Febuxostat Aurovitas 120 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Febuxostat Aurovitas 120 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

Pack contents and other information

1. What Febuxostat Aurovitas is and what it is 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 accumulates in the blood to the point where it cannot dissolve. When this occurs, urate crystals form both within and around the joints and kidneys. These crystals can cause sudden and severe pain, redness, warmth, and swelling in the joints (called a gout attack). If left untreated, large deposits called tophi may form around and within the joints. Tophi can damage joints and bones.

Febuxostat Aurovitas works by reducing the concentration of uric acid. Keeping uric acid levels low by taking febuxostat once daily helps prevent crystal formation 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 to treat and prevent high levels of uric acid in the blood that may occur when starting chemotherapy for the treatment of blood cell cancers.

When chemotherapy is administered, cancer cells are destroyed, leading to increased levels of uric acid in the blood unless its formation is prevented.

2. What you need to know before taking Febuxostat Aurovitas

Do not take Febuxostat Aurovitas:

• 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 or pharmacist before starting 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 abnormalities
• if you are being treated for 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 thyroid problems

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

Possible symptoms of allergic reactions may include:

• rash including severe forms (e.g. blisters, nodules, exfoliative rashes causing itching), itching
• swelling of the limbs or face
• difficulty breathing
• fever with swollen lymph nodes
• also severe allergic reactions that may be life-threatening, associated with circulatory arrest

Rare cases of life-threatening skin rashes (Stevens-Johnson syndrome) have been reported with the use of febuxostat. These rashes typically start on the trunk as reddish target-shaped spots or circular lesions, often with a blister in the center. They may also include mouth, throat, nose, or genital ulcers, and conjunctivitis (red, swollen eyes). The rash may progress to widespread blistering or skin peeling.

If you have developed Stevens-Johnson syndrome while taking febuxostat, you must never restart treatment with this medicine. If you develop a rash or any of these skin symptoms, seek immediate medical attention and inform your doctor that you are taking this medicine.

If you experience a gout attack (sudden, intense pain accompanied by tenderness, redness, warmth, and swelling in a joint), wait until the attack subsides before starting treatment with febuxostat.

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

Your doctor may prescribe additional medicines to prevent or treat symptoms of gout attacks (such as joint pain and swelling).

In patients with very high urate levels (e.g., those undergoing chemotherapy for cancer), treatment with medicines that lower uric acid may lead to xanthine accumulation in the urinary tract, potentially causing kidney stones. However, 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 properly.

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 Aurovitas Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

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

Pregnancy and breastfeeding

It is not known whether febuxostat may harm the unborn baby. 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 planning to breastfeed.

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

Driving and use of machines

Be aware that you may experience dizziness, drowsiness, blurred vision, or numbness and tingling sensations during treatment. If you experience any of these symptoms, you should 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 certain sugars, consult with 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; hence, it is essentially “sodium-free”.

3. How to take Febuxostat Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, 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 available as 80 mg and 120 mg film-coated tablets. Your doctor will prescribe the most appropriate dose for you.

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 as 120 mg tablets.

Start taking febuxostat two days before chemotherapy and continue using it as directed by your doctor. Generally, treatment is of short duration.

If you take more Febuxostat Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Febuxostat Aurovitas

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

If you stop taking Febuxostat Aurovitas

Even if you feel better, do not stop taking febuxostat unless instructed by your doctor. 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody 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 adverse effects (may affect up to 1 in 1,000 people), as you may then develop a severe 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 mucous membranes, for example in the mouth and genital area, painful sores in the mouth and/or genital areas, accompanied by fever, sore throat, and fatigue (Stevens-Johnson syndrome/toxic epidermal necrolysis), or swollen lymph nodes, enlarged liver, hepatitis (including liver failure), increased number of white blood cells (leukocytes) in the blood (drug hypersensitivity with eosinophilia and systemic symptoms—DRESS syndrome) (see section 2)
• generalized skin rashes

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

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

Other adverse effects not listed above are included below.

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

• decreased appetite, changes in blood sugar levels (diabetes), which may present as excessive thirst, increased blood fats, weight gain
• loss of sexual appetite
• difficulty sleeping, drowsiness
• numbness, tingling sensation, decreased or altered sensitivity (hypoesthesia, hemiparesis or paresthesia), altered sense of taste, reduced sense of smell (hyposmia)
• ECG (electrocardiogram) abnormalities, irregular or rapid heartbeat, awareness of heartbeats (palpitations)
• hot flushes or flushing (redness of the face or neck), increased blood pressure, bleeding (haemorrhage, observed only in patients receiving chemotherapy for blood disorders)
• 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 or gas, upper abdominal pain, heartburn or indigestion, constipation, more frequent bowel movements, vomiting, stomach discomfort
• itchy rash, urticaria, skin swelling or discoloration, small red or purple spots on the skin, small skin bumps, skin rashes with interconnected small bumps, rash, hives, and skin spots, increased sweating, night sweats, alopecia, 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 concentration of protein 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 in blood biochemistry or in the number of blood cells or platelets (abnormal blood test results)
• kidney stones
• erectile dysfunction
• decreased thyroid gland activity, blurred vision, visual disturbances
• ringing in the ears
• rhinorrhea
• mouth ulcers
• pancreatitis: common symptoms are abdominal pain, nausea and vomiting
• urgent need to urinate
• pain
• malaise
• increased INR
• bruising
• swelling of the lips

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

• muscle damage, which in rare cases may be severe. It may cause muscle problems and, particularly if you also feel unwell or have a high fever, may be due to abnormal muscle breakdown. Contact your doctor immediately if you experience muscle pain, tenderness 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 in breathing
• high fever accompanied by a measles-like rash, swollen lymph nodes, enlarged liver, hepatitis (including liver failure), increased number of white blood cells in blood (leukocytosis, with or without eosinophilia)
• various types of skin rashes (e.g. with white spots, blisters, pus-filled blisters, skin peeling, measles-like rash), generalized erythema, necrosis, blistering and shedding of the skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• nervousness
• sensation 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 decreased urine volume due to kidney inflammation (tubulo-interstitial nephritis)
• liver inflammation (hepatitis)
• yellowing of the skin (jaundice)
• bladder infection
• liver damage
• increased levels of creatine phosphokinase in blood (a marker of muscle damage)
• sudden cardiac death
• low red blood cell count (anemia)
• depression
• sleep disturbances
• loss of taste
• burning sensation
• dizziness
• circulatory failure
• lung infection (pneumonia)
• mouth ulcers; mouth inflammation
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• sensation of warmth
• sudden loss of vision due to blockage of an artery in the eye

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Febuxostat Aurovitas

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

Do not use this medicine after the expiry date stated on the cardboard box and blister pack after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Febuxostat Aurovitas

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

Tablet core: lactose monohydrate, microcrystalline cellulose (grade 101), sodium croscarmellose, hydroxypropylcellulose, 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 pack

Film-coated tablets, light yellow to yellow in colour, biconvex, capsule-shaped, engraved with “FEB” on one side and “120” on the other. Size: 19.2 mm x 8.7 mm.

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

Only certain pack 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

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 authorised in the European Economic Area member states 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 comprimate filmate

Date of the most recent review of this leaflet: April 2022

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