ALPHABUX 80 mg Фильм-Coated Таблетки

Содержание инструкции

1. Alphabux 80 mg film-coated tablets, 120 mg film-coated tablets
   1. What is Alphabux and what it is used for
   2. What you need to know before taking Alphabux
   3. How to take Alphabux
   4. Possible side effects
   5. How to store Alphabux
   6. Contents of the pack and other information

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

Febuxostat
Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Alphabux and what it is used for

Alphabux contains the active substance febuxostat and is 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 bones.
Alphabux works by reducing uric acid levels. Maintaining low uric acid levels by taking Alphabux once
a day prevents the accumulation of crystals, and over time reduces symptoms. If uric acid levels are
kept low for a sufficiently long time, tophi can also be reabsorbed.
Alphabux 120 mg tablets is also used for the treatment and prevention of elevated blood uric acid
levels that can occur during 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.
Alphabux is for adults.

2. What you need to know before taking Alphabux

Do not take Alphabux:

• If you are allergic to febuxostat or 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 suffer from or have suffered from heart failure or other heart problems
• If you have or have had kidney disease and/or serious 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 Alphabux, 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 serious life-threatening allergic conditions with cardiac and circulatory arrest.

The doctor may decide to permanently discontinue treatment with Alphabux.
Rare skin rashes (Stevens-Johnson syndrome) that have put the patient's life at risk have been reported with the use of Alphabux, which initially appeared on the trunk 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 skin peeling.
If you develop Stevens-Johnson syndrome with the use of febuxostat, treatment with Alphabux 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 severe pain, tenderness, redness, warmth and swelling in a joint), wait for the end of the gout attack before starting therapy with Alphabux.
In some people, gout attacks may worsen at the beginning of certain therapies used to control uric acid levels. Not all people experience exacerbations, but you may experience an exacerbation even when taking Alphabux, especially during the first few weeks or months of therapy. It is important that you continue to take Alphabux even in the presence of an exacerbation, as Alphabux continues to act to lower your uric acid level. If you continue to take Alphabux every day, over time, exacerbations will occur less frequently and will be less painful.
The 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 uric acid levels (e.g. patients undergoing chemotherapy), treatment with drugs that lower uric acid levels may cause the accumulation of xanthine in the urinary tract with possible formation of stones, although this has not been observed in patients treated with Alphabux for Tumor Lysis Syndrome.
The doctor may prescribe blood tests to check that your liver is functioning normally.
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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 Alphabux
Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 Alphabux 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
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether Alphabux can harm the fetus. Alphabux should not be used during pregnancy. It is not known whether Alphabux passes into breast milk. Do not take Alphabux if you are breastfeeding or intend to do so.

Driving and using machines
Be aware that you may experience dizziness, drowsiness, blurred vision, numbness or tingling during treatment and in such cases, if you experience these symptoms, you should not drive vehicles or use machines.

Alphabux contains lactose
Alphabux contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, talk to your doctor before taking this medicine.

3. How to take Alphabux

Always take this medicine exactly as your doctor has instructed. If you have any doubts, you should
consult your doctor or pharmacist.

Gout
Alphabux is available as film-coated tablets containing 80 mg or 120 mg. Your doctor will prescribe
the dosage most suitable for you.
The usual dose is one tablet a day.
Continue to take 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 a day.
Start taking Alphabux two days before chemotherapy and continue to take it as directed by
your doctor. Usually, the duration of use is short.

Method of administration
Alphabux is for oral use.
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The tablets can be taken with or without food.
The back of the blister pack shows the days of the week to help you keep track of whether you have taken your dose each
day.

If you take more Alphabux than you should
In case of accidental overdose, contact your doctor to find out what to do or contact the nearest
emergency room.

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 that case, skip the forgotten 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 Alphabux
Do not stop treatment with Alphabux without your doctor's consent, even if you feel better.
If you stop treatment with Alphabux, 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 doubts about the use of the 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 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, 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, e.g. 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 enlargement of the lymph nodes, enlargement of the liver, hepatitis (up to hepatic 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 tests
• diarrhea
• headache
• rash (including various types of skin eruptions, see below in the “uncommon” and “rare” sections)
• 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.
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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 levels of fats in the blood, weight gain
• loss of 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, hives, skin inflammation, changes 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 eruptions, areas of redness and spots on the skin, other skin disorders
• muscle cramps, muscle weakness, muscle pain 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 urine tests (increased levels of protein in urine), decreased ability of the kidneys to function properly
• fatigue, chest pain, thoracic 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) are:

• 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 may 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 rash, enlarged lymph nodes, enlarged liver, hepatitis (up to hepatic 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 5/7
• 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 level 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)
• jaundice (yellowing of the skin)
• liver damage
• increased level of creatine phosphokinase in the blood (an indicator of muscle damage).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalareuna-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 which is stated on the package and on the blister after “EXP”. The expiry date refers to the last day of that month.
• This medicine does not require any particular 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 Alphabux contains
The active ingredient 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: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose,
hydroxypropylcellulose, poloxamer 407, anhydrous colloidal silica, magnesium stearate.

Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171),
macrogol 4000, talc, yellow iron oxide (E172).

Description of the appearance of Alphabux and contents of the pack
Alphabux film-coated tablets are yellow, oblong, biconvex tablets, coated with
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film.
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 authorisation holder and manufacturer

Marketing authorisation holder
So.Se.PHARM S.r.l.
Via Dei Castelli Romani, 22
00071 Pomezia (Roma)
Italy

Manufacturer
Bluepharma Indústria Farmacêutica, S.A.

• S. Martinho do Bispo 3045-016 Coimbra Portugal

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