Labeling:information for the user

Febuxostat Aurovitas 120 mg film-coated tablets EFG

Read this labeling carefully before taking this medicine, because it contains important information for you.

• Keep this labeling, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this labeling. See section 4.

Contents of the package and additional information

Febuxostat Aurovitas contains the active ingredient febuxostat and is used to treat gout, which is associated with an excess of a chemical compound called uric acid (urate) in the body. In some people, uric acid accumulates in the blood to the point where it cannot be dissolved. When this occurs, urate crystals form both inside and around the joints and kidneys. These crystals can cause a sudden and intense pain, redness, heat, and swelling in the joints (known as 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 acts by reducing the concentration of uric acid. Keeping uric acid levels low by taking febuxostat once a day slows the formation of crystals and, over time, reduces symptoms. If uric acid levels are kept low for a sufficient period, the size of tophi also decreases.

Febuxostat Aurovitas 120 mg 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 to treat blood 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.

Do not take Febuxostat Aurovitas:

• if you are allergic to febuxostat or any of the other ingredients of this medication (listed in section 6)

Warnings and precautions

Consult your doctor or pharmacistbefore 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 medication used to treat gout)
• if you have or have had liver disease or liver function abnormalities
• if you are being treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare genetic disorder 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 medication (see also section 4).

Possible symptoms of allergic reactions may include:

• skin rash including severe forms (e.g. blisters, nodules, exfoliative rashes that cause itching), itching
• swelling of the limbs or face
• difficulty breathing
• fever with enlarged 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 eruptions (Stevens-Johnson syndrome) have been reported with the use of febuxostat, initially appearing on the trunk as red spots in the shape of a bull's eye or circular spots often with a blister in the center. It 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 have developed Stevens-Johnson syndrome with the use of febuxostat, do not restart treatment at any time. If you develop a rash or these symptoms on your skin, go immediately to your doctor and tell them that you are taking this medication.

If you experience a gout attack (a sudden, intense pain 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 weeks or months of treatment. It is essential to continue taking febuxostat daily, as this medication continues to act to reduce uric acid levels. If you continue to take febuxostat, gout attacks will become less frequent and less painful.

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

In patients with very high uric acid levels (e.g. those undergoing chemotherapy for cancer), treatment with medications to reduce uric acid levels may lead to the accumulation of xanthine in the urinary tract, potentially forming 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 functioning normally.

Children and adolescents

Do not administer this medication to children under 18 years of age, as the safety and efficacy have not been established.

Other medications and Febuxostat AurovitasInform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

It is especially important to inform your doctor or pharmacist if you are taking medications containing 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 immune response)
• Theophylline (used to treat asthma)

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

Febuxostat Aurovitas contains lactose

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

Febuxostat Aurovitas contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Gout

Febuxostat is marketed in film-coated tablets of 80 mg and 120 mg. 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 uric acid levels in patients undergoing chemotherapy for cancer

Febuxostat is available in 120 mg tablets.

Start taking febuxostat two days before chemotherapy and continue as directed by your doctor. The treatment is generally of short duration.

If you take more Febuxostat Aurovitas than you should

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

If you forgot to take Febuxostat Aurovitas

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

If you interrupt treatment with Febuxostat Aurovitas

Although you may be feeling 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 be experiencing a severe allergic reaction:

• Anaphylactic reactions, hypersensitivity to the medicine (see also section 2 “Warnings and precautions”)
• Skin eruptions that can be life-threatening, characterized by the formation of blisters and skin and mucous membrane peeling, for example, mouth and genital ulcers, painful mouth and/or genital ulcers, 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 (hypersensitivity to medications with eosinophilia and systemic symptoms-syndrome of DRESS) (see section 2)
• Generalized skin eruptions

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

• Abnormal liver test results
• Diarrhea
• Headache
• Rash (including various types of rash, see below the sections “infrequent” and “rare”)
• Nausea
• Increased symptoms of gout
• Localized swelling due to fluid retention in tissues (edema)
• Dizziness,
• Difficulty breathing,
• Itching,
• Pain in the limbs, muscle aches and joint pains,
• Fatigue.

Other side effects not mentioned above are included below.

Theinfrequent side effects(may affect up to 1 in 100 people) are as follows:

• Decreased appetite, change in blood sugar level (diabetes) whose symptom may be excessive thirst, increased blood fats, weight gain
• Loss of sexual appetite
• Difficulty sleeping, somnolence
• Numbness, tingling, decreased or altered sensitivity (hypoaesthesia, hemiparesis, or paresthesia), altered sense of taste, decreased sense of smell (hyposmia)
• ECG (electrocardiogram) abnormalities, irregular or rapid heartbeat, perception of heartbeats (palpitations)
• Flushes or redness (face or neck flushing), increased blood pressure, bleeding (haemorrhage, 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, stomach pain or discomfort, indigestion, constipation, frequent bowel movements, vomiting, stomach discomfort
• Rash with itching, urticaria, skin inflammation or discoloration, small red or purple spots on the skin, small skin rashes, skin rashes with small interconnected bumps, rash, rashes, and skin spots, increased sweating, nocturnal sweating, alopecia, skin redness (erythema), psoriasis, eczema, other skin changes
• Muscle cramps, muscle weakness,, bursitis or arthritis (inflammation of the joints, usually accompanied by pain, swelling, or stiffness), , back pain, muscle spasms, muscle and/or joint stiffness,
• Blood in urine, frequent urination, abnormal urine tests (increased protein concentration in urine), reduced kidney function, urinary tract infection,
• Fatigue, chest pain, chest discomfort
• Stones in the gallbladder or bile ducts (cholelithiasis)
• Increased levels of thyroid-stimulating hormone (TSH) in the blood
• Blood biochemistry changes or changes in the number of blood cells or platelets (abnormal blood test results)
• Stones in the kidney
• Difficulty achieving an erection
• Decreased thyroid gland activity, blurred vision, changes in vision,
• Tinnitus,
• Rhinorrhea,
• Mouth ulcers,
• Pancreatitis: common symptoms are abdominal pain, nausea, and vomiting,
• Urgent need to urinate,
• Pain,
• Discomfort,
• Increased INR,
• Contusion,
• Swelling of the lips.

Therare side effects(may affect up to 1 in 1,000 people) are as follows:

• Muscle damage, which in rare cases can be severe. It may cause muscle problems and, in particular, if you are 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 deeper layers of the skin, especially around the eyes, genitals, hands, feet, or tongue, which may 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 (leucocytosis, with or without eosinophilia)
• Different types of rashes (e.g., with white spots, with blisters, with pus-filled blisters, with skin peeling, rash similar to measles), generalized erythema, necrosis, blistering of the skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• Anxiety
• Thirst sensation
• Weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
• Abnormal blood cell count (white blood cells, red blood cells, or platelets)
• Changes or decreased urine volume due to kidney inflammation (tubulointerstitial nephritis)
• Liver inflammation (hepatitis)
• Yellow skin (jaundice)
• Urinary tract infection
• Liver damage
• Increased levels of creatine phosphokinase in the blood (a marker of muscle damage)
• Sudden cardiac death.
• Low red blood cell count (anemia),
• Depression,
• Sleep alteration,
• Loss of taste,
• Burning sensation,
• Dizziness,
• Circulatory insufficiency,
• Pulmonary infection (pneumonia),
• Mouth ulcers; inflammation of the mouth,
• Gastrointestinal perforation,
• Rotator cuff syndrome,
• Rheumatic polymyalgia,
• Heat sensation,
• Sudden loss of vision due to obstruction of an artery in the eye.

If you experience any side effect, consult your doctor or pharmacist. This includes any possible side effects not mentioned in this leaflet.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not appearing in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe carton box and on the blister packafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofFebuxostat Aurovitas

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

Tablet core:monohydrate lactose, microcrystalline cellulose (grade 101), sodium croscarmellose, hydroxypropyl cellulose, microcrystalline cellulose (grade 102), anhydrous colloidal silica, magnesium stearate.

Tablet coating:polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Génériques-Lyon

26 avenue Tony Garnier

69007 Lyon

France

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Febuxostat PUREN 120 mg Filmtabletten

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

Spain:Febuxostat Aurovitas 120 mg comprimidos recubiertos con película EFG

FranceFÉBUXOSTAT ARROW 120 mg, comprimé pelliculé

Italy:Febuxostat Aurobindo

Poland:Febuxostat Aurovitas

Portugal:Febuxostate Aurobindo

Czech Republic:Febuxostat Aurovitas

Romania:Febuxostat Aurobindo 120 mg comprimate filmate

Last review date of this leaflet: April 2022

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)