Febuxostat Sandoz 80 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Febuxostat Sandoz 80 mg film-coated tablets EFG

Read the entire 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 only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 side effects
5. How to store Febuxostat Sandoz
6. Contents of the pack and other information

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

Febuxostat Sandoz 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 cannot 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 a low uric acid concentration by taking febuxostat once daily prevents the formation of crystals and, over time, reduces symptoms. If the uric acid concentration is kept low for a sufficient period, the size of existing tophi also decreases.

Febuxostat is used in adults.

2. What you need to know before starting to take 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

Talk to 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:

• 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 could 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 and 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 advice 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 beginning certain medications 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 during a gout attack, as febuxostat continues to work to reduce uric acid. If you continue taking febuxostat daily, gout attacks will become less frequent and less painful over time.

If needed, 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 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 properly.

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 not known whether febuxostat could harm the unborn baby. Febuxostat must not be used during pregnancy. It is not known whether febuxostat passes into breast milk. It is unknown whether febuxostat passes into human 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, or numbness or tingling sensations during treatment. If this occurs, you should 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 them before taking this medicine.

Febuxostat Sandoz contains sodium

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

3. How to take Febuxostat Sandoz

Follow exactly the instructions given by your doctor for taking this medicine. 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.

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 missed 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 experiences 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 about to experience a serious 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 (e.g. mouth and genitals), painful sores 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, enlarged liver, 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 rash, see below under “uncommon” and “rare” sections),
• 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, change 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, decreased sense of smell (hyposmia),
• ECG (electrocardiogram) abnormalities, irregular or rapid heartbeat, awareness of heartbeats (palpitations),
• hot flushes or flushing (redness of face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients receiving chemotherapy for blood disorders),
• cough, discomfort or chest pain, inflammation of 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/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 bumps covered with small interconnected lumps, rash, bumps and spots on the skin, 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 in the number of blood cells or platelets (abnormal blood test results),
• kidney stones,
• erectile dysfunction,
• decreased thyroid gland function, blurred vision, vision changes,
• ringing in the ears,
• runny nose,
• mouth ulcers,
• inflammation of the pancreas: 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 in rare cases may be severe. It may cause muscle problems and particularly, if you also feel unwell or have a high fever, it 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, possibly causing sudden difficulty in breathing,
• high fever accompanied by 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),
• different types of rash (e.g. with white spots and blisters, with pus-filled blisters, with 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),
• nervousness,
• 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 output 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 disturbance,
• loss of sense 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.

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 sight and reach of children.

Do not use this medicine after the expiry date stated on the cardboard box and blister after CAD/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 drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

• Composition of Febuxostat Sandoz 80 mg film-coated tablets:
• The active substance 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), sodium croscarmellose, anhydrous colloidal 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), iron oxide yellow (E 172), sodium hydrogen carbonate (E500(ii)).

Appearance of the product and contents of the pack

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

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

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the European Economic Area (EEA) Member States 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 most recent revision of this leaflet: August 2020

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/