine, increased frequency of urination, abnormalities in test results

on urine (increased levels of protein in urine) decreased ability of the kidneys
to function properly

• fatigue, chest pain, chest discomfort
• gallstones or bile duct stones (cholelithiasis)
• increased levels in the blood of thyroid-stimulating hormone (TSH)
• changes in biochemical blood tests or red blood cell or platelet counts (alteration of blood test results)
• kidney stones
• difficulty achieving an erection

Rare side effects (may affect up to 1 in 1000 people):

• muscle damage, a condition that can rarely be severe. Muscle problems may develop and, in particular, if at the same time you do not feel well or have a high fever, this could be a consequence of an abnormal breakdown of muscle cells. Contact your doctor immediately if you experience muscle pain, soreness or weakness
• marked swelling of the deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet or tongue, with possible sudden difficulty breathing
• high fever associated with measles-like skin rash, enlarged lymph nodes, enlarged liver, hepatitis (up to liver failure), increased white blood cell count (leukocytosis, associated or not with eosinophilia)
• redness of the skin (erythema), rash in various types (e.g. itching, with white spots, with blisters, with blisters containing pus, with peeling of the skin, measles-like rash), widespread erythema, necrosis and blistering detachment of the epidermis and mucous membranes, resulting in exfoliation and possible sepsis (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis)
• nervousness
• thirst
• ringing in the ears
• blurred vision, change in vision
• hair loss
• mouth ulceration
• inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting
• increased sweating
• weight loss, increased appetite, 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 decrease in amount in urine due to inflammation in the kidneys (tubulo-interstitial nephritis)
• inflammation of the liver (hepatitis)
• yellowing of the skin (jaundice)
• liver damage
• increased level of creatine phosphokinase in the blood (an indicator of muscle damage)

If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly
through 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 DOC Generici

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is 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 any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FEBUXOSTAT DOC Generici contains
The active ingredient is febuxostat.
FEBUXOSTAT DOC Generici 80 mg film-coated tablet
Each film-coated tablet contains 80 mg of febuxostat (as hemihydrate).
The excipients are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460),
hydroxypropylcellulose (E463), sodium croscarmellose, anhydrous colloidal silica (E551), magnesium
stearate (E470b).

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

Appearance of FEBUXOSTAT DOC Generici and contents of the pack

FEBUXOSTAT DOC Generici 80 mg film-coated tablets
Film-coated tablets, from yellow to pale yellow in colour, capsule-shaped, and with “80”
imprinted on one side, with dimensions 16.5 mm x 7.0 mm.

FEBUXOSTAT DOC Generici 120 mg film-coated tablets
Film-coated tablets, from yellow to pale yellow in colour, capsule-shaped, and with
“120” imprinted on one side, with dimensions 18.5 mm x 9.0 mm.
FEBUXOSTAT DOC Generici 80 mg and 120 mg film-coated tablets are packaged in blisters
Al-OPA/Al/PVC or Al-PVC/PE/PVDC.

FEBUXOSTAT DOC Generici is available in packs of 28 film-coated tablets.

It is possible that not all packs are marketed.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy.

Manufacturer
Rontis Hellas Medical and Pharmaceutical Products S.A. - P.O. Box 3012 Larisa Industrial
Area, Larisa, 41004 – Greece.

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Hungary: Febuxostat Doc Generici 80 mg, 120 mg film-coated tablet
Italy: FEBUXOSTAT DOC Generici