Package leaflet: Information for the patient

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

Febuxostat
Generic medicine
Please read all of this leaflet carefully before you take 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 could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Alphabux is and what it is used for

Alphabux contains the active substance febuxostat and is used to treat gout, a condition associated with an excess of 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 this case, urate crystals may form in and around the 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 in and around the joints. Tophi can damage joints and bones.
Alphabux works by reducing uric acid levels. Maintaining low uric acid levels through once-daily administration of Alphabux prevents crystal formation and, over time, reduces symptoms. If uric acid levels are kept low for a sufficiently long period, tophi may even gradually dissolve.
Alphabux 120 mg tablets are also used for the treatment and prevention of 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 can be prevented.
Alphabux is for use in adults.

2. What you should know before taking Alphabux

Do not take Alphabux:

If you are allergic to febuxostat or to any of the other ingredients of this medicine (listed in section 6).

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Warnings and precautions
Talk to your doctor before taking Alphabux:

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 you experience allergic reactions to Alphabux, 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 skin rash), itching
Swelling of limbs or face
Difficulty breathing
Fever with swollen lymph nodes
As well as severe, life-threatening allergic conditions with cardiac and circulatory arrest.

Your doctor may decide to permanently discontinue treatment with Alphabux.
Rare, life-threatening skin rashes (Stevens-Johnson syndrome) have been reported with the use of Alphabux, 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 Alphabux 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 intense pain, tenderness, redness, warmth, and swelling in a joint), wait until the gout attack has resolved before starting treatment with Alphabux.
In some people, gout attacks may flare up at the beginning of certain therapies used to control uric acid levels. Not all people experience flares, but you may have a flare even while taking Alphabux, especially during the first weeks or months of treatment. It is important that you continue taking Alphabux even during a flare, as Alphabux continues to work to lower your uric acid levels. If you continue taking Alphabux daily, over time, flares will occur less frequently and become less painful.
Often, your doctor may prescribe additional medicines, if needed, to help prevent or treat flare symptoms (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 stone formation, although this has not been observed in patients treated with Alphabux for Tumor Lysis Syndrome.
Your doctor may prescribe blood tests to monitor that your liver is functioning normally.
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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 Alphabux
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 Alphabux 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, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether Alphabux can harm the fetus. Alphabux must not be used during pregnancy. It is not known whether Alphabux passes into breast milk. You must not take Alphabux 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; if so, you must not drive or operate machinery.
Alphabux contains lactose
Alphabux contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Alphabux

Always take this medicine exactly as directed by your doctor. If you have any doubts, you should
consult your doctor or pharmacist.
Gout
Alphabux is available as 80 mg or 120 mg film-coated tablets. Your doctor will prescribe the dosage
most suitable for you.
The usual dose is one tablet daily.
Continue taking Alphabux 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 tablet daily.
Start taking Alphabux two days before chemotherapy begins and continue taking it as advised by
your doctor. Treatment is usually of short duration.
Method of administration
Alphabux is for oral use.
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The tablets may be taken with or without food.
The back of the blister shows the days of the week to help you keep track of whether you have taken
your daily dose.
If you take more Alphabux than you should
In case of accidental overdose, contact your doctor or the nearest emergency department for advice.
If you forget to take Alphabux
If you forget to take a dose of Alphabux, 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 the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If you stop taking Alphabux
Do not stop treatment with Alphabux without consulting your doctor, even if you feel better.
If you stop taking Alphabux, your uric acid levels may start 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 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 these could be signs of a severe allergic reaction:

anaphylactic reactions, drug hypersensitivity (see also section 2 “Warnings and precautions”)
skin rashes that may be life-threatening, characterised 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) are:

abnormal 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).

Other side effects not listed above are listed below.
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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
dizziness, numbness, tingling, reduced or altered sense of touch (hypoesthesia, hemiparesis or paraesthesia), reduced or altered sense of taste (hypogeusia)
abnormalities in ECG readings, 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, inflammation of the nasal passage and/or throat (respiratory tract infection), bronchitis
dry mouth, abdominal pain or discomfort, excessive intestinal gas, heartburn/dyspepsia, 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, red area 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 (increased levels of protein 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, enlarged liver, 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, 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 5/7
blurred vision, changes in vision
hair loss
mouth 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 reduction in 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 (an indicator 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 the following website:
http://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 Alphabux

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 Alphabux contains
The active substance is febuxostat.
Alphabux 80 mg: each tablet contains 80 mg of febuxostat.
Alphabux 120 mg: each tablet contains 120 mg of febuxostat.
The other excipients are:
Tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,
hydroxypropylcellulose, poloxamer 407, anhydrous colloidal silica, magnesium stearate.
Film coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171),
macrogol 4000, talc, yellow iron oxide (E172).

Description of the appearance of Alphabux and package contents
Alphabux film-coated tablets are yellow, oblong, biconvex, film-coated tablets.
The 80 mg film-coated tablets are marked on one side with ‘80’.
The 120 mg film-coated tablets are marked on one side with ‘120’.
Alphabux is packaged in PVC/PCTFE-Aluminum blisters containing 14 tablets or in PVC/PVDC-Aluminum blisters containing 14 tablets.
Alphabux is available in packs of 28 and 84 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via Dei Castelli Romani, 22
00071 Pomezia (Rome)
Italy

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