FEBUXOSTAT SANDOZ 120 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

1. Contents of the pack and further information

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

Febuxostat tablets contain the active substance febuxostat and are used to treat gout, which is associated with excess uric acid in the body. 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 uric acid levels. 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 120 mg film-coated tablets are also used in the treatment and prevention of high uric acid levels in the blood that can occur when starting chemotherapy for blood cancer treatment.

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

Febuxostat is used in adults.

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

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 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 Febuxostat Sandoz (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 with febuxostat 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 febuxostat 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 reduce 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 Sandoz

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 using 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. It is unknown 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 Sandoz 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 Sandoz contains sodium

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

3. How to take Febuxostat Sandoz

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• 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.
• Tablets should be taken by mouth, with or without food.

Gout

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

Continue to take 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 using it as directed by your doctor. Treatment is usually short-term.

If you take more Febuxostat Sandoz than you should

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

If you forget to take Febuxostat Sandoz

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 Sandoz

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 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"),
• 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 by swollen lymph nodes, liver enlargement, hepatitis (including liver failure), increased white blood cell count (leukocytosis, with or without eosinophilia) (see section 2),
• widespread skin rashes.

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,
• difficulty breathing,
• tingling,
• limb and 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) are:

• 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),
• abnormal ECG (electrocardiogram), irregular or rapid heartbeat, perception of heartbeats (palpitations),
• flushing or reddening (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/indigestion, constipation, more frequent bowel movements, vomiting, stomach upset,
• itchy skin rash, hives, inflammation, skin discoloration, small red or purple spots on the skin, small bumps on the skin, skin rash with small interconnected bumps, rash and spots on the skin, increased sweating, night sweats, hair loss, skin reddening (erythema), psoriasis, eczema, other skin disorders,
• muscle cramps, muscle weakness, bursitis or arthritis (joint inflammation, usually accompanied by pain, swelling, and/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,
• 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),
• kidney stones,
• erectile dysfunction,
• decreased thyroid gland function, blurred vision, changes in vision,
• ringing in the ears,
• 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 can rarely be severe. 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 muscle pain, sensitivity, or weakness,
• severe swelling of the deeper 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 (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),
• 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 (a indicator of muscle damage),
• sudden cardiac death,
• low red blood cell count (anemia),
• depression,
• sleep disturbance,
• loss of sense 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 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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Febuxostat Sandoz

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 on the blister after CAD/EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

• Composition of Febuxostat Sandoz 120 mg film-coated tablets:
• The active ingredient is febuxostat.

Each film-coated tablet contains 120 mg of febuxostat (as hemihydrate).

• Other components are:

Tablet core:

Lactose monohydrate, microcrystalline cellulose (E460), hydroxypropylcellulose (E463), sodium croscarmellose, colloidal anhydrous silica (E551), magnesium stearate (E470b).

Tablet coating:

Polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol 3350 (E1521), methacrylic acid-ethyl acrylate copolymer (1:1) (Type A), yellow iron oxide (E172), sodium hydrogen carbonate (E500(ii)).

Product Appearance and Container Content

Febuxostat Sandoz 120 mg film-coated tablets are film-coated tablets, light yellow to yellow in color, capsule-shaped, with a "120" engraving on one side and smooth on the other, and with dimensions of 18.5 mm x 9.0 mm.

Febuxostat Sandoz 120 mg film-coated tablets are presented in Aluminum-OPA/Alu/PVC or Aluminum-PVC/PE/PVDC blisters.

Febuxostat 120 mg is available in packs of 14, 28, 30, 42, 56, 84, and 98 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

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) under the following names:

Germany: Febuxostat HEXAL 120 mg Filmtabletten

Austria: Febuxostat Sandoz 120 mg Filmtabletten

Belgium: Febuxostat Sandoz 120 mg filmomhulde tabletten

Slovakia: Febuxostat Sandoz 120 mg

France: Febuxostat sandoz 120 mg comprimé pelliculé

Hungary: Febuxostat Sandoz 120 mg Filmtabletta

Ireland: Febuxostat Rowex 120 mg Film-coated tablets

Italy: Febuxostat Sandoz

Czech Republic: Febuxostat Sandoz 120 mg potahované tablety

Date of the last revision of this leaflet:August 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/