Febuxostat Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

FEBUXOSTAT DOC Generici 80 mg film-coated tablets, 120 mg film-coated tablets

Equivalent medicine
Please read all of 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What FEBUXOSTAT DOC Generici is 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

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

FEBUXOSTAT DOC Generici tablets contain the active substance febuxostat and are used to treat gout, a condition associated with excess 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 (a gout attack). If left untreated, larger deposits called tophi may form within and around the joints. Tophi can damage joints and bones.
FEBUXOSTAT DOC Generici works by reducing uric acid levels. Maintaining low uric acid levels through once-daily administration of FEBUXOSTAT DOC Generici prevents crystal accumulation and, over time, reduces symptoms. If uric acid levels are kept low for a sufficiently long period, tophi may even 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 may occur during chemotherapy for blood cancers.
During chemotherapy, cancer cells are destroyed and blood uric acid levels rise, unless formation of this acid is prevented.
FEBUXOSTAT DOC Generici is for use in 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 to 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 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 FEBUXOSTAT DOC Generici, 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
• Or even severe, life-threatening allergic conditions with cardiac and circulatory arrest. Your doctor may decide to permanently discontinue treatment with FEBUXOSTAT DOC Generici.

Rare, life-threatening skin rashes (Stevens-Johnson syndrome) have been reported with the use of FEBUXOSTAT DOC Generici, initially appearing 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 DOC Generici 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 DOC Generici.

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 still have one while taking FEBUXOSTAT DOC Generici, especially during the first weeks or months of treatment. It is important that you continue taking FEBUXOSTAT DOC Generici even during a flare-up, as FEBUXOSTAT DOC Generici continues to work to lower your uric acid levels. If you continue taking FEBUXOSTAT DOC Generici 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 could lead to xanthine accumulation in the urinary tract, potentially causing stone formation, although this has not been observed in patients treated with FEBUXOSTAT DOC Generici for Tumor Lysis Syndrome.

Your doctor may prescribe blood tests to monitor your liver function.

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 DOC Generici
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 FEBUXOSTAT DOC Generici and your doctor may consider appropriate measures:

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

Pregnancy and breastfeeding
It is not known whether FEBUXOSTAT DOC Generici may harm the unborn baby. FEBUXOSTAT DOC Generici must not be used during pregnancy. It is not known whether FEBUXOSTAT DOC Generici passes into breast milk. You must not take FEBUXOSTAT DOC Generici if you are breastfeeding or planning to breastfeed.

If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

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.

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

3. How to take FEBUXOSTAT DOC Generici

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 per day. The back of the blister pack shows the days of the week to help you keep track of whether you have taken your daily dose.
• 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 most appropriate dosage for you.
Continue taking FEBUXOSTAT DOC Generici every day, even in the absence of
flare-ups or an attack of gout.

FEBUXOSTAT DOC Generici 120 mg.
Prevention and treatment of high uric acid levels in patients undergoing
chemotherapy
FEBUXOSTAT DOC Generici is available as 120 mg tablets.
Start taking FEBUXOSTAT DOC Generici two days before beginning chemotherapy and
continue taking it as advised by your doctor. Usually, treatment is short-term.

If you take more FEBUXOSTAT DOC Generici than you should
In case of accidental overdose, contact your doctor or the nearest emergency department for advice.

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 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 FEBUXOSTAT DOC Generici
Do not stop treatment with FEBUXOSTAT DOC Generici without consulting your
doctor, even if you feel better. If you stop treatment with FEBUXOSTAT DOC
Generici, your uric acid levels may start to rise again, 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 how to use 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
department if you experience any of the following rare side effects (may affect up to 1 in 1,000
people), as these could lead to a serious allergic reaction:

• anaphylactic reactions, hypersensitivity to the medicine (see also section 2 "Warnings and Precautions")
• skin rashes that may be life-threatening, characterized 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, liver enlargement, 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):

• abnormal liver function test results
• diarrhoea
• headache
• rash (including various types of skin rashes, 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 detailed below.
Uncommon side effects (may affect up to 1 in 100 people):

• 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 paraesthesia), reduced or altered sense of taste (hypogeusia)

• abnormal ECG readings, 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 or discomfort, excess intestinal gas, heartburn/dyspepsia, constipation, more frequent defecation, vomiting, gastric discomfort

• itching, hives, skin inflammation, skin colour changes, small red or purple spots on the skin, flat red spots on the skin, red areas of skin covered with small confluent raised 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 joints 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 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):

• muscle damage, a condition that 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 lips, eyes, genitals, hands, feet or tongue, possibly causing 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 rashes 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
• mouth 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 amount of urine 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)

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or
pharmacist.
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
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 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 no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What FEBUXOSTAT DOC Generici contains
The active substance 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: monohydrate lactose, microcrystalline cellulose (E460),
hydroxypropyl cellulose (E463), sodium croscarmellose, anhydrous colloidal silica (E551), magnesium stearate (E470b).
Tablet coating: polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol 3350 (E1521), copolymer of methacrylic acid and ethyl acrylate (1:1) (Type A), yellow iron oxide (E172), sodium hydrogen carbonate (E500(ii)).
Appearance of FEBUXOSTAT DOC Generici and contents of the pack
FEBUXOSTAT DOC Generici 80 mg film-coated tablets
Film-coated tablets, yellow to pale yellow in colour, capsule-shaped, with "80" printed on one side, size 16.5 mm x 7.0 mm.
FEBUXOSTAT DOC Generici 120 mg film-coated tablets
Film-coated tablets, yellow to pale yellow in colour, capsule-shaped, with "120" printed on one side, size 18.5 mm x 9.0 mm.
FEBUXOSTAT DOC Generici 80 mg and 120 mg film-coated tablets are packaged in Al-OPA/Al/PVC or Al-PVC/PE/PVDC blisters.
FEBUXOSTAT DOC Generici is available in packs of 28 film-coated tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano – Italy.
Manufacturer
Rontis Hellas Medical and Pharmaceutical Products S.A. - P.O. Box 3012 Larisa Industrial Area, Larisa, 41004 – Greece.
This medicinal product is authorized in the European Economic Area Member States under the following names:
Hungary: Febuxostat Doc Generici 80 mg, 120 mg filmtabletta
Italy: FEBUXOSTAT DOC Generici