Febuxostat PensA

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Febuxostat
Equivalent medicinal product
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 may be harmful.
• If any adverse effect occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4. Contents of this leaflet:

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

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

Febuxostat Pensa 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 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 Pensa works by reducing uric acid levels. Maintaining low uric acid levels
through daily administration of Febuxostat Pensa prevents the accumulation of crystals and, over time, reduces symptoms. If uric acid levels are kept low for a sufficiently long period, tophi may even gradually regress.
Febuxostat Pensa 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 and uric acid levels in the blood rise, unless
the formation of this acid is prevented.
Febuxostat Pensa is for use in adults.

2. What you should know before taking Febuxostat Pensa

Do not take Febuxostat Pensa:
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 Pensa:
If you have or have had heart failure or other heart problems or heart attack
If you have or have had kidney disease and/or severe allergic reactions to allopurinol (a medicine used
for the treatment of gout)
If you have or have had liver disease or abnormalities in 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 Pensa occur, 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
• Breathing difficulties
• Fever with swollen lymph nodes
• Severe, life-threatening allergic conditions with cardiac and circulatory arrest.

Your doctor may decide to permanently discontinue treatment with Febuxostat Pensa.
Rare, life-threatening skin rashes (Stevens-Johnson syndrome) have been reported with the use of
Febuxostat Pensa, appearing initially on the trunk as reddish spots 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 using febuxostat, treatment with Febuxostat
Pensa 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 Pensa.

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 even while taking
Febuxostat Pensa, especially during the first weeks or months of treatment. It is important that you
continue taking Febuxostat Pensa even during a flare-up, as Febuxostat Pensa continues to work to
lower your uric acid levels. If you continue taking Febuxostat Pensa daily, over time, flare-ups will
occur less frequently and become less painful.

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 cause xanthine accumulation in the urinary tract, potentially
leading to stone formation, although this has not been observed in patients treated with Febuxostat
Pensa for Tumor Lysis Syndrome.

Your doctor may prescribe blood tests to monitor whether 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 Pensa
Inform 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 these may interact with Febuxostat Pensa and your doctor may
wish to take 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, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
It is not known whether Febuxostat Pensa may harm the unborn baby. Febuxostat Pensa must not be
used during pregnancy. It is not known whether Febuxostat Pensa passes into breast milk. You must
not take Febuxostat Pensa 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, and in such cases, you must not drive or operate machinery.

Important information about some excipients:
Febuxostat Pensa contains lactose (a type of sugar). If your doctor has diagnosed you with an
intolerance to certain sugars, contact them before taking this medicine.
Febuxostat Pensa contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Febuxostat Pensa

Febuxostat Pensa is for oral use
Always take this medicine exactly as instructed by your doctor. If you have any doubts, you must
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 whether you have taken your daily dose.
• The tablets should be taken by mouth. They can be taken with or without food.

Gout
Febuxostat Pensa is available as film-coated tablets of 80 mg or 120 mg. Your doctor will have prescribed the dosage most suitable for you.
The usual dose is one tablet daily.
Continue taking Febuxostat Pensa every day, even in the absence of flare-ups or a gout attack.
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 Pensa 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 Pensa than you should
In case of accidental overdose, contact your doctor for advice or go to the nearest emergency department immediately.
If you forget to take Febuxostat Pensa
If you forget to take a dose of Febuxostat Pensa, 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 Pensa
Do not stop treatment with Febuxostat Pensa without consulting your doctor, even if you feel better. If you stop treatment with Febuxostat Pensa, your uric acid levels may begin to rise and your symptoms may worsen due to the formation of new urate crystals within 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 everyone experiences 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 they may indicate a severe 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 mucosal 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 rash

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

• Abnormal liver function test results
• Diarrhea
• 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 (edema)

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 libido (sexual desire)
• Difficulty sleeping, drowsiness
• Dizziness, numbness, tingling, reduced or altered sense of touch (hypoesthesia, hemiparesis, or paresthesia), reduced or altered taste, reduced sense of smell (hyposmia)
• Abnormal ECG findings, irregular or rapid heartbeat, awareness of heartbeat (palpitations)
• Hot flushes or redness (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, inflammation of the nasal passage and/or throat (respiratory tract infection), bronchitis
• Dry mouth, abdominal pain/discomfort, excess intestinal gas, heartburn/indigestion, constipation, more frequent bowel movements, vomiting, stomach discomfort
• Itching, hives, skin inflammation, skin color changes, small red or purple spots on the skin, flat red spots on the skin, red area of skin covered with small merging 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) are:

• 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 could be due to abnormal breakdown of muscle cells. Contact your doctor immediately if you experience muscle pain, tenderness, or marked weakness
• Marked swelling of the deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet, or tongue, possibly with sudden difficulty breathing
• High fever associated with 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), skin eruptions of various types (e.g., itching, 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
• Ringing in the ears
• Blurred vision, changes 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 reduced urine output due to kidney inflammation (tubulo-interstitial nephritis)
• Inflammation of the liver (hepatitis)
• Yellowing of the skin (jaundice)
• Liver damage
• Increased blood levels of creatine phosphokinase (a marker of muscle damage)
• Sudden cardiac death

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://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 Pensa

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 the 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 Pensa contains
The active substance is febuxostat.
Febuxostat Pensa 80 mg: Each film-coated tablet contains 80 mg of febuxostat.
Febuxostat Pensa 120 mg: Each film-coated tablet contains 120 mg of febuxostat.
The excipients are:
Tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,
hydroxypropylcellulose, poloxamer 407, anhydrous colloidal silica, magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc,
yellow iron oxide (E172).

Description of the appearance of Febuxostat Pensa and package contents
Febuxostat Pensa film-coated tablets are yellow, oblong, and biconvex.
The 80 mg film-coated tablets have the number '80' engraved on one side.
The 120 mg film-coated tablets have the number '120' engraved on one side.
Febuxostat Pensa is packaged in blisters (PVC/PCTFE/Aluminum or PVC/PVDC/Aluminum)
containing 14 tablets.
Febuxostat Pensa is available in packs containing 28 and 84 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12
20124 Milano
Italy

Manufacturer
Bluepharma Indústria Farmacêutica, S.A.
S. Martinho do Bispo
3045-016 Coimbra
Portugal

This Patient Information Leaflet was last revised on