FEBUXOSTAT AUROVITAS 120 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the user

Febuxostat Aurovitas 120 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 Aurovitas and what is it used for
2. What you need to know before you take Febuxostat Aurovitas
3. How to take Febuxostat Aurovitas
4. Possible side effects
5. Storing Febuxostat Aurovitas

Contents of the pack and further information

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

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

Febuxostat Aurovitas 120 mg film-coated tablets are also used in the treatment and prevention of high levels of uric acid in the blood, which can occur when chemotherapy is started for the treatment of blood cell cancer.

When chemotherapy is administered, cancer cells are destroyed, and as a result, uric acid levels in the blood increase, unless their formation is prevented.

Febuxostat Aurovitas is for adults.

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

Do not take Febuxostat Aurovitas:

• 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 the limbs or face
• difficulty breathing
• fever with swollen lymph nodes
• also life-threatening allergic reactions associated with cardiac arrest

Your doctor may decide to permanently discontinue treatment with febuxostat.

Rare cases of life-threatening skin rashes (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 experience 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 experience a gout attack when starting certain medications that control uric acid levels. Not everyone experiences these attacks, but they can occur even while taking febuxostat, especially during the first few weeks or months of treatment. It is essential to continue taking febuxostat, even if you experience 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 levels of urates (e.g., those undergoing chemotherapy for cancer), treatment with medications to reduce uric acid may 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 AurovitasTell your doctor or pharmacist if you are taking, have recently taken, or might take 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 measures:

• 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 Aurovitas contains lactose

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

Febuxostat Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 120 mg film-coated tablet; this is essentially "sodium-free".

3. How to take Febuxostat Aurovitas

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

Gout

Febuxostat is marketed in 80 mg and 120 mg film-coated tablets. Your doctor will prescribe the most suitable dose.

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

Prevention and treatment of high levels of uric acid in patients undergoing chemotherapy for cancer

Febuxostat is available in 120 mg tablets.

Start taking febuxostat two days before chemotherapy and continue using it as directed by your doctor. Treatment is usually short-term.

If you take more Febuxostat Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Febuxostat Aurovitas

If you miss a dose of febuxostat, 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 one at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Febuxostat Aurovitas

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 increase 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 product, 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")
• life-threatening skin rashes characterized by blistering 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 swollen lymph nodes, liver enlargement, hepatitis (including liver failure), increased white blood cell count (leukocytosis, with or without eosinophilia) (see section 2)
• widespread skin rash

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

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

Other side effects not mentioned above are listed below.

Uncommon side effects(may affect up to 1 in 100 people) include:

• decreased appetite, change in blood sugar levels (diabetes) whose symptom may be excessive thirst, increased blood fats, weight gain
• decreased sex drive
• difficulty sleeping, drowsiness
• numbness, tingling, decreased or altered sensation (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 (hemorrhage, observed only in patients receiving chemotherapy for blood diseases)
• cough, discomfort or pain in the chest, 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 rash 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 joint stiffness
• blood in urine, abnormally frequent urination, abnormal urine tests (increased protein concentration in urine), reduced kidney function, urinary tract infection
• fatigue, chest pain, chest discomfort
• gallstones or bile duct stones (cholelithiasis)
• increased levels of thyroid-stimulating hormone (TSH) in blood
• changes or decrease in urine volume due to kidney inflammation (tubulointerstitial nephritis)
• liver inflammation (hepatitis)
• yellowish skin (jaundice)
• bladder infection
• liver damage
• increased levels of creatine phosphokinase in blood (an indicator of muscle damage)
• sudden cardiac death
• low red blood cell count (anemia)
• depression
• sleep disturbance
• loss of taste
• burning sensation
• vertigo
• circulatory failure
• lung infection (pneumonia)
• mouth ulcers, mouth inflammation
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• feeling of heat
• sudden loss of vision due to blockage of an artery in the eye

Rare side effects(may affect up to 1 in 1,000 people) include:

• muscle damage, which can be severe in rare cases. It can cause muscle problems and, in particular, if you are also feeling unwell or have a high fever, it may be due to abnormal muscle destruction. Contact your doctor immediately if you experience pain, sensitivity, or muscle 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, hepatitis (including liver failure), increased white blood cell count in blood (leukocytosis, with or without eosinophilia)
• different 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)
• 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)
• yellowish skin (jaundice)
• bladder infection
• liver damage
• increased levels of creatine phosphokinase in blood (an indicator of muscle damage)
• sudden cardiac death
• low red blood cell count (anemia)
• depression
• sleep disturbance
• loss of taste
• burning sensation
• vertigo
• circulatory failure
• lung infection (pneumonia)
• mouth ulcers, mouth inflammation
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• feeling of heat
• sudden loss of vision due to blockage of an artery in the eye

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Febuxostat Aurovitas

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. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Content and Additional Information

Composition ofFebuxostat Aurovitas

• The active ingredient is febuxostat. Each tablet contains 120 mg of febuxostat (as hemihydrate).
• The other components are:

Core of the tablet:lactose monohydrate, microcrystalline cellulose (grade 101), sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose (grade 102), anhydrous colloidal silica, magnesium stearate.

Coating of the tablet:polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

Appearance of the Product and Packaging Content

Film-coated tablets, light yellow to yellow in color, biconvex, capsule-shaped, engraved with "FEB" on one side and "120" on the other side. The size is 19.2 mm x 8.7 mm.

Febuxostat Aurovitas is available in blister packs of 14, 28, 30, 42, 56, 84, and 98 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques-Lyon

26 avenue Tony Garnier

69007 Lyon

France

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

Germany: Febuxostat PUREN 120 mg Filmtabletten

Belgium: Febuxostat AB 120 mg filmomhulde tabletten/comprimés pélliculés/Filmtabletten

Spain: Febuxostat Aurovitas 120 mg film-coated tablets EFG

France: FÉBUXOSTAT ARROW 120 mg, comprimé pelliculé

Italy: Febuxostat Aurobindo

Poland: Febuxostat Aurovitas

Portugal: Febuxostate Aurobindo

Czech Republic: Febuxostat Aurovitas

Romania: Febuxostat Aurobindo 120 mg film-coated tablets

Date of the last revision of this leaflet: April 2022

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)