FEBUXOSTAT ARISTO 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Febuxostat Aristo 80 mg film-coated tablets EFG

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Febuxostat Aristo contains the active substance febuxostat and is used to treat gout, which is associated with an excess in the body of a chemical compound called uric acid (urate). In some people, uric acid builds up in the blood to the point where it cannot be dissolved. When this happens, urate crystals form both inside and around the joints and kidneys. These crystals can cause sudden and severe pain, redness, heat, and swelling in the joints (this is called a gout attack). If left untreated, large deposits called tophi can form around the joints and inside them. Tophi can damage the joints and bones.

Febuxostat works by reducing the concentration of uric acid. Keeping the uric acid concentration low by taking febuxostat once a day prevents the formation of crystals and, over time, reduces the symptoms. If the uric acid concentration is kept low for a long enough time, the size of the tophi is also reduced.

Febuxostat is for adults.

2. What you need to know before you take Febuxostat Aristo

Do not take Febuxostat Aristo

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take febuxostat:

• if you have or have had heart failure, heart problems, or stroke.
• 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 liver function disorders
• if you are being treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare inherited disease in which there is too much uric acid in the blood)
• if you have thyroid problems.

If you experience allergic reactions to febuxostat, stop taking this medicine (see also section 4).

Possible symptoms of allergic reactions could be:

• rash including severe forms (e.g. blisters, nodules, exfoliative rashes that cause itching), itching
• swelling of limbs or face
• difficulty breathing
• fever with swollen lymph nodes
• also severe allergic reactions that can put your life in danger, associated with cardiac arrest.

Your doctor may decide to permanently discontinue treatment with febuxostat.

Rare cases of skin rashes that can put your life in danger (Stevens-Johnson Syndrome) have been reported with the use of febuxostat, initially appearing on the trunk as reddish spots in a target shape or circular spots that often have a blister in the center. It can also include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). The rash can evolve into generalized blisters or skin peeling.

If you have developed Stevens-Johnson Syndrome with the use of febuxostat, you should not restart treatment at any time. If you develop a rash or these skin symptoms, go to the doctor immediately and tell them that you are taking this medicine.

If you suffer a gout attack (severe pain that starts suddenly accompanied by sensitivity, redness, heat, and swelling of a joint), wait for the attack to subside before starting treatment with febuxostat.

Some people may suffer a gout attack when starting to take certain medications that control uric acid levels. Not everyone suffers these attacks, but they can occur even while taking febuxostat, especially during the first weeks or months of treatment. It is essential to continue taking febuxostat even if you suffer a gout attack, as this medicine continues to work to reduce uric acid. If you continue to take febuxostat daily, gout attacks will become less frequent and less painful.

If necessary, your doctor will prescribe other medications to prevent or treat the symptoms of attacks (such as pain and joint swelling).

In patients with very high urate levels (e.g., those undergoing chemotherapy for cancer), treatment with medications to decrease uric acid could produce the accumulation of xanthine in the urinary tract, with the possible formation of stones, although this has not been observed in patients treated with febuxostat for Tumor Lysis Syndrome.

Your doctor may perform blood tests to check that your liver is working normally.

Children and adolescents

Do not give this medicine to children under 18 years of age as the safety and efficacy have not been established.

Other medicines and Febuxostat Aristo

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

It is especially important that you inform your doctor or pharmacist if you are taking medicines that contain any of the following substances, as they may interact with febuxostat, and your doctor may need to take special precautions:

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

Pregnancy and breastfeeding

It is not known if febuxostat can harm the fetus. Febuxostat should not be used during pregnancy. It is not known if febuxostat passes into breast milk. Do not use febuxostat if you are breastfeeding or planning to breastfeed.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Be aware that you may experience dizziness, drowsiness, blurred vision, and numbness or tingling during treatment, so if this happens, do not drive or operate machinery.

Febuxostat Aristo contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Febuxostat Aristo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Febuxostat Aristo

Follow exactly the administration instructions of this medicine given by your doctor.

In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet per day.
• Tablets are taken orally, with or without food.

Gout

Febuxostat Aristo is available in 80 mg and 120 mg tablets. Your doctor will prescribe the most suitable dose for you.

Continue taking febuxostat every day, even if you no longer have gout attacks.

If you take more Febuxostat Aristo than you should

In case of overdose or accidental ingestion, consult your doctor or go to the nearest emergency center, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Febuxostat Aristo

If you forget a dose of febuxostat, take it as soon as you remember, unless it is almost time for the next dose; in this case, skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for missed doses.

If you stop taking Febuxostat Aristo

Even if you feel better, do not stop taking febuxostat unless your doctor tells you to. If you stop taking febuxostat, uric acid levels may rise again, and symptoms may worsen due to the formation of new urate crystals in the joints and kidneys.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and contact your doctor immediately or go to the nearest hospital if you experience any of the following rare side effects (may affect up to 1 in 1,000 people), as you may experience a severe allergic reaction:

• anaphylactic reactions, hypersensitivity to the medicine (see also section 2 "Warnings and precautions")
• skin rashes that can put your life in danger, characterized by the formation of blisters and peeling of the skin and mucous membranes (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 by swollen lymph nodes, liver enlargement, hepatitis (including liver failure), increased white blood cell count in blood (hypersensitivity to medicines with eosinophilia and systemic symptoms - DRESS) (see section 2)
• widespread skin rashes

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

• abnormal liver test results
• diarrhea
• headache
• rash (including various types of rash, see below "uncommon" and "rare" sections)
• nausea
• increased gout symptoms
• localized swelling due to fluid retention in tissues (edema)
• dizziness
• breathing difficulties
• itching
• limb pain, muscle pain/joint pain
• fatigue

Other side effects not mentioned above are included below.

The uncommon side effects(may affect up to 1 in 100 people) are:

the following:

• decreased appetite, change in blood sugar level (diabetes) whose symptom may be excessive thirst, increased blood fats, weight gain
• decreased sex drive
• difficulty sleeping, drowsiness
• numbness, tingling, decreased or altered sensitivity (hypoesthesia, hemiparesis, or paresthesia), altered sense of taste, decreased sense of smell (hyposmia)
• abnormalities in the ECG (electrocardiogram), irregular or rapid heartbeat, perception of heartbeats (palpitations)
• hot flashes or flushing (redness of the face or neck), increased blood pressure, bleeding (hemorrhages, observed only in patients receiving chemotherapy for blood diseases)
• cough, discomfort or chest pain, inflammation of the nasal passages and/or throat (upper respiratory tract infection), bronchitis, lower respiratory tract infection
• dry mouth, abdominal pain or discomfort, gas, upper abdominal pain, heartburn or indigestion, constipation, more frequent bowel movements, vomiting, stomach upset
• itchy rash, hives, skin inflammation or discoloration, small red or purple spots on the skin, small bumps on the skin, skin bumps covered with small interconnected bumps, rash, bumps, and spots on the skin, increased sweating, night sweats, hair loss, skin redness (erythema), psoriasis, eczema, other skin disorders
• muscle cramps, muscle weakness, bursitis or arthritis (joint inflammation, usually accompanied by pain, swelling, or stiffness), back pain, muscle spasms, muscle and/or joint stiffness
• blood in urine, abnormally frequent urination, abnormal urine tests (increased protein concentration in urine), reduced kidney function, urinary tract infection
• chest pain, chest discomfort
• gallstones or bile duct stones (cholelithiasis)
• increased thyroid-stimulating hormone (TSH) levels in blood
• changes or decrease in urine volume due to kidney inflammation (tubulointerstitial nephritis)
• liver inflammation (hepatitis)
• yellowing of the skin (jaundice)
• bladder infection
• liver damage
• increased creatine phosphokinase levels in blood (an indicator of muscle damage)
• sudden cardiac death
• low red blood cell count (anemia)
• depression
• sleep disorder
• loss of taste
• burning sensation
• vertigo
• circulatory failure
• lung infection (pneumonia)
• mouth sores; mouth inflammation
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• feeling of heat
• sudden loss of vision due to blockage of an eye artery

The rare side effects(may affect up to 1 in 1,000 people) are:

• muscle damage, which can rarely be severe. It can cause muscle problems and, in particular, if you also feel unwell or have a high fever, it may be due to abnormal muscle destruction. Contact your doctor immediately if you experience muscle pain, sensitivity, or weakness
• severe swelling of the deep layers of the skin, especially around the eyes, genitals, hands, feet, or tongue, which can cause sudden difficulty breathing
• high fever accompanied by a rash similar to measles, swollen lymph nodes, liver enlargement, increased white blood cell count in blood (leukocytosis, with or without eosinophilia)
• various types of rash (e.g., with white spots with blisters, with pus-filled blisters, with skin peeling, measles-like rash), generalized redness, necrosis, blistering and peeling of the skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis)
• nervousness
• feeling of thirst
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
• muscle and/or joint stiffness
• abnormal blood cell count (white blood cells, red blood cells, or platelets)
• changes or decrease in urine volume due to kidney inflammation (tubulointerstitial nephritis)
• liver inflammation (hepatitis)
• yellowing of the skin (jaundice)
• bladder infection
• liver damage
• increased creatine phosphokinase levels in blood (an indicator of muscle damage)
• sudden cardiac death
• low red blood cell count (anemia)
• depression
• sleep disorder
• loss of taste
• burning sensation
• vertigo
• circulatory failure
• lung infection (pneumonia)
• mouth sores; mouth inflammation
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• feeling of heat
• sudden loss of vision due to blockage of an eye artery

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Febuxostat Aristo

• 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 carton and blister after EXP. The expiry date is the last day of the month shown.
• This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Febuxostat Aristo

The active substance is febuxostat.

Each tablet contains 80 mg of febuxostat (as hemihydrate).

The other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, poloxamer 407, anhydrous colloidal silica, magnesium stearate.

Tablet coating: Opadry II yellow, which contains: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol/polyethylene glycol, talc, yellow iron oxide (E172).

Appearance of the product and packaging contents

Febuxostat Aristo are yellow, oblong, and biconvex film-coated tablets.

The 80 mg film-coated tablets are marked with "80" on one side.

Febuxostat Aristo 80 mg is available in PVC/PCTFE - Aluminum or PVC/PVDC - Aluminum blisters of 14 tablets.

Febuxostat Aristo 80 mg is available in packs of 14, 28, 56, and 84 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

Bluepharma Indústria Farmacêutica, S.A.

• Martinho do Bispo

3045-016 Coimbra

Portugal

or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Local representative

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medicinal product is authorized in the following Member States of the European Economic Area with the following names:

Austria: Febuxostat Aristo 80 mg Filmtabletten

Germany: Febuxostat Aristo 80 mg Filmtabletten

Italy: Febuxostat Aristo 80 mg Compresse rivestite con film

Spain: Febuxostat Aristo 80 mg comprimidos recubiertos con película EFG

Portugal: Febuxostat Aristo 80 mg comprimidos revestidos por película

Date of last revision of this leaflet:July 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es