Febuxostat Sandoz 120 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Febuxostat Sandoz 120 mg film-coated tablets EFG

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

• Keep this leaflet, 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 personally and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

2. What you need to know before taking Febuxostat Sandoz

3. How to take Febuxostat Sandoz

4. Possible adverse effects

5. How to store Febuxostat Sandoz

6. Contents of the container and other information

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

Febuxostat tablets contain the active substance febuxostat and are 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 can no longer dissolve. When this occurs, urate crystals form both within and around the joints and kidneys. These crystals can cause sudden, intense pain, redness, heat, and swelling in the joints (this is known as gout attacks). If left untreated, large deposits called tophi may form around and within the joints. Tophi can damage joints and bones.

Febuxostat works by reducing the concentration of uric acid. Maintaining low uric acid levels 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 120 mg film-coated tablets are also used in the treatment and prevention of high levels of uric acid in the blood that may occur when starting chemotherapy for blood cell cancers.

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

Febuxostat is used in adults.

2. What you need to know before taking Febuxostat Sandoz

Do not take Febuxostat Sandoz

• if you are allergic to febuxostat or to 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 impaired liver function
• 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 Febuxostat Sandoz (see also section 4). Possible symptoms of allergic reactions may include:

• skin 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 which 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 red, target-like spots or circular lesions, often with a blister in the center. They may also include mouth, throat, nose, 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 febuxostat. If you develop a rash or these skin symptoms, seek immediate medical attention and inform your doctor that you are taking this medicine.

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

Some people may experience gout flares when beginning treatment with medicines that lower uric acid levels. Not everyone experiences these flares, 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 during a flare, as febuxostat continues to work to reduce uric acid. With daily use of febuxostat, gout flares will become less frequent and less painful over time.

If necessary, your doctor will prescribe additional medicines to prevent or treat flare symptoms (such as joint pain and swelling).

In patients with very high urate levels (e.g., those undergoing chemotherapy for cancer), treatment with uric acid-lowering medicines could 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 normally.

Children and adolescents

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

Other medicines and Febuxostat Sandoz

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 unknown whether febuxostat could harm the unborn baby. Febuxostat must not be used during pregnancy. It is not known whether febuxostat passes into breast milk. The presence of febuxostat in breast milk is unknown. 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Be aware that dizziness, drowsiness, blurred vision, numbness, or tingling sensations may occur during treatment. If you experience any of these symptoms, do not drive or operate machinery.

Febuxostat Sandoz contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

Febuxostat Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

3. How to take Febuxostat Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor. If in 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.

Gout

Febuxostat is available as 80 mg and 120 mg 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. In general, treatment is of short duration.

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 at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Febuxostat Sandoz

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 forgotten doses.

If you stop taking Febuxostat Sandoz

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 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 adverse effects (may affect up to 1 in 1,000 people), as you may be having a serious allergic reaction:

• anaphylactic reactions, drug hypersensitivity (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 (e.g. mouth and genitals), painful mouth and/or genital ulcers, accompanied by fever, sore throat, and fatigue (Stevens-Johnson syndrome/toxic epidermal necrolysis), or enlarged lymph nodes, liver enlargement, hepatitis (including liver failure), increased number of white blood cells (leukocytes) in blood (drug reaction with eosinophilia and systemic symptoms—DRESS syndrome) (see section 2),
• generalized skin rashes.

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

• abnormal liver function test results,
• diarrhea,
• headache,
• rash (including various types of rashes; see the “uncommon” and “rare” sections below),
• nausea,
• worsening of gout symptoms,
• localized swelling due to fluid retention in tissues (edema),
• dizziness,
• difficulty breathing,
• tingling,
• pain in limbs, muscles, and joints,
• fatigue.

Other adverse effects not mentioned above are listed below.

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 redness (reddening of face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients receiving chemotherapy for blood disorders),
• cough, chest discomfort or pain, nasal and/or throat inflammation (upper respiratory tract infection), bronchitis, lower respiratory tract infection,
• dry mouth, abdominal pain or discomfort or gas, upper abdominal pain, heartburn/indigestion, constipation, more frequent bowel movements, vomiting, stomach discomfort,
• itchy skin rash, urticaria, swelling, skin discoloration, small red or purple spots on the skin, small skin bumps, skin rashes, bumps, and 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, and/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,
• chest pain, chest discomfort,
• gallstones or bile duct stones (cholelithiasis),
• increased levels of thyroid-stimulating hormone (TSH) in blood,
• changes in blood biochemistry or blood cell or platelet counts (abnormal blood test results),
• kidney stones,
• erectile dysfunction,
• decreased thyroid gland function, blurred vision, vision changes,
• ringing in the ears,
• runny nose,
• mouth ulcers,
• pancreatitis: common symptoms are abdominal pain, nausea, and vomiting,
• urgent need to urinate,
• pain,
• malaise,
• increased INR,
• bruising,
• swelling of the lips.

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

• muscle damage, which may occasionally 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 deeper layers of the skin, especially around the eyes, genitals, hands, feet, or tongue, which may cause sudden breathing difficulties,
• high fever accompanied by a measles-like rash, enlarged lymph nodes, enlarged liver, hepatitis (including liver failure), increased number of white blood cells in blood (leukocytosis, with or without eosinophilia),
• various types of rashes (e.g. with white spots and blisters, pus-filled blisters, skin peeling, measles-like rash), generalized erythema, necrosis, blistering detachment of the skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis),
• restlessness,
• sensation of thirst,
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia),
• abnormal blood cell count (white cells, red 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 (an indicator of muscle damage),
• sudden cardiac death,
• low red blood cell count (anemia),
• depression,
• sleep disturbances,
• loss of taste,
• burning sensation,
• vertigo,
• circulatory failure,
• lung infection (pneumonia),
• mouth ulcers, mouth inflammation,
• gastrointestinal perforation,
• rotator cuff syndrome,
• polymyalgia rheumatica,
• sensation of warmth,
• sudden vision loss due to blockage of an artery in the eye.

Reporting of adverse effects

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

5. Storage of Febuxostat Sandoz

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 after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

• Composition of Febuxostat Sandoz 120 mg film-coated tablets:
• The active substance 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)).

Nature of the product and pack contents

Febuxostat Sandoz 120 mg film-coated tablets are film-coated, light yellow to yellow, capsule-shaped tablets, with "120" engraved on one side and smooth on the other, measuring 18.5 mm x 9.0 mm.

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

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

Only some pack sizes may be commercially available.

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 European Economic Area (EEA) Member States 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 most recent review of this leaflet: August 2022

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