FEBUXOSTAT SANDOZ 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Febuxostat Sandoz 80 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

1. Package contents and additional 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 an excess of a chemical compound called uric acid (urate) 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 intense 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 the concentration of uric acid. Keeping the uric acid concentration low by taking febuxostat once a day prevents the formation of crystals and, over time, reduces symptoms. If the uric acid concentration is kept low for a long enough time, the size of the tophi also decreases.

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 any of the other components of this medication (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 medication used to treat gout)
• if you have or have had liver disease or liver function alterations
• 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 may include:

• 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 severe allergic reactions that can be life-threatening, associated with cardio-circulatory 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 medication.

If you experience a gout attack (a sudden and 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 to take 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, as it 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 decrease uric acid may 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 functioning normally.

Children and adolescents

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

Other medications and Febuxostat Sandoz

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

It is especially important that you inform your doctor or pharmacist if you are using medications 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 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. Febuxostat should not be used 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 medication.

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 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 Sandoz contains sodium

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

3. How to take Febuxostat Sandoz

Follow the instructions for administration of this medication 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 orally, 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 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

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 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 missed 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Stop taking this medication 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 medication (see also section 2 "Warnings and precautions"),
• skin rashes that can be life-threatening, 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 in blood (hypersensitivity to medications with eosinophilia and systemic symptoms - DRESS syndrome) (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 "uncommon" and "rare" sections below),
• nausea,
• increased gout symptoms,
• localized swelling due to fluid retention in tissues (edema),
• dizziness,
• difficulty breathing,
• tingling,
• pain in limbs and muscles and joints,
• 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 level (diabetes) whose symptom may be excessive thirst, increased blood fats, weight gain,
• decreased sexual appetite,
• difficulty sleeping, drowsiness,
• numbness, tingling, decreased or altered sensation (hypoesthesia, hemiparesis, or paresthesia), altered sense of taste, decreased sense of smell (hyposmia),
• abnormalities in the ECG (electrocardiogram), irregular or rapid heartbeat, perception of heartbeats (palpitations),
• flushing or redness (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, hives, and spots on the skin, increased sweating, night sweats, hair loss, 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 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,
• decreased libido,
• 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 be severe in rare cases. It can cause muscle problems, and particularly 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 deep 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 in blood (leukocytosis, with or without eosinophilia),
• different types of rash (e.g., with white spots with blisters, with pus-filled blisters, with skin peeling), generalized erythema, 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 in blood biochemistry or blood cell count (abnormal blood test results),
• kidney stones,
• 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Febuxostat Sandoz

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

Do not use this medication after the expiration date stated on the carton and blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

• 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 ingredients are:

Tablet core:

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

Tablet coating:

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

Appearance and Packaging of the Product

Febuxostat Sandoz 80 mg film-coated tablets are yellow to light yellow, film-coated tablets, capsule-shaped, with an "80" engraved on one side and smooth on the other, and with dimensions of 16.5 mm x 7.0 mm.

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

Febuxostat 80 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 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 revision of this leaflet:August 2020

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/