Package Insert: Information for the User

Febuxostat Sandoz 80 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medicine because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given 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 package insert. See section 4.

6.Contents of the pack and additional information

Febuxostat tablets contain 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 sudden and intense pain, redness, heat, and swelling in the joints (this is called gout attacks). 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 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 long enough, the size of tophi also decreases.

Febuxostat is used in adults.

Do not take Febuxostat Sandoz

• 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 Sandoz:

• if you have or have had heart failure, other heart problems or a 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 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 Febuxostat Sandoz (see also section 4). Possible symptoms of allergic reactions may be:

• eruption including severe forms (e.g. blisters, nodules, exfoliative eruptions that cause itching), itching
• swelling of the limbs or face
• difficulty breathing
• fever with enlarged lymph nodes
• also severe allergic reactions that can put your life at risk, associated with cardio-circulatory 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 target 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 eruption may progress to generalized blisters or skin peeling.

If you have developed Stevens-Johnson syndrome with the use of febuxostat, do not restart treatment with febuxostat 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 medicine.

If you experience a gout attack (a sudden onset of 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 medicines 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 it 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 medicines to prevent or treat the symptoms of gout attacks (such as joint pain and swelling).

In patients with very high uric acid levels (e.g. those undergoing chemotherapy for cancer), treatment with medicines to reduce uric acid levels may lead to 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 functioning normally.

Children and adolescents

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

Other medicines and Febuxostat Sandoz

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicines, including those purchased without a prescription.

It is especially important to inform your doctor or pharmacist if you are using 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

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

Febuxostat Sandoz contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Febuxostat Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; 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 blister pack has the days of the week printed on the back to help you check that you take your dose every day.
• The tablets should be taken by mouth, with or without food.

Dose

Febuxostat is available in tablets of 80 mg and 120 mg. 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 Sandoz than you should

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

If you forget to takeFebuxostat Sandoz

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 Sandoz

Although you may be feeling better, do not stop taking febuxostat unless your doctor tells you to. If you stop taking febuxostat, your uric acid level 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 experience 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 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 the blood (hypersensitivity to medications with eosinophilia and systemic symptoms - DRESS syndrome) (see section 2),
• generalized skin eruptions.

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

• abnormal liver test results,
• diarrhea,
• headache,
• eruption (including various types of eruption, see the following sections “infrequent” and “rare”),
• nausea,
• increased symptoms of gout,
• localized swelling due to fluid retention in tissues (edema),
• dizziness,
• difficulty breathing,
• tingling,
• muscle and joint pain,
• fatigue.

Other side effects not mentioned earlier are listed below.

Infrequent side effects (may affect up to 1 in 100 people)

• decreased appetite, change in blood sugar level (diabetes) whose symptom may be excessive thirst, increased triglycerides in the blood, 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 anomalies, irregular or rapid heartbeat, perception of heartbeats (palpitations),
• flushes or redness (flushing of the face or neck), increased tension, 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, abdominal pain or discomfort, gas, indigestion, constipation, frequent bowel movements, vomiting, stomach discomfort,
• skin eruption with itching, urticaria, inflammation, skin discoloration, small red or purple spots on the skin, small rashes on the skin, rashes on the skin covered with small interconnected bumps, eruption, rashes, and spots on the skin, increased sweating, nocturnal sweating, alopecia, facial redness (erythema), psoriasis, eczema, other skin changes,
• muscle cramps, muscle weakness, bursitis or arthritis (inflammation of the joints, usually accompanied by pain, swelling, and/or stiffness), back pain, muscle spasms, muscle and/or joint stiffness,
• blood in the urine, frequent urination, abnormal urine test results (increased protein concentration in urine), reduced kidney function, urinary tract infection,
• chest pain, chest discomfort,
• gallstones or bile duct stones (cholelithiasis),
• increased levels of thyroid-stimulating hormone (TSH) in the blood,
• changes in blood biochemistry or the number of blood cells or platelets (abnormal blood test results),
• kidney stones,
• erectile dysfunction,
• thyroid gland dysfunction, blurred vision, changes in vision,
• tinnitus,
• runny nose,
• mouth ulcers,
• pancreatitis: common symptoms are abdominal pain, nausea, and vomiting,
• urgent need to urinate,
• pain,
• discomfort,
• increased INR,
• bruising,
• swelling of the lips.

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

• muscle damage, which in rare cases can be severe. It may cause muscle problems and particularly, 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 in the blood (leucocytosis, with or without eosinophilia),
• different types of eruptions (e.g. with white spots with blisters, with blisters containing pus, with peeling of the skin, eruption 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,
• feeling thirsty,
• 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 disturbance,
• loss of taste,
• burning sensation,
• dizziness,
• circulatory insufficiency,
• lung infection (pneumonia),
• mouth ulcers, inflammation of the mouth,
• gastrointestinal perforation,
• rotator cuff syndrome,
• polymyalgia rheumatica,
• feeling of heat,
• sudden loss of vision due to obstruction of an eye artery.

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 that does not appear in this leaflet. You can also report them directly through theSpanish 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 use this medication after the expiration date that appears on the carton box and on the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

• Composition of Febuxostat Sandoz 80 mg film-coated tablets:
• The active ingredient is febuxostat.

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

• The other components are:

Tablet core:

Lactose monohydrate, microcrystalline cellulose (E 460), hydroxypropylcellulose (E 463), croscarmellose sodium, anhydrous colloidal silica (E 551), magnesium stearate (E 470b).

Film coating:

Polvinyl alcohol (E 1203), talc (E 553b), titanium dioxide (E 171), macrogol 3350 (E 1521), acid methacrylic copolymer (1:1) (Type A), yellow iron oxide (E 172), sodium hydrogen carbonate (E500(ii)).

Appearance of the product and contents of the package

Febuxostat Sandoz 80 mg film-coated tablets are yellowish clear to yellow, film-coated, capsule-shaped tablets, with an “80” engraved on one face and smooth on the other, and with dimensions of 16.5 mm x 7.0 mm.

Febuxostat Sandoz 80 mg film-coated tablets are presented in aluminum-OPA/Alu/PVC or aluminum-PVC/PE/PVDC blisters.

Febuxostat 80 mg is available in pack sizes of 14, 28, 30, 42, 56, 84, and 98 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible:

Rontis Hellas Medical and Pharmaceutical Products S.A.

Industrial Area of Larissa, P.O. Box 3012

41004 Larissa

Greece

or

Salutas Pharma GmbH

Otto von Guericke Alle, 1 Sachsen Anhalt

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d

Verovškova ulica 57

1526 Ljubljana

Slovenia

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany:Febuxostat HEXAL 80 mg Filmtabletten

Austria:Febuxostat Sandoz 80 mg - Filmtabletten

Belgium:Febuxostat Sandoz 80 mg filmomhulde tabletten

France:FEBUXOSTAT SANDOZ 80 mg, comprimé pelliculé

Hungary:Febuxostat Sandoz 80 mg Filmtabletta

Ireland:Febuxostat Rowex 80 mg Film-coated tablets

Italy:Febuxostat Sandoz

Czech Republic:Febuxostat Sandoz 80 mg potahované tablety

Date of the last review of this leaflet:August 2020

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