Patient Information Leaflet

GOTTART 80 mg film-coated tablets, 120 mg film-coated tablets

Febuxostat
Equivalent medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What GOTTART is and what it is used for
What you need to know before taking GOTTART
How to take GOTTART
Possible side effects
How to store GOTTART
Contents of the pack and other information

1. What GOTTART is and what it is used for

GOTTART 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 people, the amount of uric acid accumulating in the blood may become too high to
remain dissolved. In such cases, urate crystals may form within and around joints and kidneys.
These crystals can cause sudden, intense pain, redness, warmth, and swelling in a joint
(gout attack). If left untreated, larger deposits called tophi may form within and around joints.
Tophi can damage joints and bones.
GOTTART works by reducing uric acid levels. Maintaining low uric acid levels through daily
administration of GOTTART once a day prevents crystal accumulation and, over time,
reduces symptoms. If uric acid levels are kept low for a sufficiently long period, existing tophi
may even be reabsorbed.
GOTTART 120 mg tablets are also used for the treatment and prevention of elevated blood
uric acid levels 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.
GOTTART is for use in adults.

2. What you need to know before taking GOTTART

Do not take GOTTART:

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 GOTTART:

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 GOTTART, 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 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 GOTTART.

Rare, life-threatening skin rashes (Stevens-Johnson syndrome) have been reported with the use of febuxostat, appearing initially 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 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 flare up at the beginning of certain treatments used to control uric acid levels. Not everyone experiences flare-ups, but you may experience one 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.
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 may lead to xanthine accumulation in the urinary tract, possibly 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 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 GOTTART
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 they may interact with GOTTART and your doctor may need to take appropriate measures:

Mercaptopurine (used to treat cancer)
Azathioprine (used to suppress the immune response)
Theophylline (used to treat asthma).

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

3. How to take GOTTART

Take this medicine exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Gout
GOTTART is available as film-coated tablets of 80 mg or 120 mg. Your doctor will
prescribe the dosage most suitable for you.
The recommended dose is one tablet daily.
Continue taking GOTTART every day, even in the absence of flare-ups or gout attacks.
Prevention and treatment of elevated uric acid levels in patients undergoing
chemotherapy
The recommended dose is one 120 mg tablet daily.
Start taking GOTTART two days before beginning chemotherapy and continue taking it
as advised by your doctor. Treatment is usually of short duration.
Method of administration
GOTTART is for oral use.
The tablets can be taken with or without food.
If you take more GOTTART than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest
emergency department.
If you forget to take GOTTART
If you forget to take a dose of GOTTART, 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 GOTTART
Do not stop treatment with GOTTART without consulting your doctor, even if you feel
better. If you stop treatment with GOTTART, your uric acid levels may start to rise 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 room if you experience the following rare side effects (may affect up to 1 in 1,000 people), as a severe allergic reaction may follow:

anaphylactic reactions, drug hypersensitivity (see also section 2 “Warnings and Precautions”)
skin rashes that may be life-threatening, characterized by blister formation and skin peeling, as well as peeling of internal body surfaces such as 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 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) are:

abnormalities in liver function test results
diarrhoea
headache
rash (including various types of skin eruptions, 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 or joint pain
fatigue.

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 fat levels, weight gain
loss of sexual desire
difficulty sleeping, drowsiness
numbness, tingling, reduced or altered sense of touch (hypoesthesia, hemiparesis or paraesthesia), altered taste, reduced sense of smell (hyposmia)
abnormalities in ECG tracings, irregular or rapid heartbeat, awareness of heartbeat (palpitations)
hot flushes or flushing (e.g. redness of face or neck), increased blood pressure, bleeding (haemorrhage, observed only in patients undergoing chemotherapy for blood disorders)
cough, chest pain, inflammation of nasal passage and/or throat (respiratory tract infection), bronchitis, lower respiratory tract infection
dry mouth, abdominal pain or discomfort, excess intestinal gas, upper abdominal pain, heartburn/dyspepsia, constipation, more frequent defecation, vomiting, gastric discomfort
itching, hives, skin inflammation, skin colour changes, 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, 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, abnormalities in 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, change in vision
ringing in the ears
runny nose
mouth ulceration
pancreatitis: common symptoms are abdominal pain, nausea and vomiting
urgency to urinate
pain
malaise
increased INR (a measure of blood clotting)
bruising
swelling of the lips.

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 particularly 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 the deeper layers of the skin, especially around the eyes, genitals, hands, feet or tongue, possibly with sudden difficulty breathing
high fever associated with measles-like skin rash, swollen lymph nodes, enlarged liver, 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, pus-filled blisters, 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 red blood cell count (anaemia)
depression
sleep disorders
loss of taste
burning sensation
vertigo
circulatory failure
lung infection (pneumonia)
mouth ulceration, mouth inflammation
gastrointestinal perforation
rotator cuff syndrome
polymyalgia rheumatica
feeling 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 national reporting system at the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store GOTTART

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, on the vial, and on the 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 GOTTART contains

The active substance is febuxostat.
GOTTART 80 mg: Each film-coated tablet contains 80 mg of febuxostat
(as febuxostat dihydrate).
GOTTART 120 mg: Each film-coated tablet contains 120 mg of febuxostat
(as febuxostat dihydrate).
The other ingredients (excipients) are:
Tablet core: microcrystalline cellulose, lactose monohydrate, 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 GOTTART and package contents
GOTTART film-coated tablets are yellow, biconvex and oblong.
The 80 mg film-coated tablets are marked with ‘80’ on one side and ‘A275’ on the other.
The 120 mg film-coated tablets are marked with ‘120’ on one side and ‘A265’ on the other.
Packaging
PVC/PVDC/Aluminum blisters
28 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F Group Srl
Via Tiburtina, 1143
00156 Rome
Italy
Manufacturers
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun
ZTN 3000 - Malta
Teva Gyógyszergyár Zrt.
Pallagi ut 13
Debrecen 4042
Hungary

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